Notices. Notice

15,344 words·~70 min read·/register/2006/05/22/06-4709

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

BILLING CODE 6690-01-M 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 16, 2006. **A. Federal Reserve Bank of Chicago** (Patrick M.

Wilder, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414: *1. Oswego Community Bank Employee Stock Ownership Plan* , Oswego, Illinois; to acquire an additional 13.29 percent, for a total of 51 percent, of the voting shares of Oswego Bancshares, Inc., and thereby indirectly acquire additional voting shares of Oswego Community Bank, both of Oswego, Illinois. Board of Governors of the Federal Reserve System, May 17, 2006. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc.

E6-7756 Filed 5-19-06; 8:45 am] BILLING CODE 6210-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-06-05BZ] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention

(CDC)publishes a list of information collection requests under review by the Office of Management and Budget

(OMB)in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at

(404)639-5960 or send an e-mail to *omb@cdc.gov.* Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to

(202)395-6974. Written comments should be received within 30 days of this notice. Proposed Project Evaluation of the Effectiveness of the Smoke Alarm Installation and Fire Safety Education (SAIFE) Program—New—National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC). Background and Brief Description Each year approximately 400,000 residential fires occur in the United States. Smoke alarms have been shown to reduce fire-related injury and fatality. This project will use data from in-person interviews, paper and pencil

(PAPI)and telephone surveys to determine the degree to which the Smoke Alarm Installation and Fire Safety Education (SAIFE) program improves knowledge, attitudes, and practices about fire and burn safety and its efficacy in delivering fire safety information. The data will be collected from a convenience sample of adults 18 years of age or older who volunteer to participate in the SAIFE program. Program participants will be asked to complete a 15-minute survey twice while taking part in the SAIFE program, once immediately before the intervention and 6 months after equipment installation. Approximately 10% of the respondents surveyed will be randomly selected for an extensive 1 hour face to face interview 6 months following the installation period. The evaluation will measure changes across time, between groups, and within groups among communities involved in the program. CDC currently funds 16 states to provide installation of smoke alarms plus general fire safety education in households at high risk for fire and fire-related injury and death. Programs of this type are thought to prevent fire-related injury and mortality, but have not been studied scientifically to assess their impact on fire-related injury outcomes. The proposed study represents the first formal effort to evaluate the effectiveness and cost implications of the SAIFE program as implemented in North Carolina. The data collected in this study will have the potential to impact other smoke alarm installation programs, as well as indicate future priorities in prevention and preparedness for residential fires. There are no costs to the respondents other than their time. The total estimated annualized burden hours are 251. Estimated Annualized Burden Hours Respondents No. of respondents No. of responses per respondent Average burden per response (in hours). Adult male and female (age 18+ years) screened 425 1 5/60 Adult male and female (age 18+ years) Pre/Post Evaluation survey 360 2 15/60 Adult male and female (age 18+ years) household visit 36 1 1 Dated: May 8, 2006. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E6-7732 Filed 5-19-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Decision To Evaluate a Petition To Designate a Class of Employees at Monsanto Chemical Company, Dayton, Ohio, To Be included in the Special Exposure Cohort AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice. SUMMARY: The Department of Health and Human Services

(HHS)gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at Monsanto Chemical Company, Dayton, Ohio, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: *Facility:* Monsanto Chemical Company. *Location:* Dayton, Ohio. *Job Titles and/or Job Duties:* Directors and subordinates, physicists, chemists, technicians, and workers. *Period of Employment:* 1943-1949. FOR FURTHER INFORMATION CONTACT: Larry Elliott, Director, Office of Compensation Analysis and Support, National Institute for Occupational Safety and Health, 4676 Columbia Parkway, MS C-46, Cincinnati, OH 45226, Telephone 513-533-6800 (this is not a toll-free number). Information requests can also be submitted by e-mail to *OCAS@CDC.GOV.* John Howard, Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. [FR Doc. E6-7777 Filed 5-19-06; 8:45 am] BILLING CODE 4163-19-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Privacy Act of 1974; Report of a New System of Records AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS). ACTION: Notice of a New System of Records (SOR). SUMMARY: In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new SOR titled, “Organ Procurement Organizations System (OPOS), System No. 09-70-0575.” The Organ Procurement Organization

(OPO)Certification Act of 2000 (§ 701 of Pub. L. 106-505) directs the Secretary of HHS to establish regulations that provide the statutory qualifications and requirements that an OPO must meet in order for organ procurement costs to be reimbursed under the Medicare and Medicaid programs. As part of the efficient administration of this program, CMS is charged with the responsibility to conduct investigations, analysis, and reporting of adverse events that are described as an untoward, undesirable, and unanticipated event that causes death or serious injury. At this time, individually-identifiable data is only requested from OPOs under two circumstances:

(1)Due to the suspicion that an infectious disease has been transmitted to a recipient; and

(2)when there has been a complaint alleged against an OPO. CMS regional office survey and certification staff would request individually-identifiable data to complete the investigation. Due to certain investigatory activities related to this system, CMS proposes to exempt this system from the notification, access, correction and amendment provisions of the Privacy Act of 1974. The purpose of this system is to collect and maintain individually identifiable information pertaining to complaint allegations filed by a complainant, beneficiary, or providers of services made against OPOs, information gathered during the complaint investigation, findings and results of the investigation, and correspondence relating to the outcome of the investigation. Information retrieved from this system will also be disclosed to:

(1)Support regulatory, reimbursement, and policy functions performed within the agency, or by a contractor, consultant or grantee;

(2)assist another Federal or state agency in the enforcement of OPO regulations where sharing the information is necessary to complete the processing of a complaint, contribute to the accuracy of CMS's proper payment of Medicare benefits, and/or enable such agency to administer a Federal health benefits program;

(3)support constituent requests made to a Congressional representative; and

(4)support litigation involving the agency. We have provided background information about the modified system in the “Supplementary Information” section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See “Effective Dates” section for comment period. DATES: *Effective Date:* CMS filed a new SOR report with the Chair of the House Committee on Government Reform and Oversight, the Chair of the Senate Committee on Homeland Security & Governmental Affairs, and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget

(OMB)on May 15, 2006. To ensure that all parties have adequate time in which to comment, the new system will become effective 30 days from the publication of the notice, or 40 days from the date it was submitted to OMB and the Congress, whichever is later. We may defer implementation of this system or one or more of the routine use statements listed below if we receive comments that persuade us to defer implementation. ADDRESSES: The public should address comment to the CMS Privacy Officer, Mail Stop N2-04-27, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Comments received will be available for review at this location, by appointment, during regular business hours, Monday through Friday from 9 a.m.-3 p.m., eastern daylight time. FOR FURTHER INFORMATION CONTACT: Michele Walton, Division of Continuing Care Providers, Survey and Certification Group, Center for Medicaid and State Operations, CMS, 7500 Security Boulevard, Mail Stop S2-01-16, Baltimore, Maryland 21244-1849. She can be reached by telephone at

(410)786-3353, or via e-mail at *Michele.Walton@cms.hhs.gov.* SUPPLEMENTARY INFORMATION: OPOs play a crucial role in ensuring that an immensely valuable, but scarce resource—transplantable human organs—become available to seriously ill patients who are on a waiting list for an organ transplant. OPOs are responsible for identifying potential organ donors and for obtaining as many organs as possible from those donors. They are also responsible for ensuring that the organs they obtain are properly preserved and quickly delivered to a suitable recipient awaiting transplantation. Therefore, OPO performance is a critical element of the organ transplant system in the United States. An OPO that is efficient in procuring organs and delivering them to recipients will, quite literally, save more lives than an ineffective OPO. CMS believes that OPOs will continue to improve their performance. CMS has four Regional OPO Coordinators, who work directly with the OPOs to increase organ donation rates by assisting them in developing and implementing quality assessment and performance improvement programs. In addition, they also make periodic quality visits to identify areas in which an OPO needs to improve. The CMS Regional OPO Coordinators collaborate with the Health Resources and Services Administration, the OPOs, and the hospitals to ensure the continuous implementation of best practices identified through the Organ Donation Breakthrough Collaborative (the Collaborative). However, the Collaborative is a voluntary initiative and, as such, has no enforcement mechanism. Pursuant to the Health Insurance Portability and Accountability Act (HIPAA), individually-identifiable data is protected from disclosure to third parties, unless an individual has given his or her permission for the information to be disclosed, or the disclosure falls under an exception or permissible use. At this time, individually-identifiable data is only requested from OPOs under two circumstances. This data would be requested whenever there is an investigation due to the suspicion that an infectious disease has been transmitted to a recipient. The request for this data falls under the public health exception in HIPAA. The second is when there has been a complaint alleged against an OPO. CMS is required to investigate complaints made against OPOs. The regional office survey and certification staff would request individually-identifiable data to complete the investigation. The request for this data would be covered under the oversight exception in HIPAA. I. Description of the Proposed System of Records A. Statutory and Regulatory Basis for SOR Authority for this system is given under the Organ Procurement Organization Certification Act of 2000 (§ 701 of Pub. L. 106-505) and § 219 of the Conference Report accompanying the Consolidated Appropriations Act, 2001 (Pub. L. 106-554) containing identical provisions that amended § 371(b)

(1)of the Public Health Service

(PHS)Act (42 U.S.C. 273(b) (1)). Authority is also given under §§ 1102 and 1138 of the Social Security Act (the Act) (42 U.S.C. 1302, and 42 U.S.C. 1320b-8), § 1138(b) of the Act also specifies that an OPO must operate under a grant made under § 371(a) of the PHS Act. B. Collection and Maintenance of Data in the System OPOS will maintain a file of complaint allegations filed by a complainant, beneficiary, or providers of services made against OPOs, information gathered during the complaint investigation, findings and results of the investigation, and correspondence relating to the investigation. The collected information will contain name, address, telephone number, health insurance claim number, geographic location, as well as, background information relating to Medicare or Medicaid issues of the complainant. II. Agency Policies, Procedures, and Restrictions on the Routine Use A. Agency Policies, Procedures, and Restrictions on the Routine Use The Privacy Act permits us to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such disclosure of data is known as a “routine use.” The government will only release OPOS information that can be associated with an individual as provided for under “Section III. Proposed Routine Use Disclosures of Data in the System.” Both identifiable and non-identifiable data may be disclosed under a routine use. We will only collect the minimum personal data necessary to achieve the purpose of OPOS. CMS has the following policies and procedures concerning disclosures of information that will be maintained in the system. Disclosure of information from the SOR will be approved only to the extent necessary to accomplish the purpose of the disclosure and only after CMS: 1. Determines that the use or disclosure is consistent with the reason that the data is being collected, e.g., to collect and maintain individually identifiable information pertaining to complaint allegations filed by a complainant, beneficiary, or providers of services made against OPOs, information gathered during the complaint investigation, findings and results of the investigation, and correspondence relating to the outcome of the investigation. 2. Determines that: a. The purpose for which the disclosure is to be made can only be accomplished if the record is provided in individually identifiable form; b. The purpose for which the disclosure is to be made is of sufficient importance to warrant the effect and/or risk on the privacy of the individual that additional exposure of the record might bring; and c. There is a strong probability that the proposed use of the data would in fact accomplish the stated purpose(s). 3. Requires the information recipient to: a. Establish administrative, technical, and physical safeguards to prevent unauthorized use of disclosure of the record; b. Remove or destroy at the earliest time all patient-identifiable information; and c. Agree to not use or disclose the information for any purpose other than the stated purpose under which the information was disclosed. 4. Determines that the data are valid and reliable. III. Proposed Routine Use Disclosures of Data in the System A. The Privacy Act allows us to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such compatible use of data is known as a “routine use.” The proposed routine uses in this system meet the compatibility requirement of the Privacy Act. We are proposing to establish the following routine use disclosures of information maintained in the system: 1. To agency contractors, consultants or grantees who have been engaged by the agency to assist in the performance of a service related to this system of records and who need to have access to the records in order to perform the activity. We contemplate disclosing information under this routine use only in situations in which CMS may enter into a contractual or similar agreement with a third party to assist in accomplishing CMS function relating to purposes for this system. CMS occasionally contracts out certain of its functions when doing so would contribute to effective and efficient operations. CMS must be able to give contractors, consultants or grantees whatever information is necessary for the contractors, consultants or grantees to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the contractors, consultants or grantees from using or disclosing the information for any purpose other than that described in the contract and requires the contractors, consultants or grantees to return or destroy all information at the completion of the contract. 2. To another Federal or state agency to: a. Assist in the enforcement of Organ Procurement Organizations regulations for violations of Conditions for Coverage for Organ Procurement Organizations where sharing the information is necessary to complete the processing of a complaint, b. Contribute to the accuracy of CMS's proper payment of Medicare benefits, and/or c. Enable such agency to administer a Federal health benefits program, or as necessary to enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds. Other Federal or state agencies in their administration of a Federal health program may require OPOS information in order to investigate complaint allegations, evaluate information gathered during the complaint investigation, review findings and results of the investigation relating to the enforcement of OPO regional office investigations. 3. To a member of Congress or to a Congressional staff member in response to an inquiry of the Congressional office made at the written request of the constituent about whom the record is maintained. Beneficiaries sometimes request the help of a member of Congress in resolving an issue relating to a matter before CMS. The member of Congress then writes CMS, and CMS must be able to give sufficient information to be responsive to the inquiry. 4. To the Department of Justice (DOJ), court or adjudicatory body when: a. The agency or any component thereof, or b. Any employee of the agency in his or her official capacity, or c. Any employee of the agency in his or her individual capacity where the DOJ has agreed to represent the employee, or d. The United States Government is a party to litigation or has an interest in such litigation, and by careful review, CMS determines that the records are both relevant and necessary to the litigation and that the use of such records by the DOJ, court or adjudicatory body is compatible with the purpose for which the agency collected the records. Whenever CMS is involved in litigation, and occasionally when another party is involved in litigation and CMS' policies or operations could be affected by the outcome of the litigation, CMS would be able to disclose information to the DOJ, court or adjudicatory body involved. B. Additional Provisions Affecting Routine Use Disclosures. To the extent this system contains Protected Health Information

(CMS)Central Office and Regional Offices, and at various contractor locations. Categories of Individuals Covered by the System: OPOS will maintain a file of complaint allegations filed by a complainant, beneficiary, or providers of services made against OPOs, information gathered during the complaint investigation, findings and results of the investigation, and correspondence relating to the investigation. Categories of Records in the System: The collected information will contain name, address, telephone number, health insurance claim number (HICN), geographic location, as well as, background information relating to Medicare or Medicaid issues of the complainant. Authority for Maintenance of the System: Authority for this system is given under the Organ Procurement Organization Certification Act of 2000 (§ 701 of Pub. L. 106-505) and § 219 of the Conference Report accompanying the Consolidated Appropriations Act, 2001 (Pub. L. 106-554) containing identical provisions that amended § 371(b)(1) of the Public Health Service

(1)Support regulatory, reimbursement, and policy functions performed within the agency, or by a contractor, consultant or grantee;

(3)support constituent requests made to a Congressional representative; and

(4)support litigation involving the agency. Routine Uses of Records Maintained in the System, Including Categories or Users and the Purposes of Such Uses: C. The Privacy Act allows us to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such compatible use of data is known as a “routine use.” The proposed routine uses in this system meet the compatibility requirement of the Privacy Act. We are proposing to establish the following routine use disclosures of information maintained in the system: 1. To agency contractors, consultants or grantees who have been engaged by the agency to assist in the performance of a service related to this system of records and who need to have access to the records in order to perform the activity. 2. To another Federal or state agency to: a. Assist in the enforcement of Organ Procurement Organizations regulations for violations of Conditions for Coverage for Organ Procurement Organizations where sharing the information is necessary to complete the processing of a complaint, b. Contribute to the accuracy of CMS's proper payment of Medicare benefits, and/or c. Enable such agency to administer a Federal health benefits program, or as necessary to enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds. 3. To a member of Congress or to a Congressional staff member in response to an inquiry of the Congressional office made at the written request of the constituent about whom the record is maintained. 4. To the Department of Justice (DOJ), court or adjudicatory body when: a. The agency or any component thereof, or b. Any employee of the agency in his or her official capacity, or c. Any employee of the agency in his or her individual capacity where the DOJ has agreed to represent the employee, or d. The United States Government is a party to litigation or has an interest in such litigation, and by careful review, CMS determines that the records are both relevant and necessary to the litigation and that the use of such records by the DOJ, court or adjudicatory body is compatible with the purpose for which the agency collected the records. D. Additional Provisions Affecting Routine Use Disclosures. To the extent this system contains Protected Health Information

(PHI)as defined by HHS regulation “Standards for Privacy of Individually Identifiable Health Information” (45 CFR parts 160 and 164, subparts A and E) 65 FR 82462 (12-28-00). Disclosures of such PHI that are otherwise authorized by these routine uses may only be made if, and as, permitted or required by the “Standards for Privacy of Individually Identifiable Health Information.” (See 45 CFR 164.512(a)(1)). In addition, our policy will be to prohibit release even of data not directly identifiable, except pursuant to one of the routine uses or if required by law, if we determine there is a possibility that an individual can be identified through implicit deduction based on small cell sizes (instances where the patient population is so small that individuals who are familiar with the enrollees could, because of the small size, use this information to deduce the identity of the individual). Policies and Practices for Storing, Retrieving, Accessing, Retaining, and Disposing of Records in the System: Storage: All records are stored electronically and in hard copy. Retrievability: The complaint data are retrieved by an individual identifier i.e., name of complainant. Safeguards: CMS has safeguards in place for authorized users and monitors such users to ensure against excessive or unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations may apply but are not limited to: The Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002, the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: all pertinent National Institute of Standards and Technology publications; the HHS Information Systems Program Handbook and the CMS Information Security Handbook. Retention and Disposal: CMS will retain complaint information for a total period not to exceed 25 years. System Manager and Address: Director, Division of Continuing Care Providers, Survey and Certification Group, Center for Medicaid and State Operations, CMS, 7500 Security Boulevard, Mail Stop S2-01-16, Baltimore, Maryland 21244-1849. Notification Procedure: This system is exempt under the provisions of 5 U.S.C. 552a(k)(2) of the Privacy Act. However, portions of this system notice are non-exempt and consideration will be given to requests addressed to the system manager for those portions. For general inquiries, it would be helpful if the request included the system name, address, age, sex, and for verification purposes, the subject individual's name (woman's maiden name, if applicable) and complaint tracking identification number. Record Access Procedure: For purpose of access, use the same procedures outlined in Notification Procedures above. Requestors should also reasonably specify the record contents being sought. (These procedures are in accordance with Department regulation 45 CFR 5b.5(a)(2).) Contesting Records Procedures: The subject individual should contact the system manager named above and reasonably identify the records and specify the information to be contested. State the corrective action sought and the reasons for the correction with supporting justification. (These Procedures are in accordance with Department regulation 45 CFR 5b.7). Records Source Categories: CMS investigative files maintained in OPOS are either received as electronic documents or paper records that are compiled for administrative, civil, and law enforcement purposes. In the course of investigations, CMS often has a need to obtain confidential information involving individuals other than the complainant. Systems Exempted from Certain Provisions of the Act: HHS claims exemption of certain records (case files on active fraud investigations) in the system from notification and access procedures under 5 U.S.C. 552a(k)(2) inasmuch as these records are investigatory materials compiled for program, administrative, and law enforcement in anticipation of a criminal or administrative proceedings. (See Department Regulation (45 CFR 5b.11)). [FR Doc. E6-7690 Filed 5-19-06; 8:45 am] BILLING CODE 4120-03-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0097] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of Qualified Health Claims: Consumer Inferences About Omega-3 Fatty Acids, Monounsaturated Fatty Acids From Olive Oil, and Green Tea AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a proposed collection of information has been submitted to the Office of Management and Budget

(OMB)for review and clearance under the Paperwork Reduction Act of 1995 (the PRA). DATES: Fax written comments on the collection of information by June 21, 2006. ADDRESSES: OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for FDA, FAX: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Experimental Study of Qualified Health Claims: Consumer Inferences About Omega-3 Fatty Acids, Monounsaturated Fatty Acids From Olive Oil, and Green Tea FDA regulates health claims in the labeling of food products under the Nutrition Labeling and Education Act of 1990 (NLEA). NLEA regulations establish general requirements for health claims in food labeling. A manufacturer is required to provide a description of the scientific evidence supporting a proposed health claim to FDA for review before the claim may appear in labeling (§§ 101.14(c) and (d), 101.70 (21 CFR 101.14(c) and (d), 101.70)). If FDA determines that there is significant scientific agreement among experts that the proposed health claim is supported by the totality of publicly available evidence, FDA issues a regulation authorizing the claim. Health claims must be “complete, truthful, and not misleading” (§101.14(d)(2)(iii)) and must “enable the public to comprehend the information provided and to understand the relative significance of such information in the context of a total daily diet” (§ 101.14 (d)(2)(v)). In 2003, an FDA Task Force on Consumer Health Information for Better Nutrition issued a report that provided guidance on an interim review process for health claims that do not meet the significant scientific agreement

(SSA)standard for the issuance of a regulation authorizing the claim. These claims, referred to as “qualified health claims,” are evaluated according to an interim evidence-based ranking system for scientific data and include a disclaimer or other qualifying language to distinguish them from claims that meet the SSA standard. The report also identified the need for consumer research to examine ways to communicate the level of scientific support associated with qualified health claims. In the fall of 2004, FDA issued letters of enforcement discretion for two qualified health claims about the relationship between risk of coronary heart disease and consumption of monounsaturated fatty acids from olive oil and omega-3 fatty acids, respectively. The qualified health claims appear below: 1. Limited and not conclusive scientific evidence suggests that eating about 2 tablespoons (23 grams) of olive oil daily may reduce the risk of coronary heart disease due to the monounsaturated fat in olive oil. To achieve this possible benefit, olive oil is to replace a similar amount of saturated fat and not increase the total number of calories you eat in a day. One serving of this product [Name of food] contains [x] grams of olive oil. 2. Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of [name of food] provides [x] grams of EPA and DHA omega-3 fatty acids. [See nutrition information for total fat, saturated fat and cholesterol content.] In June 2005, FDA issued a letter of enforcement discretion for two qualified health claims about the relationship between risk of breast and prostate cancers and consumption of green tea. The qualified claims appear below: 1. Two studies do not show that drinking green tea reduces the risk of breast cancer in women, but one weaker, more limited study suggests that drinking green tea may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of breast cancer. 2. One weak and limited study does not show that drinking green tea reduces the risk of prostate cancer, but another weak and limited study suggests that drinking green tea may reduce this risk. Based on the studies, FDA concludes that it is highly unlikely that green tea reduces the risk of prostate cancer. In November 2005, FDA released the results of a prior study of qualified health claims to assess the effectiveness of claim language and grading schemes for conveying the level of scientific evidence supporting the claim. The study showed that report card schemes helped consumers distinguish between various levels of scientific support. However, the report card scheme inadvertently conveyed other nutrient and product attributes to consumers. In particular, report card schemes resulted in “halo effects” and other misperceptions concerning the general healthfulness and quality of the product. In addition, the study showed that consumers attributed higher levels of scientific support to certain qualified health claims bearing a grade of “B” than to non-graded claims that meet FDA's standard of “SSA”. Thus, the study proposed here will further explore the report card grading scheme by modifying it in two ways. First, the study will test the ability of grade disclaimers to correct for some of the misperceptions created by report card schemes observed in the earlier study. Second, the study will include SSA claims as “A” grade claims within the report card grade scheme. The study proposed here is part of an ongoing effort by FDA to collect data concerning qualified health claims and their impact on consumer perceptions and behavior. Previous FDA studies have examined hypothetical qualified health claims to evaluate ways to communicate the strength of scientific evidence supporting a claim. This study will examine four qualified health claims and two SSA claims to evaluate whether consumers comprehend the information in the claim and whether consumers understand the relative significance of the information in the context of a total diet. In addition, the study will broaden FDA's understanding about how consumers interpret qualified health claims, particularly as they pertain to the level of scientific evidence conveyed by the message and to any differences there may be between qualified health claims on dietary supplements versus foods. The experimental study data will be collected using participants of an Internet panel. Participation in the experimental study is voluntary. In the **Federal Register** of March 30, 2005 (70 FR 16291), FDA published a 60-day notice requesting public comment on the information collection provisions. At that time, the experimental study was titled “Experimental Study of Qualified Health Claims: Consumer Inferences about Omega-3 Fatty Acids and Monounsaturated Fatty Acids from Olive Oil.” Previously, it did not include the two qualified health claims for green tea or the two SSA health claims, and the study also did not include further exploration of the report card grading scheme for health claims. The study is now renamed to indicate the inclusion of the green tea claims. Burden estimates have also been adjusted to account for the increase in respondents necessary to make these changes in the study. FDA received four letters in response to the notice, each containing one or more comments. One of the letters and portions of another letter contained comments that were not responsive to the four PRA questions for which comments were requested. One of these comments was about the presence of monounsaturated fatty acids in oils other than olive oil, while the others raised legal issues outside the scope of the PRA. These comments will not be addressed in this document, which is intended to summarize and respond to comments about PRA issues. The comments that addressed the four PRA questions and our responses follow. One comment expressed concern that the proposed collection of information is unnecessary for the proper performance of the agency's functions and that the information will have no practical utility. The comment asserted that the information to be collected will be inadequate for the agency to assess whether consumer confusion will arise from the claims. FDA disagrees. The study is part of an ongoing effort by FDA to collect data concerning the communications effects of qualified health claims on consumer perceptions and judgments. The purpose of the study is to assess how some claim language compares to other claim language in conveying information to consumers. The study uses an experimental design to assess consumer reactions to health claim language intended to convey both the potential health benefits and the level of scientific support for the health claim. The comment also suggested that the information will not be useful if it is the agency's intent to alter or restrict the wording of qualified health claims because, according to the comment, consumers have the right to receive truthful information, regardless of whether they understand that information. FDA disagrees. The agency has a responsibility to ensure that disclaimers and other qualifying language intended to prevent consumer deception are effective in serving that purpose. The study is designed to evaluate whether certain variants of the qualified health claims are more effective than others at conveying to consumers the potential health benefits and the level of scientific support for the health claim. FDA expects this study to be useful in determining language that effectively conveys this information to consumers. The comment suggested that there might be ways to improve the quality or utility of the information collection, yet did not offer specific recommendations to modify the study and analysis. In particular, the comment expressed concern that an Internet survey cannot be used to measure consumer confusion. FDA responds that the experimental study that is the basis of this information collection request is an Internet-based experiment, not an Internet survey. The experimental study is intended to assess the communication effects, in a large sample of study participants, of both existing health claim language that appears on dietary supplements and conventional food products and variants of such language. The study is not intended to measure consumer confusion per se. One comment recommended that, to help maximize the quality, utility and accuracy of the data to be collected in the study, FDA should test the qualified claim language exactly as stated in the **Federal Register** notice published March 30, 2005. FDA agrees. The experimental study will test the qualified claim language exactly as it appears in the notice, in addition to variants of the claim language. A comment urged FDA to takes steps to ensure that using electronic data collection is reliable and verifiable for the study. FDA is confident that the methodology is reliable and verifiable for this type of study. FDA will closely monitor the contractor that implements the experiment to ensure the validity and accuracy of the collected data. Another comment supported FDA's efforts to understand consumer responses to food and dietary supplement labels, but expressed concern that FDA has not supplied sufficient information to evaluate whether the estimated burden of the proposed collection is accurate. FDA believes that the estimate of burden is accurate because the estimate is based on past experience with Internet panel experiments similar in complexity and duration to the one proposed here. The study protocol will be available for public viewing when this 30-day notice is published. FDA has followed the procedures for public notice and comment about this information collection set out in the PRA (44 U.S.C. 3501-3520) and OMB regulations (5 CFR part 1320). ** Table 1.—Estimated Annual Reporting Burden 1 ** No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours 30 (pre-test) 1 30 .16 5 7,440 (experiment) 1 7,440 .16 1,191 TOTAL 1,196 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: May 12, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-7692 Filed 5-19-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0443] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Focus Groups as Used by the Food and Drug Administration AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that a collection of information entitled “Focus Groups as Used by the Food and Drug Administration” has been approved by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659. SUPPLEMENTARY INFORMATION: In the **Federal Register** of February 27, 2006 (71 FR 9828), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. 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. OMB has now approved the information collection and has assigned OMB control number 0910-0497. The approval expires on November 30, 2007. A copy of the supporting statement for this information collection is available on the Internet at *http://www.fda.gov/ohrms/dockets* . Dated: May 12, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-7698 Filed 5-19-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0183] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Reagents for Detection of Specific Novel Influenza A Viruses 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 guidance on reagents for detection of specific novel influenza A viruses. DATES: Submit written or electronic comments on the collection of information by July 21, 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. Guidance on Reagents for Detection of Specific Novel Influenza A Viruses—21 CFR 866.3332—(OMB Control Number 0910-0584)—Extension In accordance with section 513 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c), FDA evaluated an application for an in vitro diagnostic device for detection of influenza subtype H5 (Asian lineage), commonly known as avian flu. FDA concluded that this device is properly classified into class II in accordance with 21 U.S.C. 360c(a)(1)(B), because it is a device for which the general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, but there is sufficient information to establish special controls to provide such assurance. The statute permits FDA to establish as special controls many different things, including post market surveillance, development and dissemination of guidance, recommendations, and “other appropriate actions as the Secretary deems necessary” (21 U.S.C. 360c(a)(1)(B)). This information collection is a measure that FDA determined to be necessary to provide reasonable assurance of safety and effectiveness of reagents for detection of specific novel influenza A viruses. FDA issued an order classifying the H5 (Asian lineage) diagnostic device into class II on February 3, 2006, establishing the special controls necessary to provide reasonable assurance of the safety and effectiveness of that device and similar future devices. The new classification will be codified in 21 CFR 866.3332, a regulation that will describe the new classification for reagents for detection of specific novel influenza A viruses and set forth the special controls that help to provide a reasonable assurance of the safety and effectiveness of devices classified under that regulation. The regulation will refer to the special control guidance document, “Class II Special Controls Guidance Document: Reagents for Detection of Specific Novel Influenza A Viruses,” which provides recommendations for measures to help provide a reasonable assurance of safety and effectiveness for these reagents. The guidance document recommends that sponsors obtain and analyze postmarket data to ensure the continued reliability of their device in detecting the specific novel influenza A virus that it is intended to detect, particularly given the propensity for influenza viruses to mutate and the potential for changes in disease prevalence over time. As updated sequences for novel influenza A viruses become available (from the World Health Organization, National Institutes of Health, and other public health entities), sponsors of reagents for detection of specific novel influenza A viruses will collect this information, compare them with the primer/probe sequences in their devices, and incorporate the result of these analyses into their quality management system, as required by 21 CFR 820.100(a)(1). These analyses will be evaluated against the device design validation and risk analysis required by 21 CFR 820.30(g), to determine if any design changes may be necessary. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours Total Operating and Maintenance Costs 10 2 20 10 200 $3,500 1 There are no capital costs associated with this collection of information. FDA estimates that 10 respondents will be affected annually. Each respondent will collect this information twice per year, estimated to take 10 hours. This results in a total data collection burden of 200 hours (10 x 20 = 200). FDA estimates that cost of developing standard operating procedures for each data collection is $350 (10 hours of work at $35/hour). This results in a total cost to industry of $3,500 ($350 x 10 respondents). Dated: May 12, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-7708 Filed 5-19-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D-0021] International Conference on Harmonisation; Guidance on Q8 Pharmaceutical Development; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a guidance entitled “Q8 Pharmaceutical Development.” The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes the suggested contents for the pharmaceutical development section of a regulatory submission in the ICH M4 Common Technical Document

(CTD)format. The guidance also indicates areas where the provision of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches. DATES: Submit written or electronic comments on agency guidance at any time. ADDRESSES: Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . Submit written requests for single copies of the guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or the Office of Communication, Training and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. Send two self-addressed adhesive labels to assist the office in processing your requests. Requests and comments should be identified with the docket number found in brackets in the heading of this document. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: *Regarding the guidance* : Moheb Nasr, Center for Drug Evaluation and Research (HFD-800), Food and Drug Administration, Bldg. 21, rm. 2630, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1900; or Christopher Joneckis, Center for Biologics Evaluation and Research (HFM-20), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-435-5681. *Regarding the ICH* : Michelle Limoli, Office of International Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4480. SUPPLEMENTARY INFORMATION: I. Background In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies. ICH was organized to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products among three regions: The European Union, Japan, and the United States. The six ICH sponsors are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; the Centers for Drug Evaluation and Research and Biologics Evaluation and Research; FDA; and the Pharmaceutical Research and Manufacturers of America. The ICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA). The ICH Steering Committee includes representatives from each of the ICH sponsors and the IFPMA, as well as observers from the World Health Organization, Health Canada, and the European Free Trade Area. In the **Federal Register** of February 9, 2005 (70 FR 6888), FDA published a notice announcing the availability of a draft tripartite guidance entitled “Q8: Pharmaceutical Development.” The notice gave interested persons an opportunity to submit comments by April 11, 2005. To provide additional time for public comment consistent with the time for comment provided by other ICH regulatory agencies, FDA reopened the comment period until June 11, 2005 (70 FR 24819, May 11, 2005). After consideration of the comments received and revisions to the guidance, a final draft of the guidance was submitted to the ICH Steering Committee and endorsed by the three participating regulatory agencies in November 2005. The guidance describes the suggested contents for the pharmaceutical development section (section 3.2.P.2) of a regulatory submission in the CTD format for drug products as defined in the scope of module 3 of the CTD. The information and knowledge gained from pharmaceutical development studies provide scientific understanding to support the establishment of specifications and manufacturing controls. The guidance also indicates areas where the provision of greater understanding of pharmaceutical and manufacturing sciences can create a basis for flexible regulatory approaches. This guidance applies to pharmaceutical studies as defined in section 3.2.P.2 of module 3 of the CTD. The guidance does not apply to submissions for drug products during the clinical research stages. However, the principles described in the guidance are important to consider during product development. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on this topic. 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 statutes and regulations. II. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments on the guidance at any time. 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. The guidance and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the document at *http://www.fda.gov/ohrms/dockets/default.htm* , *http://www.fda.gov/cder/guidance/index.htm* , or *http://www.fda.gov/cber/publications.htm* . Dated: May 15, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-7727 Filed 5-19-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection Comment Request In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration

(HRSA)will publish periodic summaries of proposed projects being developed for submission to the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans, call the HRSA Reports Clearance Officer on

(301)443-1129. Comments are invited on:

(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;

(b)the accuracy of the agency's estimate of the burden of the proposed collection of information ;

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

(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques of other forms of information technology. Proposed Project: Loan Information System Records for the DHHS and DHUD Hospital Mortgage Insurance, Guarantee, and Direct Loan Programs (OMB No. 0915-0174)—Extension The Division of Facilities and Loans within the Health Resources and Services Administration monitors outstanding direct and guaranteed loans made under section 621 of Title VI and section 1601 of Title XVI of the Public Health Service Act, as well as loans insured under the Section 242 Hospital Mortgage Insurance Program of the National Housing Act. These programs were designed to aid construction and modernization of health care facilities by increasing the access of facilities to capital through the assumption of the mortgage credit risk by the Federal Government. Operating statistics and financial information are collected annually from hospitals with mortgages that are insured under these programs. The information is used to monitor the financial stability of the hospitals to protect the Federal investment in these facilities. The form used for the data collection is the Hospital Facility Data Abstract. No changes in the form are proposed. The estimated response burden is as follows: Form Number of respondents Responses per respondent Hours per response Total hour burden Hospital Facility Data Abstract 80 1 1 80 Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance Officer, Room 10-33 Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857. Written comments should be received with 60 days of this notice. Dated: May 16, 2006. Tina M. Cheatham, Director, Division of Policy Review and Coordination. [FR Doc. E6-7726 Filed 5-19-06; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HOMELAND SECURITY Bureau Of Customs And Border Protection Notice of Cancellation of Customs Broker License Due to Death of the License Holder AGENCY: Bureau of Customs and Border Protection, U.S. Department of Homeland Security. ACTION: General notice. SUMMARY: Notice is hereby given that, pursuant to Title 19 of the Code of Federal Regulations 111.51(a), the following individual Customs broker licenses and any and all permits have been cancelled due to the death of the broker: Name; License # *Port Name* Peter Gawi 10645 New York. Kirk K. Lakis 6361 Dallas. George J. Young 02612 Los Angeles. Daniel J. Hayes, Sr. 3758 Los Angeles. James J. Rea 5498 New York. Eugenio D. Santana 6864 New York. Dennis Nowakowski 20659 Buffalo. Terry M. Hatada 3679 San Francisco. Dated: May 15, 2006. Jayson P. Ahern, Assistant Commissioner, Office of Field Operations. [FR Doc. E6-7725 Filed 5-19-06; 8:45 am] BILLING CODE 9111-14-P DEPARTMENT OF HOMELAND SECURITY Bureau of Customs and Border Protection Notice of Cancellation of Customs Broker License AGENCY: Bureau of Customs and Border Protection, U.S. Department of Homeland Security. ACTION: General notice. SUMMARY: Pursuant to section 641 of the Tariff Act of 1930, as amended, (19 U.S.C. 1641) and the Customs Regulations (19 CFR 111.51), the following Customs broker licenses are cancelled without prejudice. Name License # Issuing port Roopa Mirchandani 9890 New York. Lynne A. Palmitier 13772 Detroit. Elsie M. Clark 10280 Los Angeles. Allstates Customs Brokerage, Inc 20638 Atlanta. Arzoon Global Commerce, Inc 21283 San Francisco. Panta Enterprises, Inc 14584 Miami. Associated Customhouse Brokers, Inc 9706 Miami. James P. Cesped 4581 San Francisco. Steve A. Ashline 7054 Champlain. All-Ways Customs Broker, Inc 20131 Miami. Marialuisa Yoshikawa 10998 San Francisco. 2nd Edison, Inc 22315 San Francisco. Harry S. Sanders 9716 New York. Barbara A. Elibay 6095 Savannah. Dated: May 15, 2006. Jayson P. Ahern, Assistant Commissioner, Office of Field Operations. [FR Doc. E6-7724 Filed 5-19-06; 8:45 am] BILLING CODE 9111-14-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1636-DR] Arkansas; 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 State of Arkansas (FEMA-1636-DR), dated April 12, 2006, and related determinations. DATES: *Effective Date:* April 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 State of Arkansas is hereby amended to include the Public Assistance Program for 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 April 12, 2006: Cross, Greene, and Randolph Counties for Public Assistance (already designated for Individual 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, Acting Director, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. E6-7742 Filed 5-19-06; 8:45 am] BILLING CODE 9110-10-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-3266-EM] Connecticut; 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 Connecticut (FEMA-3266-EM), dated May 2, 2006, and related determinations. DATES: *Effective Date:* May 2, 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 May 2, 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 impact in certain areas of the State of Connecticut resulting from the record snowfall during the period of February 11-12, 2006, is 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 (the Stafford Act). Therefore, I declare that such an emergency exists in the State of Connecticut. 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 emergency protective measures under the Public Assistance program to save lives and protect public health, safety, and property. Other forms of assistance under Title V of the Stafford Act may be added at a later date, as you deem appropriate. This emergency assistance will be provided for any continuous 48-hour period during or proximate to the incident period. You may extend the period of assistance, as warranted. This assistance excludes regular time costs for sub-grantees' regular employees. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provide under the Stafford Act for Public Assistance will be limited to 75 percent of the total eligible costs in the designated areas. 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 Acting Director, Department of Homeland Security, under Executive Order 12148, as amended, Kevin Merli, 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 Connecticut to have been affected adversely by this declared emergency: The counties of Fairfield, Hartford, New Haven, Tolland, and Windham for emergency protective measures (Category B) under the Public Assistance program for any continuous 48-hour period during or proximate to the incident period. (Catalog of Federal Domestic Assistance No. 97.036, Disaster Assistance.) R. David Paulison, Acting Director, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. E6-7738 Filed 5-19-06; 8:45 am] BILLING CODE 9110-10-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1631-DR] Missouri; 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 Missouri (FEMA-1631-DR), dated March 16, 2006, and related determinations. DATES: *Effective Date:* April 25, 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 Missouri 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 March 16, 2006: Lawrence and Vernon Counties for Public Assistance (already designated for Individual 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, Acting Director, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. E6-7743 Filed 5-19-06; 8:45 am] BILLING CODE 9110-10-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1631-DR] Missouri: Amendment No. 5 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 for the State of Missouri (FEMA-1631-DR), dated March 16, 2006, and related determinations. DATES: *Effective Date:* April 25, 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 the incident period is now March 8, 2006, through and including March 13, 2006. (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, Acting Director, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. E6-7745 Filed 5-19-06; 8:45 am] BILLING CODE 9110-10-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1611-DR] Northern Mariana Islands; 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 for the Commonwealth of the Northern Mariana Islands (FEMA-1611-DR), dated November 8, 2005, and related determinations. DATES: *Effective Date:* May 1, 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 special cost sharing arrangements are warranted regarding Federal funds provided under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (Stafford Act). Therefore, consistent with 48 U.S.C. 1469a(d), pertaining to insular areas, and the President's declaration letter dated November 8, 2005, Federal funds for the Hazard Mitigation Grant Program are authorized at 100 percent of total eligible costs for the Commonwealth of the Northern Mariana Islands. This cost share is effective as of the date of the President's major disaster declaration. (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, Acting Director, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. E6-7748 Filed 5-19-06; 8:45 am] BILLING CODE 9110-10-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1632-DR] Oregon; 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 State of Oregon (FEMA-1632-DR), dated March 20, 2006, and related determinations. DATES: *Effective Date:* April 20, 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 Oregon 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 March 20, 2006: Yamhill County 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, Acting Director, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. E6-7744 Filed 5-19-06; 8:45 am] BILLING CODE 9110-10-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1634-DR] Tennessee; Amendment No. 5 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 Tennessee (FEMA-1634-DR), dated April 5, 2006, and related determinations. DATES: *Effective Date:* April 24, 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 Acting Director, Department of Homeland Security, under Executive Order 12148, as amended, Michael Bolch, of FEMA is appointed to act as the Federal Coordinating Officer for this declared disaster. This action terminates my appointment of Michael Karl 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, Acting Director, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. E6-7739 Filed 5-19-06; 8:45 am] BILLING CODE 9110-10-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1634-DR] Tennessee; 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 Tennessee (FEMA-1634-DR), dated April 5, 2006, and related determinations. DATES: *Effective Date:* April 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 State of Tennessee 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 April 5, 2006: Benton, Cannon, Cheatham, Cumberland, Davidson, Dickson, Sumner, and Warren Counties for Public Assistance (already designated for Individual 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, Acting Director, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. E6-7741 Filed 5-19-06; 8:45 am] BILLING CODE 9110-10-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1624-DR] Texas; Amendment No. 5 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 for the State of Texas (FEMA-1624-DR), dated January 11, 2006, and related determinations. DATES: *Effective Date:* April 25, 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 the incident period for this declared disaster is now November 27, 2005, and continuing. (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, Acting Director, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. E6-7746 Filed 5-19-06; 8:45 am] BILLING CODE 9110-10-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1624-DR] Texas; Amendment No. 6 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 Texas (FEMA-1624-DR), dated January 11, 2006, and related determinations. DATES: *Effective Date:* May 1, 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 Texas 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 January 11, 2006: Kerr County for Individual Assistance (already designated for Public Assistance Category B (emergency protective measures), subject to subsequent designation by FEMA for reimbursement.) (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, Acting Director, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. E6-7747 Filed 5-19-06; 8:45 am] BILLING CODE 9110-10-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Endangered and Threatened Species Permit Applications AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of receipt of applications. SUMMARY: The following applicants have applied for permits to conduct certain activities with endangered species. DATES: Written data or comments must be received on or before June 21, 2006. ADDRESSES: Send written data or comments to the Regional Director, U.S. Fish and Wildlife Service, Ecological Services, 1 Federal Drive, Fort Snelling, Minnesota 55111-4056. FOR FURTHER INFORMATION CONTACT: Mr. Peter Fasbender,

(612)713-5343. SUPPLEMENTARY INFORMATION: The following applicants have applied for a scientific research permit to conduct certain activities with endangered species pursuant to section 10(a)(1)(A) of the Endangered Species Act (16 U.S.C. 1531 et seq.). The U.S. Fish and Wildlife Service (“we”) solicits review and comment from local, State, and Federal agencies, and the public on the following permit requests. Permit Number TE125544 *Applicant:* Smithsonian Institution, Washington, DC The applicant requests a permit to take the Kirtland's warbler ( *Dendroica kirtlandii* ) throughout Michigan. The scientific research is aimed at enhancement of survival of the species in the wild. Permit Number TE125549 *Applicant:* Maartan Vonhof, Kalamazoo, Michigan The applicant requests a permit to take the Indiana bat ( *Myotis sodalis* ) throughout Michigan. The scientific research is aimed at enhancement of survival of the species in the wild. Permit Number TE125552 *Applicant:* Michael Burt, Kirksville, Missouri The applicant requests a permit to take the Indiana bat ( *Myotis sodalis* ) throughout Missouri. The scientific research is aimed at enhancement of survival of the species in the wild. Permit Number TE120231 *Applicant:* John Timpone, Ballwin, Missouri The applicant requests a permit to take the Indiana bat ( *Myotis sodalis* ) throughout Maryland, Missouri, Ohio, Pennsylvania, and West Virginia. The scientific research is aimed at enhancement of survival of the species in the wild. Authority: This notice is provided pursuant to section 10(c) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531, *et seq.* ). Dated: April 28, 2006. Wendi Weber, Assistant Regional Director, Ecological Services, Region 3, Fort Snelling, Minnesota. [FR Doc. E6-7728 Filed 5-19-06; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service Proposed Programmatic Statewide Red-Cockaded Woodpecker Safe Harbor Agreement, North Carolina AGENCY: Fish and Wildlife Service, Interior. ACTION: Notice of availability. SUMMARY: This notice advises the public that the North Carolina Wildlife Resources Commission (NCWRC, or Applicant) has applied to the Fish and Wildlife Service (Service) for an enhancement of survival permit

(ESP)under section 10(a)(1)(A) of the Endangered Species Act of 1973, as amended (Act). The ESP application includes a proposed Safe Harbor Agreement

(SHA)for the endangered Red-cockaded Woodpecker ( *Picoides borealis* )

(RCW)for a period of 99 years, along with a supporting Environmental Assessment (EA). We announce the opening of a 30-day comment period and request comments from the public on the proposed SHA and the supporting EA. DATES: Written comments should be sent to the Service's Regional Office (see ADDRESSES ) and must be received on or before June 21, 2006. ADDRESSES: To obtain copies of the proposed SHA and the supporting EA for review, write to the Service's Southeast Regional Office, 1875 Century Boulevard, Suite 200, Atlanta, Georgia 30345 (Attn: Endangered Species Permits). Send your comments to this address as well. For commenting guidelines, see “Public Comments” under SUPPLEMENTARY INFORMATION. Documents will also be available for public inspection by appointment during normal business hours at the Regional Office in Atlanta, or at the Field Office at 551-F Pylon Drive, Raleigh, North Carolina, 27636. Do not write to this address. FOR FURTHER INFORMATION CONTACT: Mr. Rick Gooch, Regional Safe Harbor Coordinator, at the Atlanta address above, 404-679-7124 (phone), or 404-679-7081 (facsimile), or John Hammond, Fish and Wildlife Biologist, at the Raleigh address above or 919-856-4556 (phone). SUPPLEMENTARY INFORMATION: The Applicant has applied to the Service for an ESP under section 10(a)(1)(A) of the Endangered Species Act of 1973, as amended

(Act)(16 U.S.C. 1531 et seq.). The application includes a proposed SHA for the endangered RCW for a period of 99 years, along with a supporting EA. We announce the opening of a 30-day comment period and request comments from the public on the proposed SHA and the supporting EA. If approved, the SHA would allow the Applicant to issue certificates of inclusion throughout certain areas of North Carolina to eligible non-Federal landowners that complete an approved Safe Harbor Management Agreement (SHMA). Background The EA identifies and describes several alternatives. All comments received, including names and addresses, will become part of the official administrative record and may be made available to the public, subject to the requirements of the Privacy Act and Freedom of Information Act. For further information and instructions on reviewing and commenting on this application, see ADDRESSES and, in this section, “Public Comments.” Under a SHA, participating property owners voluntarily undertake management activities on their property to enhance, restore, or maintain habitat benefiting species listed under the Act. SHAs encourage private and other non-Federal property owners to implement conservation efforts for listed species by assuring property owners they will not be subjected to increased property use restrictions if their efforts attract listed species to their property or increase the numbers or distribution of listed species already on their property. Application requirements and issuance criteria for enhancement of survival permits through SHAs are found in 50 CFR 17.22 and 17.32. NCWRC's proposed Statewide SHA is designed to encourage voluntary RCW habitat restoration or enhancement activities by relieving a landowner who enters into a landowner-specific agreement ( *i.e.,* the SHMA) from any additional responsibility under the Act beyond that which exists at the time he or she enters into the program. The SHMA will identify any existing RCWs and any associated habitat (the baseline) and will describe the actions that the landowner commits to take ( *e.g.,* hardwood midstory removal, cavity provisioning) or allows to be taken to improve RCW habitat on the property, and the time period within which those actions are to be taken and maintained. A participating landowner must maintain the baseline on his/her property ( *i.e.,* any existing RCW groups and/or associated habitat), but may be allowed the opportunity to incidentally take RCWs at some point in the future if above-baseline numbers of RCWs are attracted to that site by the proactive management measures undertaken by the landowner. It is important to note that the SHA does not envision, nor will it authorize, incidental take of existing RCW groups, with one exception. This exception is incidental take related to a baseline shift; in this circumstance, the baseline will be maintained but redrawn or shifted on that landowner's property. Among the minimization measures proposed by the Applicant are no incidental taking of RCWs during the breeding season, consolidation of small, isolated RCW populations at sites capable of supporting a viable RCW population, and measures to improve current and potential habitat for the species. Further details on the topics described above are found in the aforementioned documents available for review under this notice. The geographic scope of the Applicant's SHA is the State of North Carolina, with the exception of six counties (Cumberland, Harnett, Hoke, Moore, Richmond, and Scotland) located in the Sandhills Region that are already covered in an existing SHA (U.S. Fish and Wildlife Service Permit Number TE798839-12)). Lands potentially eligible for inclusion include all privately owned lands, State lands, and public lands owned by cities, counties, and municipalities with potentially suitable RCW habitat. We have evaluated several alternatives to the proposed action, and these are described at length in the accompanying EA. The alternative of our paying landowners for desired management practices is not being pursued because we are presently unable to fund such a program. An alternative by which interested private or non-Federal property owners would prepare an individual permit application/Agreement with us also was evaluated. Under that alternative, we would process each permit application/Agreement individually. This would increase the effort, cost, and amount of time it would take to provide safe harbor assurances to participating landowners and also cause such benefits to be applied on a piecemeal, individual basis. We have determined the previously identified alternatives, which would result in delays and lack of a coordinated effort, would likely result in a continued decline of the RCWs on private lands due to habitat fragmentation, lack of beneficial habitat management, and the effects of demographic isolation. A no-action alternative was also explored, but this alternative is not likely to increase the number of RCW groups or RCW habitat, nor would it alleviate landowner conflicts. Instead, the action proposed here, although it authorizes future incidental take, is expected to attract sufficient interest among North Carolina landowners to generate substantial net conservation benefits to the RCW on a landscape level. The proposed SHA was developed in an adaptive management framework to allow changes in the program based on new scientific information, including but not limited to biological needs and management actions proven to benefit the species or its habitat. Public Comments Written data or comments should be submitted to the Regional Office at the address listed under ADDRESSES and must be submitted in writing to be adequately considered our in the Service's decision-making process. Please reference the “Proposed Programmatic North Carolina Statewide Red-cockaded Woodpecker Safe Harbor Agreement” in your comments, or in requests for the documents discussed in this notice. Decision We will not make our final determination until after the end of the 30-day comment period, and we will fully consider all comments received during the comment period. If the final analysis shows the SHA to be consistent with the Service's policies and applicable regulations, the Service will sign the SHA and issue the ESP. Authority We are providing this notice under section 10(c) of the Endangered Species Act and implementing regulations for the National Environmental Policy Act (40 CFR part 1506). Dated: May 16, 2006. Jackie Parrish, Acting Regional Director, Southeast Region. [FR Doc. E6-7731 Filed 5-19-06; 8:45 am] BILLING CODE 4310-55-P DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs Notice of Availability of the Draft Environmental Impact Statement for the Cowlitz Indian Tribe's Proposed 151.87 Acre Fee-To Trust Transfer, Reservation Proclamation and Casino-Resort Project, Clark County, WA; Correction AGENCY: Bureau of Indian Affairs, Interior. ACTION: Notice; correction. SUMMARY: This notice advises the public of three corrections to the Notice of Availability of the Draft Environmental Impact Statement

(DEIS)for the Cowlitz Indian Tribe's Proposed Fee-to Trust Transfer, Reservation Proclamation and Casino-Resort Project, Clark County, Washington, published in the **Federal Register** on April 12, 2006, 71 FR 18767 (FR Doc. E6-5383). The U.S. Environmental Protection Agency

(EPA)was erroneously included among the cooperating agencies. EPA is not a cooperating agency for this DEIS. This notice also corrects the name, address and telephone number of the contact person for the DEIS. FOR FURTHER INFORMATION CONTACT: Gerald Henrickson,

(503)231-6927. Correction On page 18767, in the third column under the SUMMARY heading, in the first sentence, remove the words “U.S. Environmental Protection Agency (EPA).” On page 18768, in the first column under the ADDRESSES heading, correct the last paragraph to read: To obtain a copy of the DEIS, please write to Gerald Henrickson, Northwest Regional Office, Bureau of Indian Affairs, 911 N.E. 11th Avenue, Portland, Oregon 97232, or call him at the number provided below. On page 18768, in the first column under the FOR FURTHER INFORMATION CONTACT heading, correct the name and telephone number to read: Gerald Henrickson,

(503)231-6927. Dated: May 16, 2006. Michael D. Olsen, Acting Principal Deputy Assistant Secretary—Indian Affairs. [FR Doc. E6-7773 Filed 5-19-06; 8:45 am] BILLING CODE 4310-W7-P DEPARTMENT OF THE INTERIOR National Park Service Notice of Boundary Revision, Big Thicket National Preserve SUMMARY: This notice announces the revision to the boundary of Big Thicket National Preserve to include the parcel of land known as Tract 223-09. The United States will acquire this tract from The Conservation Fund upon the revision of the boundary. The National Park Service has determined that this boundary revision is necessary and that the acquisition of this tract would make a significant contribution to the purposes for which the preserve was created. DATES: The effective date of this boundary revision is the date on which this notice is published in the **Federal Register.** FOR FURTHER INFORMATION CONTACT: Superintendent, Big Thicket National Preserve, 6044 Farm Road 420, Kountze, Texas 77625 or by telephone 409-951-6700. SUPPLEMENTARY INFORMATION: The Act establishing Big Thicket National Preserve, as amended in 1993, 16 U.S.C. 698(b), provides that, after notifying the House Committee on Resources and the Senate Committee on Energy and Resources, the Secretary of the Interior is authorized to make this boundary revision. This action will add one parcel composed of 200 acres of land to Big Thicket National Preserve. The National Park Service proposes to purchase this parcel from The Conservation Fund. This parcel is bounded on the north, south, and east by the preserve. The acquisition of this parcel is required to maintain the ecology and the present rural character for which the preserve was created. The above parcel is depicted as tract number 223-09 on land acquisition segment map 223, having drawing number 175-80,010 dated November, 2004. This map is on file at the National Park Service Land Resources Program Center, Intermountain Region, Santa Fe, New Mexico, and at the Office of the Superintendent at Big Thicket National Preserve, Kountze, Texas. Michael D. Snyder, Director, Intermountain Region. [FR Doc. 06-4709 Filed 5-19-06; 8:45 am]

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