Notices. Notice

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BILLING CODE 4160-90-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Toxic Substances and Disease Registry [ATSDR-230] Public Health Assessments and Health Consultations Completed January 2007-March 2007 AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (HHS). ACTION: Notice. SUMMARY: This notice announces those sites for which ATSDR has completed public health assessments and health consultations during the period from January 1, 2007 through March 31, 2007. This list includes sites that are on or proposed for inclusion on the National Priorities List

(NPL)and includes sites for which assessments or consultations were prepared in response to requests from the public. FOR FURTHER INFORMATION CONTACT: William Cibulas, Jr., PhD, Director, Division of Health Assessment and Consultation, Agency for Toxic Substances and Disease Registry, 1600 Clifton Road, NE., Mailstop E-32, Atlanta, Georgia 30333, telephone

(404)498-0007. SUPPLEMENTARY INFORMATION: The most recent list of completed public health assessments and health consultations was published in the **Federal Register** on March 20, 2007 [72 FR 13115]. This announcement is the responsibility of ATSDR under the regulation “Public Health Assessments and Health Effects Studies of Hazardous Substances Releases and Facilities” [42 CFR Part 90]. This rule sets forth ATSDR's procedures for the conduct of public health assessments under section 104(i) of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), as amended by the Superfund Amendments and Reauthorization Act

(SARA)[42 U.S.C. 9604(i)]. Availability The completed public health assessments and health consultations are available for public inspection at the ATSDR Records Center, 1825 Century Boulevard, Atlanta, Georgia (not a mailing address), between 8 a.m. and 4:30 p.m., Monday through Friday except legal holidays. Public health assessments and health consultations are often available for public review at local repositories such as libraries in corresponding areas. Many public health assessments and health consultations are available through ATSDR's Web site at *http://www.atsdr.cdc.gov/HAC/PHA/.* In addition, the completed public health assessments are available by mail through the U.S. Department of Commerce, National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, Virginia 22161, or by telephone at

(800)553-6847. NTIS charges for copies of public health assessments. The NTIS order numbers are listed in parentheses following the site names. Public Health Assessments Completed or Issued Between January 1, 2007, and March 31, 2007, public health assessments were issued for the sites listed below: NPL and Proposed NPL Sites Georgia Alternate Energy Resources, Inc.—(PB2007-106100); January 25, 2007. Idaho Bunker Hill Mining and Metallurgical Complex Operable Unit 3 (a/k/a Coeur D'Alene River Basin)—(PB2007-107841); March 26, 2007. Illinois Hegeler Zinc—(PB2007-106152); February 2, 2007. New Hampshire Former Chlor Alkali Facility Below Saw Mill Dam—(PB2007-106545); February 7, 2007. Tennessee Evaluation of Current (1990-2003) and Future Chemical Exposures in the Vicinity of the Oak Ridge Reservation, U.S. Department of Energy—(PB2007-106119); January 31, 2007. Texas Sandy Beach Road Groundwater Plume—(PB2007-104896); January 17, 2007. West Virginia Ravenswood PCE Ground Water Plume Site—(PB2007-107220); March 14, 2007. Non-NPL Petitioned Sites Florida Coronet Industries, Incorporated (a/k/a Borden Feed Phosphate Complex)—(PB2007-104895); January 18, 2007. Massachusetts Evaluation of Cancer Incidence, 1982-2000, and Environmental Concerns Related to the Bird Landfill—(PB2007-106569); February 15, 2007. Texas East Kelly Air Force Base—(PB2007-106614); February 27, 2007. Base de Fuerza Aerea, East Kelly (Spanish Version)—(PB2007-107191); February 27, 2007. Health Consultations Completed or Issued Between January 1, 2007, and March 31, 2007, health consultations were issued for the sites listed below: Arizona Evaluation of Primary Metals in Private Drinking Water Wells in the Walker Area; March 6, 2007. Lone Butte Industrial Park—Perchlorate; March 8, 2007. Lone Butte Industrial Park—TCE; January 10, 2007. North Indian Bend Wash, Area 7 Groundwater Extraction and Treatment Facility; March 8, 2007. California Evaluation of Indoor Air Migration in Building On-Site and Adjacent to the Omega Chemical Site; March 20, 2007. Klau/Buena Vista Mines—Evaluation of Fish Consumption from Lake Nacimiento—Exposure Investigation Report; February 6, 2007. Colorado A1 Stop Laundry and Dry Cleaners—Indoor Air Quality Assessment of a Residential Neighborhood Overlying a Tetrachloroethylene

(PCE)Groundwater Plume; February 20, 2007. Connecticut Raymark Industries, Inc.—Evaluation of Soils at Selected School/Daycare Properties Located Near Raymark Industries Waste Disposal Areas; February 13, 2007. Somers Plating, Inc.—Public Health Evaluation of Soil Sampling Data for Lagoon 3; February 13, 2007. Florida Former Royal Oaks Charcoal Facility—Air Testing; January 17, 2007. Lincoln Park Complex, Durrs Neighborhood (Off-Site) Soil; March 27, 2007. Georgia Miller Bottom Road Municipal Solid Waste Landfill; March 28, 2007. Idaho Sunnyside Area Groundwater Contamination—Evaluation of Antibiotic, Steroid Hormone & Nitrate Compounds in Groundwater Near a Confined Animal Feeding Operation (CAFO); March 19, 2007. Indiana Rumpke Medora Landfill—Exposure Investigation Report; February 1, 2007. Louisiana Bayou Bonfouca—Post-Hurricane Evaluation; January 24, 2007. Michigan Kingsford Middle School; March 30, 2007. Ontonagon High School Mercury Release; March 30, 2007. Nebraska Arsenic in Soil in East Omaha, Nebraska; March 20, 2007. New Jersey Celotex Corporation; January 10, 2007. North Carolina APAC Carolina Inc. and Associated Asphalt Inc., Jake Alexander Boulevard; February 14, 2007. Weyerhaeuser Pulp and Paper Mill—Exposure Investigation Report; March 22, 2007. Pennsylvania Ivy Industrial Park Site—Public Health Evaluation of Residential Indoor Air and Well Water Sample Results; March 5, 2007. Remacor Site; January 10, 2007. Tennessee Mr. Zip Convenience Store; March 14, 2007. Texas Former Delroc Oil Refinery/Woodwind Lakes Subdivision; February 23, 2007. Utah Vermiculite Intermountain and Intermountain Products, Inc.—Epidemiological Investigation of Human Exposure to a Contaminated Vermiculite Ore Processing Site in Utah; March 1, 2007. Washington Home Heating Oil Release, Technical Review of the Site Hazard Assessment; March 29, 2007. Wisconsin Amery-Dresser Trail; January 23, 2007. Dated: May 2, 2007. Kenneth Rose, Acting Director, Office of Policy, Planning, and Evaluation, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry. [FR Doc. E7-8758 Filed 5-7-07; 8:45 am] BILLING CODE 4163-70-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Privacy Act of 1974; Report of a Modified or Altered System of Records AGENCY: Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS). ACTION: Notice of a Modified or Altered System of Records (SOR). SUMMARY: In accordance with the requirements of the Privacy Act of 1974, CMS is proposing to modify or alter existing system of records titled “Complaints Against Health Insurance Issuers and Health Plans (CAHII),” System No. 09-70-9005, established at 66 FR 9858, (February 12, 2001). We propose to assign a new CMS identification number to this system to simplify the obsolete and confusing numbering system originally designed to identify the Bureau, Office, or Center that maintained information in the Health Care Financing Administration systems of records. The new assigned identifying number for this system should read: System No. 09-70-0516. We propose to modify existing routine use number 1 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that require CMS data to carry out that activity, are classified separate from CMS contractors and/or consultants. The modified routine use will remain as routine use number 1. We will delete routine use number 2 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the “prior written consent” of the data subject. We propose to add 2 new routine uses authorizing disclosure to support a CMS contractor, consultant, or a grantee of a CMS-administered grant program, when disclosure is deemed reasonably necessary by CMS to combat fraud, waste, and abuse in certain health care programs. The new routine use will be published as routine use number 6. We will add a second new routine use to support another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States, when disclosure is deemed reasonably necessary by CMS to combat fraud, waste, and abuse in certain health care programs. This new routine use will be published as routine use number 7. We will broaden the scope of this system by including the section titled “Additional Circumstances Affecting Routine Use Disclosures,” that addresses “Protected Health Information (PHI)” and “small cell size.” The requirement for compliance with HHS regulation “Standards for Privacy of Individually Identifiable Health Information” apply when ever the system collects or maintain PHI. This system may contain PHI. In addition, our policy to prohibit release if there is a possibility that an individual can be identified through “small cell size” will apply to the data disclosed from this system. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003

(MMA)(Pub. L. 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of this system is to collect and maintain information initiated by consumers complaints/reports to CMS that their health insurance issuers and/or non-Federal governmental health plans are in violation of one or more of the following statutes: §§ 2722 and 2761 of the Public Health Service

(PHS)Act; the Mental Health Parity Act of 1996 (MHPA); the Newborns' and Mothers' Health Protection Act of 1996 (NMHPA); and, the Women's Health and Cancer Rights Act of 1998 (WHCRA). Information maintained in 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, agency of a state government, an agency established by state law, or its fiscal agent;

(3)assist third party contacts in situations where the party to be contacted has, or is expected to have information relating to the individual's capacity to manage his or her affairs or to his or her eligibility for, or an entitlement to benefits under the Medicare program;

(4)inform a health insurance issuer and/or health plan who has been named in a complaint/inquiry and is believed to be potentially in violation of relevant portions of the PHS;

(5)support litigation involving the Agency; and

(6)combat fraud, waste, and abuse in certain health benefits programs. We have provided background information about this new 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 Dates:* CMS filed a new system report with the Chair of the House Committee on Government Reform and Oversight, the Chair of the Senate Committee on Homeland Security and Governmental Affairs, and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget

(OMB)on April 12, 2007. To ensure that all parties have adequate time in which to comment, the new SOR, including routine uses, will become effective 40 days from the publication of the notice, or from the date it was submitted to OMB and the Congress, whichever is later, unless CMS receives comments that require alterations to this notice. ADDRESSES: The public should address comments to: CMS Privacy Officer, Division of Privacy Compliance, Enterprise Architecture and Strategy Group, Office of Information Services, CMS, Room 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 Time zone. FOR FURTHER INFORMATION CONTACT: Dave Mlawsky, Health Insurance Specialist, Division of Employer Operations, Employer Policy and Operations Group, Center for Beneficiary Choices, CMS, 7500 Security Boulevard, Mail Stop S3-16-26, Baltimore, Maryland 21244-1850. The telephone number is 410-786-6851 or e-mail *david.mlawsky@cms.hhs.gov.* SUPPLEMENTARY INFORMATION: I. Description of the Modified or Altered System of Records A. Statutory and Regulatory Basis for SOR Authority for maintenance of this system is given under §§ 2722 and 2761 of the Public Health Service

(PHS)Act; the Mental Health Parity Act of 1996 (MHPA); the Newborns' and Mothers' Health Protection Act of 1996 (NMHPA); and the Women's Health and Cancer Rights Act of 1998 (WHCRA) with respect to non-Federal governmental plans. B. Collection and Maintenance of Data in the System This system will collect and maintain individually identifiable and other data collected on individuals/consumers who make complaints/inquiries to CMS that their health insurance issuers and/or non-Federal governmental health plans are in violation of the PHS. The system contains information such as consumer's name, address, phone number, the name and address of their health plan or health insurance issuer, their plan ID number or social security number, the nature of their complaint/inquiry against their health plan or issuer, and any medical and other additional information that is necessary for CAHII to help resolve the consumer's complaint. II. Agency Policies, Procedures, and Restrictions on the Routine Use A. 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 CAHII 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 CAHII. 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 data is being collected; e.g., to collect and maintain information initiated by consumers complaints/reports to CMS that their health insurance issuers and/or non-Federal governmental health plans are in violation of the PHS; 2. Determines that the purpose for which the disclosure is to be made can only be accomplished if the record is provided in individually identifiable form; a. 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 b. 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. Modified 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 support Agency contractors, consultants, or grantees that have been contracted by the Agency to assist in accomplishment of a CMS function relating to the purposes for this system and who need access to the records in order to assist CMS. 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 a 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 a contractor, consultant, or grantee whatever information is necessary for the contractor, consultant, or grantee to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the contractor, consultant, or grantee from using or disclosing the information for any purpose other than that described in the contract and requires the contractor or consultant to return or destroy all information at the completion of the contract. 2. To assist another Federal or state agency, agency of a state government, an agency established by state law, or its fiscal agent to: a. Contribute to the accuracy of CMS's proper payment of Medicare benefits, b. 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, and/or c. Refer a complaint or inquiry with respect to Title I of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Mental Health Parity Act of 1996 (MHPA), the Newborns' and Mothers' Health Protection Act of 1996 (NMHPA), and the Women's Health and Cancer Rights Act of 1998 (WHCRA). CAHII shares enforcement responsibilities with the U.S. Department of Labor, the U.S. Department of Treasury and State regulatory bodies with respect to Title I of HIPAA, MHPA, NMHPA and WHCRA. CAHII's enforcement responsibilities are discussed in the “Description of the New System of Records” section above. The Department of Labor enforces Title I of HIPAA, MHPA, NMHPA and WHCRA with respect to private group health plans. The Department of Treasury may levy excise taxes against private group health plans that do not comply with these Acts, except for WHCRA. In States that are substantially enforcing Title I of PHS, MHPA, NMHPA and WHCRA, the appropriate State agency enforces these provisions with respect to health insurance issuers. Occasionally, CAHII will receive an inquiry or complaint related to one of these four Acts in situations where it is within Labor's or Treasury's or a State's, and not CAHII's, jurisdiction to resolve. In such cases, CAHII must disclose information from the system of records to the appropriate agency so they can perform their enforcement function. Other Federal or state agencies in their administration of a Federal health program may require CAHII information in order to support evaluations and monitoring of Medicare claims information of beneficiaries, including proper reimbursement for services provided. In addition, other state agencies in their administration of a Federal health program may require CAHII information for the purposes of determining, evaluating and/or assessing cost, effectiveness, and /or the quality of health care services provided in the state. 3. To assist third party contacts in situations where the party to be contacted has, or is expected to have information relating to the individual's capacity to manage his or her affairs or to his or her eligibility for, or an entitlement to, benefits under the Medicare program and, a. The individual is unable to provide the information being sought (an individual is considered to be unable to provide certain types of information when any of the following conditions exists: The individual is confined to a mental institution, a court of competent jurisdiction has appointed a guardian to manage the affairs of that individual, a court of competent jurisdiction has declared the individual to be mentally incompetent, or the individual's attending physician has certified that the individual is not sufficiently mentally competent to manage his or her own affairs or to provide the information being sought, the individual cannot read or write, cannot afford the cost of obtaining the information, a language barrier exist, or the custodian of the information will not, as a matter of policy, provide it to the individual), or b. The data are needed to establish the validity of evidence or to verify the accuracy of information presented by the individual, and it concerns one or more of the following: The individual's entitlement to benefits under the Medicare program, the amount of reimbursement, and in cases in which the evidence is being reviewed as a result of suspected fraud and abuse, program integrity, quality appraisal, or evaluation and measurement of activities. Third parties contacts require CAHII information in order to provide support for the individual's entitlement to benefits under the Medicare program; to establish the validity of evidence or to verify the accuracy of information presented by the individual, and assist in the monitoring of Medicare claims information of beneficiaries, including proper reimbursement of services provided. 4. To inform a health insurance issuer and/or health plan, who has been named in a complaint and is believed to be potentially in violation of relevant portions of the PHS Act. When individuals file complaints or inquiries asking CAHII to clarify or enforce their rights under Title I of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Mental Health Parity Act of 1996 (MHPA), the Newborns' and Mothers' Health Protection Act of 1996 (NMHPA), and the Women's Health and Cancer Rights Act of 1998 (WHCRA), CAHII often must disclose information maintained in this system of records to the individual's health insurance issuer or health plan in order for CAHII to satisfy its statutory charge to enforce these Federal Acts with respect to non-Federal governmental health plans in all States and health insurance issuers in some States. 5. To assist 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, or occasionally when another party is involved in litigation and CMS's 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. 6. To support a CMS contractor that assists in the administration of a CMS-administered health benefits program, or to a grantee of a CMS-administered grant program, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste or abuse in such programs. We contemplate disclosing information under this routine use only in situations in which CMS may enter into a contract or grant with a third party to assist in accomplishing CMS functions relating to the purpose of combating fraud, waste or abuse. CMS occasionally contracts out certain of its functions when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor or grantee whatever information is necessary for the contractor or grantee to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the contractor or grantee from using or disclosing the information for any purpose other than that described in the contract and requiring the contractor or grantee to return or destroy all information. 7. To support another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any state or local governmental agency), that administers, or that has the authority to investigate potential fraud, waste, or abuse in a program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste or abuse in such programs. Other agencies may require CAHII information for the purpose of combating fraud, waste or abuse in such Federally-funded programs. B. 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 could, because of the small size, use this information to deduce the identity of the beneficiary). IV. Safeguards CMS has safeguards in place for authorized users and monitors such users to ensure against 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. V. Effects of the Modified or Altered System of Records on Individual Rights CMS proposes to modify this system in accordance with the principles and requirements of the Privacy Act and will collect, use, and disseminate information only as prescribed therein. Data in this system will be subject to the authorized releases in accordance with the routine uses identified in this system of records. CMS will take precautionary measures to minimize the risks of unauthorized access to the records and the potential harm to individual privacy or other personal or property rights of patients whose data are maintained in the system. CMS will collect only that information necessary to perform the system's functions. In addition, CMS will make disclosure from the proposed system only with consent of the subject individual, or his/her legal representative, or in accordance with an applicable exception provision of the Privacy Act. CMS, therefore, does not anticipate an unfavorable effect on individual privacy as a result of information relating to individuals. Dated: April 12, 2007. Charlene Frizzera, Acting Chief Operating Officer Centers for Medicare & Medicaid Services. System No. 09-70-0516. System Name: • Complaints Against Health Insurance Issuers and Health Plans (CAHII),” HHS/CMS/CBC. Security Classification: Level Three Privacy Act Sensitive Data. System Location: CMS Data Center, 7500 Security Boulevard, North Building, First Floor, Baltimore, Maryland 21244-1850 and at various other contractor locations. Categories of Individuals Covered by the System: This system will collect and maintain individually identifiable and other data collected on individuals/consumers who make complaints/inquiries to CMS that their health insurance issuers and/or non-Federal governmental health plans are in violation of the PHS ACT. Categories of Records in the System: The system contains information such as consumer's name, address, phone number, the name and address of their health plan or health insurance issuer, their plan ID number or social security number, the nature of their complaint/inquiry against their health plan or issuer, and any medical and other additional information that is necessary for CAHII to help resolve the consumer's complaint. Authority for Maintenance of the System: Authority for maintenance of this system is given under §§ 2722 and 2761 of the Public Health Service

(PHS)Act; the Mental Health Parity Act of 1996 (MHPA); the Newborns' and Mothers' Health Protection Act of 1996 (NMHPA); and , the Women's Health and Cancer Rights Act of 1998 (WHCRA). Information maintained in 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, agency of a state government, an agency established by state law, or its fiscal agent;

(4)inform a health insurance issuer and/or health plan who has been named in a complaint/inquiry and is believed to be potentially in violation of relevant portions of the PHS ACT;

(5)support litigation involving the Agency; and

(6)combat fraud, waste, and abuse in certain health benefits programs. Routine Uses of Records Maintained in the System, Including Categories or Users and the Purposes of Such Uses: 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 support Agency contractors, consultants, or grantees that have been contracted by the Agency to assist in accomplishment of a CMS function relating to the purposes for this system and who need access to the records in order to assist CMS. 2. To assist another Federal or state agency, agency of a state government, an agency established by state law, or its fiscal agent to: a. Contribute to the accuracy of CMS's payment of Medicare benefits, b. 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, and/or c. Refer a complaint or with respect to Title I of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Mental Health Parity Act of 1996 (MHPA), the Newborns' and Mothers' Health Protection Act of 1996 (NMHPA), and the Women's Health and Cancer Rights Act of 1998 (WHCRA). 3. To assist third party contacts in situations where the party to be contacted has, or is expected to have information relating to the individual's capacity to manage his or her affairs or to his or her eligibility for, or an entitlement to, benefits under the Medicare program and, a. The individual is unable to provide the information being sought (an individual is considered to be unable to provide certain types of information when any of the following conditions exists: The individual is confined to a mental institution, a court of competent jurisdiction has appointed a guardian to manage the affairs of that individual, a court of competent jurisdiction has declared the individual to be mentally incompetent, or the individual's attending physician has certified that the individual is not sufficiently mentally competent to manage his or her own affairs or to provide the information being sought, the individual cannot read or write, cannot afford the cost of obtaining the information, a language barrier exists, or the custodian of the information will not, as a matter of policy, provide it to the individual), or b. The data are needed to establish the validity of evidence or to verify the accuracy of information presented by the individual, and it concerns one or more of the following: The individual's entitlement to benefits under the Medicare program, the amount of reimbursement, and in cases in which the evidence is being reviewed as a result of suspected fraud and abuse, program integrity, quality appraisal, or evaluation and measurement of activities. 4. To inform a health insurance issuer and/or health plan, who has been named in a complaint and is believed to be potentially in violation of relevant portions of the PHS Act. 5. To assist 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. 6. To support a CMS contractor that assists in the administration of a CMS-administered health benefits program, or to a grantee of a CMS-administered grant program, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud or abuse in such programs. 7. To support another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any state or local governmental agency), that administers, or that has the authority to investigate potential fraud or abuse in a program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud or abuse in such programs. B. Additional Provisions Affecting Routine Use Disclosures To the extent this system contains Protected Health Information

(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 could, because of the small size, use this information to deduce the identity of the beneficiary). Policies and Practices for Storing, Retrieving, Accessing, Retaining, and Disposing of Records in the System: Storage: All records are stored on electronic media. Retrievability: The collected data are retrieved by an individual identifier; e.g., consumer's name or health insurance claims number, if, applicable. Safeguards: CMS has safeguards in place for authorized users and monitors such users to ensure against 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 information for a total period not to exceed 6 years. All claims-related records are encompassed by the document preservation order and will be retained until notification is received from DOJ. System Manager and Address: Director, Division of Policy, Employer Policy and Operations Group, Center for Beneficiary Choices, CMS, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Notification Procedure: For purpose of access, the subject individual should write to the system manager who will require the system name, employee identification number, tax identification number, national provider number, and for verification purposes, the subject individual's name (woman's maiden name, if applicable), HICN, and/or SSN (furnishing the SSN is voluntary, but it may make searching for a record easier and prevent delay). 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

(ESRD)Program Management and Medical Information System (PMMIS), System No. 09-70-0520,” and last modified at 67 Fed. Reg. 41244 (June 17, 2002). This system contains records on individuals with ESRD who are entitled to receive Medicare benefits or who are treated by Department of Veteran Affairs

(DVA)health care facilities. We propose to modify existing routine use number 1 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. The modified routine use will remain as routine use number 1. For further clarity, we propose to separate existing routine use number 3 that permit disclosures to ESRD Network Organizations and to Quality Improvement Organizations into separate routine uses. The activities performed by the 2 different type organizations are not so closely related that they should be combined in one routine use. The modified routine use will be republished as routine use number 3 for ESRD Network Organizations and routine use number 4 for Quality Improvement Organizations. We will delete routine use number 5 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the “prior written consent” of the data subject. We propose to broaden the scope of the disclosure provisions of this system by adding a routine use to permit the release of priority personal information to complete a transfer out event from a losing ESRD facility and/or a transfer-in event to a gaining ESRD facility to:

(1)Contribute to the accuracy of CMS' proper payment of Medicare benefits; and

(2)enable such facilities to ensure the proper transfer of health records, and/or as necessary to enable such a facility 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)assist ESRD programs which may require PMMIS information for purposes related to this system. Information will be released to these organizations upon specific request, and only for those organizations if they meet the following requirements:

(1)Provide an attestation or other qualifying information that they are providing assistance to qualified ESRD beneficiaries;

(2)submit a report of the transfer-in or transfer-out event;

(3)safeguard the confidentiality of the data and prevent unauthorized access; and

(4)complete a written statement attesting to the information recipient's understanding of and willingness to abide by these provisions. The PMMIS data will provide the ESRD facility with information regarding its enrollees' enrollment status, transplant activities, dialysis activities, and Medicare utilization; facilitate the facility's required utilization reviews and medication management program activities; and assist in quality of care issues as they relate to the beneficiary. The added routine use will be numbered as routine use number 6. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003

(MMA)(Pub. L. 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of the system of records is to maintain information on Medicare ESRD beneficiaries, non-Medicare ESRD patients, Medicare approved ESRD hospitals and dialysis facilities, and Department of Veterans Affairs

(DVA)patients. The ESRD/PMMIS is used by CMS and the renal community to perform their duties and responsibilities in monitoring the Medicare status, transplant activities, dialysis activities, and Medicare utilization (inpatient and physician/supplier bills) of ESRD patients and their Medicare providers, as well as in calculating the Medicare covered periods of ESRD. Information retrieved from this system of records 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, agency of a state government, an agency established by state law, or its fiscal agent;

(3)support an ESRD Network Organizations;

(4)assist Quality Improvement Organizations

(QIO)to implement quality improvement programs;

(5)facilitate research on the quality and effectiveness of care provided and payment related projects;

(6)permit the release of priority personal information to complete a transfer out event and/or a transfer-in event;

(7)support litigation involving the agency; and,

(8)combat fraud, waste, and abuse in certain health benefits programs. We have provided background information about the new 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 Dates:* CMS filed a modified or altered system 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 April 12, 2007. To ensure that all parties have adequate time in which to comment, the modified system, including routine uses, will become effective 30 days from the publication of the notice, or 40 days from the date it was submitted to OMB and Congress, whichever is later, unless CMS receives comments that require alterations to this notice. ADDRESSES: The public should address comments to: CMS Privacy Officer, Division of Privacy Compliance, Enterprise Architecture and Strategy Group, Office of Information Services, CMS, Room 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 time zone. FOR FURTHER INFORMATION CONTACT: Dennis Stricker, Director, Information Support Group, Office of Clinical Standards and Quality, CMS, Room S3-02-01, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. The telephone number is

(410)786-3116. The e-mail address is *dennis.stricker@cms.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Description of the Proposed System of Records A. Statutory and Regulatory Basis for SOR The statutory authority for this system is given under the provisions of Sections 226A, 1875, and 1881 of the Social Security Act (the Act) (Title 42 United States Code (U.S.C.), sections 426-1, 1395ll, and 1395rr). B. Collection and Maintenance of Data in the System This system will collect and maintain individually identifiable and other data collected on individuals with ESRD who receive Medicare benefits or who are treated by DVA health care facilities. The system contains information on both the beneficiary and the provider of services. The collected information will include, but is not limited to beneficiary/patient medical records, claims data, and payment data collected from several non-reimbursement data collection instruments and Medicare bills. The provider of services' name, address, Medicare identification number, types of services provided, certification and or termination date, and ESRD network number. II. Agency Policies, Procedures, and Restrictions on the Routine Use A. 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 PMMIS 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 PMMIS. CMS has the following policies and procedures concerning disclosures of information that will be maintained in the system. Disclosure of information from the system 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 maintain information on Medicare ESRD beneficiaries, non-Medicare ESRD patients, Medicare approved ESRD hospitals and dialysis facilities, and Department of Veterans Affairs

(DVA)patients. 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 collection 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 a contractor, consultant or grantee whatever information is necessary for the contractor, consultant or grantee to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the contractor, consultant or grantee from using or disclosing the information for any purpose other than that described in the contract and requires the contractor, consultant or grantee to return or destroy all information at the completion of the contract. 2. To another Federal or state agency, agency of a state government, an agency established by state law, or its fiscal agent to: a. Contribute to the accuracy of CMS's proper payment of Medicare benefits, b. 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, and/or c. Determine compliance with the Federal conditions that an ESRD facility must meet in order to participate in Medicare. Other Federal or State agencies in their administration of a federal health program may require PMMIS information in order to support evaluations and monitoring of Medicare claims information of beneficiaries, including proper reimbursement for services provided. In addition, other state agencies in their administration of a Federal health program may require PMMIS information for the purposes of determining, evaluating and/or assessing cost, effectiveness, and/or the quality of health care services provided in the state. In addition, disclosure under this routine use shall be used by state agencies pursuant to agreements with the HHS for determining Medicare eligibility, for quality control studies, for determining eligibility of recipients of assistance under titles IV, XVIII, and XIX of the Act, and for the administration of the Medicare program. Data will be released to the state only on those individuals who are patients under the services of a program within the state or who are residents of that state. We also contemplate disclosing information under this routine use in situations in which state auditing agencies require PMMIS information for auditing eligibility considerations. CMS may enter into an agreement with state auditing agencies to assist in accomplishing functions relating to purposes for this system of records. 3. To ESRD Network Organizations in connection with review of claims, or in connection with studies or quality improvements projects or other review activities, and in performing affirmative outreach activities to individuals for the purpose of establishing and maintaining their entitlement to Medicare benefits or health insurance plans. ESRD Network Organizations will work to implement quality improvement programs, provide consultation to CMS, its contractors, and its state agencies, in connection with studies or quality improvements projects or in performing affirmative outreach activities to individuals. 4. To Quality Improvement Organizations in connection with review of claims, or in connection with studies or quality improvements projects or other review activities, conducted pursuant to Part B of Title XI of the Social Security Act and in performing affirmative outreach activities to individuals for the purpose of establishing and maintaining their entitlement to Medicare benefits or health insurance plans. QIOs will work to implement quality improvement programs, provide consultation to CMS, its contractors, and its state agencies, in connection with studies or quality improvements projects or other review activities. The QIOs will assist the state agencies in related monitoring and enforcement efforts; assist CMS and intermediaries in program integrity assessment; and prepare summary information for release to CMS. 5. To an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects. The PMMIS data will provide for research or support of evaluation projects and a broader, longitudinal, national perspective of the status of Medicare beneficiaries. CMS anticipates that many researchers will have legitimate requests to use these data in projects that could ultimately improve the care provided to Medicare beneficiaries and the policies that govern their care. 6. To assist with a transfer out event from a losing ESRD facility and/or a transfer-in event to a gaining ESRD facility to: a. Contribute to the accuracy of CMS' proper payment of Medicare benefits; and b. Enable such facilities to ensure the proper transfer of health records, and/or as necessary to enable such a facility 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; and c. Assist ESRD programs which may require PMMIS information for purposes related to this system. Information will be released to these facilities upon specific request, and only for those facilities if they meet the following requirements: a. Provide an attestation or other qualifying information that they are providing assistance to qualified ESRD beneficiaries/patients; b. Submit a report of the transfer-in or transfer-out event with the following required priority information: Name, address, HICN or SSN, date of birth; c. Safeguard the confidentiality of the data and prevent unauthorized access; and d. complete a written statement attesting to the information recipient's understanding of and willingness to abide by these provisions. Both the gaining and losing facilities may require priority information submitted as a transfer-in or transfer-out report to implement quality transfer of beneficiaries from one facility to another; provide consultation to CMS, its contractors, and its state agencies, in connection with transfer of patients. 7. 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. 8. To a CMS contractor (including, but not necessarily limited to, fiscal intermediaries and carriers) that assists in the administration of a CMS-administered health benefits program, or to a grantee of a CMS-administered grant program, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, or abuse in such program. We contemplate disclosing information under this routine use only in situations in which CMS may enter into a contractual, grantee, cooperative agreement or consultant relationship with a third party to assist in accomplishing CMS functions relating to the purpose of combating fraud, waste, or abuse. CMS occasionally contracts out certain of its functions or makes grants or cooperative agreements when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor, grantee, consultant or other legal agent whatever information is necessary for the agent to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the agent from using or disclosing the information for any purpose other than that described in the contract and requiring the agent to return or destroy all information. 9. To another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any State or local governmental agency), that administers, or that has the authority to investigate potential fraud, waste, or abuse in, a health benefits program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, or abuse in such programs. Other agencies may require PMMIS information for the purpose of combating fraud, waste, and abuse in such Federally-funded programs. B. 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 Fed. Reg. 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 could, because of the small size, use this information to deduce the identity of the beneficiary). IV. Safeguards CMS has safeguards in place for authorized users and monitors of 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. V. Effects of the Modified System of Records on Individual Rights CMS proposes to establish this system in accordance with the principles and requirements of the Privacy Act and will collect, use, and disseminate information only as prescribed therein. Data in this system will be subject to the authorized releases in accordance with the routine uses identified in this system of records. CMS will take precautionary measures to minimize the risks of unauthorized access to the records and the potential harm to individual privacy or other personal or property rights of patients whose data are maintained in this system. CMS will collect only that information necessary to perform the system's functions. In addition, CMS will make disclosure from the proposed system only with consent of the subject individual, or his/her legal representative, or in accordance with an applicable exception provision of the Privacy Act. CMS, therefore, does not anticipate an unfavorable effect on individual privacy as a result of information relating to individuals. Dated: April 12, 2007. Charlene Frizzera, Acting Chief Operating Officer, Centers for Medicare & Medicaid Services. System No. 09-70-0520. System Name: “ESRD Program Management and Medical Information (PMMIS),” HHS/CMS/OCSQ. Security Classification: Level Three Privacy Act Sensitive Data. System Location: CMS Data Center, 7500 Security Boulevard, North Building, First Floor, Baltimore, Maryland 21244-1850 and at various other contractor locations. Categories of Individuals Covered by the System: This system will collect and maintain individually identifiable and other data collected on individuals with ESRD who receive Medicare benefits or who are treated by DVA health care facilities. The system contains information on both the beneficiary and the provider of services. Categories of Records in the System: The collected information will include, but is not limited to beneficiary/patient medical records, claims data, and payment data collected from several non-reimbursement data collection instruments and Medicare bills. The provider of services' name, address, Medicare identification number, types of services provided, certification and or termination date, and ESRD network number. Authority for Maintenance of the System: The statutory authority for this system is given under the provisions of Sections 226A, 1875, and 1881 of the Social Security Act (the Act) (Title 42 United States Code (U.S.C.), sections 426-1, 1395ll, and 1395rr). Purpose(s) of the System: The primary purpose of the system of records is to maintain information on Medicare ESRD beneficiaries, non-Medicare ESRD patients; Medicare approved ESRD hospitals and dialysis facilities, and Department of Veterans Affairs

(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, agency of a state government, an agency established by state law, or its fiscal agent;

(3)support an ESRD Network Organizations;

(4)assist Quality Improvement Organizations

(QIO)to implement quality improvement programs;

(5)facilitate research on the quality and effectiveness of care provided and payment related projects;

(6)permit the release of priority personal information to complete a transfer out event and/or a transfer-in event;

(7)support litigation involving the agency; and,

(8)combat fraud, waste, and abuse in certain health benefits programs. Routine Uses of Records Maintained in the System, Including Categories or Users and the Purposes of Such Uses: 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 collection and who need to have access to the records in order to perform the activity. 2. To another Federal or state agency, agency of a state government, an agency established by state law, or its fiscal agent to: a. Contribute to the accuracy of CMS's proper payment of Medicare benefits, b. 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, and/or c. Determine compliance with the Federal conditions that an ESRD facility must meet in order to participate in Medicare. 3. To ESRD Network Organizations in connection with review of claims, or in connection with studies or quality improvements projects or other review activities, and in performing affirmative outreach activities to individuals for the purpose of establishing and maintaining their entitlement to Medicare benefits or health insurance plans. 4. To Quality Improvement Organizations in connection with review of claims, or in connection with studies or quality improvements projects or other review activities, conducted pursuant to Part B of Title XI of the Social Security Act and in performing affirmative outreach activities to individuals for the purpose of establishing and maintaining their entitlement to Medicare benefits or health insurance plans. 5. To an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects. 6. To assist with a transfer out event from a losing ESRD facility and/or a transfer-in event to a gaining ESRD facility to: a. Contribute to the accuracy of CMS' proper payment of Medicare benefits; and b. Enable such facilities to ensure the proper transfer of health records, and/or as necessary to enable such a facility 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; and c. Assist ESRD programs which may require PMMIS information for purposes related to this system. Information will be released to these facilities upon specific request, and only for those facilities if they meet the following requirements: d. Provide an attestation or other qualifying information that they are providing assistance to qualified ESRD beneficiaries/patients; e. Submit a report of the transfer-in or transfer-out event with the following required priority information: Name, address, HICN or SSN, date of birth; f. Safeguard the confidentiality of the data and prevent unauthorized access; and g. Complete a written statement attesting to the information recipient's understanding of and willingness to abide by these provisions. 7. 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. 8. To a CMS contractor (including, but not necessarily limited to, fiscal intermediaries and carriers) that assists in the administration of a CMS-administered health benefits program, or to a grantee of a CMS-administered grant program, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, or abuse in such program. 9. To another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any State or local governmental agency), that administers, or that has the authority to investigate potential fraud, waste, or abuse in, a health benefits program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, or abuse in such programs. B. Additional Provisions Affecting Routine Use Disclosures: To the extent this system contains Protected Health Information

(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 could, because of the small size, use this information to deduce the identity of the beneficiary). Policies and Practices for Storing, Retrieving, Accessing, Retaining, and Disposing of Records in the System: Storage: All records are stored on electronic media. Retrievability: The collected data are retrieved by an individual identifier; e.g., beneficiary name or HICN, and unique provider identification number. 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: Records will be retained until an approved disposition authority is obtained from the National Archives and Records Administration. All claims-related records are encompassed by the document preservation order and will be retained until notification is received from DOJ. System Manager and Address: Director, Information Support Group, Office of Clinical Standards and Quality, CMS, Room S3-02-01, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Notification Procedure: For purpose of access, the subject individual should write to the system manager who will require the system name, employee identification number, tax identification number, national provider number, and for verification purposes, the subject individual's name (woman's maiden name, if applicable), HICN, and/or SSN (furnishing the SSN is voluntary, but it may make searching for a record easier and prevent delay). 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 Record Procedures: The subject individual should contact the system manager named above, and reasonably identify the record 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: The data contained in these records are obtained from Medicare ESRD medical evidence reports, kidney transplant reports, ESRD beneficiary reimbursement method selection forms, ESRD death notification forms, Medicare bills, CMS Medicare Master files, ESRD facility surveys, ESRD facility certification notices, and the Medicare/Medicaid Automated Certification System (MMACS). Systems Exempted from Certain Provisions of the Act: None. Appendix A 1. ESRD Network of New England, Incorporated, Post Office Box 9484, New Haven, Connecticut 06534. 2. ESRD Network of New York, Incorporated, 1249 Fifth Avenue, A-419, New York, New York 10029. 3. Trans-Atlantic Renal Council, Cranbury Plaza, 2525 Route 130—Building C, Cranbury, New Jersey 08512-9595. 4. ESRD Network Organization Number 4, 200 Lothrop Street, Pittsburgh, Pennsylvania 15213-2582. 5. Mid-Atlantic Renal Coalition, 1527 Huguenot Road, Midlothian, Virginia 23113. 6. Southeastern Kidney Council, Incorporated, 1000 Saint Albans Drive, Suite 270, Raleigh, North Carolina 27609. 7. ESRD Network of Florida, Incorporated, One Davis Boulevard, Suite 304, Tampa, Florida 33606. 8. Network 8, Incorporated, Post Office Box 55868, Jackson, Mississippi 39296-5868. 9 & 10. The Renal Network, Incorporated, 911 East 86th Street, Suite 202, Indianapolis, Indiana 46240. 11. Renal Network of the Upper Midwest, 970 Raymond Avenue #205, Saint Paul, Minnesota 55114. 12. ESRD Network Number 12, 7509 NW T Tiffany Spring Parkway, Suite 105, Kansas City, Missouri 64153. 13. ESRD Network Organization Number 13, 6600 North Meridan Avenue, Suite 155, Oklahoma City, Oklahoma 73116-1411. 14. ESRD Network of Texas, Incorporated, 14114 Dallas Parkway, Suite 660, Dallas, Texas 75240-4349. 15. Intermountain ESRD Network, Incorporated, 1301 Pennsylvania Street, Suite 220, Denver, Colorado 80203-5012. 16. Northwest Renal Network, 4702 42nd Avenue, Seattle, Washington 98116. 17. TransPacific Renal Network, 25 Mitchell Boulevard, Suite 7, San Rafael, California 94903. 18. Southern California Renal Disease Council, 6255 Sunset Boulevard, Suite 2211, Los Angeles, California 90082. [FR Doc. E7-8759 Filed 5-7-07; 8:45 am] BILLING CODE 4120-03-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N-0349] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Survey of Current Manufacturing Practices in the Food Industry 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. DATES: Fax written comments on the collection of information by June 7, 2007. ADDRESSES: 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: FDA Desk Officer, FAX: 202-395-6974. All comments should be identified with the OMB control number, “0910-NEW” and title, “FDA Survey of Current Manufacturing Practices in the Food Industry.” Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (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. FDA Survey of Current Manufacturing Practices in the Food Industry—(OMB Control Number 0910-NEW) The authority for FDA to collect the information derives from the FDA Commissioner's authority, as specified in section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)). FDA's regulations in 21 CFR part 110 describe the methods, equipment, facilities, and controls for producing processed food, hereafter referred to as food CGMPs. As the minimum sanitary and processing requirements for producing safe and wholesome food, CGMPs are an important part of regulatory control of the nation's food supply. FDA believes that it is necessary to revisit and modernize the food CGMPs. Since the food CGMPs were last revised in 1986, there have been significant changes in food production technology and important advances in the understanding of foodborne illnesses. Accordingly, the agency will rigorously assess the impacts of any modernization policies on food facilities. To assess the impacts of the modernization policy, information is needed to help understand baseline or current industry practice. At present, however, FDA lacks baseline information on the nature of current manufacturing practices that would serve as part of a regulatory impact analysis. FDA plans to conduct an Internet survey of all domestic FDA-registered facilities that primarily manufacture or process food and all foreign FDA-registered facilities that primarily manufacture or process food, which are located in those countries that are the largest food exporters to the United States: Japan, Canada, China, France, Italy, and Mexico. The Internet survey may be supplemented by extended case study interviews with selected respondents from the survey. The survey and extended case studies will solicit detailed information about six key topics relevant to the food CGMPs modernization effort: employee training, sanitation and personal hygiene, allergen controls, process controls, post-production processing, and recordkeeping. Additionally, FDA will collect information on establishment characteristics, such as facility size and industry, which are expected to correlate with the presence or absence of various manufacturing practices, such as electronic recordkeeping, ongoing employee training in food safety, and product-to-label conformance procedures. The case study interviews, if conducted, will provide qualitative, in-depth information about various factors that influence decisions to implement these types of manufacturing practices, as well as about the circumstances that underlie the cost and effectiveness of such programs. The survey will be sent to every FDA-registered facility in the United States, Japan, Canada, China, France, Italy, and Mexico that primarily manufactures or processes food products and that included an e-mail address with its registration. Participation will be voluntary and the respondent identifiers that would permit an association of specific responses to specific respondents will not be accessible to FDA. The proposed Internet survey will collect the information from respondents electronically. With a custom-designed online survey system, responses will be entered directly into a computer database, eliminating the need for additional coding and data entry operations. Also, the system will ensure that conditional questions are asked in proper order, freeing the respondent from the need to keep track of the question order and skip patterns. The data quality will also be higher because the instrument will contain built-in edits, prompts, and data validation features. The Internet survey method was selected due to the following considerations:

(1)E-mail addresses of the respondents are available from the FDA Food Facility Registration database and are continuously validated by FDA,

(2)the Internet survey method is the least costly to the agency when compared with other modes of collection and generates the timeliest responses,

(3)the Internet survey will impose a relatively modest reporting burden on small entities, and

(4)the Internet survey method is the only feasible method by which FDA may survey foreign facilities that export food products to the United States. The Internet survey includes a pledge of confidentiality regarding the contractor's use of the data provided by the respondents. All data will be collected and compiled by Eastern Research Group, Inc. (ERG), an independent consulting firm contracted by FDA. ERG will provide FDA personnel only with a summary of data (aggregated statistical data) compiled in the course of the study. No reports will have information about individual facility participation or lack of participation, or information that enables FDA to determine individual responses. In keeping with longstanding FDA practice, ERG will not provide FDA with identifiers that would permit the association of specific responses with a given respondent. Responses will not be the property of the Federal government. The raw data generated by the Internet survey will not be owned by FDA, will not be an FDA record, and will not be provided, or otherwise made available, to FDA. The key information to be collected includes responses to questions about the following:

(1)Training procedures and practices for food production managers, production supervisors, quality control personnel, sanitation and cleaning supervisors, and production line employees on the topics of food safety, basic cleaning, sanitizing, sanitation, personal hygiene, specific product and equipment training, and allergen control;

(2)pest control and sanitation procedures and practices for food contact surfaces, non-food contact surfaces, production areas, and warehouses;

(3)allergen control procedures and practices for soybean or soybean-based ingredients, peanuts or peanut-based ingredients, finfish and crustacea, tree nuts, milk and other diary products, eggs, and wheat or wheat-based products;

(4)process controls, including written procedures for handling incoming raw materials, approving vendors, the calibration of operating equipment, pathogen control, and a Hazard Analysis and Critical Control Point system;

(5)recordkeeping practices;

(6)the primary operation characteristics conducted at the facility, such as the type of food manufactured or processed for human consumption; and

(7)fresh produce and ready to eat packing practice and post harvest operations. In the **Federal Register** of September 14, 2005 (70 FR 54390), FDA published a 60-day notice requesting public comment on the information collection provisions. We received comments from three respondents on the 60-day notice regarding the collection entitled “FDA Survey of Current Manufacturing Practices in the Food Industry.” One of the respondents' comments was received after the 60-day comment period closed and is not addressed. Respondents were asked to submit comments pertaining to 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. Comments outside the scope of these four questions are not addressed in this notice. (Comment 1) One industry respondent wanted assurances from FDA that individual company information was not subject to release under the Freedom of Information Act (FOIA). (Response 1) The Internet survey includes a pledge of confidentiality regarding the data provided by the respondent. All data will be collected, compiled, and owned by ERG, an independent consulting firm contracted by FDA. ERG is contractually obligated to retain the raw data and to not provide FDA with access to it. ERG will provide FDA personnel only with anonymous summary and aggregate statistical data compiled during the course of the study; ERG is contractually restricted from providing FDA with raw or other data that has identifiers that would permit the association of specific responses to a given respondent. Data that FDA does not own cannot be requested through the FOIA. (Comment 2) The respondent requests that only one contact be made for each individual firm through the parent company contact listed on the firm's facility registration form and not to each location where the firm has a production facility. (Response 2) We recognize the additional burden this places on a firm but because we need current information from each manufacturing plant we do not believe that we have an alternative approach. Not every facility processes the same types of foods with the same preventive controls even when the parent company is the same. We need to get an idea of CGMPs at each facility location. Having a parent company respond could give us inaccurate information. (Comment 3) The respondent requests that each firm (facility) receive only one solicitation for information. (Response 3) Response to this survey is voluntary. For the sake of statistical reliability, we must contact non-responders more than just initially or our survey data result could be subject to a non-response bias. Non-response bias is affected by both the proportion of non-responders and the extent to which non-respondents and respondents differ on key questions being measured in the survey. To reduce the bias, it is necessary to reduce the number of non-responders by contacting them multiple times. It also helps to obtain information about non-responders to assess whether their socio-demographic characteristics differ systematically from survey responders. Survey researchers should always try to follow up with individuals who do not consent to participate in a survey and ascertain their reasons for non-response. We do recognize that there should be an upper limit for the number of times a non-responder should be contacted before being dropped. From our experience, data quality will not be improved significantly by more than six contacts, so we will set our upper limit at six contacts. (Comment 4) One respondent opposes investigating foreign manufacturers. (Response 4) We are not investigating foreign manufacturers; we are surveying them to get an idea about their manufacturing practices. Nearly 20 percent of all imports into the United States are food and food products; imported fresh produce and seafood make up a large percentage of these imports. All food, including imported and domestic food, must follow the same manufacturing regulations, thus information on foreign manufacturing processes is necessary and relevant to help inform us about how to modernize our regulation on CGMPs for food facilities. At the time of the 60-day notice, approximately 45,000 domestic and 55,000 foreign facilities were registered with FDA. Now approximately 126,000 domestic and 81,000 facilities from Japan, Canada, China, France, Italy, and Mexico are registered with FDA. Recent experience with online surveys has shown that fewer respondents respond than estimated at the time of the 60-day notice. Estimates of public burden have been adjusted to account for the increase in respondents and our estimate of the decrease in response rate. FDA estimates the burden of this collection of information as follows: **Table 1.—Estimated Annual Reporting Burden** 1 Activity No. of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours Domestic Facilities Screening questions only 17,000 1 17,000 .067 1,139 Completed survey 44,500 1 44,500 .75 33,375 Total domestic 61,500 61,500 34,514 Foreign Facilities Screening questions only 14,000 1 14,000 .067 938 Completed survey 26,000 1 26,000 .75 19,500 Total foreign 40,000 1 40,000 20,438 Grand total 101,500 54,952 1 There are no capital costs or operating and maintenance costs associated with this collection of information. These estimates of the number of respondents and the burden hours per response are based on FDA's registration database and FDA and the contractor's experience with previous surveys. The respondents are divided into two groups: Domestic and foreign. We estimate the number of domestic facilities at 126,000 based on information in the registration database. However, we do not expect that all of these firms will participate in the survey. We anticipate that approximately 61,500 facilities will participate, which takes into account typical response rates to these types of surveys and inaccurate contact information that facilities have entered into the registration database (see *http://www.cfsan.fda.gov/~furls/ffregacc.html* ). Similarly, among the 81,000 foreign facilities in the registration database, we expect that 40,000 foreign facilities will respond. We estimate that it will take a respondent 4 minutes (.067 hours) to complete the screening questions and 45 minutes (0.75 hours) to complete the entire survey. Prior to the administration of the survey, the agency plans to conduct a pretest of the final survey to identify and resolve potential problems. The pretest will be conducted with nine participants. Dated: May 2, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-8783 Filed 5-7-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0363] Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Absorbable Hemostatic Device; Availability; Reopening of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of comment period. SUMMARY: The Food and Drug Administration

(FDA)is reopening until June 7, 2007, the comment period for a draft guidance entitled “Class II Special Controls Guidance Document: Absorbable Hemostatic Device.” FDA published a notice of availability of the draft guidance in the **Federal Register** of October 31, 2006 (71 FR 63774). The draft guidance describes a means by which the absorbable hemostatic device may comply with the requirement of special controls for class II devices, if the device is reclassified. Elsewhere in this issue of the **Federal Register** , FDA is reopening the comment period on a proposed rule to reclassify the absorbable hemostatic device from class III (premarket approval) into class II (special controls) DATES: Submit written or electronic comments on the draft guidance by June 7, 2007. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the draft guidance document entitled “Class II Special Controls Guidance Document: Absorbable Hemostatic Device” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments *http://www.fda.gov/dockets/ecomments* . Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: David Krause, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3090, ext. 141. SUPPLEMENTARY INFORMATION: I. Background In the **Federal Register** of October 31, 2006 (71 FR 63728), FDA published a proposed rule to reclassify the absorbable hemostatic device intended to produce hemostasis from class III (premarket approval) into class II (special controls). In the same issue of the **Federal Register** (71 FR 63774), FDA published a notice of availability of a draft guidance document entitled “Class II Special Controls Guidance Document: Absorbable Hemostatic Device.” The draft guidance describes a means by which the absorbable hemostatic device may comply with the requirement of special controls if they were reclassified. FDA invited interested persons to comment on the proposed rule and on the draft guidance document by January 29, 2007. Two companies requested FDA to extend the comment period on the proposed rule by 90 days because the proposal presented complex medical and scientific issues that required the company to assemble a team of many different specialties in order to prepare their comments. Elsewhere in this issue of the **Federal Register** , FDA is reopening the comment period on the proposed rule for 30 days. Because the issues presented by the guidance document are intertwined with those presented by the proposed rule, FDA is reopening the comment period on the guidance document for the same period. II. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. To receive the draft guidance document entitled “Class II Special Controls Document: Absorbable Hemostatic Device,” you may either send an e-mail request to *dsmica@fda.hhs.gov* to receive an electronic copy of the document, or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number 1558 to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, **Federal Register** reprints, information on premarket submissions (including lists of approved submissions, approved applications, and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at *http://www.fda.gov/cdrh* . A search capability for all CDRH guidance documents are also available on the Division of Dockets Management Internet site at *http://www.fda.gov/ohrms/dockets.* III. Request for Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments on the draft guidance document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: April 25, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-8780 Filed 5-7-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007D-0027] Voluntary Self-Inspection of Medicated Feed Manufacturing Facilities; Draft Compliance Policy Guide; Availability; Reopening of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of comment period. SUMMARY: The Food and Drug Administration

(FDA)is reopening to June 8, 2007, the comment period for the notice of availability that appeared in the **Federal Register** of February 12, 2007 (72 FR 6572). In the notice, FDA requested comments on the draft compliance policy guide on voluntary self-inspection of medicated feed manufacturing facilities. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. DATES: Submit written and electronic comments by June 8, 2007. ADDRESSES: Submit written comments on the draft compliance policy guide 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* . See the SUPPLEMENTARY INFORMATION section for electronic access to the documents. FOR FURTHER INFORMATION CONTACT: Paul Bachman, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9225, e-mail: *Paul.Bachman@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background In the **Federal Register** of February 12, 2007 (72 FR 6572), FDA published a notice of availability with a 75-day comment period to request comments on a draft compliance policy guide

(CPG)on voluntary self inspection of medicated feed manufacturing facilities. The purpose of this CPG is intended to provide guidance to FDA field offices on considering, among other factors, the conduct of self-inspections when prioritizing inspections of medicated feed manufacturing facilities for compliance with Current Good Manufacturing Practices for Medicated Feeds regulations. The agency has received a request for an extension of the comment period for the draft compliance policy guide. This request conveyed concern that the current 75-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the compliance policy guide. FDA has considered the request and is reopening the comment period for the draft compliance policy guide until June 8, 2007. The agency believes this reopening allows adequate time for interested persons to submit comments. II. Request for Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments on these documents. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: May 1, 2007. David Horowitz, Assistant Commissioner for Regulatory Affairs. [FR Doc. E7-8781 Filed 5-7-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review—Comment Request Periodically, the Health Resources and Services Administration

(HRSA)publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on

(301)443-1129. The following request has been submitted to OMB for review under the Paperwork Reduction Act of 1995: Proposed Project: National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners: Regulations and Forms (OMB No. 0915-0126)—Extension The National Practitioner Data Bank

(NPDB)was established through Title IV of Public Law (Pub. L.) 99-660, the *Health Care Quality Improvement Act of 1986,* as amended. Final regulations governing the NPDB are codified at 45 CFR part 60. Responsibility for NPDB implementation and operation resides in the Bureau of Health Professions, Health Resources and Services Administration, Department of Health and Human Services. The NPDB began operation on September 1, 1990. The intent of Title IV of Pub. L. 99-660 is to improve the quality of health care by encouraging hospitals, State licensing boards, professional societies, and other entities providing health care services, to identify and discipline those who engage in unprofessional behavior; and to restrict the ability of incompetent physicians, dentists, and other health care practitioners to move from State-to-State without disclosure of the practitioner's previous damaging or incompetent performance. The NPDB acts primarily as a flagging system; its principal purpose is to facilitate comprehensive review of practitioners' professional credentials and background. Information on medical malpractice payments, adverse licensure actions, adverse clinical privileging actions, adverse professional society actions, and Medicare/Medicaid exclusions is collected from, and disseminated to, eligible entities. It is intended that NPDB information should be considered with other relevant information in evaluating a practitioner's credentials. The reporting forms and the request for information forms (query forms) are accessed, completed, and submitted to the NPDB electronically through the NPDB Web site at *http://www.npdb-hipdb.hrsa.gov.* All reporting and querying is performed through this secure Web site. Due to overlap in requirements for the Healthcare Integrity and Protection Data Bank (HIPDB), some of the NPDB's burden has been subsumed under the HIPDB. *Estimates of annualized burden are as follows:* Regulation citation No. of respondents Frequency of responses Hours per response (minutes) Total burden hours 60.6(a) Errors & Omissions 315 4 15 315 60.6(b) Revisions to Actions 109 1 30 54.5 60.7(b) Medical Malpractice Payment Reports 519 29 45 11,288.25 60.8(b) Adverse Action Reports—State Boards 0 0 0 60.9(a)3 Adverse Action Reports—Clinical Privileges & Professional Society 480 2 45 720 Requests for Hearings by Entities 0 0 480 0 60.10(a)(1) Queries by Hospital—Practitioner Applications 0 0 0 0 60.10(a)(2) Queries by Hospitals—2 Year Cycle 5,996 213 5 106,429 60.11(a)(1) Disclosure to Hospitals 0 0 0 0 60.11(a)(2) Disclosure to Practitioners (Self-Query) 0 0 0 0 60.11(a)(3) Disclosure to Licensure Boards 87 645 5 4,676.25 60.11(a)(4) Queries by Non-Hospital Health Care Entities 7,305 322 5 196,017.5 60.11(a)(5) Queries by Plaintiffs' Attorneys 5 1 30 2.5 60.11(a)(6) Queries by Non-Hospital Health Care Entities-Peer Review 0 0 0 0 60.11(a)(7) Requests by Researchers for Aggregate Data 20 1 30 10 60.14(b) Practitioner Places a Report in Disputed Status 404 1 15 101 60.14(b) Practitioner Statement 1,415 1 45 1,061.25 60.14(b) Practitioner Requests for Secretarial Review 27 1 480 216 60.3 Entity Registration—Initial 1,447 1 60 1,447 60.3 Entity Registration—Update 13,115 1 5 1,092.92 60.11(a) Authorized Agent Designation—Initial 717 1 15 179.25 60.11(a) Authorized Agent—Update 139 1 5 11.58 60.12(c) Account Discrepancy Report 5 1 15 1.25 60.12(c) Electronic Funds Transfer Authorization 284 1 15 71 60.3 Entity Reactivation 0 1 Total Burden Hours 323,694.25 Numbers in the table may not add up exactly due to rounding. Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to: Karen Matsuoka, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503. Dated: May 2, 2007. Caroline Lewis, Associate Administrator for Management. [FR Doc. E7-8796 Filed 5-7-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration

(301)443-1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: The Stem Cell Therapeutic Outcomes Database—(New) The Stem Cell Therapeutic and Research Act of 2005 establishes the C.W. Bill Young Cell Transplantation Program and provides for the collection and maintenance of human blood stem cells for the treatment of patients and for research. The Health Resources and Services Administration's (HRSA), Healthcare Systems Bureau (HSB), is establishing the Stem Cell Therapeutic Outcomes Database as one component of the C.W. Bill Young Cell Transplantation Program. Operation of this database necessitates certain reporting requirements in order to perform the functions related to hematopoietic stem cell transplantation under contract to HHS. The Act requires the Secretary to contract for the collection and maintenance of information related to patients who have received stem cell therapeutic products and to do so using a standardized, electronic format. Data will be collected from transplant centers in a manner similar to the data collection activities historically conducted by the Medical College of Wisconsin's Center for International Blood and Marrow Transplant Research (CIBMTR) and will be used for ongoing analysis of transplant outcomes. HRSA will use the information in order to carry out its statutory responsibilities. Information is needed to monitor the clinical status of transplantation, and to provide the Secretary with an annual report of transplant center-specific survival data. The estimate of burden is as follows: Form Estimated number of respondents Responses per respondent Total Responses Hours per response Total burden hours Baseline Pre-TED (Transplant Essential Data) 225 32 7,200 0.85 6,120 Product Form (includes Infusion, HLA, and Infectious Disease Marker inserts) 225 14 3,150 1.5 4,725 100-Day Post-TED 225 32 7,200 0.85 6,120 6-Month Post-TED 225 23 5,175 1.00 5,175 12-Month Post-TED 225 20 4,500 1.00 4,500 Annual Post-TED 225 16 3,600 1.50 5,400 Total 225 30,825 32,040 The Pre-TED, Product Form, 100-Day Post-TED, 6-Month Post-TED, and 12-Month Post-TED will be collected on all patients during their first year of transplant. In subsequent years, patient outcomes will be reported on the Annual Post-TED form. There will be a gradual increase in the cumulative reporting burden over time commensurate with the number of survivors for which transplant centers must submit an Annual Post-TED. Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to: Karen Matsuoka, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503. Dated: May 2, 2007. Caroline Lewis, Associate Administrator for Management. [FR Doc. E7-8799 Filed 5-7-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Announcement of a Change to the Awarding Factors Under the Fiscal Year 2007 New Access Points in High Poverty Counties (HRSA-07-069) Grant Opportunity AGENCY: Health Resources and Services Administration (HRSA), HHS. ACTION: Revision to awarding factors. SUMMARY: The Health Resources and Services Administration

(HRSA)is announcing a change to the awarding factors under the HRSA-07-069 “New Access Points in High Poverty Counties” funding opportunity [issued on Grants.gov March 14, 2007] as they relate to awards made under the HRSA-07-067 “New Access Points” funding opportunity for the President's first Health Centers Initiative [issued on Grants.gov October 6, 2006]. In making award decisions for fiscal year

(FY)2007, HRSA will now consider granting the same organization a new access point award under HRSA-07-067 and HRSA-07-069. HRSA will consider more than one FY 2007 new access point award to an organization if, and only if each application submitted (by the same organization for the two different funding opportunities) proposes a separate and distinct project to serve different counties. That is, there must be no overlap or duplication of service area, target population, or sites. (Under previous HRSA policy, if an organization receives a grant award in FY 2007 under the first opportunity, HRSA-07-067, it could not be awarded funds in FY 2007 under HRSA-07-069). Applicants for HRSA-07-069 should also be aware that each new access point application must be complete and must be able to stand alone. The changes announced in this **Federal Register** Notice do not impact any HRSA policy for eligibility under the HRSA-07-069. Organizations continue to be eligible to submit one application under HRSA-07-069, irrespective of whether they applied under HRSA-07-067 or not. Additionally, all other awarding factors detailed in HRSA-07-069 remain the same. *Reference:* HRSA-07-069 is available online via the HRSA Web site at: *http://www.hrsa.gov/grants/technicalassistance/pi2nap.htm* or *http://www.grants.gov* . FOR FURTHER INFORMATION CONTACT: Preeti Kanodia, Division of Policy and Development, Bureau of Primary Health Care, Health Resources and Services Administration. Ms. Kanodia may be contacted by e-mail at *DPDGeneral@hrsa.gov* or via telephone at

(301)594-4300. Dated: May 2, 2007. Dennis P. Williams, Deputy Administrator. [FR Doc. E7-8712 Filed 5-7-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HOMELAND SECURITY Office of Operations Coordination; Homeland Security Information Network Advisory Council AGENCY: Office of Operations Coordination, DHS. ACTION: Committee Management; Request for Applicants for Appointment to the Homeland Security Information Network Advisory Council. SUMMARY: The Office of Operations Coordination at the Department of Homeland Security is requesting individuals who are interested in serving on the Homeland Security Information Network Advisory Council (HSINAC) to apply for appointment. The HSINAC provides advice and makes recommendations to the leadership of the Department of Homeland Security, particularly the Director, Office of Operations Coordination, on the requirements of end users within State, Local, Federal and Tribal governments and the Private Sector regarding the Homeland Security Information Network (HSIN). DATES: Applications for membership should reach the Department of Homeland Security at the address below on or before June 22, 2007. ADDRESSES: If you wish to apply for membership, your application should be submitted by: • E-mail: *hsinac.comments@dhs.gov.* • Fax: 202-282-8191. FOR FURTHER INFORMATION CONTACT: David Castillo, 202-282-9580. SUPPLEMENTARY INFORMATION: The Homeland Security Information Network Advisory Committee is an advisory committee established in accordance with the provisions of the Federal Advisory Committee Act

(FACA)5 U.S.C. App. (Pub. L. 92-463). HSINAC membership shall include not more than 20 representatives from State, Tribal and Local governments and the Private Sector, who are outstanding within their specialty field, and who have the experience to ensure the Director, and DHS leadership, is informed of the needs and requirements of the information network users and communities of users. Members will be drawn from currently serving Homeland Security Advisors; State, Tribal, or Local Law Enforcement; Federal Law Enforcement; the Fire Service; Public Health; Emergency Managers; and, the Private Sector. The committee will convene no more than twice per year. Travel and per diem will be provided by the Department. Term length shall generally be 3 years. The initial members of the HSINAC shall be appointed to terms of office of 2, 3, and 4 years in order to promote continuity and an orderly turnover of committee membership. A security clearance is preferred, but is not a requirement for appointment to the committee. Those applicants who do not have a security clearance may be required to undergo a background investigation. HSINAC members will be appointed as Special Government Employees

(SGEs)as such term is defined for purposes of 18 U.S.C. 202(a). Appointments will be made by the Department of Homeland Security Secretary who will receive recommendations from the Office of Operations Coordination Director. As candidates for appointment as SGEs, applicants are required to complete Confidential Financial Disclosure Reports (OGE Form 450). DHS may not release the reports or the information in them to the public except under an order issued by a Federal court or as otherwise provided under the Privacy Act (5 U.S.C. 552a). Applicants can obtain this form by going to the Web site of the Office of Government Ethics ( *http://www.oge.gov* ), or by contacting David Castillo at the number listed above. Applications which are not accompanied by a completed OGE Form 450 will not be considered. In support of the policy of the Department of Homeland Security on gender and ethnic diversity, qualified women and minorities are encouraged to apply for membership. Dated: April 30, 2007. Roger Rufe, Jr., Director, Office of Operations Coordination, U.S. Department of Homeland Security. [FR Doc. E7-8739 Filed 5-7-07; 8:45 am] BILLING CODE 4410-10-P DEPARTMENT OF HOMELAND SECURITY Office of the Secretary Exercise of Authority Under Section 212(d)(3)(B)(i) of the Immigration and Nationality Act AGENCY: Office of the Secretary, DHS. ACTION: Notice of determination. DATES: This determination is effective April 27, 2007. *Authority:* 8 U.S.C. 1182(d)(3)(B)(i). Following consultations with the Secretary of State and the Attorney General, I hereby conclude, as a matter of discretion in accordance with the authority granted to me by Section 212(d)(3)(B)(i) of the Immigration and Nationality Act (“the Act”), considering the national security and foreign policy interests deemed relevant in these consultations, that subsection 212(a)(3)(B)(iv)(VI) of the Act shall not apply with respect to material support provided under duress to a terrorist organization as described in subsection 212(a)(3)(B)(vi)(I) or subsection 212(a)(3)(B)(vi)(II) if warranted by the totality of the circumstances. This exercise of authority as a matter of discretion shall apply to an alien who satisfies the agency that he:

(a)Is seeking a benefit or protection under the Act and has been determined to be otherwise eligible for the benefit or protection;

(b)Has undergone and passed relevant background and security checks;

(c)Has fully disclosed, in all relevant applications and interviews with U.S. Government representatives and agents, the nature and circumstances of each provision of such material support; and

(d)Poses no danger to the safety and security of the United States. Implementation of this determination will be made by U.S. Citizenship and Immigration Services (USCIS), in consultation with U.S. Immigration and Customs Enforcement (ICE). USCIS has discretion to determine whether the criteria are met. When determining whether the material support was provided under duress, the following factors, among others, may be considered: whether the applicant reasonably could have avoided, or took steps to avoid, providing material support, the severity and type of harm inflicted or threatened, to whom the harm was directed, and, in cases of threats alone, the perceived imminence of the harm threatened and the perceived likelihood that the harm would be inflicted. When considering the totality of the circumstances, factors to be considered, in addition to the duress-related factors stated above, may include, among others: the amount, type and frequency of material support provided, the nature of the activities committed by the terrorist organization, the alien's awareness of those activities, the length of time since material support was provided, the alien's conduct since that time, and any other relevant factor. I may revoke this exercise of authority as a matter of discretion and without notice at any time with respect to any and all persons subject to it. Any determination made under this exercise of authority as set out above shall apply to any subsequent benefit or protection application, unless it has been revoked. This exercise of authority shall not be construed to prejudice, in any way, the ability of the U.S. Government to commence subsequent criminal or civil proceedings in accordance with U.S. law involving any beneficiary of this exercise of authority (or any other person). This exercise of authority is not intended to create any substantive or procedural right or benefit that is legally enforceable by any party against the United States or its agencies or officers or any other person. This exercise of authority does not affect the continued applicability of any other security-related ground of inadmissibility in section 212 of the Act, including subsections 212(a)(3)(B)(iv)(I) through (V), which continue to render inadmissible those who have engaged in terrorist activity as enumerated by those subsections. In accordance with Section 212(d)(3)(B)(ii) of the Act, a report on the aliens to whom this exercise of authority is applied, on the basis of case-by-case decisions by the U.S. Department of Homeland Security shall be provided to the specified congressional committees not later than 90 days after the end of the fiscal year. This determination is based on an assessment related to the national security and foreign policy interests of the United States as they apply to the particular aliens described herein and shall not have any application with respect to other persons or to other provisions of U.S. law. Dated: April 27, 2007. Michael Chertoff, Secretary of Homeland Security. [FR Doc. E7-8751 Filed 5-7-07; 8:45 am] BILLING CODE 4410-10-P DEPARTMENT OF HOMELAND SECURITY Coast Guard [USCG-2007-27857] Recreational Boating Safety Projects, Programs and Activities Funded Under Provisions of the Transportation Equity Act for the 21st Century; Accounting of AGENCY: Coast Guard, DHS. ACTION: Notice. SUMMARY: For seven fiscal years starting in 1999, the Transportation Equity Act for the 21st Century has made $5 million available to the Secretary of Homeland Security for payment of Coast Guard expenses for personnel and activities directly related to coordinating and carrying out the national recreational boating safety program. In 2005, the law was amended and the amount was increased to $5.5 million. This notice is being published to satisfy a requirement of the Act that a detailed accounting of the projects, programs, and activities funded under the national recreational boating safety program provision of the Act be published annually in the **Federal Register** . In this notice we have specified the amount of monies the Coast Guard has committed, obligated or expended during fiscal year 2006, as of September 30, 2006. FOR FURTHER INFORMATION CONTACT: Jeff Ludwig, Regulations Development Manager, telephone 202-372-1062, fax 202-372-1932. *Background and Purpose:* The Transportation Equity Act for the 21st Century became law on June 9, 1998 (Pub. L. 105-178; 112 Stat. 107). The Act required that of the $5 million made available to carry out the national recreational boating safety program each year, $2 million shall be available only to ensure compliance with Chapter 43 of Title 46, U.S. Code—Recreational Vessels. On September 29, 2005, the Sportfishing and Recreational Boating Safety Amendments Act of 2005 was enacted (Pub. L. 109-74; 119 Stat. 2030). This Act increased the funds available to the national recreational boating safety program from $5 million to $5.5 million annually, and stated that “not less than” $2 million shall be available only to ensure compliance with Chapter 43 of Title 46, U.S. Code—Recreational Vessels. The responsibility to administer these funds was delegated to the Commandant of the United States Coast Guard. Subsection

(c)of section 7405 of the Act directs that no funds available to the Secretary under this subsection may be used to replace funding traditionally provided through general appropriations, nor for any purposes except those purposes authorized; namely, for personnel and activities directly related to coordinating and carrying out the national recreational boating safety program. Amounts made available each fiscal year from 1999 through 2006 shall remain available until expended. Use of these funds requires compliance with standard Federal contracting rules with associated lead and processing times resulting in a lag time between available funds and spending. The total amount of funding, transferred to the Coast Guard from the Sport Fish Restoration and Boating Trust Fund, committed, obligated, and/or expended during fiscal year 2006 for each activity is shown below. *Factory Visit Program:* Funding was provided to continue the national recreational boat factory visit program, initiated in January 2001. The factory visit program currently allows contractor personnel, acting on behalf of the Coast Guard, to visit 2,000 recreational boat manufacturers each year to inspect for compliance with federal regulations, communicate with the manufacturers as to why they need to comply with federal regulations, and educate them, as necessary, on how to comply with federal regulations. ($2,105,905) *Boat Compliance Testing:* Funding was provided for expansion of the boat compliance testing program whereby new manually propelled and outboard recreational boats are purchased in the open market and tested for compliance with the Federal flotation standards. The expanded program includes inboard/sterndrive boats and used boats. ($100,000) *Associated Equipment Compliance Testing:* A contract was awarded to buy recreational boat “associated equipment” ( *e.g.* , starters, alternators, fuel pumps, and bilge pumps) and test this equipment for compliance with federal safety regulations. This new initiative complements the boat compliance testing program. ($150,000) *New Recreational Boating Safety Associated Travel:* Travel by employees of the Office of Boating Safety was performed to carry out additional recreational boating safety actions and to gather background and planning information for new recreational boating safety initiatives. ($17,457) *Carbon Monoxide Research:* Under a Memorandum of Agreement between the Office of Boating Safety and the Department of Health and Human Services, U.S. Public Health Service, Federal Occupational Health Program, funding was provided to continue investigation into identifying and classifying additional recreational boating carbon monoxide hazards. ($150,000) *Boating Accident News Clipping Service:* A contract was awarded to gather daily news stories of recreational boating accidents nationally for more real time accident information and to identify accidents that may involve regulatory non-compliances or safety defects. ($37,896) *Accident Investigation Tiger Team:* A contract was awarded to provide on-call expert accident investigative services for any boating accident that appeared to involve a regulatory non-compliance or safety defect. ($56,575) *Web-based Document Management System:* A contract was awarded to provide web-based document management to better enable the handling of thousands of recreational boating recall cases and campaign reports. ($65,217) *Safety Decals:* Emergency Radio Call Procedures Decal used to promote proper emergency radio procedures for recreational vessels were produced and distributed. These are designed to be displayed immediately adjacent to the vessel's VHF-FM marine radio and assist vessel operators in properly making emergency radio calls. ($25,810) *Low Power Radio Transmitter System:* The project funded a low power travelers information radio transmitter system in the 13th Coast Guard District for continual transmission of Bar conditions and restrictions as well as boating safety information to the boating public. ($28,471) *Recreational Boating Safety

(RBS)Outreach Program:* Funding was provided for this program which provides full marketing, media, public information, and program strategy support to the nation-wide RBS effort. The goal is to coordinate the RBS outreach initiatives and campaigns some of which include: National Boating Under the Influence Campaign (BUI), “You're in Command. Boat Responsibly!”, PFD Wear, Vessel Safety Check Program (VSC), Boating Safety Education Courses, Propeller Strike Avoidance, Carbon Monoxide Poisoning, and other recreational boating safety issues on an as needed basis. ($1,032,258) *Virtual Reality Personal Watercraft (PWC):* A virtual reality PWC was developed under contract to provide a platform to gather objective data on operator reactions to various scenarios. This information would otherwise be unobtainable or would require more costly methods and sources, due to the risk of injury to the operator as well as due to the difficulty of accurately replicating conditions for all operators. The virtual reality PWC is being used in various test scenarios to collect human factors data including the measurement of reactive movements and reaction time that will assist in making decisions or taking action to improve personal watercraft safety. The data from this effort will give greater insight into the human-machine interface related to PWC operation and will assist in the effort to attempt to reduce PWC accidents. ($50,000) *Boating Accident Report Database

(BARD)Web System:* BARD Web System funding enables reporting authorities in the 50 States, five U.S. Territories and the District of Columbia to manage their accident reports electronically over a secure Internet environment. The system also enables the user community to generate statistical reports that show the frequency, nature, and severity of boating accidents. FY 06 funds supported system maintenance, technical (hotline) support and formal classroom instruction for the entire user community. ($438,781) *Personnel Support:* Funding was provided for personnel to support the development of new regulations, to support new contracting activities associated with the additional funding, and to monitor and manage the contracts awarded. ($573,188) *Propeller Injury Avoidance Working Group:* Travel expenses were reimbursed for subject-matter experts to convene as a working group to explore ways that injuries associated with propeller strikes could be minimized. ($12,505) *National Recreational Boating Safety Program Strategic Planning:* Meetings were conducted to continue strategic planning for the national recreational boating safety program. Funds were expended on meeting space, supplies, and travel expenses for members of the strategic planning panel. ($95,172) *National Recreational Boating Survey:* A national recreational boating survey was conducted to obtain up-to-date statistical estimates on recreational boating. Over 25,000 surveys were completed with individuals who boated between September 2001 and September 2002. Survey findings were extrapolated to produce national, regional and State estimates of boat use as well as the characteristics of boat operators, passengers, boats, safety equipment, and the boating environment. ($118,056) A total of $26,365,949 of the $35,000,000 made available to the Coast Guard through annual transfers of $5 million in fiscal years 1999, 2000, 2001, 2002, 2003, 2004 and 2005 has been committed, obligated or expended as of September 30, 2005. Of the $5.5 million made available to the Coast Guard in fiscal year 2006, $2,711,375 has been committed, obligated or expended and an additional $2,345,916 of prior fiscal year funds has been committed, obligated or expended, as of September 30, 2006. Therefore, a total of $31,423,240 of the $40,500,000 made available to the Coast Guard through annual transfers of $5 million in fiscal years 1999, 2000, 2001, 2002, 2003, 2004, 2005 and $5.5 million in 2006 has been committed, obligated or expended as of September 30, 2006. Of the remaining funds that have not been committed, obligated or expended, $8.1 million is being reserved for a multi-year national boating study. Dated: April 24, 2007. F.J. Sturm, Captain, U.S. Coast Guard, Acting Director of Inspections and Compliance. [FR Doc. E7-8738 Filed 5-7-07; 8:45 am] BILLING CODE 4910-15-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Federal Emergency Management Agency, DHS. ACTION: Notice and request for comments. SUMMARY: The Federal Emergency Management Agency (FEMA), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a proposed continuing information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning temporary housing units for disaster victims of federally declared disasters. SUPPLEMENTARY INFORMATION: Public Law 93-288, as amended by Public Law 100-707, the Robert T. Stafford Disaster Relief and Emergency Assistance Act, section 408, authorizes FEMA to provide Temporary Housing Assistance. This type of assistance could be in form of mobile homes, travel trailers, or other readily fabricated dwellings. This assistance is used when required to provide disaster housing for victims of federally declared disasters. Accordingly the FEMA Form 90-1 is designed to ensure sites for temporary housing units that will accommodate the home and comply with local, State and Federal regulations regarding the placement of the temporary housing unit; FEMA Form 90-31, ensures that the landowner (if other than the recipient of the housing unit) will allow the temporary housing unit to be placed on the property; and ensure that routes on the ingress and egress to and from the property are maintained. Collection of Information *Title:* Request for Site Inspection; Landowners Authorization/Ingress-Egress Agreement. *Type of Information Collection:* Revision of a currently approved collection. *OMB Number:* 1660-0030. *Form Numbers:* FEMA Form 90-1 (Request for Site Inspection) and FEMA Form 90-31 Landowners Authorization/Ingress-Egress Agreement. *Abstract:* FEMA's Temporary Housing Assistance is used to provide mobile homes, travel trailers, or other forms of readily fabricated forms of housing for the purpose of providing temporary housing to eligible applicants or victims of federally declared disasters. This information is required to determine the feasibility of the site for installation of the housing unit and ensured written permission of the property owner is obtained to allow the housing unit on the property to include ingress and egress permission. *Affected Public:* Individuals or Households. *Estimated Total Annual Burden Hours:* 38,868. Annual Burden Hours Project/activity (survey, form(s), focus group, worksheet, etc.) No. of respondents

(A)Frequency of responses

(B)Burden hours per respondent

(C)Annual responses

(D)= (A×B) Total annual burden hours

(E)= (C×D) 90-1 117,071 1 0.166 or (10 min) 117,071 19,434 90-31 117,071 1 0.166 or (10 min) 117,071 19,434 Total 234,142 234,142 38,868 *Estimated Cost:* $107,664.36. *Comments:* Written comments are solicited to

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

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

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

(d)minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, *e.g.* , permitting electronic submission of responses. Comments must be submitted on or before July 9, 2007. ADDRESSES: Interested persons should submit written comments to Chief, Records Management and Privacy Section, Information Resources Management Branch, Information Technology Services Division, Federal Emergency Management Agency, 500 C Street, SW., Room 609, Washington, DC 20472. FOR FURTHER INFORMATION CONTACT: Contact Anthony Johnson, Program Specialist, Disaster Assistance Directorate, telephone number

(202)314-5536 for additional information. You may contact the Records Management Branch for copies of the proposed collection of information at facsimile number

(202)646-3347 or e-mail address: *FEMA-Information-Collections@dhs.gov.* Dated: April 27, 2007. John A. Sharetts-Sullivan, Chief, Records Management and Privacy, Information Resources Management Branch, Information Technology Services Division, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. E7-8749 Filed 5-7-07; 8:45 am] BILLING CODE 9110-10-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1693-DR] Maine; Major Disaster and Related Determinations AGENCY: Federal Emergency Management Agency, DHS. ACTION: Notice. SUMMARY: This is a notice of the Presidential declaration of a major disaster for the State of Maine (FEMA-1693-DR), dated April 25, 2007, and related determinations. DATES: *Effective Date:* April 25, 2007. FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Disaster Assistance Directorate, Federal Emergency Management Agency, Washington, DC 20472,

(202)646-2705. SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter dated April 25, 2007, the President declared a major disaster under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act), as follows: I have determined that the damage in certain areas of the State of Maine resulting from severe storms and inland and coastal flooding beginning on April 15, 2007, and continuing, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act). Therefore, I declare that such a major disaster exists in the State of Maine. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses. You are authorized to provide Public Assistance in the designated areas, Hazard Mitigation throughout the State, and any other forms of assistance under the Stafford Act that you deem appropriate. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Public Assistance and Hazard Mitigation will be limited to 75 percent of the total eligible costs. If Other Needs Assistance under Section 408 of the Stafford Act is later warranted, Federal funding under that program will also be limited to 75 percent of the total eligible costs. Further, you are authorized to make changes to this declaration to the extent allowable under the Stafford Act. The Federal Emergency Management Agency

(FEMA)hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Albert L. Lewis, of FEMA is appointed to act as the Federal Coordinating Officer for this declared disaster. I do hereby determine the following areas of the State of Maine to have been affected adversely by this declared major disaster: Androscoggin, Cumberland, Kennebec, Knox, Oxford, and York Counties for Public Assistance. All counties within the State of Maine are eligible to apply for assistance under the Hazard Mitigation Grant Program. (The following Catalog of Federal Domestic Assistance Numbers

(CFDA)are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis Counseling; 97.033, Disaster Legal Services Program; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance; 97.048, Individuals and Households Housing; 97.049, Individuals and Households Disaster Housing Operations; 97.050 Individuals and Households Program-Other Needs, 97.036, Public Assistance Grants; 97.039, Hazard Mitigation Grant Program.) R. David Paulison, Administrator, Federal Emergency Management Agency. [FR Doc. E7-8740 Filed 5-7-07; 8:45 am] BILLING CODE 9110-10-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1693-DR] Maine; Amendment No. 1 to Notice of a Major Disaster Declaration AGENCY: Federal Emergency Management Agency, DHS. ACTION: Notice. SUMMARY: This notice amends the notice of a major disaster declaration for the State of Maine (FEMA-1693-DR), dated April 25, 2007, and related determinations. DATES: *Effective Date:* April 30, 2007. FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Disaster Assistance Directorate, Federal Emergency Management Agency, Washington, DC 20472,

(202)646-2705. SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration for the State of Maine 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 25, 2007: Franklin, Hancock, Lincoln, Sagadahoc, Somerset, and Waldo Counties for Public Assistance. (The following Catalog of Federal Domestic Assistance Numbers

(CFDA)are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis Counseling; 97.033, Disaster Legal Services Program; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance; 97.048, Individuals and Households Housing; 97.049, Individuals and Households Disaster Housing Operations; 97.050 Individuals and Households Program-Other Needs, 97.036, Public Assistance Grants; 97.039, Hazard Mitigation Grant Program.) R. David Paulison, Administrator, Federal Emergency Management Agency. [FR Doc. E7-8741 Filed 5-7-07; 8:45 am] BILLING CODE 9110-10-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1695-DR] New Hampshire; Major Disaster and Related Determinations AGENCY: Federal Emergency Management Agency, DHS. ACTION: Notice. SUMMARY: This is a notice of the Presidential declaration of a major disaster for the State of New Hampshire (FEMA-1695-DR), dated April 27, 2007, and related determinations. DATES: *Effective Date:* April 27, 2007. FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Disaster Assistance Directorate, Federal Emergency Management Agency, Washington, DC 20472,

(202)646-2705. SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter dated April 27, 2007, the President declared a major disaster under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act), as follows: I have determined that the damage in certain areas of the State of New Hampshire resulting from severe storms and flooding beginning on April 15, 2007, and continuing, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act). Therefore, I declare that such a major disaster exists in the State of New Hampshire. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses. You are authorized to provide Individual Assistance and Public Assistance in the designated areas and Hazard Mitigation throughout the State. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Public Assistance, Hazard Mitigation, and Other Needs Assistance will be limited to 75 percent of the total eligible costs. Further, you are authorized to make changes to this declaration to the extent allowable under the Stafford Act. The time period prescribed for the implementation of section 310(a), Priority to Certain Applications for Public Facility and Public Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed six months after the date of this declaration. The Federal Emergency Management Agency

(FEMA)hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Albert L. Lewis, of FEMA is appointed to act as the Federal Coordinating Officer for this declared disaster. I do hereby determine the following areas of the State of New Hampshire to have been affected adversely by this declared major disaster: Grafton, Hillsborough, Merrimack, Rockingham, and Strafford Counties for Individual Assistance. Belknap, Carroll, Cheshire, Grafton, Hillsborough, Merrimack, Rockingham, Strafford, and Sullivan Counties for Public Assistance. All counties within the State of New Hampshire are eligible to apply for assistance under the Hazard Mitigation Grant Program. (The following Catalog of Federal Domestic Assistance Numbers

(CFDA)are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis Counseling; 97.033, Disaster Legal Services Program; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance; 97.048, Individuals and Households Housing; 97.049, Individuals and Households Disaster Housing Operations; 97.050 Individuals and Households Program-Other Needs, 97.036, Public Assistance Grants; 97.039, Hazard Mitigation Grant Program.) R. David Paulison, Administrator, Federal Emergency Management Agency. [FR Doc. E7-8750 Filed 5-7-07; 8:45 am] BILLING CODE 9110-10-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1694-DR] New Jersey; Major Disaster and Related Determinations AGENCY: Federal Emergency Management Agency, DHS. ACTION: Notice. SUMMARY: This is a notice of the Presidential declaration of a major disaster for the State of New Jersey (FEMA-1694-DR), dated April 26, 2007, and related determinations. DATES: *Effective Date:* April 26, 2007. FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Disaster Assistance Directorate, Federal Emergency Management Agency, Washington, DC 20472,

(202)646-2705. SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter dated April 26, 2007, the President declared a major disaster under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act), as follows: I have determined that the damage in certain areas of the State of New Jersey resulting from severe storms and inland and coastal flooding during the period of April 14-20, 2007, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act). Therefore, I declare that such a major disaster exists in the State of New Jersey. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses. You are authorized to provide Individual Assistance in the designated areas, Hazard Mitigation throughout the State, and any other forms of assistance under the Stafford Act that you deem appropriate. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation and Other Needs Assistance will be limited to 75 percent of the total eligible costs. If Public Assistance is later warranted, Federal funds provided under that program will also be limited to 75 percent of the total eligible costs. Further, you are authorized to make changes to this declaration to the extent allowable under the Stafford Act. The time period prescribed for the implementation of section 310(a), Priority to Certain Applications for Public Facility and Public Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed six months after the date of this declaration. The Federal Emergency Management Agency

(FEMA)hereby gives notice that pursuant to the authority vested in the Administrator, Department of Homeland Security, under Executive Order 12148, as amended, Peter J. Martinasco, of FEMA is appointed to act as the Federal Coordinating Officer for this declared disaster. I do hereby determine the following areas of the State of New Jersey to have been affected adversely by this declared major disaster: Bergen, Burlington, Essex, Passaic, Somerset, and Union Counties for Individual Assistance. All counties within the State of New Jersey are eligible to apply for assistance under the Hazard Mitigation Grant Program. (The following Catalog of Federal Domestic Assistance Numbers

(CFDA)are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis Counseling; 97.033, Disaster Legal Services Program; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance; 97.048, Individual and Household Housing; 97.049, Individual and Household Disaster Housing Operations; 97.050 Individual and Household Program-Other Needs, 97.036, Public Assistance Grants; 97.039, Hazard Mitigation Grant Program). R. David Paulison, Administrator, Federal Emergency Management Agency. [FR Doc. E7-8744 Filed 5-7-07; 8:45 am] BILLING CODE 9110-10-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1694-DR] New Jersey; Amendment No. 1 to Notice of a Major Disaster Declaration AGENCY: Federal Emergency Management Agency, DHS. ACTION: Notice. SUMMARY: This notice amends the notice of a major disaster declaration for the State of New Jersey (FEMA-1694-DR), dated April 26, 2007, and related determinations. DATES: *Effective Date:* April 27, 2007. FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Disaster Assistance Directorate, Federal Emergency Management Agency, Washington, DC 20472,

(202)646-2705. SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration for the State of New Jersey 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 26, 2007: Hudson, Middlesex, and Morris Counties for Individual Assistance. Bergen, Burlington, Essex, Passaic, Somerset, and Union Counties for Public Assistance (already designated for Individual Assistance). Camden, Hudson, Mercer, Middlesex, and Sussex Counties for Public Assistance. (The following Catalog of Federal Domestic Assistance Numbers

(CFDA)are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis Counseling; 97.033, Disaster Legal Services Program; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance; 97.048, Individuals and Households Housing; 97.049, Individuals and Households Disaster Housing Operations; 97.050 Individuals and Households Program-Other Needs, 97.036, Public Assistance Grants; 97.039, Hazard Mitigation Grant Program). R. David Paulison, Administrator, Federal Emergency Management Agency. [FR Doc. E7-8746 Filed 5-7-07; 8:45 am] BILLING CODE 9110-10-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1694-DR] New Jersey; Amendment No. 2 to Notice of a Major Disaster Declaration AGENCY: Federal Emergency Management Agency, DHS. ACTION: Notice. SUMMARY: This notice amends the notice of a major disaster declaration for the State of New Jersey (FEMA-1694-DR), dated April 26, 2007, and related determinations. DATES: *Effective Date:* April 30, 2007. FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Disaster Assistance Directorate, Federal Emergency Management Agency, Washington, DC 20472,

(202)646-2705. SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration for the State of New Jersey 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 26, 2007: Gloucester County for Individual Assistance. Camden and Mercer Counties for Individual Assistance (already designated 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, Administrator, Federal Emergency Management Agency. [FR Doc. E7-8748 Filed 5-7-07; 8:45 am] BILLING CODE 9110-10-P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1692-DR] New York; Major Disaster and Related Determinations AGENCY: Federal Emergency Management Agency, DHS. ACTION: Notice. SUMMARY: This is a notice of the Presidential declaration of a major disaster for the State of New York (FEMA-1692-DR), dated April 24, 2007, and related determinations. DATES: *Effective Date:* April 24, 2007. FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Disaster Assistance Directorate, Federal Emergency Management Agency, Washington, DC 20472,

(202)646-2705. SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter dated April 24, 2007, the President declared a major disaster under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act), as follows: I have determined that the damage in certain areas of the State of New York resulting from severe storms and inland and coastal flooding during the period of April 14-18, 2007, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act). Therefore, I declare that such a major disaster exists in the State of New York. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses. You are authorized to provide Individual Assistance in the designated areas, Hazard Mitigation throughout the State, and any other forms of assistance under the Stafford Act that you deem appropriate. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation and Other Needs Assistance will be limited to 75 percent of the total eligible costs. If Public Assistance is later warranted, Federal funds provided under that program will also be limited to 75 percent of the total eligible costs. Further, you are authorized to make changes to this declaration to the extent allowable under the Stafford Act. The time period prescribed for the implementation of section 310(a), Priority to Certain Applications for Public Facility and Public Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed six months after the date of this declaration. The Federal Emergency Management Agency

(FEMA)hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Marianne C. Jackson, of FEMA is appointed to act as the Federal Coordinating Officer for this declared disaster. I do hereby determine the following areas of the State of New York to have been affected adversely by this declared major disaster: Orange, Rockland, and Westchester Counties for Individual Assistance. All counties within the State of New York are eligible to apply for assistance under the Hazard Mitigation Grant Program. (The following Catalog of Federal Domestic Assistance Numbers

(CFDA)are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis Counseling; 97.033, Disaster Legal Services Program; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance; 97.048, Individuals and Households Housing; 97.049, Individuals and Households Disaster Housing Operations; 97.050 Individuals and Households Program-Other Needs, 97.036, Public Assistance Grants; 97.039, Hazard Mitigation Grant Program.) R. David Paulison, Administrator, Federal Emergency Management Agency. [FR Doc. E7-8743 Filed 5-7-07; 8:45 am] BILLING CODE 9110-10-P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5123-N-11] Notice of Submission of Proposed Information Collection to OMB; Emergency Comment Request, Alternative Housing Pilot Program Evaluation Baseline Survey AGENCY: Office of the Assistant Secretary for Policy Development and Research, HUD. ACTION: Notice of proposed information collection. SUMMARY: The proposed information collection requirement described below has been submitted to the Office of Management and Budget

(OMB)for emergency review and approval, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. DATES: *Comments Due Date:* May 22, 2007. ADDRESSES: Interested persons are invited to submit comments regarding this proposal. Comments must be received within fourteen

(14)days from the date of this Notice. Comments should refer to the proposal by name and should be sent to: HUD Desk Officer, Office of Management and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington, DC 20503. FOR FURTHER INFORMATION CONTACT: Lillian L. Deitzer, Departmental Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 Seventh Street, SW., Washington, DC 20410; e-mail *Lillian_L_Deitzer@HUD.gov* ; telephone

(202)708-2374. This is not a toll-free number. Copies of available documents submitted to OMB may be obtained from Ms. Deitzer. SUPPLEMENTARY INFORMATION: This Notice informs the public that the U.S. Department of Housing and Urban Development

(HUD)has submitted to OMB, for emergency processing, a proposed information collection requirement as described below. This Notice is soliciting comments from members of the public and affecting agencies concerning the proposed collection of information to:

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

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

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

(4)Minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. This Notice also lists the following information: *Title of Proposal:* Alternative Housing Pilot Program Evaluation Baseline Survey. *Description of Information Collection:* The proposed information collection will collect baseline data from families before they received housing under FEMA's Alternative Housing Pilot Program. HUD is conducting an evaluation of AHPP. Four states affected by Hurricanes Katrina and Rita received AHPP grants to test out alternative approaches to providing temporary housing after a disaster. HUD is charged with measuring what benefits and costs are associated with each of the alternatives being implemented by the states. Measuring the program impact on health, satisfaction, and general well-being of the occupants are a key part of the evaluation. This baseline survey is needed to know the characteristics of eligible households applying to participate in the program. This information is critical as an evaluation tool to:

(1)Document the demographic characteristics of those that apply for the program;

(2)Provide information about how the disaster affected their pre-storm housing and information on their expectations at securing permanent housing at some point; and

(3)Capture limited baseline information for comparison at a later time on impact measures of interest (such as income, source of income, perceptions of housing and neighborhood quality, and physical and mental health). These data are also important as covariates in estimating program impacts after 2 years and 4 years of occupancy. HUD is working with states to make selection of those that actually receive a unit (from a pool of those eligible and applying) to be random. A random selection process will allow HUD to evaluate program impacts by comparing the outcomes of those offered a unit against outcomes for those not offered a unit. *OMB Control Number:* To be assigned. *Agency Form Numbers:* None. *Members of Affected Public:* Individuals still requiring temporary housing due to Hurricanes Katrina or Rita. *Estimation of the total number of hours needed to prepare the information collection including number of respondents, frequency of responses, and hours of response:* The estimated number of burden hours needed to prepare the information collection is 4,167 hours; the number of respondents is estimated as 10,000, generating approximately 10,000 annual responses; the frequency of response is once at the time of application for the AHPP program; each response is estimated to take 25 minutes. *Status:* Proposed new collection. Authority: The Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35, as amended. Dated: May 1, 2007. Lillian L. Deitzer, Departmental Reports Management Officer, Office of the Chief Information Officer. [FR Doc. E7-8718 Filed 5-7-07; 8:45 am] BILLING CODE 4210-67-P DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs Request for Nominations of Members To Serve on the Bureau of Indian Education Advisory Board for Exceptional Education AGENCY: Bureau of Indian Education, Interior. ACTION: Request for nominations. SUMMARY: Pursuant to the Federal Advisory Committee Act and the Individuals with Disabilities Education Improvement Act (IDEIA), the Bureau of Indian Education requests nominations of individuals to serve on the Advisory Board for Exceptional Education (Advisory Board). The Bureau of Indian Education

(BIE)will consider nominations received in response to this Request for Nominations, as well as other sources. The SUPPLEMENTARY INFORMATION section for this notice provides committee and membership criteria. DATES: Nomination applications must be received on or before June 30, 2007. ADDRESSES: Please submit nomination applications to Gloria Yepa, Supervisory Education Specialist, Bureau of Indian Education, Albuquerque Service Center, Division of Performance and Accountability, P.O. Box 1088, Albuquerque, New Mexico 87103-1088, Telephone 505-563-5264. FOR FURTHER INFORMATION CONTACT: Gloria Yepa, Supervisory Education Specialist, at the above listed address, Telephone 505-563-5264. SUPPLEMENTARY INFORMATION: The Advisory Board was established in accordance with the Federal Advisory Committee Act, Public Law 92-463. The following provides information about the Committee, the membership and the nomination process. Objective and Duties

(a)Members of the Advisory Board will provide guidance, advice and recommendations with respect to special education and related services for children with disabilities in Bureau-funded schools in accordance with the requirements of IDEIA of 2004.

(b)The Advisory Board will:

(1)Provide advice and recommendations for the coordination of services within the BIE and other local, State and Federal agencies.

(2)Provide advice and recommendations on a broad range of policy issues dealing with the provision of educational services to American Indian children with disabilities.

(3)Serve as advocates for American Indian students with special education needs by providing advice and recommendations regarding best practices, effective program coordination strategies, and recommendations for improved educational programming.

(4)Provide advice and recommendations for the preparation of information required to be submitted to the Secretary of Education under section 611(h)(2)(D).

(5)Provide advice and recommend policies concerning effective inter/intra-agency collaboration, including modifications to regulations, and the elimination of barriers to inter/intra-agency programs and activities.

(6)Report and direct all correspondence to the Assistant Secretary-Indian Affairs through the Director, BIE with a courtesy copy to the Designated Federal Official (DFO). Membership

(a)As required by IDEIA of 2004, section 611(h)(6), the Advisory Board shall be composed of individuals involved in or concerned with the education and provision of services to Indian infants, toddlers, children, and youth with disabilities. The Advisory Board composition will reflect a broad range of viewpoints and will include at least one member representing each of the following interests: Indians with disabilities, teachers of children with disabilities, Indian parents or guardians of children with disabilities, service providers, State Education Officials, Local Education Officials, State Interagency Coordinating Councils (for states having Indian reservations), tribal representatives or tribal organization representatives, and other members representing the various divisions and entities of the BIE.

(b)The Assistant Secretary—Indian Affairs may provide the Secretary of the Interior recommendations for the chairperson; however, the chairperson and other board members will be appointed by the Secretary of the Interior. Advisory Board members shall serve staggered terms of 2 years or 3 years from the date of their appointment. Miscellaneous

(a)Members of the Advisory Board will not receive compensation, but will be reimbursed for travel, including subsistence, and other necessary expenses incurred in the performance of their duties in the same manner as persons employed intermittently in Government Service under 5 U.S.C. 5703.

(b)A member may not participate in matters that will directly affect, or appear to affect, the financial interests of the member or the member's spouse or minor children, unless authorized by the DFO. Compensation from employment does not constitute a financial interest of the member so long as the matter before the committee will not have a special or distinct effect on the member or the member's employer, other than as part of a class. The provisions of this paragraph do not affect any other statutory or regulatory ethical obligations to which a member may be subject.

(c)The Committee meets at least twice a year, budget permitting, but additional meetings may be held as deemed necessary by the Assistant Secretary-Indian Affairs or DFO.

(d)All Committee meetings are open to the public in accordance with the Federal Advisory Committee Act regulations. Nomination Information

(a)We are seeking nominations from individuals, organizations, and federally recognized tribes, as well as from State Directors of Special Education (within the 23 states in which Bureau-funded schools are located) concerned with the education of Indian children with disabilities as described above. We will consider self-nominations as well as those submitted by a tribe or organization.

(b)Nominees should have expertise and knowledge of the issues and/or needs of American Indian children with disabilities. This knowledge and expertise are needed to provide advice and recommendations to BIE regarding the needs of American Indian children with disabilities.

(c)Each application must include a copy of the form, printed with this notice and a summary of the candidate's qualifications (résumé or curriculum vitae). Nominees must have the ability to attend Advisory Committee meetings, carry out Committee assignments, participate in teleconference calls, and work in groups.

(d)The Department of the Interior is committed to equal opportunity in the workplace and seeks diverse Committee membership. The Indian Preference Act of 1990 (25 U.S.C. 472) applies to selection of members. Dated: April 29, 2007. Carl J. Artman, Assistant Secretary—Indian Affairs. Bureau of Indian Education Advisory Board for Exceptional Education Membership Nomination Form Nomination Information A. Nominations are requested from individuals, organizations, and federally recognized tribes, as well as from State Directors of Special Education (within the 23 states in which Bureau funded schools are located) concerned with the education of Indian children with disabilities as described above. B. Nominees should have expertise and knowledge of the issues and/or needs of American Indian children with disabilities. Such knowledge and expertise are needed to provide advice and recommendations to the Bureau of Indian Education

(BIE)regarding the needs of American Indian children with disabilities. C. A summary of the candidate's qualifications ( *résumé or curriculum vitae) must be included with the nomination application.* Nominees must have the ability to

(1)attend Advisory Committee meetings,

(2)carry out committee assignments,

(3)participate in teleconference calls, and

(4)work in groups. D. The Department of the Interior is committed to equal opportunity in the workplace and seeks diverse Committee membership; however, the Department is also bound by the Indian Preference Act of 1990 (25 U.S.C. 472). Objective and Duties A. The Advisory Board provides guidance, advice and recommendations with respect to special education and related services for children with disabilities in BIE-funded schools in accordance with the requirements of IDEIA of 2004. B. The Advisory Board provides advice and recommendations for the coordination of services within the BIE and with other local, State, and Federal agencies. C. The Advisory Board provides advice and recommendations on a broad range of policy issues dealing with the provision of educational services to American Indian children with disabilities. D. The Advisory Board serves as an advocate for American Indian students with special education needs by providing advice and recommendations regarding best practices, effective program coordination strategies, and recommendations for improved educational programming. E. The Advisory Board provides advice and recommendations for the preparation of information required to be submitted to the Secretary of Education. F. The Advisory Board provides advice and recommends policies concerning effective inter/intra-agency collaboration, including modifications to regulations, and the elimination of barriers to inter/intra-agency programs and activities. G. The Advisory Board reports and directs all correspondence to the Assistant Secretary—Indian Affairs through the Director of the Bureau of Indian Education with a courtesy copy to the Designated Federal Official (DFO). Membership A. The Advisory Board shall be composed of 15 members. The Assistant Secretary-Indian Affairs may provide the Secretary of the Interior recommendations for the Chairperson. However all advisory board members will be appointed by the Secretary of the Interior as required. Advisory Board members shall serve staggered terms of two years or three years from the date of their appointment. The Secretary may remove members from the Advisory Board at any time at his/her discretion. B. As required by the IDEIA of 2004, the Advisory Board will be composed of individuals involved in or concerned with the education and provision of services to Indian children with disabilities. The Advisory Board composition will reflect a broad range of viewpoints and will include at least one member representing each of the following interests: Indian persons with disabilities, teachers of children with disabilities, Indian parents or guardians of children with disabilities, service providers, State Education Officials, Local Education Officials, State Interagency Coordinating Councils (for states having Indian reservations), tribal representatives or tribal organization representatives, and BIA employees concerned with the education of children with disabilities. C. Members of the Advisory Board will not receive compensation, but will be reimbursed for travel, subsistence, and other necessary expenses incurred in the performance of their duties consistent with the provisions of 5 U.S.C. 5703. D. A member may not participate in matters that will directly affect, or appear to affect, the financial interests of the member or the member's spouse or minor children, unless authorized by the DFO. Compensation from employment does not constitute a financial interest of the member so long as the matter before the committee will not have a special or distinct effect on the member or the member's employer, other than as part of a class. The provisions of this paragraph do not affect any other statutory or regulatory ethical obligations to which a member may be subject. E. The Advisory Board meets at least twice a year, budget permitting, but additional meetings may be held as deemed necessary by the Assistant Secretary or DFO. BILLING CODE 4310-6W-P EN08MY07.020 EN08MY07.021 EN08MY07.022 [FR Doc. E7-8769 Filed 5-7-07; 8:45 am] BILLING CODE 4310-6W-C DEPARTMENT OF THE INTERIOR Bureau of Land Management [WO-220-1020-PB-241A] Extension of Approved Information Collection, OMB Control Number 1004-0041 AGENCY: Bureau of Land Management, Interior. ACTION: Notice and request for comments. SUMMARY: In accordance with the Paperwork Reduction Act of 1995, the Bureau of Land Management

(BLM)plans to request the Office of Management and Budget

(OMB)to extend an existing approval to collect information from permittees and lessees on the actual grazing use by their livestock. The BLM requires permittees and lessees to submit the required information on Forms 4130-1 4130-1a, 4130-1b, 4130-3a, 4130-4, and 4130-5 and, nonform information under 43 CFR subparts 4110 and 4130 for grazing use management. DATES: You must submit your comments to BLM at the address below on or before July 9, 2007. BLM will not necessarily consider any comments received after the above date. ADDRESSES: You may send comments to the OMB, Interior Department Desk Officer (1004-0041), at OMB-OIRA via e-mail *OIRA_DOCKET@omb.eop.gov* or via facsimile at

(202)395-6566. Also please send a copy of your comments to BLM via Internet and include your name, address, and *ATTN:* 1004-0041 in your Internet message to *comments_washington@blm.gov* or via mail to: U.S. Department of the Interior, Bureau of Land Management, Mail Stop 401LS, 1849 C Street, NW., *ATTN:* Bureau Information Collection Clearance Officer (WO-630), Washington, DC 20240. You may deliver comments to the Bureau of Land Management, Administrative Record, Room 401, 1620 L Street, NW., Washington, DC. Comments will be available for public review at the L Street address during regular business hours (7:45 a.m. to 4:15 p.m.) Monday through Friday. FOR FURTHER INFORMATION CONTACT: You may contact Ken Visser, on

(775)861- 6492 (Commercial or FTS). Persons who use a telecommunication device for the deaf

(TDD)may call the Federal Information Relay Service

(FIRS)on 1-800-877-8330, 24 hours a day, seven days a week, to contact Mr. Visser. SUPPLEMENTARY INFORMATION: 5 CFR 1320.12(a) requires that we provide a 60-day notice in the **Federal Register** concerning a collection of information to solicit comments on:

(a)Whether the collection of information is necessary for the proper functioning of the agency, including whether the information will have practical utility;

(b)The accuracy of our estimates of the information collection burden, including the validity of the methodology and assumptions we use;

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

(d)Ways to minimize the information collection burden on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. The Taylor Grazing Act of 1934 (43 U.S.C. 315, 315a through 315r) and the Federal Land Policy and Management Act of 1976 (43 U.S.C. 1701 *et seq.* ) authorize the Bureau of Land Management

(BLM)to administer the livestock grazing program consistent with land use plans, multiple use objectives, sustained yield, environmental values, economic considerations, and other factors. The BLM must maintain accurate records on:

(1)Permittee and lessee qualifications for a grazing permit or lease;

(2)Base property used in conjunction with public lands; and

(3)The actual use made by livestock authorized to graze on the public lands. The BLM also collects nonform information on grazing management from permittees and lessees. Form 4130-1, Grazing Schedule The BLM uses the required information this form to adjudicate conflicting requests for grazing use, determine legal qualifications of applicants, issue permits, and document transfers. Form 4130-1a, Grazing Application—Preference Summary The BLM uses the required information on this form to verify what the BLM needs to effectuate a grazing preference transfer. Form 4130-1b, Grazing Application (Supplemental Information) The BLM uses the required information on this form to certify an applicant's qualifications for a grazing permit or lease and to provide other information necessary for the administration of the grazing permit or lease. Form 4130-3a, Automated Grazing Application The BLM uses the required information in this form to approve changes of grazing use within the terms and conditions of permits or leases. Form 4130-4, Exchange of Use Grazing Agreement The BLM uses this form to exchange grazing of livestock on private lands during certain periods. Form 4130-5, Actual Grazing Use Report The BLM uses the required information to determine if we need to adjust the amount of grazing use or if other management actions are needed. This form enables the BLM to calculate billings and to monitor and evaluate livestock grazing use on the public lands. Burden hours information collected Number of actions per year Burden hours per action Total annual burden hours Total annual burden cost

(a)Grazing Schedule, (Form 4130-1) and non-form information in 43 CFR 4110 and 4130 6,000 8 48,000 $3,600,000

(b)Grazing Application—Preference Summary (Form 4130-1a) and non-form information in 43 CFR 4110 and 4130 6,000 8 48,000 3,600,000

(c)Grazing Application (Supplemental Information) (Form 4130-1b) and non-form information in 43 CFR 4110 and 4130 6,000 8 48,000 3,600,000

(d)Automated Grazing Application (Form 4130-3a) and non-form information in 43 CFR 4110 and 4130 7,689 8 61,512 4,613,400

(e)Exchange of Use Grazing Agreement (Form 4130-4) and non-form information in 43 CFR 4110 and 4130 600 8 4,800 360,000

(f)Actual Grazing Use Report (Form 4130-5) and non-form information in 43 CFR 4110 and 4130 15,000 8 120,000 9,000,000 Total 41,289 330,312 24,773,400 You must submit the requested information and forms to the proper BLM office. We estimate 41,289 responses per year and an annual information collection burden of 330,312 hours. The BLM will summarize all responses to this notice and include them in the request for OMB approval. All comments will become a matter of public record. Dated: May 3, 2007. Ted R. Hudson Bureau of Land Management, Information Collection Clearance Officer. [FR Doc. 07-2253 Filed 5-7-07; 8:45 am]

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