Fed. Reg. Notices — Notice of availability

BILLING CODE 6820-KF-M ENVIRONMENTAL PROTECTION AGENCY [FRL-8302-1] Clean Water Act Section 303(d): Final Agency Action on Eighty Total Maximum Daily Loads (TMDLs) AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of availability. SUMMARY: This notice announces final agency action on eighty TMDLs prepared by EPA Region 6 for waters listed in Louisiana's Red River, Sabine River, and Terrebonne Basins, under section 303(d) of the Clean Water Act (CWA). Documents from the administrative record file for the eighty TMDLs, including TMDL calculations and responses to comments, may be viewed at *http://www.epa.gov/earth1r6/6wq/npdes/tmdl/index.htm.* The administrative record file may be examined by calling or writing Ms.

Diane Smith at the address below. Please contact Ms. Smith to schedule an inspection. FOR FURTHER INFORMATION CONTACT: Diane Smith, Environmental Protection Specialist, Water Quality Protection Division, U.S. EPA Region 6, 1445 Ross Avenue, Dallas, TX 75202-2733,

(214)665-2145. SUPPLEMENTARY INFORMATION: In 1996, two Louisiana environmental groups, the Sierra Club and Louisiana Environmental Action Network (plaintiffs), filed a lawsuit in Federal Court against the EPA, styled *Sierra Club, et al.* v. *Clifford, et al.* , No. 96-0527, (E.D. La.). Among other claims, plaintiffs alleged that EPA failed to establish Louisiana TMDLs in a timely manner. EPA established 63 of these TMDLs pursuant to a consent decree entered in this lawsuit. EPA Takes Final Agency Action on Eighty TMDLs By this notice EPA is taking final agency action on the following eighty TMDLs for waters located within the Louisiana river basins: Subsegment Waterbody name Pollutant 100306 Kelly Bayou—AR State Line to Black Bayou Fecal Coliform. 100309 Cross Bayou Turbidity, TDS, Chloride, Sulfate, and TSS. 100406 Flat River—Headwaters to Loggy Bayou Fecal Coliform and TDS. 100602 Boggy Bayou Turbidity and Sedimentation/siltation. 100603 Wallace Lake Turbidity and Sedimentation/siltation. 100701 Black Lake Bayou Turbidity, TDS, and Sedimentation/siltation. 100704 Kepler Creek TDS. 100707 Castor Creek—Headwaters to Black Lake Bayou Fecal Coliform. 100708 Unnamed Tributary to Castor Creek near Town of Castor Sulfate and TDS. 100709 Grand Bayou—Headwaters to Black Lake Bayou Fecal Coliform. 100710 Unnamed Tributary to Grand Bayou near Town of Hall Summit TDS, Chloride, and Sulfate. 100801 Saline Bayou—from its origin near Arcadia to LA Hwy 156 in Winn Parish (scenic) Fecal Coliform. 100804 Unnamed Tributary to Saline Bayou near Town of Arcadia TDS and Sulfate. 100901 Nantaches Creek—Headwaters to Nantaches Lake Fecal Coliform. 101101 Cane River—above Natchitoches to Red River TDS and Chloride. 101103 Bayou Kisatchie—entrance into Kisatchie National Forest to Old River (scenic) Fecal Coliform and TDS. 101301 Rigolette Bayou—Headwaters to Red River Fecal Coliform. 101303 Iatt Creek—Headwaters to Iatt Lake TDS. 101401 Buhlow Lake (Pineville) Turbidity. 101601 Bayou Cocodrie—from Little Cross Bayou to Wild Cow Bayou (scenic) Turbidity. 110202 Pearl Creek—from its origin to its entrance into Sabine River (scenic) Fecal Coliform. 110401 Bayou Toro—Headwaters to LA Hwy 473 Fecal Coliform. 110402 Bayou Toro—LA Hwy 473 to its entrance into Sabine River Fecal Coliform. 110501 West Anacoco Creek—Headwaters to Vernon Lake Fecal Coliform. 110504 Bayou Anacoco—Vernon Lake to Anacoco Lake Fecal Coliform. 110601 Vinton Waterway Turbidity. 120101 Bayou Portage TDS, Chloride, Fecal Coliform, and TSS. 120102 Bayou Poydras Sediment, Sulfate, TDS, TSS, and Fecal Coliform. 120104 Bayou Grosse Tete Fecal Coliform and TDS. 120105 Chamberlin Canal Fecal Coliform, TSS, and Sediment. 120106 Bayou Plaquemine Turbidity. 120109 Intracoastal Waterway Fecal Coliform. 120110 Bayou Cholpe TDS and Sulfate. 120111 Bayou Maringouin—Headwaters to East Atchafalaya Basin Levee Fecal Coliform and TDS. 120112 Bayou Fordoche Fecal Coliform and TDS. 120201 Lower Grand River and Belle River Fecal Coliform and Sulfate. 120206 Grand Bayou and Little Grand Bayou Fecal Coliform. 120301 Bayou Terrebonne Fecal Coliform. 120502 Bayou Grand Caillou Fecal Coliform. 120503 Bayou Petit Caillou Fecal Coliform. 120504 Bayou Petit Caillou Fecal Coliform. 120506 Bayou du Large Fecal Coliform. 120507 Bayou Chauvin Fecal Coliform. 120508 Houma Navigation Canal Fecal Coliform. 120602 Bayou Terrebonne Fecal Coliform. 120605 Bayou Pointe au Chien Fecal Coliform. 120606 Bayou Blue Fecal Coliform. 120701 Bayou Grand Caillou Fecal Coliform. 120703 Bayou du Large Fecal Coliform. 120707 Lake Boudreaux Fecal Coliform. 120708 Lost Lake, Four League Bay Fecal Coliform. EPA requested the public to provide EPA with any significant data or information that might impact the eighty Final TMDLs in the **Federal Register** Notice: Volume 71, Number 195, pages 59504-59506 (October 10, 2006). The comments received and the EPA's response to comments and the TMDLs may be found at *http://www.epa.gov/earth1r6/6wq/npdes/tmdl/index.htm.* Dated: April 11, 2007. William K. Honker, Deputy Director, Water Quality Protection Division, EPA Region 6. [FR Doc. E7-7459 Filed 4-18-07; 8:45 am] BILLING CODE 6560-50-P FEDERAL COMMUNICATIONS COMMISSION [Report No. 2812] Petition for Reconsideration of Action in Rulemaking Proceeding April 10, 2007 A Petition for Reconsideration has been filed in the Commission's Rulemaking proceeding listed in this Public Notice and published pursuant to 47 CFR 1.429(e). The full text of this document is available for viewing and copying in Room CY-B402, 445 12th Street, SW., Washington, DC or may be purchased from the Commission's copy contractor, Best Copy and Printing, Inc.

(BCPI)(1-800-378-3160). Oppositions to this petition must be filed by May 4, 2007. See Section 1.4(b)(1) of the Commission's rules (47 CFR 1.4(b)(1)). Replies to an opposition must be filed within 10 days after the time for filing oppositions have expired. *Subject:* In the Matter of Revision of the Commission's Rules to Ensure Compatibility with Enhanced 911 Emergency Calling Systems (CC Docket 94-102). In the Matter of Request for Limited Waiver of Washington RSA No. 8 Limited Partnership. *Number of Petitions Filed:* 1. Marlene H. Dortch, Secretary. [FR Doc. E7-7450 Filed 4-18-07; 8:45 am] BILLING CODE 6712-01-P FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 *et seq.* ) (BHC Act), Regulation Y (12 CFR Part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center Web site at *www.ffiec.gov/nic/* . Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than May 14, 2007. **A. Federal Reserve Bank of Atlanta** (David Tatum, Vice President) 1000 Peachtree Street, NE., Atlanta, Georgia 30309: *1. BankCap Special Limited Partner, L.P.; BankCap Special Limited Partner GP, LLC; BankCap Services, L.P.; and BankCap Services GP, LLC* , all of Dallas, Texas; to become bank holding companies by indirectly acquiring up to 49.9 percent of the outstanding shares of Atlantic Capital Bancshares, Inc. and, Atlantic Capital Bank, both of Atlanta, Georgia. Comments regarding this application must be received not later than May 4, 2007. **B. Federal Reserve Bank of Kansas City** (Donna J. Ward, Assistant Vice President) 925 Grand Avenue, Kansas City, Missouri 64198-0001: *1. Country Bancshares, Inc.* , Jamesport, Missouri; to acquire up to 14 percent of the voting shares of Liberty First Bancshares, Inc., Liberty, Missouri, and thereby indirectly acquire voting shares of Park Bank, Parkville, Missouri, and Liberty First Bank, Liberty, Missouri. *2. Liberty First Bancshares, Inc.* , Liberty, Missouri; to acquire 100 percent of the voting shares of Park Bank, Parkville, Missouri. *3. Midwest Regional Bancorp, Inc.* , Festus, Missouri; to become a bank holding company by acquiring 100 percent of the voting shares of Federated Bancshares, Inc., Stilwell, Kansas, and thereby indirectly acquire voting shares of The Bank of Otterville, Otterville, Missouri. Board of Governors of the Federal Reserve System, April 16, 2007. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E7-7436 Filed 4-18-07; 8:45 am] BILLING CODE 6210-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Privacy Act of 1974; Retraction of a New System of Records AGENCY: Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS). ACTION: Notice of Retraction of a New System of Records. SUMMARY: The Centers for Medicare & Medicaid Services CMS inadvertently published a new system of records titled “Master Demonstration, Evaluation, and Research Studies

(DERS)for the Office of Research, Development and Information (ORDI)” System No. 09-70-0591 in the **Federal Register**

(FR)on Tuesday, April 10, 2007 (72 FR 17918). CMS is withdrawing the Tuesday, April 10, 2007 notification due to the inadvertent inclusion of an existing system of records that should not be deleted from the existing inventory, “End Stage Renal Disease Program Management and Medical Information System,” System No. 09-70-0520, last published at 67 FR 41244 (June 17, 2002). The notice of a new system of records will be republished. FOR FURTHER INFORMATION CONTACT: Inquiries may be directed 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. He can also be reached at 410-786-5357 or by e-mail at *walter.stone@cms.hhs.gov.* Dated: April 11, 2007. William Saunders, Acting Deputy Director, Office of Information Services, Centers for Medicare & Medicaid Services. [FR Doc. E7-7400 Filed 4-18-07; 8:45 am] BILLING CODE 4120-03-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Privacy Act of 1974; Report of a New System of Records AGENCY: Department of Health and Human Services (HHS), Center for Medicare & Medicaid Services (CMS). ACTION: Notice of a new system of records (SOR). SUMMARY: In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, “Master Demonstration, Evaluation, and Research Studies

(DERS)for the Office of Research, Development and Information (ORDI),” System No. 09-70-0591. This notice serves as the Master system for all demonstrations, evaluation, and research studies administered by ORDI. Fifteen existing ORDI demonstration, evaluation, and research studies will be included under this notice and the separate, existing systems of records notices for those studies will be deleted upon the effective date of this notice. DERS will become effective 30 days from the publication of the notice in the **Federal Register** , or 40 days from the date submitted to OMB and the Congress, whichever is later. With the publication of this master system, ORDI will only be deleting the systems of records listed below as separate stand alone notices to the public. Retention and destruction of the data contained in these systems will follow the schedules listed in this DERS system notice. The existing ORDI systems of records to be included under DERS and which will be deleted by this notice are as follows: • “Municipal Health Services Program System No. 09-70-0022,” 65 **Federal Register**

(FR)37792 (June 16, 2000); • “Monitoring of the Home Health Agency Prospective Payment Demonstration,” System No. 09-70-0048, 65 FR 37792 (June 16, 2000); • “Person-Level Medicaid Data System, System No. 09-70-0507” last published at 71 FR 60726 (October 16, 2006); • “Medicare Cancer Registry Record System,” System No. 09-70-0509, last published at 71 FR 67133 (November 20, 2006); • “Evaluations of the Medicaid Reform Demonstrations,” System No. 09-70-0523, last published at 71 FR 60540 (October 13, 2006); • “MMA Section 641 Prescription Drug Benefit Demonstration,” System No. 09-70-0545, last published at 69 FR 32587 (June 10, 2004); • “Medicare Physician Group Practice Demonstration,” System No. 09-70-0559, last published at 70 FR 58432 (October 6, 2005); • “Cancer Prevention and Treatment Demonstration for Ethnic and Racial Minorities,” System No. 09-70-0560, last published at 70 FR 57602 (October 3, 2005); • “Medicare Care Management Performance Demonstration,” System No. 09-70-0562, last published at 70 FR 58442 (October 6, 2005); • “Rural Hospice Demonstration,” System No. 09-70-0563, last published at 71 FR 57968 (October 2, 2006); • “Medicare Chiropractic Coverage Demonstration and Evaluation,” System No. 09-70-0577, last published at 71 FR 41450 (July 21, 2006); • “Low Vision Rehabilitation Demonstration,” System No. 09-70-0582, last published at 71 FR 58621 (October 4, 2006); • “Medicare Lifestyle Modification Program Demonstration,” System No. 09-70-0585, last published at 71 FR 41807 (July 24, 2006); • “Competitive Bidding for Clinical Laboratory Services,” System No. 09-70-0589, last published at 71 FR 60713 (October 16, 2006); and • “Senior Risk Reduction Demonstration and Evaluation,” System No. 09-70-0592, last published at 71 FR 60718 (October 16, 2006). The purpose of this system is to document, track, monitor, evaluate, and conduct ORDI-administered demonstration, evaluation, and research studies. Information retrieved from this system may be disclosed to:

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

(2)assist another Federal or state agency with information to contribute to the accuracy of CMS's payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds;

(3)support 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;

(4)support litigation involving the agency; and

(5)combat fraud, waste and abuse in certain Federally-funded 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 Date” section for comment period. DATES: *Effective Date:* CMS filed a new SOR report with the Chair of the House Committee on Oversight and Government Reform, 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 new system will become effective 30 days from the publication of the notice, or 40 days from the date it was submitted to OMB and the Congress, whichever is later. We may defer implementation of this system or one or more of the routine use statements listed below if we receive comments that persuade us to defer implementation. ADDRESSES: The public should send 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: James Beyer, Division of Research and Information Dissemination, Information and Methods Group, Office of Research Development and Information, Mail Stop C3-24-01, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1849. He can be reached by telephone at 410-786-6693, or via e-mail at *James.Beyer@cms.hhs.gov* . SUPPLEMENTARY INFORMATION: The DERS system of records will serve as the constructive notice to the Medicare beneficiary population and health care communities on activates related to all demonstrations, evaluation, and research studies administered by ORDI. The consolidation of the existing multiple notices into one master notice will serve the public interest by providing a single clear and concise format, a plain language notification easily understood, a central point of contact for access and correction of record information, and a new web based service to provide detailed information on each separate ORDI project. ORDI currently has 43 active projects and an additional 8 future projects anticipated to be included under DERS. An electronic web based list of current and each new demonstration, evaluation, and research studies administered by ORDI will be made accessible via the CMS public Web site. In addition to the Web based information and notification, other methods of direct notification, CMS will publish timely modification and updates to DERS as required keeping our Medicare community as informed as possible. I. Description of the Proposed System of Records A. Statutory and Regulatory Basis for SOR The statutory authority for maintenance of this system is given under the provisions of § 1110 of the Social Security Act (the Act), which authorizes research and demonstration projects under Social Security Act programs; § 1115 of the Act, which authorizes Medicaid demonstrations; and § 402 of the Social Security Amendments of 1967 (42 U.S.C. 1395b-1), which authorizes waivers of Medicaid and Medicare provisions under certain demonstrations. Many of the individual studies and demonstrations are specifically mandated in other legislation (§§ 235, 302

(b)[amends section 1847(e) (42 United States Code (U.S.C.) §§ 1395w-3)], 303(d), 409, 410(a), 434, 623(e), 641, 646, 648, 649, 651, 702, and 703 of the Medicare Modernization Act, §§ 121 and 122 of the Benefits Improvement and Protection Act of 2000, the Deficit Reduction Act of 1984, § 5007 of the Deficit Reduction Act of 2005, the Balanced Budget Act of 1997, § 222 of the Consolidated Appropriations Act of 2001, and Conference Report No. 106-1033 for the Consolidated Appropriations Act of 2001. This system also covers all demonstrations, evaluation, and research studies administered by ORDI that may be authorized or mandated by future legislation. B. Collection and Maintenance of Data in the System The system will collect and maintain records related to Medicare beneficiaries, Medicaid recipients, and physician and providers of services who voluntarily participate in demonstrations, evaluation, and research studies administered by ORDI. In addition, Medicare enrollment data, claims data or provider enrollment information currently maintained in existing systems of records will be used in demonstrations, evaluation, and research studies administered by ORDI. Examples include, but are not limited to: provider name, unique provider identification number, unique demonstration practice identification number, beneficiary name, health insurance claim number, beneficiary demographic and diagnostic information relevant to the project, types and costs of health services used, and measures of the quality of health care received. 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 DERS 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 DERS. 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 document, track, monitor, evaluate, and conduct ORDI-administered research, demonstration, and evaluation activities. 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 or 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 functions 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 or consultant 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 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. Assist Federal/state Medicaid programs within the state. Other Federal or state agencies, in their administration of a Federal health program, may require DERS information in order to support evaluations and monitoring of Medicare claims information of beneficiaries, including proper reimbursement for services provided. 3. 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 DERS 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. 4. To the Department of Justice (DOJ), court or adjudicatory body when: a. The agency or any component thereof, or b. Any employee of the agency in his or her official capacity, or c. Any employee of the agency in his or her individual capacity where the DOJ has agreed to represent the employee, or d. The United States Government, is a party to litigation or has an interest in such litigation, and, by careful review, CMS determines that the records are both relevant and necessary to the litigation and that the use of such records by the DOJ, court or adjudicatory body is compatible with the purpose for which the agency collected the records. Whenever CMS is involved in litigation, and occasionally when another party is involved in litigation and CMS policies or operations could be affected by the outcome of the litigation, CMS would be able to disclose information to the DOJ, court or adjudicatory body involved. 5. 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 and 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. 6. 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 DERS 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 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 an individual 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 Proposed 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: March 28, 2007. Charlene Frizzera, Acting Chief Operating Officer, Centers for Medicare & Medicaid Services. SYSTEM NO. 09-70-0591 SYSTEM NAME: “Master Demonstration, Evaluation, and Research Studies for the Officer of Research, Development and Information (DERS),” HHS/CMS/ORDI. SECURITY CLASSIFICATION: Level Three Privacy Act Sensitive Data. SYSTEM LOCATION: Centers for Medicare & Medicaid Services

(CMS)Data Center, 7500 Security Boulevard, North Building, First Floor, Baltimore, Maryland 21244-1850 and at various co-locations of CMS agents. CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM: The system will collect and maintain records related to Medicare beneficiaries, Medicaid recipients, and physician and providers of services who voluntarily participate in demonstrations, evaluation, and research studies administered by ORDI. In addition, Medicare enrollment data, claims data or provider enrollment information currently maintained in existing systems of records will be used in demonstrations, evaluation, and research studies administered by ORDI. CATEGORIES OF RECORDS IN THE SYSTEM: The collected information will include, but is not limited to: provider name, unique provider identification number, unique demonstration practice identification number, beneficiary name, health insurance claim number (HICN), beneficiary demographic and diagnostic information relevant to the project, types and costs of health services used, and measures of the quality of health care received. AUTHORITY FOR MAINTENANCE OF THE SYSTEM: The statutory authority for maintenance of this system is given under the provisions of § 1110 of the Social Security Act (the Act), which authorizes research and demonstration projects under Social Security Act programs; § 1115 of the Act, which authorizes Medicaid demonstrations; and § 402 of the Social Security Amendments of 1967 (42 U.S.C. 1395b-1), which authorizes waivers of Medicaid and Medicare provisions under certain demonstrations. Many of the individual studies and demonstrations are specifically mandated in other legislation (§§ 235, 302

(b)[amends section 1847(e) (42 United States Code (U.S.C.) §§ 1395w-3)], 303(d), 409, 410(a), 434, 623(e), 641, 646, 648, 649, 651, 702, and 703 of the Medicare Modernization Act, §§ 121 and 122 of the Benefits Improvement and Protection Act of 2000, the Deficit Reduction Act of 1984, § 5007 of the Deficit Reduction Act of 2005, the Balanced Budget Act of 1997, § 222 of the Consolidated Appropriations Act of 2001, and Conference Report No. 106—1033 for the Consolidated Appropriations Act of 2001. This system also covers all demonstrations, evaluation, and research studies administered by ORDI that may be authorized or mandated by future legislation. PURPOSE(S) OF THE SYSTEM: The purpose of this system is to document, track, monitor, evaluate, and conduct ORDI-administered demonstration, evaluation, and research studies. Information retrieved from this system may be disclosed to:

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

(2)assist another Federal or state agency with information to contribute to the accuracy of CMS's payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds;

(3)support 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;

(4)support litigation involving the agency; and

(5)combat fraud, waste and abuse in certain federally-funded 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 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. Assist Federal/state Medicaid programs within the state. 3. 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. 4. To the Department of Justice (DOJ), court or adjudicatory body when: a. The agency or any component thereof, or b. Any employee of the agency in his or her official capacity, or c. Any employee of the agency in his or her individual capacity where the DOJ has agreed to represent the employee, or d. The United States Government, is a party to litigation or has an interest in such litigation, and, by careful review, CMS determines that the records are both relevant and necessary to the litigation and that the use of such records by the DOJ, court or adjudicatory body is compatible with the purpose for which the agency collected the records. 5. 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. 6. 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

(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 an individual 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 the name or other identifying information of the participating provider or beneficiary, and may also be retrieved by a distinct identifier such as the HICN, at the individual beneficiary level. 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 identifiable information maintained in the DERS system of records for a period of 5 years after the end of the research, demonstration, or evaluation project. Data residing with the designated claims payment contractor shall be returned to CMS at the end of the project, with all data then being the responsibility of CMS for adequate storage and security. 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: Deputy Director, Office of Research Development and Information, Mail Stop C3-18-07, CMS, 7500 Security Boulevard, Baltimore, MD 21244-1849. 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: Data will be collected from Medicare administrative and claims records, patient medical charts, and physician records. SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT: None. Appendix A. Current ORDI run Demonstration, Evaluation and Research Activities The following is a listing of the current ORDI run demonstration, evaluation and research activities at CMS, with the appropriate contact person. A perpetual list of current demonstrations and evaluations will be made accessible through the CMS public Web site ( *http://www.cms.hhs.gov* ). The list will be amended for each new project that is implemented. 1. ORDI Run Demonstration, Evaluation and Research Activities • Bundled Case-Mix Adjusted Payment System for End Stage Renal Disease Services Demonstration Contact: Henry Bachofer, 410-786-0340 • Cancer Prevention and Treatment Demonstration for Ethnic and Racial Minorities Contact: Diane Merriman, 410-786-7237 • Consumer Directed Chronic Outpatient Services Contact: Pauline Lapin, 410-786-6883 • Cost-effectiveness of Daily versus Conventional Hemodialysis for the Medicare Population Contact: Penny Mohr, 410-786-6502 • Data Collection and Administering the Medicare Health Improvement Survey Contact: David Bott, 410-786-0249 • Design and Implementation of a Beneficiary Survey on Access to Selected Prescriptions and Biologicals Contact: Penny Mohr, 410-786-6502 • Disease Management for Severely Chronically Ill Medicare Beneficiaries Contact: J. Sherwood, 410-786-6651 • End Stage Renal Disease

(ESRD)Disease Management Demonstration Contact: Sid Mazumdar, 410-786-6673 • Evaluation of Care Management for High Cost Beneficiaries Demonstration Contact: David Bott, 410-786-0249 • Evaluation of Second Phase of Oncology Demonstration Program Contact: James Menas, 410-786-4507 • Evaluation of the Medicare Preferred Provider Organization Demonstration Contact: Victor McVicker, 410-786-6681 • Evaluation of the State Medicaid Reform Demonstrations Contact: Paul Boben, 410-786-6629 • Expansion of Coverage of Chiropractic Services Demonstration Contact: Carol Magee, 410-786-6611 • Frontier Extended Stay Clinic Demonstration Project Contact: Sid Mazumdar, 410-786-6673 • Home Health Agency Prospective Payment Demonstration Contact: J. Sherwood, 410-786-6651 • Impact of Payment Reform for Part B Covered Outpatient Drugs and Biologicals Contact: Usree Bandyopadhyay, 410-786-6650 • Informatics for Diabetes Education and Telemedicine Demonstration (IDEATel) Contact: Diana Ayres: 410-786-7203 • Inhalation Drug Therapy Demonstration Contact: Debbie Vanhoven, 410-786-6625 • Life Masters Contact: Linda Colantino, 410-786-3343 • Low Vision Rehabilitation Demonstration Contact: James Coan, 410-786-9168 • Massachusetts Senior Care Options Contact: William Clark, 410-786-1484 • Medical Adult Day Care Services Demonstration Contact: Armen Thoumaian, PhD, 410-786-6672 • Medicare + Choice Phase II—PPO Demonstration Contact: Debbie Vanhoven, 410-786-6625 • Medicare Advantage CCRC (Erickson) Demonstration Contact: Henry Bachofer, 410-786-0340 • Medicare Cancer Registry Record System Contact: Gerald Riley, 410-786-6699 • Medicare Care Management Performance Demonstration Contact: Jody Blatt, 410-786-6921 • Medicare Clinical Laboratory Services Competitive Bidding Demonstration Project Contact: Linda Lebovic, 410-786-3402 • Medicare Coordinated Care Demonstration Contact: Cynthia Mason, 410-786-6680 • Medicare Drug Replacement Demonstration Contact: Jody Blatt, 410-786-6921 • Medicare Health Care Quality Demonstration Programs Contact: Cynthia Mason, 410-786-6680 • Medicare Home Health Independence Demonstration Contact: Armen Thoumaian, Ph.D., 410-786-6672 • Medicare Hospital Gainsharing Demonstration Contact: Lisa Waters, 410-786-6615 • Medicare Preventive Services—Medicare Lifestyle Modification Program Demonstration Contact: Armen Thoumaian, PhD, 410-786-6672 • Mercy Medicare Skilled Nursing Facility Payment Demonstration Contact: J. Sherwood, 410-786-6651 • Minnesota Senior Health Options Contact: Susan Radke, 410-786-4450 • Municipal Health Services Program Demonstration Contact: Michael Henesch, 410-786-6685 • New York Graduate Medical Education Demonstration Contact: Sid Mazumdar, 410-786-6673 • Nursing Home Value-Based Purchasing Contact: Ronald Lambert, 410-786-6624 • PACE-for-Profit Demonstration Contact: Michael Henesch, 410-786-6685 • Payment Development, Implementation and Monitoring for the BIPA Disease Management Demonstration Contact: J. Sherwood, 410-786-6651 • Person-Level Medicaid Data System Contact: Dave Baugh, 410-786-7716 • Physician Group Practice Demonstration Contact: John Pilotte, 410-786-6658 • Premier Hospital Quality Incentive Demonstration Contact: Katharine Pirotte, 410-786-6774 • Rural Community Hospital Demonstration Contact: Sid Mazumdar, 410-786-6673 • Rural Hospice Demonstration: Quality Assurance Metrics Implementation Support Contact: Cindy Massuda, 410-786-0652 • Senior Risk Reduction Demonstration Contact: Pauline Lapin, 410-786-6883 • Social Health Maintenance Organization for Long-Term Care Demonstration Contact: Thomas Theis, 410-786-6654 • State-based Home Health Agency TPL Payments Contact: J. Sherwood, 410-786-6651 • United Mine Workers of America Demonstration Contact: Jason Petroski, 410-786-4681 • Utah Graduate Medical Education Contact: Sid Mazumdar, 410-786-6673 • Wisconsin Partnership Program Contact: James Hawthorne, 410-786-6689 [FR Doc. E7-7403 Filed 4-18-07; 8:45 am] BILLING CODE 4120-03-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Privacy Act of 1974; Report of a New System of Records AGENCY: Department of Health and Human Services (HHS), Center for Medicare & Medicaid Services (CMS). ACTION: Notice of a New System of Records (SOR). SUMMARY: In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, “Post-Acute Care Payment Reform / Continuity of Assessment Report and Evaluation Demonstration and Evaluation (PAC-CARE), System No. 09-70-0569.” The program is authorized under Section 5008 of the Deficit Reduction Act of 2005, which allows for the establishment of a demonstration program for purposes of understanding costs and outcomes across different post-acute care sites. The PAC-CARE will collect information that will enable CMS to better understand the relationships among patient needs, post-acute care placement, patient outcomes, and post-acute care related costs in the Medicare program. Anticipated results of the PAC-CARE include a standardized assessment instrument for post-acute care patients and a proposal for site-neutral payment for post-acute care services. The purpose of this system is to collect and maintain demographic, health, and health resource use related data on the target population of Medicare beneficiaries who require treatment in a designated acute care or post-acute care facility. We will also collect certain identifying information on Medicare providers who provide services to such beneficiaries. Information retrieved from this system may be disclosed to:

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

(2)assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds;

(3)support 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;

(4)support the functions of Quality Improvement Organizations;

(5)support the functions of national accrediting organizations;

(6)support litigation involving the agency; and

(7)combat fraud, waste, and abuse in certain Federally-funded 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 Date:* CMS filed a new SOR report with the Chair of the House Committee on Government Reform and Oversight, the Chair of the Senate Committee on Homeland Security & Governmental Affairs, and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget

(OMB)on April 13, 2007. To ensure that all parties have adequate time in which to comment, the new system will become effective 30 days from the publication of the notice, or 40 days from the date it was submitted to OMB and the Congress, whichever is later. We may defer implementation of this system or one or more of the routine use statements listed below if we receive comments that persuade us to defer implementation. ADDRESSES: The public should address comments to the CMS Privacy Officer, Division of Privacy Compliance, Enterprise Architecture and Strategy Group, Mail-stop N2-04-27, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Comments received will be available for review at this location by appointment during regular business hours, Monday through Friday from 9 a.m.-3 p.m., eastern time. FOR FURTHER INFORMATION CONTACT: Shannon Flood, Division of Payment Research, Research and Evaluation Group, Office of Research Development & Information, Mail Stop C3-19-26, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1849. She can be reached by telephone at 410-786-2583, or via e-mail at *Shannon.Flood@cms.hhs.gov* . SUPPLEMENTARY INFORMATION: Medicare beneficiaries frequently require post-acute care for rehabilitation and recovery following a hospital stay. The level and length of care required varies with the individual patient and the condition(s) requiring hospitalization. The type of care ranges from outpatient therapy to multi-day stays in a variety of post-acute care settings. The PAC-CARE will study Medicare beneficiaries as they are discharged from participating hospitals and move among post-acute care settings. Patient functional assessments will be performed at regular intervals beginning at hospital discharge and continuing as patients move among post-acute care settings until the episode of care has completed. Cost data will be collected from the post-acute care settings, combined with other cost information collected by Medicare Fiscal Intermediaries or Carriers, and combined with claims and patient outcome data to develop a payment reform proposal. I. Description of the Proposed System of Records A. Statutory and Regulatory Basis for SOR The statutory authority for this system is given under Section 5008 of the Deficit Reduction Act of 2005. B. Collection and Maintenance of Data in the System This system will collect and maintain individually identifiable and other data collected on Medicare beneficiaries who require treatment in a designated acute care or post-acute care facility. We will also collect certain identifying information on Medicare providers who provide services to such beneficiaries. The collected information will include, but is not limited to: Medicare claims and eligibility data, name, address, telephone number, health insurance claims number, race/ethnicity, gender, date of birth, provider name, unique provider identification number, medical record number, as well as clinical, demographic, health/well-being, family and/or caregiver contact information, and background information relating to Medicare issues. Data will be collected from Medicare administrative and claims records, PAC-CARE site administrative data systems, patient medical charts, physician records, and via information submitted by beneficiaries and providers. 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 PAC-CARE 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 PAC-CARE. 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 collect and maintain demographic, health, and health resource use related data on the target population of Medicare beneficiaries who require treatment in a designated acute care or post-acute care facility. We will also collect certain identifying information on Medicare providers who provide services to such beneficiaries. 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 or consultant 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 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. Assist Federal/state Medicaid programs within the state. Other Federal or state agencies, in their administration of a Federal health program, may require PAC-CARE information in order to support evaluations and monitoring of Medicare claims information of beneficiaries, including proper reimbursement for services provided. 3. 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 PAC-CARE 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 researchers may 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. 4. To support Quality Improvement Organizations

(QIO)in connection with review of claims, or in connection with studies or other review activities conducted pursuant to Part B of Title XI of the 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. The QIO may use this data to support quality improvement activities and other QIO responsibilities as detailed in Title XI §§ 1151-1164. The QIO will work to implement quality improvement programs, provide consultation to CMS, its contractors, and to state agencies. The QIO will assist 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 assist national accrediting organization(s) whose accredited facilities are presumed to meet certain Medicare requirements for inpatient hospital rehabilitation services (e.g., the Joint Commission for the Accreditation of Healthcare Organizations, the American Osteopathic Association, or the Commission on Accreditation of Rehabilitation Facilities). Information will be released to these organizations for only those facilities that they accredit and that participate in the Medicare program and if they meet the following requirements: a. Provide identifying information for post acute care facilities that have an accreditation status with the requesting deemed organization; b. Submission of a finder file identifying beneficiaries/patients receiving post acute care services; c. Safeguard the confidentiality of the data and prevent unauthorized access; and d. Upon completion of a signed data exchange agreement or a CMS data use agreement. At this time, CMS anticipates providing accrediting organizations with PAC-CARE information to enable them to target potential identified problems during the organization's accreditation review process of the facility. 6. 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. 7. 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, and 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, and 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. 8. 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 PAC-CARE 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 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 Proposed 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. 09-70-0569 System Name: “Post-Acute Care Payment Reform/Continuity of Assessment Report and Evaluation Demonstration and Evaluation (PAC-CARE),” HHS/CMS/ORDI. Security Classification: Level Three Privacy Act Sensitive Data. System Location: Centers for Medicare & Medicaid Services

(CMS)Data Center, 7500 Security Boulevard, North Building, First Floor, Baltimore, Maryland 21244-1850 and at various co-locations of CMS agents. Categories of Individuals Covered by the System: This system will collect and maintain individually identifiable and other data collected on Medicare beneficiaries who require treatment in a designated acute care or post-acute care facility. We will also collect certain identifying information on Medicare providers who provide services to such beneficiaries. Categories of Records in the System: The collected information will include, but is not limited to: Medicare claims and eligibility data, name, address, telephone number, health insurance claims number, race/ethnicity, gender, date of birth, provider name, unique provider identification number, medical record number, as well as clinical, demographic, health/well-being, family and/or caregiver contact information, and background information relating to Medicare issues. Data will be collected from Medicare administrative and claims records, PAC-CARE site administrative data systems, patient medical charts, physician records, and via information submitted by beneficiaries and providers. Authority for Maintenance of the System: The statutory authority for this system is given under Section 5008 of the Deficit Reduction Act of 2005. Purpose(s) of the System: The purpose of this system is to collect and maintain demographic, health, and health resource use related data on the target population of Medicare beneficiaries who require treatment in a designated acute care or post-acute care facility. We will also collect certain identifying information on Medicare providers who provide services to such beneficiaries. Information retrieved from this system may be disclosed to:

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

(2)assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds;

(3)support 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;

(4)support the functions of Quality Improvement Organizations;

(5)support the functions of national accrediting organizations;

(6)support litigation involving the agency; and

(7)combat fraud, waste, and abuse in certain Federally-funded 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 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. Assist Federal/state Medicaid programs within the state. 3. 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. 4. To support Quality Improvement Organizations

(QIO)in connection with review of claims, or in connection with studies or other review activities conducted pursuant to Part B of Title XI of the 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 assist national accrediting organization(s) whose accredited facilities are presumed to meet certain Medicare requirements for inpatient hospital rehabilitation services (e.g., the Joint Commission for the Accreditation of Healthcare Organizations, the American Osteopathic Association, or the Commission on Accreditation of Rehabilitation Facilities). Information will be released to these organizations for only those facilities that they accredit and that participate in the Medicare program and if they meet the following requirements: a. Provide identifying information for post acute care facilities that have an accreditation status with the requesting deemed organization; b. Submission of a finder file identifying beneficiaries/patients receiving post acute care services; c. Safeguard the confidentiality of the data and prevent unauthorized access; and d. Upon completion of a signed data exchange agreement or a CMS data use agreement. 6. 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. 7. 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, and abuse in such program. 8. 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

(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). 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. 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: 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, Research and Evaluation Group, Office of Research Development & Information, Mail Stop C3-19-26, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1849. 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: Data will be collected from Medicare administrative and claims records (Outcome and Assessment Information Set, Inpatient Rehabilitation Facilities Patient Assessment Instrument, Long Term Care Minimum Data Set), post-acute care site administrative data systems, patient medical charts, physician records, and via information submitted by beneficiaries and providers. Systems Exempted From Certain Provisions of the Act: None. [FR Doc. E7-7404 Filed 4-18-07; 8:45 am] BILLING CODE 4120-03-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0077] Withdrawal of Approval of New Animal Drug Applications; Pyrantel; Tylosin; Tylosin and Sulfamethazine AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is withdrawing approval of three new animal drug applications (NADAs) for intermediate premixes used to manufacture Type C medicated feeds. In a final rule published elsewhere in this issue of the **Federal Register** , FDA is amending the animal drug regulations to remove portions reflecting approval of these NADAs. FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9067, e-mail: *pamela.esposito@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: Custom Feed Services Corp., 2100 N. 13th St., Norfolk, NE 68701, has requested that FDA withdraw approval of NADA 121-200 for Tylosin 10 Premix (tylosin), NADA 129-159 for TYLAN 40 Sulfa-G (tylosin and sulfamethazine), and NADA 137-484 for Swine Guard-BN (pyrantel). All are intermediate premixes used to manufacture Type C medicated feeds. This action is requested because the products are no longer manufactured or marketed. Therefore, under authority delegated to the Commissioner of Food and Drugs, redelegated to the Center for Veterinary Medicine, and in accordance with 21 CFR 514.115 *Withdrawal of approval of applications* , notice is given that approval of NADA 121-200, NADA 129-159, and NADA 137-484, and all supplements and amendments thereto, are hereby withdrawn, effective April 30, 2007. In a final rule published elsewhere in this issue of the **Federal Register** , FDA is amending the animal drug regulations to reflect the withdrawal of approval of these NADAs. Dated: April 9, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E7-7461 Filed 4-18-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0078] Withdrawal of Approval of New Animal Drug Applications; Estradiol Benzoate AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)has withdrawn approval of two new animal drug applications (NADAs) for a suspension implant of estradiol benzoate microspheres used in steers and heifers fed in confinement for slaughter for increased rate of weight gain and improved feed efficiency, and in suckling beef calves for increased rate of weight gain. In a final rule published elsewhere in this issue of the **Federal Register** , FDA is amending the animal drug regulations to remove portions reflecting approval of these NADAs. FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9067; e-mail: *pamela.esposito@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: PR Pharmaceuticals, Inc., 1716 Heath Pkwy., Fort Collins, CO 80524, has requested that FDA withdraw approval of NADA 141-040 for DURALEASE (estradiol benzoate), a suspension implant of estradiol benzoate microspheres used in steers and heifers fed in confinement for slaughter for increased rate of weight gain and improved feed efficiency and NADA 141-041 for CELERIN-C (estradiol benzoate), a similar product used in suckling beef calves for increased rate of weight gain. This action is requested because the products are no longer manufactured or marketed. Therefore, under authority delegated to the Commissioner of Food and Drugs, redelegated to the Center for Veterinary Medicine, and in accordance with 21 CFR 514.115, notice is given that approval of NADA 141-040 and NADA 141-041 and all supplements and amendments thereto, were withdrawn as of September 29, 2006. In a final rule published elsewhere in this issue of the **Federal Register** , FDA is amending the animal drug regulations to reflect the withdrawal of approval of these NADAs. Dated: April 9, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. 07-1941 Filed 4-18-07; 8:45 am]

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