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Code · REGISTER · 2007-08-07 · Centers for Medicare & Medicaid Services (CMS), HHS · Notices

Notices. Notice with comment period

15,689 words·~71 min read·/register/2007/08/07/07-3850

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

BILLING CODE 4163-19-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-3188-NC] Medicare Program; Evaluation Criteria and Standards for Quality Improvement Program Organization Contracts AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice with comment period. SUMMARY: This notice with comment period describes the criteria we intend to use to evaluate the efficiency and effectiveness of Quality Improvement Organizations
(QIOs)currently under contract with CMS in accordance with the Social Security Act. These evaluation criteria are based on the tasks and related subtasks set forth in the QIO's Scope of Work (SOW). The current 8th SOW includes Tasks 1, 3, and 4 (Task 2 is reserved) with subtasks included under Tasks 1 and 3. QIOs were awarded contracts for the 8th SOW, or 8th Round, for 3 years, with staggered starting dates beginning August 2005, November 2005, and February 2006. Comments on this notice will also be considered in the development of the 9th SOW. DATES: To be assured of consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on September 6, 2007. ADDRESSES: In commenting, please refer to file code CMS-3188-NC. Because of staff and resource limitations, we cannot accept comments by facsimile
(FAX)transmission. You may submit comments in one of four ways (no duplicates, please): 1. *Electronically.* You may submit electronic comments on specific issues in this regulation to *http://www.cms.hhs.gov/eRulemaking* . Click on the link “Submit electronic comments on CMS regulations with an open comment period.” (Attachments should be in Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft Word.) 2. *By regular mail.* You may mail written comments (one original and two copies) to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3188-NC, P.O. Box 8010, Baltimore, MD 21244-8010. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. *By express or overnight mail.* You may send written comments (one original and two copies) to the following address only: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3188-NC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-8010. 4. *By hand or courier.* If you prefer, you may deliver (by hand or courier) your written comments (one original and two copies) before the close of the comment period to one of the following addresses. If you intend to deliver your comments to the Baltimore address, please call telephone number
(410)786-9994 in advance to schedule your arrival with one of our staff members. Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201; or 7500 Security Boulevard, Baltimore, MD 21244-8010. (Because access to the interior of the HHH Building is not readily available to persons without Federal Government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.) Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Terry Lied
(410)786-8973. SUPPLEMENTARY INFORMATION: *Submitting Comments:* We welcome comments from the public on all issues set forth in this notice with comment period to assist us in fully considering issues and developing policies. You can assist us by referencing the file code CMS-3188-NC and the specific “issue identifier” that precedes the section on which you choose to comment. *Inspection of Public Comments:* All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: *http://www.cms.hhs.gov/eRulemaking* . Click on the link “ *Electronic Comments on CMS Regulations* ” on that Web site to view public comments. Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951. I. Background [If you choose to comment on issues in this section, please include the caption “BACKGROUND” at the beginning of your comments.] The Peer Review Improvement Act of 1982 (Title I, Subtitle C of Pub. L. 97-248) amended Part B of Title XI of the Social Security Act (the Act) to establish the Peer Review Organization
(PRO)programs. The PRO program (now called the Quality Improvement Organization
(QIO)program) was established to redirect, simplify, and enhance the cost-effectiveness and efficiency of the medical peer review process. Sections 1152, 1153(b), and 1153(c) of the Act define the types of organizations eligible to become QIOs, and establish certain limitations and priorities regarding QIO contracting. The Secretary enters into contracts with QIOs to perform three broad functions: • Improve quality of care for beneficiaries by ensuring that beneficiary care meets professionally recognized standards of health care; • Protect the integrity of the Medicare Trust Fund by ensuring that Medicare pays only for services and items that are reasonable and medically necessary and that are provided in the most economical setting; • Protect beneficiaries by expeditiously addressing individual cases such as beneficiary quality of care complaints, contested hospital issued notices of noncoverage (HINNs), alleged Emergency Medical Treatment and Labor Act (EMTALA) violations, and other statutory responsibilities. Section 1154 of the Act requires that QIOs review those services furnished by physicians; other health care practitioners; and institutional and non-institutional providers of health care services, including health maintenance organizations and competitive medical plans. Section 109 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), Public Law 108-173, amended section 1154(a)(1) of the Act to expand the scope of review of QIOs to include Medicare Advantage Organizations, and prescription drug sponsors. Section 109 of the MMA also created a new section 1154(a)(17) of the Act, which requires QIOs to offer to providers, practitioners, Medicare Advantage Plans and prescription drug sponsors, quality improvement assistance pertaining to prescription drug therapy. Section 1153(h)(2) of the Act requires the Secretary to publish in the **Federal Register** the general criteria and standards that would be used to evaluate the efficient and effective performance of contract obligations by QIOs and to provide the opportunity for public comment. The QIO contracts for the 8th SOW were awarded for 3 years with starting dates staggered into three approximately equal groups (rounds) starting August 2005, November 2005, and February 2006, respectively. Comments on this notice will also be considered in the development of the 9th scope of work. II. Measuring QIO Performance & Criteria for Non-Competitive Renewal of Contracts [If you choose to comment on issues in this section, please include the caption “MEASURING QIO PERFORMANCE” at the beginning of your comments.] Under the 8th Round contracts, QIOs are responsible for completing the requirements of the following specific tasks and subtasks: Task 1: Assisting Providers in Developing the Capacity for and Achieving Excellence. a. Subtask 1a: Nursing Home. b. Subtask 1b: Home Health. c. Subtask 1c1: Hospital. d. Subtask 1c2: Critical Access Hospital/Rural Hospital. e. Subtask 1d1: Physician Practice. f. Subtask 1d2: Physician Practice: Underserved Populations. g. Subtask 1d3: Physician Practice/Pharmacy: Part D Benefit. Task 2: Reserved. Task 3: Protecting Beneficiaries and the Medicare Program. a. Subtask 3a: Beneficiary Protection. b. Subtask 3b: Hospital Payment Monitoring Program Task 4: Special Studies and Projects (Special Studies defined as work that CMS directs a QIO to perform or work that a QIO elects to perform with CMS approval which is not currently defined under Tasks 1-3 of the SOW but falls within the scope of the contract and section 1154 of the Act). Under this SOW, to merit having its contract renewed non-competitively, the QIO must meet the performance criteria on the tasks and subtasks. For Tasks 1 and 3, the QIO will be scored using the following four classifications: • Excellent Pass • Full Pass • Conditional Pass • Not Pass For all nine subtasks related to tasks 1 and 3, the QIO must achieve at least a Conditional Pass to be eligible to have its contract renewed non-competitively. A QIO that receives a “Not Pass” on any subtask will be invited to our evaluation panel (subject to CMS approval). In addition, the QIO must achieve at least a “Full Pass” or “Excellent Pass” on seven of the nine subtasks to be eligible to have its contract renewed non-competitively. A QIO that receives a “Conditional Pass” on three or more subtasks will be invited to our evaluation panel (subject to CMS approval). However, an “Excellent Pass” on one or more subtasks may negate a “Conditional Pass” on one subtask. That is, a QIO that receives an “Excellent Pass” on one or more subtasks and receives a “Conditional Pass” on no more than three subtasks and does not receive a “Not Pass” on any subtasks may be eligible to have its contract renewed non-competitively. A QIO working only seven or eight subtasks due to valid exemptions as specified in the SOW will be treated as though it has received a “Full Pass” in the subtasks from which it is exempt. The QIO must still achieve at least a “Full Pass” or “Excellent Pass” on seven of the nine subtasks in order to have its contract non-competitively renewed. We may revise the performance criteria for a QIO before signing a contract with that QIO. The target performance levels for individual tasks and subtasks may vary across QIOs. We will provide these specific performance criteria during the Request for Proposal
(RFP)process. We will assess the QIO's task and subtask-specific performance in November 2007 based on the data available at that time. The specific evaluation criteria are described below for each task and subtask. Task 4 (special projects) will not be subject to these evaluation criteria. Projects funded to reduce hospital payment error under Task 4 will affect QIOs evaluation as specified in Task 3b. The assessment of performance on all other special projects under Task 4 will affect the QIO's eligibility to receive funding for additional special projects under the current or subsequent QIO contracts, but will not affect eligibility for non-competitive renewal of the QIO contract. For the 9th SOW, we intend to revise the criteria required for non-competitive renewal of contracts. For the 9th SOW, we are considering a requirement that QIOs achieve a “full pass” or an “excellent pass” on all tasks and sub-tasks for the non-competitive renewal of their contracts for the 10th SOW. We are also reviewing the process by which a QIO contract can be terminated, during the course of a SOW, on performance grounds. III. Standards for Minimum Performance [If you choose to comment on issues in this section, please include the caption “STANDARDS FOR MINIMUM PERFORMANCE” at the beginning of your comments.] Task 1: Assisting Providers in Developing the Capacity for and Achieving Excellence Subtasks of Task 1 will include statewide and identified participant components. (The term “statewide” is used for activities directed toward a QIO's entire State/jurisdiction—that is, one of the 50 States, the District of Columbia, Puerto Rico, or the Virgin Islands.) Subtask evaluation will be based on the following five dimensions of performance: • Performance measure results (changes and improvements in rates). • Clinical performance reporting (increases in number of measures reported). • Providers' adoption and use of systems. • Implementation of key process changes. • Changes in organizational culture. Each subtask of Task 1 will include a requirement to meet Satisfaction and Knowledge/Perception performance criteria for provider identified participants
(IPG)and non-identified participants (Non-IPG). Satisfaction and knowledge/perception surveys and stakeholder knowledge/perception surveys will be used to measure performance. “Identified Participants” are providers that received focused assistance on at least one quality measure from QIOs. “Non-Identified Participants” are providers that received no focused assistance from QIOs. Task 1a: Nursing Home Under Task 1a, the QIO will focus on the following: • Improving clinical performance. • Setting improvement targets. • Measuring the nursing home experience. The QIO will focus on decreasing the rate of pressure ulcers among high risk individuals, decreasing the use of physical restraints, improving the management of depressive symptoms, and improving the management of pain in chronic (long stay) residents among a select group of identified participant nursing homes
(IPG1)as well as other nursing homes requesting assistance from the QIO. The QIO must also work with a second select group of identified participants
(IPG2)that focuses on decreasing the rate of pressure ulcers among high risk individuals and decreasing the use of physical restraints. The QIO will set statewide targets for (at a minimum) pressure ulcers among high-risk residents and physical restraints. In addition, the QIO will work with all nursing homes throughout the State/jurisdiction to set quality improvement targets for (at a minimum) pressure ulcers and physical restraints on an annual basis. In the area of organizational culture, the QIO must work with both groups of identified participants (IPG1 and IPG2) to collect information on resident and staff experience/satisfaction with care and staff turnover by engaging in activity that is likely to improve organizational culture. ( **Note:** In four States/jurisdictions (WY, AK, DC, and PR), the QIO must work with its Project Officer to develop alternative Task 1a evaluation criteria for this SOW. The QIO must receive approval from its Project Officer and the Task 1a Government Task Leader
(GTL)on its alternative Task 1a evaluation criteria). Task 1b: Home Health QIO work in the home health setting will focus at the statewide level on meeting or exceeding the statewide targets on the Outcome and Assessment Information Set (OASIS). Information on OASIS can be found at *http://www.cms.hhs.gov/OASIS/* . In addition, the QIO must work with home health agencies
(HHAs)in setting targets for acute care hospitalization and other publicly reported OASIS measures to be determined by CMS. The QIO must also work to increase the number of HHAs that incorporate an assessment of influenza and pneumococcal vaccination status into the patient comprehensive assessment, offer these vaccinations, and provide follow-up. The QIO must also work with two groups of identified participants: A Clinical Performance Identified Participant Group
(IPG)and a Systems Improvement and Organizational Culture Change
(SIOC)IPG. The QIO will focus in the Clinical Performance IPG on meeting or exceeding the IPG target on the OASIS measure for acute care hospitalization and one additional HHA-selected publicly reported OASIS measure through the Outcome Based Quality Improvement
(OBQI)process. Information on OBQI can be found at: *http://www.cms.hhs.gov/HomeHealthQualityInits/16_HHQIOASISOBQI.asp* . With the SIOC IPG, the QIO will work to implement and/or use emerging telehealth technologies to help reduce acute care hospitalization and work to build capacity within these HHAs to evaluate and improve organizational culture. Both at the statewide level and with a Clinical Performance IPG, the QIO must improve clinical performance measure results. The QIO will be evaluated on its ability to work with HHAs to incorporate influenza and pneumococcal immunizations into the comprehensive patient assessment. The QIO will also be evaluated on the following: • Implementation of a CMS survey tool that measures specific dimensions of organizational culture change. • Submission by an HHA of a Plan of Action
(POA)based on the results of the organizational culture change survey and implementation of a quality improvement activity. • The QIO will have extra credit added to its total Task 1b evaluation score for improving results on both the OASIS acute care hospitalization measure and the selected publicly reported OASIS outcome measure. The QIO may receive extra credit for one or more of the following: • Improving results for the identified participant OASIS measure. • Improving results for the statewide and identified participant Acute Care Hospitalization measure. • Improving the statewide immunization assessment rate beyond the target rate. • Working with HHAs to set targets. Task 1c1: Hospital For Task 1c1, the QIO must work with hospitals to achieve system-level changes through the use of four strategies: Increasing clinical performance measurement and reporting; process improvement; systems improvement; and organizational culture change. The QIO will work to improve quality of care in hospitals through several distinct efforts aligned with each strategy. For clinical performance measure results, the QIO will assist an IPG, including both rural and urban Prospective Payment System
(PPS)hospitals, in improving performance on an Appropriate Care Measure (ACM). (The ACM is defined as a composite measure of care at the patient level for three clinical topics—AMI, HF, and PNE.) The QIO will work at the statewide level to encourage hospitals to submit data on the full Hospital Quality Alliance
(HQA)measure set of 22 measures ( *http://www.cms.hhs.gov/HospitalQualityInits/15_HospitalQualityAlliance.asp.* ). The QIO will also work to increase the validity of all data the hospitals submit to the QIO Clinical Data Warehouse. With a major focus on process improvement in this SOW, the QIO will work through statewide and identified participant efforts to get hospitals to adopt standard processes of care in five different areas: Prevention of surgical site infections, cardiovascular complications, venous thromboembolism, ventilator-associated pneumonia, and promotion of the use of fistulas for hemodialysis. To encourage systems improvement and organizational culture change, the QIO will work with identified participants (including both PPS and Critical Access Hospitals (CAHs)) to engage senior hospital leadership in the use of Computerized Physician Order Entry (CPOE), barcoding, and/or telehealth systems. Task 1c2: Critical Access Hospital/Rural PPS Hospital The QIO must promote transformational change in CAHs and rural PPS hospitals by working on clinical performance quality measures and organizational safety culture relevant to the care provided in these hospitals. For purposes of Task 1c2, a rural PPS hospital is defined as a PPS hospital located in a non-Metropolitan Statistical Area (non-MSA) county. The QIO must assist identified participant CAHs/rural PPS hospitals in assessing their organizational safety culture. The QIO must also assist these hospitals in selecting, testing, and implementing changes that will demonstrate improvement in the organization's safety culture. Task 1d1: Physician Practice The QIO will work with physician practice sites statewide and with an IPG. With an IPG, the QIO will focus on more reliable delivery of preventive services and effective management of patients with chronic conditions, in particular diabetes and heart disease. Working with their IPG, the QIO will seek to demonstrate improvement in clinical performance measures through the production and effective use of electronic clinical information
(ECI)in conjunction with redesign of patient care processes within the physician practice sites. In addition to executing the work described for Task 1d1, the QIO will work with other organizations and agencies that have similar goals. The QIO must be actively involved with or promote the convening of local multi-stakeholder organizations that seek to promote the production and use of electronic clinical information and healthcare information exchange necessary for improving clinical performance. The QIO may work with these organizations to: • Provide information on products, functionality, value, and costs of ECI systems; • Promote production and use of ECI; • Promote ECI sharing in accordance with the Health Insurance Portability and Accountability Act standards (including the Privacy and Security Rules) and QIO confidentiality requirements, as applicable; and • Promote improved healthcare through use of and reporting of performance on the clinical quality measures specified for this Task. The QIO must work with physician practice sites and others to improve care for Medicare beneficiaries on a statewide basis. The QIO must support quality initiatives including the Physician Voluntary Reporting Program
(PVRP)by activities that include providing information to physicians on participation in the initiative and on physician performance and improvement for those that report. The QIO must promote statewide quality improvement by working with public health, provider groups, and other broad-based agencies to support the use of appropriate preventive and disease-based care processes. Medicare Advantage The Project Officer will evaluate performance based on the assistance provided to Medicare Advantage Organizations. The Medicare Advantage part of Task 1d1 will be waived for States/jurisdictions that had low MA enrollment among the eligible Medicare beneficiaries during calendar year 2004. Clinical Performance Measurement and Reporting: The objective of this element is to encourage physician practice sites to submit data on the DOQ clinical measures to the QIO Data Warehouse for all Medicare patients. Practice sites must demonstrate an ability to submit data to the Data Warehouse. The QIO must collaborate with the Medicare Care Management Performance Demonstration (section 649 of MMA) contractors by providing them with physician practice information the QIO already has or will collect, acquire, or generate in performing its own QIO tasks, provided the individual practices have requested and agreed to these disclosures. The QIO will be evaluated using the criteria deemed acceptable by CMS as outlined in the QIO's proposal. Task 1d2: As part of QIO efforts in the physician practice setting, the QIO must, at the statewide level, work to improve clinical performance measure results for clinical quality indicators in the areas of diabetes, mammography, and adult immunizations for underserved racial/ethnic populations. With one IPG, the QIO will work to promote systems improvement through DOQ activities with a representative underserved population under Task 1d1. With a Task 1d2-specific IPG, the QIO will work on practice site and practitioner system changes related to Culturally and Linguistically Appropriate Services
(CLAS)standards and culturally competent care. For more information on CLAS standards refer to: *http://www.omhrc.gov/templates/browse.aspx?lvl=2&lvlID=15.* Task 1d2 is composed of core and non-core tasks. The core tasks include satisfactory completion of the CLAS/Cultural Competency IPG at the practice site and practitioner level and the Satisfaction and Knowledge/Perception survey for the relevant respondents. The non-core task is statewide measure improvement. Satisfactory completion of the core tasks will achieve a Full Pass for Task 1d2. Task 1d3: Physician Practice/Pharmacy: Part D Benefit As part of QIO efforts in the physician practice setting in this SOW, the QIO must focus on improving safety in the delivery of prescription drugs. Widespread use of e-prescribing with comprehensive decision support tools is expected to improve the quality of prescription drug delivery. Until this broader use is in place, the QIO must implement quality improvement projects focusing on improved prescribing, using evidence-based guidelines. Over the course of the 8th SOW contract, we will work with the QIO to develop and implement new methods to gather and disseminate better evidence for healthcare decision-making. This activity will include collection, linkage, and de-identification of Part D and other public and private administrative data; assisting in implementation of clinical registries and practical clinical trials; and other work necessary to support the development and use of better evidence for decisions. A variety of methods are available to accomplish these activities. We support engaging physicians because improving prescribing begins with modifying physicians' behavior. This can be accomplished by providing data and information in ways that support behavior change. We also support working with dispensing pharmacists because they detect errors and problems with the medications they dispense, and they interact with beneficiaries. Pharmacy policies, procedures, and quality checks need to be implemented to be consistent with quality, safety, and cost-effectiveness goals. By partnering with prescription drug plans
(PDPs)and using the drug data available, the QIO can affect prescribing by physicians and improve delivery of services at the pharmacy level. Medicare Advantage PDPs will have similar goals as fee-for-service
(FFS)Medicare PDPs and will have both more information and more direct control than FFS Medicare PDPs over the care that Medicare beneficiaries receive. With the enactment of MMA, we are committed to providing a robust drug benefit to seniors, implementing responsible cost management provisions, as well as monitoring and improving drug therapies using current evidence-based guidelines. As authorized by section 109(b) of MMA, the QIO must offer quality improvement assistance pertaining to prescription drug therapy to the following: • All Medicare providers and practitioners; • Medicare Advantage organizations offering Medicare Advantage plans under Part C; and • Organizations offering Prescription Drug Plans
(PDPs)under Part D. The Part D benefit was implemented January 1, 2006. The QIOs began to implement quality improvement projects starting August 2006. Before August 2006, we identified the set of quality measures for Task 1d3 which were derived from evidence-based guidelines and developed in collaboration with participating PDPs, physician societies, and other national leaders. The QIO will be held accountable for work with identified participants on clinical performance measure results. Because of the relatively new nature of the work, the evaluation of this task is more process and customer satisfaction oriented than other tasks in the contract. The QIO earns a conditional pass if it designs and completes, to CMS satisfaction, a quality improvement project designed to improve care with its stakeholders. The QIO will receive a full pass if, in addition to completing the project, 80 percent of its surveyed project partners report that they are satisfied with their work with the QIO. The QIO will earn an excellent pass if, in addition to the above two criteria, the project achieves improvement in the measures targeted by its project. Task 2: (Reserved) Task 3a: Beneficiary Protection This task involves all case review activities, including mediation, that are necessary to conduct statutorily mandated review of beneficiary complaints about the quality of health care services. It also involves all activities associated with other required case reviews, including Emergency Medical Treatment and Active Labor Act (EMTALA) reviews, beneficiary appeals of discharge, and fiscal intermediary referrals. All case review activities must be conducted in accordance with our instructions. Additional required activities under this Task are physician acknowledgment monitoring; inter-rater reliability
(IRR)assessment; procedures based on the result of a review or analysis of review data; development of an Annual Report; and maintenance of a Medicare Helpline. Task 3b: Hospital Payment Monitoring Program In the 8th SOW contract, we directed the QIOs to continue the Hospital Payment Monitoring Program (HPMP). The purpose of HPMP is to measure, monitor, and reduce the incidence of improper fee-for-service inpatient payments, including errors in: DRG coding; provision of medically necessary services; and appropriateness of setting, billing, and prepayment denial. The basis for HPMP is statutory and regulatory. Section 1154 of the Act statutorily mandates utilization review of professional activities subject to the requirements of subsection (d). In accordance with 42 CFR 412.508(a), QIO review must include long-term acute care services. For FFS inpatient hospital claims (paid and denied), HPMP fulfills our requirement to comply with the Improper Payment Information Act of 2002 (Pub. L. 107-300). The QIO will be judged successful if, at remeasurement, the absolute (gross total of under- and overpayments) and net (difference between over- and underpayments) payment error rates are no greater than 1.5 standard errors above the respective absolute and net baseline payment error rate. The QIOs will also be judged in terms of timeliness of reviews. Monitoring activities must be summarized for payment error rates and hospital admission, coding, and billing patterns for short-term acute care inpatient FFS reimbursements in the QIO's State/jurisdiction including hospital profiling and trend monitoring. The QIO must submit its summary electronically to the Project Officer via a designated database as directed by CMS. Whether demonstrations of reductions in dollars or percent dollars paid in error and whether substantive knowledge are gained in the project will be determined by the Task 3b GTL and the QIO's Project Officer. Task 4: Special Studies and Projects A Special Project is defined as work that we direct a QIO to perform or work that a QIO elects to perform with our approval that is not defined under Tasks 1-3 of the contract. The Special Project work must fall within the scope of the contract and of section 1154 of the Act. The Special Project must be conducted in accordance with contract sections B.4, Task 4 Special Projects; G.18, Procedures for Special Projects; and H.12, CMS-Directed Subcontracts/Special Project Lead QIOs. The term “Special Project” is a more accurate term for the type of activities and requirements characteristically implemented under Task 4. Other terms, previously commonly used, for activities under this task include “special study”, “special study project”, and “special work.” All Special Projects awarded/approved under Task 4 will be evaluated individually. The QIO's success or failure on a Special Project will not be factored into the evaluation of the QIO's work under Tasks 1-3 of the contract, except for projects funded to meet the requirements of Task 3b: Hospital Payment Monitoring Program. The assessment of performance on all other special projects under Task 4 will affect the QIO's eligibility to receive funding for additional special projects under the current or subsequent QIO contracts, but will not affect eligibility for non-competitive renewal of the QIO contract. Although individual projects may include additional project-specific assessment criteria and performance measures, every project awarded/approved under Task 4 is subject to evaluation on at least the following dimensions of performance, which apply to any and all projects awarded/approved under Task 4: • Completion of specific tasks (deliverables) required in the special project. • Financials. • Appropriateness of QIO staffing for this special project including number of staff as well as skill sets of staff. • Performance in meeting the needs of QIOs, other Quality Improvement Organization Support Centers, GTLs, etc., and the quality of activities to improve performance. • Participation in other improvement activities. • Efforts to address issues/barriers identified. Performance assessment for each project will be conducted jointly by the QIO's regularly assigned CMS Project Officer and the specific Special Project GTL (SPGTL). Authority: Section 1153 of the Social Security Act (42 U.S.C. 1320c-2) (Catalog of Federal Domestic Assistance Program No. 93.774, Medicare—Supplementary Medical Insurance Program). Dated: March 8, 2007. Leslie Norwalk, Acting Administrator, Centers for Medicare & Medicaid Services. Editorial Note: The Office of the Federal Register received this document on August 2, 2007. [FR Doc. E7-15342 Filed 8-6-07; 8:45 am] BILLING CODE 4120-01-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)Centers 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, “Healthcare Common Procedure Coding System (HCPCS) Level II, System No. 09-70-0576.” In October 2003, the Secretary of HHS delegated authority under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to CMS to maintain and distribute HCPCS Level II Codes. Level II of the HCPCS is a standardized coding system that is used primarily to identify products and services not included in the HCPCS Level I Current Procedural Terminology
(CPT)codes, such as: Injectable drugs administered in a physician office; durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) when used outside a physician's office; and ambulance services. HCPCS Level II codes were established to identify these products on insurance claims. There are about 4000 HCPCS Level II codes available for assignment by insurers in accordance with their policies. The primary purpose of this system is to facilitate the management and maintenance of the HCPCS Level II code set. Information in this system will also be used to:
(1)Support regulatory and policy functions performed within the Agency or by a contractor, consultant, or grantee;
(2)assist another Federal or state agency;
(3)support litigation involving the Agency related to this system; and
(4)combat fraud, waste, and abuse in certain health benefits programs. We have provided background information about the proposed system in the Supplementary Information section below. Although the Privacy Act requires only that the “routine use” portion of the system be published for comment, CMS invites comments on all portions of this notice. See *Effective Dates* section for comment period. DATES: *Effective Dates:* 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 August 1, 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: CMS Privacy Officer, Division of Privacy Compliance, Enterprise Architecture and Strategy Group, CMS, Mail Stop N2-04-27, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Comments received will be available for review at this location, by appointment, during regular business hours, Monday through Friday from 9 a.m.-3 p.m., eastern daylight time. FOR FURTHER INFORMATION CONTACT: Trish Brooks, Division of Home Health, Hospice, and HCPCS, Chronic Care Policy Group, Center for Medicare Management, CMS, Mail Stop C5-09-16, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Her telephone number is 410-786-4561, or email at *Trish.Brooks@cms.hhs.gov.* SUPPLEMENTARY INFORMATION: Each year, in the United States, health care insurers process over 5 billion claims for payment. For Medicare and other health insurance programs to ensure that these claims are processed in an orderly and consistent manner, standardized coding systems are essential. The HCPCS Level II Code Set is one of the standard code sets adopted under the HIPAA, used for this purpose. The HCPCS Level II coding system is a comprehensive and standardized system that classifies similar products that are medical in nature into categories for the purpose of efficient claims processing. For each alphanumeric HCPCS code, there is descriptive terminology that identifies a category of like items. These codes are used primarily for billing purposes. For example, suppliers use HCPCS Level II codes to identify items on claim forms that are being billed to a private or public health insurer. HCPCS is a system for identifying items and services. While these codes are used for billing purposes, decisions regarding the addition, deletion, or revision of HCPCS codes are made independent of the process for making determinations regarding coverage and payment. Currently, there are national HCPCS codes representing approximately 4,000 separate categories of like items or services that encompass millions of products from different manufacturers. When submitting claims, suppliers are required to use one of these codes to identify the items they are billing. The descriptor that is assigned to a code represents a category of similar items. Anyone can submit a request for modifications to the HCPCS Level II National Code Set and/or provide comments regarding pending requests. The HCPCS coding review process is an ongoing continuous process; requests and other correspondence may be submitted at any time throughout the year. However, for a consideration of coding action with an effective date of January 1, a completed application must be received by January 3rd, or the first business day of the year prior. Applications received after January 3rd will be considered in the subsequent cycle. I. Description of the Proposed System of Records A. Statutory and Regulatory Basis for the System Authority for this system is given under the Health Insurance Portability and Accountability Act (HIPAA) of 1996, Public Law 104-191, its implementing regulation on “Code Sets” (45 Code of Federal Regulations Part 162, Subpart J) and 65 **Federal Register** 50312 (8-17-00). B. Collection and Maintenance of Data in the System Information is collected for this system on individuals who voluntarily submit information regarding any modification and/or applications to modify the HCPCS Level II Code Set. Information collected for this system will include, but is not limited to, applicant name, company name, product's generic or trade name, company mailing address, email address, telephone number, and fax number. II. Agency Policies, Procedures, and Restrictions on the Routine Use A. Agency Policies, Procedures, and Restrictions on the Routine Use The Privacy Act permits us to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such disclosure of data is known as a “routine use.” The government will only release HCPCS 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 management of HCPCS. 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 facilitate the management and maintenance of the HCPCS Level II code set. 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 contracted by the Agency to assist in accomplishment of a CMS function relating to the purposes for this system and who need to have 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 CMS functions relating to purposes for this system. CMS occasionally contracts out certain of its functions when this 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 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 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 HCPCS information in order to ensure that claims are processed in an orderly and consistent manner. 3. 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. 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. A determination would be made in each instance that, under the circumstances involved, the purposes served by the use of the information in the particular litigation is compatible with a purpose for which CMS collects the information. 4. To a CMS contractor (including, but not necessarily limited to Medicare administrative contractors, 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 relationship or grant 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 and makes grants 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. 5. 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 HCPCS 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 specified population is so small that an individual could, because of the small size, use this information to deduce the identity of the applicant). 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, the Federal Records Act of 1950, as amended, 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, CMS Information Security Handbook, and the National Archives and Records Administration's General Record Schedules and CMS' Records Schedules. 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 applicants 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 the disclosure of information relating to individuals. Date: July 30, 2007. Charlene Frizzera, Chief Operating Officer, Centers for Medicare & Medicaid Services. SYSTEM NO.: 09-70-0576. SYSTEM NAME: “Healthcare Common Procedure Coding System (HCPCS) Level II”. SECURITY CLASSIFICATION: Level 3 Privacy Act Sensitive. SYSTEM LOCATION: Centers for Medicare & Medicaid Services (CMS), 7500 Security Boulevard, Baltimore, Maryland 21244-1850. CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM: Information is collected for this system on individuals who voluntarily submit information regarding any modification and/or applications to modify the HCPCS Level II Code Set. CATEGORIES OF RECORDS IN THE SYSTEM: Information collected for this system will include, but is not limited to, applicant name, company name, product's generic or trade name, company mailing address, e-mail address, telephone number, and fax number. AUTHORITY FOR MAINTENANCE OF THE SYSTEM: Authority for this system is given under the Health Insurance Portability and Accountability Act (HIPAA) of 1996, Public Law 104-191, its implementing regulation on “Code Sets” (45 Code of Federal Regulations part 162, Subpart J) and 65 **Federal Register** 50312 (8-17-00). PURPOSE
(S)OF THE SYSTEM: The primary purpose of this system is to facilitate the management and maintenance of the HCPCS Level II code set. Information in this system will also be used to:
(1)Support regulatory and policy functions performed within the Agency or by a contractor, consultant, or grantee;
(2)assist another Federal or state agency;
(3)support litigation involving the Agency related to this system; and
(4)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 contractor, consultant, or grantee who have been contracted by the Agency to assist in accomplishment of a CMS function relating to the purposes for this system and who need to have access to the records in order to assist CMS. 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 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. 4. To a CMS contractor (including, but not necessarily limited to Medicare administrative contractors, 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. 5. 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 specified population is so small that an individual could, because of the small size, use this information to deduce the identity of the applicant). POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM: STORAGE: All records are stored on electronic and hard copy media. RETRIEVABILITY: Information can be retrieved by applicant name, e-mail address, manufacturer name, product name, generic name, or code assigned. 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, the Federal Records Act of 1950, as amended, 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, CMS Information Security Handbook, and the National Archives and Records Administration's General Record Schedules and CMS' Records Schedules. RETENTION AND DISPOSAL: CMS will retain information for a total period of 15 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, Chronic Care Policy Group, Centers for Medicare Management, CMS, Mail Stop C5-09-16, 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, and for verification purposes, the subject individual's name (woman's maiden name, if applicable). 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.) RECORD SOURCE CATEGORIES: Sources of information contained in this records system include data collected from HCPCS applications, submitted by the individuals who voluntarily apply for HCPCS Level II Code modifications. SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT: None. [FR Doc. E7-15250 Filed 8-6-07; 8:45 am] BILLING CODE 4120-03-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006P-0462] Determination That PREVACID NAPRAPAC (Copackaged Lansoprazole Delayed-Release 15-Milligram Capsules and Naproxen 250-Milligram Tablets) Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)has determined that PREVACID NAPRAPAC 250 (copackaged lansoprazole delayed-release 15-milligram
(mg)capsules and naproxen 250-mg tablets) was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for copackaged lansoprazole delayed-release 15-mg capsules and naproxen 250-mg tablets. FOR FURTHER INFORMATION CONTACT: Marguerita B. Sims, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-5041. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA sponsors must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. Sponsors of ANDAs do not have to repeat the extensive clinical testing otherwise necessary to gain approval of an NDA. The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug. The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is generally known as the “Orange Book.” Under FDA regulations, drugs are withdrawn from the list if the agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a)(1) (21 CFR 314.161(a)(1)), the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved. FDA may not approve an ANDA that does not refer to a listed drug. PREVACID NAPRAPAC 250 is the subject of NDA 21-507 held by Tap Pharmaceuticals, Inc. (TAP). PREVACID NAPRAPAC 250 is a copackaged drug product that contains Prevacid (lansoperazole) 15-mg delayed-release capsules (a proton-pump inhibitor) and Naprosyn (naproxen) 250-mg tablets (a nonsteroidal anti-inflammatory drug product (NSAID) with analgesic and antipyretic properties). PREVACID NAPRAPAC 250 is indicated for reducing the risk of NSAID-associated gastric ulcers in patients with a history of documented gastric ulcer(s) who require the use of an NSAID for treatment of the signs and symptoms of rheumatoid arthritis, osteoarthritis, and/or ankylosing spondylitis. TAP's PREVACID NAPRAPAC 250 was discontinued in October 2006. In a citizen petition received on November 13, 2006 (Docket No. 2006P-0462/CP1), submitted under 21 CFR 10.30 and in accordance with § 314.161, Robert W. Pollock of Lachman Consultant Services, Inc., requested that FDA determine whether PREVACID NAPRAPAC 250 was withdrawn from sale for reasons of safety or effectiveness. For the reasons outlined previously, FDA has determined that TAP's PREVACID NAPRAPAC 250 was not withdrawn from sale for reasons of safety or effectiveness. In support of this finding, the agency notes that a higher strength of PREVACID NAPRAPAC 250 [PREVACID NAPRAPAC 500 (15 mg/500 mg)] is currently being marketed. In addition, the petitioner identified no data or information suggesting that PREVACID NAPRAPAC 250 was withdrawn from sale for reasons of safety or effectiveness. FDA's independent evaluation of relevant literature and data has not uncovered anything that would indicate that this product was withdrawn for reasons of safety or effectiveness. After considering the citizen petition and reviewing agency records concerning the withdrawal, FDA found no indication that the decision not to commercially market PREVACID NAPRAPAC 250 was a result of any safety or effectiveness concerns regarding the product. Accordingly, the agency will continue to list PREVACID NAPRAPAC 250 in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to PREVACID NAPRAPAC 250 may be approved by the agency as long as they meet all relevant legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for these drug products should be revised to meet current standards, the agency will advise ANDA applicants to submit such labeling. Dated: July 30, 2007. Randall W. Lutter Deputy Commissioner for Policy. [FR Doc. E7-15233 Filed 8-6-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006P-0125] Determination That DEXEDRINE (Dextroamphetamine Sulfate) Oral Solution, 5 Milligrams per 5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)has determined that DEXEDRINE (dextroamphetamine sulfate) oral solution, 5 milligrams
(mg)per 5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for dextroamphetamine sulfate oral solution, 5 mg/5 mL. FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA sponsors must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. Sponsors of ANDAs do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug. The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is generally known as the “Orange Book.” Under FDA regulations, drugs are withdrawn from the list if the agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a)(1) (21 CFR 314.161(a)(1)), the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved. FDA may not approve an ANDA that does not refer to a listed drug. DEXEDRINE (dextroamphetamine sulfate) oral solution, 5 mg/5 mL, is the subject of approved ANDA 83-902 held by GlaxoSmithKline (GSK). DEXEDRINE (dextroamphetamine sulfate) oral solution is indicated for the treatment of attention deficit hyperactivity disorder (ADHD). GSK's ANDA 83-902 was originally approved in 1976 and was discontinued in 1988. Lachman Consultant Services, Inc., submitted a citizen petition dated March 17, 2006 (Docket No. 2006P-0125/CP1), under 21 CFR 10.30, requesting that the agency determine, as described in § 314.161, whether DEXEDRINE (dextroamphetamine sulfate) oral solution, 5 mg/5 mL, was withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing agency records, FDA has determined that GSK's DEXEDRINE (dextroamphetamine sulfate) oral solution, 5 mg/5 mL, was not withdrawn from sale for reasons of safety or effectiveness. In support of this finding, we note that DEXEDRINE (dextroamphetamine sulfate) is available in an extended release capsule form and is a widely used product that has been marketed for many decades in many dosage forms. Neither the petition nor any comment to the petition identified evidence suggesting that DEXEDRINE (dextroamphetamine sulfate) oral solution, 5 mg/5 mL, was withdrawn from sale for reasons of safety or effectiveness. FDA has independently evaluated relevant literature and data for adverse event reports and has found no information that would indicate that DEXEDRINE (dextroamphetamine sulfate) oral solution, 5 mg/5 mL, was withdrawn for reasons of safety or effectiveness. For the reasons outlined in this document, FDA determines that GSK's DEXEDRINE (dextroamphetamine sulfate) oral solution, 5 mg/5 mL, was not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will continue to list DEXEDRINE (dextroamphetamine sulfate) oral solution, 5 mg/5 mL, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to DEXEDRINE (dextroamphetamine sulfate) oral solution, 5 mg/5 mL, may be approved by the agency as long as they meet all relevant legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for these drug products should be revised to meet current standards, the agency will advise ANDA applicants to submit such labeling. Dated: July 30, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7-15236 Filed 8-6-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for ACTIQ (fentanyl), ALDARA (imiquimod), AMBIEN (zolpidem), COREG (carvedilol), PROVIGIL (modafinil), and ZYPREXA (olanzapine). These summaries are being made available consistent with the Best Pharmaceuticals for Children Act (the BPCA). For all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of the pediatric studies conducted for the supplement. ADDRESSES: Submit written requests for single copies of the summaries to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Please specify by product name which summary or summaries you are requesting. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the summaries. FOR FURTHER INFORMATION CONTACT: Grace Carmouze, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6460, Silver Spring, MD 20993-0002, 301-796-0700, e-mail: *grace.carmouze@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies conducted for ACTIQ (fentanyl), ALDARA (imiquimod), AMBIEN (zolpidem), COREG (carvedilol), PROVIGIL (modafinil), and ZYPREXA (olanzapine). The summaries are being made available consistent with section 9 of the BPCA (Public Law 107-109). Enacted on January 4, 2002, the BPCA reauthorizes, with certain important changes, the pediatric exclusivity program described in section 505A of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355a). Section 505A of the act permits certain applications to obtain 6 months of marketing exclusivity if, in accordance with the requirements of the statute, the sponsor submits requested information relating to the use of the drug in the pediatric population. One of the provisions the BPCA added to the pediatric exclusivity program pertains to the dissemination of pediatric information. Specifically, for all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of pediatric studies conducted for the supplement (21 U.S.C. 355a(m)(1)). The summaries are to be made available not later than 180 days after the report on the pediatric study is submitted to FDA (21 U.S.C. 355a(m)(1)). Consistent with this provision of the BPCA, FDA has posted on the Internet at *http://www.fda.gov/cder/pediatric/index.htm* summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for ACTIQ (fentanyl), ALDARA (imiquimod), AMBIEN (zolpidem), COREG (carvedilol), PROVIGIL (modafinil), and ZYPREXA (olanzapine). Copies are also available by mail (see ADDRESSES ). II. Electronic Access Persons with access to the Internet may obtain the document at *http://www.fda.gov/cder/pediatric/index.htm* . Dated: July 30, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7-15234 Filed 8-6-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Poison Control Center Stabilization and Enhancement Grant Programs AGENCY: Health Resources and Services Administration (HRSA), HHS. ACTION: Response to solicitation of comments. SUMMARY: A notice was published in the **Federal Register**
(FR)on February 13, 2007, (Vol. 72, p. 6738-6739), describing HRSA's proposal to institute an exception to the Department of Health and Human Services' policy directive governing indirect cost recovery. The notice requested public comments on the proposed exception to Departmental policy requirements to be sent to HRSA no later than March 15, 2007. Three comments were received, one from a Poison Control Center
(PCC)host institution (grant recipient) and two from individual PCCs. Two of the three commenters supported HRSA's plan to institute an exception from the grants policy directive, which would permanently limit indirect cost recovery to 10 percent for the Poison Control Center Stabilization and Enhancement Grant Programs. Issue: Institution of a 10 Percent Limit on the Indirect Cost *Comments:* Two of the three commenters fully supported HRSA's proposal to permanently limit indirect cost recovery rates to 10 percent for this program. One commenter raised concern that the limitation would impose greater burdens on the host institution by shifting the unrecovered administrative costs to the host institution. In response, we replied that the 10 percent limitation had been in effect since the institution of the award program. *Agency Response:* As noted in the referenced **Federal Register** Notice, since 2001, the HRSA Poison Control Program has limited indirect costs to 10 percent of the allowable total direct costs for grantees with negotiated rate agreements. This limitation on indirect costs was requested annually because many PCCs are housed within universities and hospitals (the official grantees) which have established indirect cost rates in the range of 30 to 50 percent. Without a limitation on indirect cost rates, the objectives of the grant programs would not be met for the following reason: The average amount of these grant awards has been approximately $200,000, with some amounts as low as $30,000. Depending upon the host institution's indirect cost rate, as much as 50 percent of the grant award could be consumed by the institution's indirect costs, thus significantly reducing the amount of funds available to initiate and maintain the activities of the grant. Given the adverse impact on grant activities for this program if full indirect cost recovery were permitted, and that comments received were generally favorable to HRSA's proposal, HRSA is instituting the 10 percent limitation for the Poison Control Center Stabilization and Enhancement Grant Programs. FOR FURTHER INFORMATION CONTACT: Maxine Jones at *mjones@hrsa.gov.,* Health Resources and Services Administration, Healthcare Systems Bureau, Poison Control Program. Dated: July 30, 2007. Elizabeth M. Duke, Administrator. [FR Doc. E7-15352 Filed 8-6-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources And Services Administration National Vaccine Injury Compensation Program; List of Petitions Received AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice. SUMMARY: The Health Resources and Services Administration
(HRSA)is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (“the Program”), as required by section 2112(b)(2) of the Public Health Service
(PHS)Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions. FOR FURTHER INFORMATION CONTACT: For information about requirements for filing petitions, and the Program in general, contact the Clerk, United States Court of Federal Claims, 717 Madison Place, NW., Washington, DC 20005,
(202)357-6400. For information on HRSA's role in the Program, contact the Director, National Vaccine Injury Compensation Program, 5600 Fishers Lane, Room 11C-26, Rockville, MD 20857;
(301)443-6593. SUPPLEMENTARY INFORMATION: The Program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa-10 *et seq.* , provides that those seeking compensation are to file a petition with the U.S. Court of Federal Claims and to serve a copy of the petition on the Secretary of Health and Human Services, who is named as the respondent in each proceeding. The Secretary has delegated his responsibility under the Program to HRSA. The Court is directed by statute to appoint special masters who take evidence, conduct hearings as appropriate, and make initial decisions as to eligibility for, and amount of, compensation. A petition may be filed with respect to injuries, disabilities, illnesses, conditions, and deaths resulting from vaccines described in the Vaccine Injury Table (the Table) set forth at Section 2114 of the PHS Act or as set forth at 42 CFR 100.3, as applicable. This Table lists for each covered childhood vaccine the conditions which may lead to compensation and, for each condition, the time period for occurrence of the first symptom or manifestation of onset or of significant aggravation after vaccine administration. Compensation may also be awarded for conditions not listed in the Table and for conditions that are manifested outside the time periods specified in the Table, but only if the petitioner shows that the condition was caused by one of the listed vaccines. Section 2112(b)(2) of the PHS Act, 42 U.S.C. 300aa-12(b)(2), requires that the Secretary publish in the **Federal Register** a notice of each petition filed. Set forth below is a list of petitions received by HRSA on January 1, 2007, through March 31, 2007. Section 2112(b)(2) also provides that the special master “shall afford all interested persons an opportunity to submit relevant, written information” relating to the following: 1. The existence of evidence “that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition,” and 2. Any allegation in a petition that the petitioner either:
(a)“Sustained, or had significantly aggravated, any illness, disability, injury, or condition not set forth in the Table but which was caused by” one of the vaccines referred to in the Table, or
(b)“Sustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table the first symptom or manifestation of the onset or significant aggravation of which did not occur within the time period set forth in the Table but which was caused by a vaccine” referred to in the Table. This notice will also serve as the special master's invitation to all interested persons to submit written information relevant to the issues described above in the case of the petitions listed below. Any person choosing to do so should file an original and three
(3)copies of the information with the Clerk of the U.S. Court of Federal Claims at the address listed above (under the heading “For Further Information Contact”), with a copy to HRSA addressed to Director, Division of Vaccine Injury Compensation Program, Healthcare Systems Bureau, 5600 Fishers Lane, Room 11C-26, Rockville, MD 20857. The Court's caption (Petitioner's Name v. Secretary of Health and Human Services) and the docket number assigned to the petition should be used as the caption for the written submission. Chapter 35 of title 44, United States Code, related to paperwork reduction, does not apply to information required for purposes of carrying out the Program. List of Petitions 1. Stacey Heinzelman, Milwaukee, Wisconsin, Court of Federal Claims Number 07-0001V. 2. Wilma Fagio, Monroe, North Carolina, Court of Federal Claims Number 07-0005V. 3. Norma and Douglas Rosenberg on behalf of Kevin Rosenberg, Lake Success, New York, Court of Federal Claims Number 07-0009V. 4. Annie Bell, Greensboro, North Carolina, Court of Federal Claims Number 07-0011V. 5. Anthony Nevels, Aurora, Illinois, Court of Federal Claims Number 07-0019V. 6. Louise Schmidt, Cherry Hill, New Jersey, Court of Federal Claims Number 07-0020V. 7. Shemeka Ramsey on behalf of Demarius Jamar Ramsey, Deceased, Columbia, South Carolina, Court of Federal Claims Number 07-0021V. 8. Sybil and Brent Morgan on behalf of Spencer Morgan, Bedford, Texas, Court of Federal Claims Number 07-0022V. 9. Jennifer and Eric Claasen on behalf of Ryan Claasen, Boise, Idaho, Court of Federal Claims Number 07-0023V. 10. Beverly Chaney on behalf of Payne Chaney, Boston, Massachusetts, Court of Federal Claims Number 07-0024V. 11. Shawn and Scott Valentine on behalf of Christian Valentine, Independence, Missouri, Court of Federal Claims Number 07-0025V. 12. Andrew Laurie, Tucson, Arizona, Court of Federal Claims Number 07-0026V. 13. Jean Lydon, Waukon, Iowa, Court of Federal Claims Number 07-0030V. 14. Chelsie Kramer, Atwood, Kansas, Court of Federal Claims Number 07-0033V. 15. Kendra Solko, Atwood, Kansas, Court of Federal Claims Number 07-0034V. 16. Beverly and Keith Langland on behalf of Mackenzie Grace Langland, Ponte Vedra Beach, Florida, Court of Federal Claims Number 07-0036V. 17. William Rodriguez, Tampa, Florida, Court of Federal Claims Number 07-0038V. 18. Samantha and James Mannion on behalf of James Mannion, Great Neck, New York, Court of Federal Claims Number 07-0039V. 19. Amy and Stewart McIntyre on behalf of Craigmiles McIntyre, Hannibal, Missouri, Court of Federal Claims Number 07-0040V. 20. Laurel Austin-Lemon on behalf of Jeremy Austin, Shawnee Mission, Kansas, Court of Federal Claims Number 07-0041V. 21. Josette and Nicholas Johnson on behalf of Jordan Johnson, Great Neck, New York, Court of Federal Claims Number 07-0042V. 22. Crystal and Kevin Worley on behalf of Sasha Worley, Great Neck, New York, Court of Federal Claims Number 07-0043V. 23. Wendy Diamond on behalf of Dalton Diamond, Great Neck, New York, Court of Federal Claims Number 07-0044V. 24. Cara and Korey King on behalf of Alex King, Great Neck, New York, Court of Federal Claims Number 07-0045V. 25. Diane and Andrew Davis on behalf of Jessica Davis, Great Neck, New York, Court of Federal Claims Number 07-0046V. 26. Lourdes Reantillo and Alfred Belmont on behalf of Christopher Belmonte, Great Neck, New York, Court of Federal Claims Number 07-0048V. 27. Diane and Andrew Davis on behalf of Luke Davis, Great Neck, New York, Court of Federal Claims Number 07-0049V. 28. Pamela and Michael Szal on behalf of Andrea Szal, Great Neck, New York, Court of Federal Claims Number 07-0050V. 29. Stacie and Kevin Babula on behalf of Brielle Babula, Great Neck, New York, Court of Federal Claims Number 07-0051V. 30. Kathy Meeks Sharp and Greg Sharp on behalf of Raigan Mae Sharp, Jacksonville Beach, Florida, Court of Federal Claims Number 07-0052V. 31. Suzanne and Stephen Sykes on behalf of Brandon Sykes, Cape May Courthouse, New Jersey, Court of Federal Claims Number 07-0053V. 32. Kavitha Raghunathan and Balaji Bashyam on behalf of Hridhay Bashyam, Foster City, California, Court of Federal Claims Number 07-0057V. 33. Elizabeth and Adam Sucher on behalf of Evelyn Sucher, Boston, Massachusetts, Court of Federal Claims Number 07-0058V. 34. Lilia and Jed Snyder on behalf of Nicholas Snyder, Las Vegas, Nevada, Court of Federal Claims Number 07-0059V. 35. Frank Harris on behalf of Jordan Harris, Boston, Massachusetts, Court of Federal Claims Number 07-0060V. 36. Bonnie Dauterman on behalf of John Thomas Dauterman, Winchester, Oregon, Court of Federal Claims Number 07-0061V. 37. Danell and Robert Drew Rice on behalf of Hayden Charles Rice, New Orleans, Louisiana, Court of Federal Claims Number 07-0063V. 38. Doug Kuhl, St. Louis, Missouri, Court of Federal Claims Number 07-0064V. 39. Stacey Ronzetti and Mark St. Amour on behalf of Zachary Ethan Ronzetti St. Amour, Alpharetta, Georgia, Court of Federal Claims Number 07-0066V. 40. Kristen and Michael Jackson on behalf of Cameron Jackson, Somers Point, New Jersey, Court of Federal Claims Number 07-0068V. 41. Pamela and Gabriel Karathomas on behalf of Stephen Karathomas, Rexford, New York, Court of Federal Claims Number 07-0069V. 42. Paula and Adam Ramirez on behalf of Simone Ramirez, La Palma, California, Court of Federal Claims Number 07-0070V. 43. Julie and Christopher Neumann on behalf of Maximilian Neumann, Granada Hills, California, Court of Federal Claims Number 07-0071V. 44. Stephany Dixon, Louisville, Kentucky, Court of Federal Claims Number 07-0072V. 45. Rosiette Jules and Geffrard Charles on behalf of Kelsey Charles, Fort Lauderdale, Florida, Court of Federal Claims Number 07-0075V. 46. Latrisha Rumensky, Salem, Virginia, Court of Federal Claims Number 07-0077V. 47. Elaine and Ross Kronenthal on behalf of Steven Kronenthal, Somers Point, New Jersey, Court of Federal Claims Number 07-0079V. 48. Shannon Celeste Huffman on behalf of Austin Taylor Huffman, Harrisonburg, Virginia, Court of Federal Claims Number 07-0081V. 49. Leann Campbell on behalf of David Campbell, Indio, California, Court of Federal Claims Number 07-0083V. 50. Laura Foster on behalf of Dorrie Foster, Phoenix, Arizona, Court of Federal Claims Number 07-0086V. 51. Crystal and Nicholas Cianci on behalf of William Cianci, Griswold, Connecticut, Court of Federal Claims Number 07-0087V. 52. Allene Mikolyski on behalf of Joy Mikolyski, North Hollywood, California, Court of Federal Claims Number 07-0088V. 53. Kelly and Andrew Reed-Brozyna on behalf of Ashley Brozyna, Portland, Oregon, Court of Federal Claims Number 07-0089V. 54. Furman Edwards, San Diego, California, Court of Federal Claims Number 07-0091V. 55. Talta Kern, Des Moines, Iowa. Court of Federal Claims Number 07-0092V. 56. Alice Wachol on behalf of Nicholas Wachol, Bloomfield, Michigan, Court of Federal Claims Number 07-0093V. 57. Sonia Kazangian on behalf of Andrew Kazangian, Glendale, Arizona, Court of Federal Claims Number 07-0094V. 58. Mandy Ramos on behalf of Eddy Ramos, Naples, Florida, Court of Federal Claims Number 07-0096V. 59. Mary and Robert Goldsberry on behalf of Evelyn Goldsberry, Salt Lake City, Utah, Court of Federal Claims Number 07-0098V. 60. Anita and Kenny Davis on behalf of Ethan Davis, New Albany, Mississippi, Court of Federal Claims Number 07-0101V. 61. Dawn and Housam Moursi on behalf of Jacob Moursi, Varico, Florida, Court of Federal Claims Number 07-0102V. 62. Brenda Nosek, Prescott, Arizona, Court of Federal Claims Number 07-0103V. 63. Patricia and Alex Gatsacos on behalf of Constantine Gatsacos, Chicago, Illinois, Court of Federal Claims Number 07-0105V. 64. Tracy Cook, La Grande, Oregon, Court of Federal Claims Number 07-0106V. 65. Irene Prempeh on behalf of Duke Darkwah, Newark, New Jersey, Court of Federal Claims Number 07-0108V. 66. Kelly Butland on behalf of Lenzie Butland, Montgomery, Alabama, Court of Federal Claims Number 07-0111V. 67. Nur and John David Duncan on behalf of Baris John Duncan, Lake Success, New York, Court of Federal Claims Number 07-0117V. 68. Carrie Elsass on behalf of Jordan Elsass, Conway, Arkansas, Court of Federal Claims Number 07-0119V. 69. Kevin Orlando, Sarasota, Florida, Court of Federal Claims Number 07-0121V. 70. Louis Sampt, Riverview, Michigan, Court of Federal Claims Number 07-0122V. 71. Nadia and Ronald Jacops on behalf of Clint Carson Jacops, Youngstown, Ohio, Court of Federal Claims Number 07-0129V. 72. Jerome Anhalt, Munster, Indiana, Court of Federal Claims Number 07-0131V. 73. Cheryl Matthews on behalf of Brendan Conkey, Dearborn, Michigan, Court of Federal Claims Number 07-0132V. 74. Linda Provencher on behalf of Dylan Provencher, Van Nuys, California, Court of Federal Claims Number 07-0133V. 75. Steven Zwick, Laguna Hills, California, Court of Federal Claims Number 07-0135V. 76. Gerard Abate, Williamsburg, Virginia, Court of Federal Claims Number 07-0136V. 77. Peter Broekelschen, M.D. on behalf of Peter Broekelschen, Newport Beach, California, Court of Federal Claims Number 07-0137V. 78. Jennifer Johnson on behalf of Alexander Johnson, Deceased, Orlando, Florida, Court of Federal Claims Number 07-0138V. 79. Debra and Jeffrey Mason on behalf of Justin Mason, Waldorf, Maryland, Court of Federal Claims Number 07-0152V. 80. Barbara Turner Roderick, Redwood City, California, Court of Federal Claims Number 07-0158V. 81. Gail Katz, West Covina, California, Court of Federal Claims Number 07-0159V. 82. Patricia Boyer on behalf of Richard Carl Swonger, Los Angeles, California, Court of Federal Claims Number 07-0161V. 83. Lynne Sanchez on behalf of David Sanchez, Minneapolis, Minnesota, Court of Federal Claims Number 07-0168V. 84. Patricia Walker on behalf of Robert Walker, Temecula, California, Court of Federal Claims Number 07-0169V. 85. Scott Hammitt on behalf of Rachel Hammitt, Willoughby Hills, Ohio, Court of Federal Claims Number 07-0170V. 86. Jose Morel on behalf of Omar Morel, Washington, DC, Court of Federal Claims Number 07-0171V. 87. Kimberly Wood, Westmoreland, Pennsylvania, Court of Federal Claims Number 07-0172V. 88. George Daily, Northvale, New Jersey, Court of Federal Claims Number 07-0173V. 89. Megan Vaughan on behalf of Aurora Leigh Husk, Middlebury, Vermont, Court of Federal Claims Number 07-0175V. 90. Cheryl and Greg Berry on behalf of William Joseph Berry, Arlington, Texas, Court of Federal Claims Number 07-0177V. 91. Melissa and Cesar Rodriguez on behalf of Noah Rodriguez, Temecula, California, Court of Federal Claims Number 07-0178V. 92. Carolyn Werley on behalf of Logan Storm, Temecula, California Court of Federal Claims No: 07-0179V. 93. Debra and Jeffrey Mason on behalf of Brian Mason, Waldorf, Maryland, Court of Federal Claims Number 07-0180V. 94. Amie Timonere on behalf of Raechel Morrison, Ashtabula, Ohio, Court of Federal Claims Number 07-0182V. 95. Janice Peterson on behalf of Brian Peterson, Minneapolis, Minnesota, Court of Federal Claims Number 07-0185V. 96. Elizabeth Davis, Dothan, Alabama, Court of Federal Claims Number 07-0193V. 97. George Roland , Benton, Tennessee, Court of Federal Claims Number 07-0198V. 98. Rhonda Wood on behalf of Breckyn Wood, Zebulon, North Carolina, Court of Federal Claims Number 07-0199V. 99. Maxine A. Gleason, Gilbertville, Iowa, Court of Federal Claims Number 07-0202V. 100. Peter Anthony Reale, Mount Pleasant, Michigan, Court of Federal Claims Number 07-0203V 101. Nadia and Ronald Jacops on behalf of Wyatt Evan Jacops, Youngstown, Ohio, Court of Federal Claims Number 07-0207V. Dated: July 30, 2007. Elizabeth M. Duke, Administrator. [FR Doc. E7-15349 Filed 8-6-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; Comment Request Application for the Pharmacology Research Associate Program *Summary:* Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of General Medical Sciences (NIGMS), the National Institutes of Health
(NIH)has submitted to the Office of Management and Budget
(OMB)a request to review and approve the information collection listed below. This proposed information collection was previously published in the **Federal Register** on May 25, 2007, pages 29338-29339, and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. *Proposed Collection: Title:* Application for the Pharmacology Research Associate Program. *Type of Information Collection Request:* Extension of a currently approved collection. *Need and Use of Information Collection:* The Pharmacology Research Associate
(PRAT)Program will use the applicant and referee information to award opportunities for training and experience in laboratory or clinical investigation to individuals with a Ph.D. degree in pharmacology or a related science, M.D., or other professional degree through appointments as PRAT Fellows at the National Institutes of Health or the Food and Drug Administration. The goal of the program is to develop leaders in pharmacological research for key positions in academic, industrial, and Federal research laboratories. *Frequency of Response:* Once a year. *Affected Public:* Individuals or households; businesses or other for-profit. *Type of Respondents:* Applicants and referees. The annual reporting burden is as follows: Type and number of respondents Estimated number of responses per respondent Estimated total responses Average burden hours per responses Estimated total annual burden hours requested Applicants, 25 1 25 8.00 200 Referees, 75 1 75 1.75 131.25 *Total Number of Respondents:* 100. T *otal Number of Responses:* 100. *Total Hours:* 331.25. The annualized cost to respondents is estimated at: *Applicants:* $10,250.00. *Referees:* $6,562.50. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report. *Request for Comments:* Written comments and/or suggestions from the public and affected agencies should address one or more of the following points:
(1)Evaluate whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility;
(2)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;
(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 the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. *Direct Comments to OMB:* Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Ms. Sally Lee, NIGMS, NIH, Natcher Building, Room 2AN-18H, 45 Center Drive, MSC 6200, Bethesda, MD 20892-6200, or call non-toll-free number 301-594-2755 or e-mail your request, including your address to *LeeS@nigms.nih.gov.* *Comments Due Date:* Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. Dated: August 1, 2007. Sally Lee, Acting Executive Officer, National Institute of General Medical Sciences, National Institutes of Health. [FR Doc. E7-15348 Filed 8-6-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request; A Process Evaluation of the NIH Director's Pioneer Award
(NDPA)Program SUMMARY: In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Office of the Director, the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget
(OMB)for review and approval. *Proposed Collection: Title:* A Process Evaluation of the NIH Director's Pioneer Award
(NDPA)Program. *Type of Information Collection Request:* Extension of a currently approved collection. *Need and Use of Information Collection:* This study will assess the NDPA Program operations and the outputs of the identification, evaluation and selection process. The primary objectives of the study are to:
(1)Assess the NDPA award selection process;
(2)determine if the program was implemented as planned; and
(3)determine if the process was conducted in accordance with the overall mission of the NDPA program. The findings will provide valuable information concerning:
(1)The characteristics of applicants and reviewers;
(2)the criteria used to evaluate and select awardees; and
(3)aspects of the process that could be revised or improved. *Frequency of Response:* Once. *Affected Public:* none. *Type of Respondents:* Applicants, Reviewers and Panelists, Liaisons. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. *Frequency of Response:* Once. *Affected Public:* none. *Type of Respondents:* Applicants, Reviewers and Panelists. *Estimated Number of Respondents:* 710; *Estimated Number of Responses per Respondent:* 1: *Average Burden Hours Per Response:* .25 (15 minutes), and *Estimated Total Annual Burden Hours Requested:* 177.50 and the annualized cost to respondents is estimated at $9,662.50. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Table l and Table 2 respectively present data concerning the burden hours and cost burdens for this data collection. Table 1.—Annualized Estimate of Hour Burden Type of respondents Number of respondents Frequency of response Average time for response
(hr)Total hour burden* Applicants 600 1 .25 150 Extramural evaluators 110 1 .25 27.50 Total 710 1 .25 177.50 Total Burden = N Respondents * Response Frequency * minutes to complete/60. Table 2.—Annualized Cost to Respondents Type of respondents Number of respondents Response frequency Approx. hourly wage rate Total respondent cost** Applicants 1200 1 $55.00 $8,250 Extramural evaluators 220 1 55.00 1,512.50 Total 710 1 55.00 9,662.50 **Total Respondent Cost = N Respondents * Response Frequency * minutes to complete/60 * hourly rate. *Request for Comments:* Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points:
(1)Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility;
(2)the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3)ways to enhance the quality, utility, and clarity of the information to be collected; and
(4)ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact G. Stephane Philogene, PhD, Assistant Director for Policy and Planning, Office of Behavioral and Social Sciences Research, National Institutes of Health, 31 Center Drive. Building 31, Room B2-B37 Bethesda, MD 20892, or call non-toll-free number 301-402-3902, or E-mail your request, including your address to: *philoges@od.nih.gov* . *Comments Due Date:* Comments regarding this information collection are best assured of having their full effect if received within 60-days of the date of this publication. Dated: July 31, 2007. G. Stephane Philogene, Assistant Director for Policy and Planning, Office of Behavioral and Social Sciences Research, National Institutes of Health. [FR Doc. E7-15350 Filed 8-6-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice of Establishment Pursuant to the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), the Director, National Institutes of Health (NIH), announces the establishment of the Interagency Autism Coordinating Committee (Committee). The Committee shall coordinate all efforts within the Department of Health and Human Services concerning autism spectrum disorder to combat autism through research, screening, intervention and education. The Committee's primary mission is to facilitate the efficient and effective exchange of information on autism activities among the member agencies, and to coordinate autism-related programs and initiatives. The Committee will serve as a forum and assist in increasing public understanding of the member agencies' activities, programs, policies, and research, and in bringing important matters of interest forward for discussion. Duration of this committee is two years from the date the Charter is filed. Dated: July 31, 2007. Elias Zerhouni, Director, National Institutes of Health. [FR Doc. 07-3850 Filed 8-6-07; 8:45 am]
Connectionstraces to 8
10 references not yet in our index
  • Pub. L. 97-248
  • Pub. L. 108-173
  • 42 CFR 412.508(a)
  • Pub. L. 107-300
  • Pub. L. 104-191
  • 45 CFR 164.512(a)(1)
  • 45 CFR 5
  • Pub. L. 98-417
  • Pub. L. 107-109
  • 42 CFR 100.3
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Notices
Notice with comment period
U.S.C.§ 1320c–2
U.S.C.§ 355
C.F.R.§ 314.162
C.F.R.§ 314.161
C.F.R.§ 10.30
U.S.C.§ 355a
U.S.C.§ 300aa–10
U.S.C.§ 300aa–12
Pub. L.Pub. L. 97-248
Pub. L.Pub. L. 108-173
Cite42 CFR 412.508(a)
Pub. L.Pub. L. 107-300
Cites 18 · showing 12Cited by 0 across 0 sources
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