Rules and Regulations. Notice and request for comments

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BILLING CODE 6714-01-M FEDERAL MARITIME COMMISSION Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Federal Maritime Commission. ACTION: Notice and request for comments. SUMMARY: As part of our continuing effort to reduce paperwork and respondent burden, and as required by the Paperwork Reduction Act of 1995, the Federal Maritime Commission invites comments on the continuing information collection (extension with no changes) listed below in this notice.

DATES: Comments must be submitted on or before February 26, 2007. ADDRESSES: You may send comments to: Peter J. King, Acting Director, Office of Administration, Federal Maritime Commission, 800 North Capitol Street, NW., Washington, DC 20573, (Telephone:

(202)523-5800), *administration@fmc.gov.* Please reference the information collection's title, and form and OMB numbers (if any) in your comments. FOR FURTHER INFORMATION CONTACT: To obtain additional information, copies of the information collection and instructions, or copies of any comments received, contact Jane Gregory, Management Analyst, Office of Administration, Federal Maritime Commission, 800 North Capitol Street, NW., Washington, DC 20573, (Telephone:

(202)523-5800), *jgregory@fmc.gov.* SUPPLEMENTARY INFORMATION: Request for Comments The Federal Maritime Commission, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on the continuing information collection listed in this notice, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). Comments submitted in response to this notice will be included or summarized in our request for Office of Management and Budget

(OMB)approval of the relevant information collection. All comments are part of the public record and subject to disclosure. Please do not include any confidential or inappropriate material in your comments. We invite comments on:

(1)The necessity and utility of the proposed information collection for the proper performance of the agency's functions;

(2)the accuracy of the estimated burden;

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

(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Information Collection Open for Comment *Title:* 46 CFR Part 535—Ocean Common Carrier and Marine Terminal Operator Agreements Subject to the Shipping Act of 1984. *OMB Approval Number:* 3072-0045 (Expires March 31, 2007). *Abstract:* Section 4 of the Shipping Act of 1984, 46 U.S.C. 40301, identifies certain commercial agreements by or among ocean common carriers that fall within the jurisdiction of that Act. Section 5 of the Act, 46 U.S.C. 40302, requires that carriers file those agreements with the Federal Maritime Commission. Section 6 of the Act, 46 U.S.C. 40304, specifies the Commission actions that may be taken with respect to filed agreements, including requiring the submission of additional information. Section 15 of the Act, 46 U.S.C. 40104, authorizes the Commission to require that ocean common carriers, among other persons, file periodic reports. Requests for additional information and the filing of periodic reports are meant to assist the Commission in fulfilling its statutory mandate of overseeing the activities of the ocean transportation industry. These reports are necessary so that the Commission can monitor agreement parties' activities to determine how or if their activities will have an impact on competition. *Current Actions:* There are no changes to this information collection, and it is being submitted for extension purposes only. *Type of Review:* Extension. *Needs and Uses:* The Commission staff uses the information filed by agreement parties to monitor their activities as required by the Shipping Act of 1984. Under the general standard set forth in section 6(g) of the Act, 46 U.S.C. 41307, the Commission must determine whether filed agreements will have substantially anticompetitive effects on prevailing trade conditions and, if so, whether the agreements will likely, by a reduction in competition, result in an unreasonable reduction in competition, result in an unreasonable reduction in transportation service or an unreasonable increase in transportation cost. If it is shown, based on information collected under this rule, that an agreement is likely to have the foregoing adverse effects, the Commission may bring suit in U.S. District Court to enjoin the operation of that agreement. The information collected is not disclosed to the public and is only for internal analysis in support of the Commission's decision-making process. *Frequency:* This information is collected generally on a quarterly basis or as required under the rules. *Type of Respondents:* The types of respondents are ocean common carriers and marine terminal operators subject to the Shipping Act of 1984. *Number of Annual Respondents:* The Commission estimates a potential annual respondent universe of 574 entities. *Estimated Time Per Response:* The average time for filing agreements, including the preparation and submission of information required on Form FMC-150, Information Form for Agreements Between or Among Ocean Common Carriers, is estimated to be 37 person-hours per response. The average time for completing Form FMC-151, Monitoring Report for Agreements Between or Among Ocean Common Carriers, is estimated to range between 40 to 250 person-hours per response, depending on the complexity of the required information. The total average time for reporting and recordkeeping for all responses is 18.75 person-hours. *Total Annual Burden:* The Commission estimates the total person-hour burden at 31,385 person-hours. Bryant L. VanBrakle, Secretary. [FR Doc. E6-21985 Filed 12-21-06; 8:45 am] BILLING CODE 6730-01-P FEDERAL RESERVE SYSTEM Proposed Agency Information Collection Activities; Comment Request AGENCY: Board of Governors of the Federal Reserve System SUMMARY: Background On June 15, 1984, the Office of Management and Budget

(OMB)delegated to the Board of Governors of the Federal Reserve System ("Board") its approval authority under the Paperwork Reduction Act, as per 5 CFR 1320.16, to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board under conditions set forth in 5 CFR 1320 Appendix A.1. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the OMB 83-Is and supporting statements and approved collection of information instruments are placed into OMB's public docket files. The Federal Reserve 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. Request for comment on information collection proposal The following information collection, which is being handled under this delegated authority, has received initial Board approval and is hereby published for comment. At the end of the comment period, the proposed information collection, along with an analysis of comments and recommendations received, will be submitted to the Board for final approval under OMB delegated authority. Comments are invited on the following: a. Whether the proposed collection of information is necessary for the proper performance of the Federal Reserve's functions; including whether the information has practical utility; b. The accuracy of the Federal Reserve's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used; c. Ways to enhance the quality, utility, and clarity of the information to be collected; and d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology. DATES: Comments must be submitted on or before February 20, 2007. ADDRESSES: You may submit comments, identified by FR Y-12 or FR Y-12A, by any of the following methods: •• Agency Web Site: http://www.federalreserve.gov. Follow the instructions for submitting comments at http://www.federalreserve.gov/generalinfo/foia/ProposedRegs.cfm. • Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. • E-mail: regs.comments@federalreserve.gov. Include docket number in the subject line of the message. • FAX: 202-452-3819 or 202-452-3102. • Mail: Jennifer J. Johnson, Secretary, Board of Governors of the Federal Reserve System, 20th Street and Constitution Avenue, N.W., Washington, DC 20551. All public comments are available from the Board's web site at www.federalreserve.gov/generalinfo/foia/ProposedRegs.cfm as submitted, unless modified for technical reasons. Accordingly, your comments will not be edited to remove any identifying or contact information. Public comments may also be viewed electronically or in paper in Room MP-500 of the Board's Martin Building (20th and C Streets, N.W.) between 9:00 a.m. and 5:00 p.m. on weekdays. FOR FURTHER INFORMATION CONTACT: A copy of the proposed form and instructions, the Paperwork Reduction Act Submission (OMB 83-I), supporting statement, and other documents that will be placed into OMB's public docket files once approved may be requested from the agency clearance officer, whose name appears below. Michelle Long, Federal Reserve Board Clearance Officer (202-452-3829), Division of Research and Statistics, Board of Governors of the Federal Reserve System, Washington, DC 20551. Telecommunications Device for the Deaf

(TDD)users may contact (202-263-4869), Board of Governors of the Federal Reserve System, Washington, DC 20551. Proposal to approve under OMB delegated authority the extension for three years, with revision, of the following collection of information: *Report title:* Consolidated Bank Holding Company Report of Equity Investments in Nonfinancial Companies, and the Annual Report of Merchant Banking Investments Held for an Extended Period. *Agency form number:* FR Y-12 and FR Y-12A, respectively *OMB control number:* 7100-0300 *Frequency:* FR Y-12, quarterly and semiannually; FR Y-12A, annually Reporters: Bank holding companies, financial holding companies *Annual reporting hours:* FR Y-12, 1,824; FR Y-12A, 105 *Estimated average hours per response:* FR Y-12, 16; FR Y-12A, 7 *Number of respondents:* FR Y-12, 30; FR Y-12A, 15 *General description of report:* This collection of information is mandatory pursuant to Section 5(c) of the Bank Holding Company Act (12 U.S.C. 1844(c)). The FR Y-12 data are not considered confidential, however, bank holding companies may request confidential treatment pursuant to Sections (b)(4) and (b)(8) of the Freedom of Information Act

(FOIA)(5 U.S.C. 552(b)(4) and (b)(8)). The FR Y-12A data would be considered confidential on the basis that disclosure of specific commercial or financial data relating to investments held for extended periods of time could result in substantial harm to the competitive position of the financial holding company pursuant to the FOIA (5 U.S.C. 552(b)(4) and (b)(8)). *Abstract:* The FR Y-12 collects data from certain domestic bank holding companies on their equity investments in nonfinancial companies on four schedules: Type of Investments, Type of Security, Type of Entity within the Banking Organization, and Nonfinancial Investment Transactions during Reporting Period. The FR Y-12 data serve as an important risk-monitoring device for institutions active in this business line by allowing the Federal Reserve to monitor an institution's activity between review dates. It also serves as an early warning mechanism to identify institutions whose activities in this area are growing rapidly and therefore warrant special supervisory attention. *Current actions:* The Federal Reserve proposes to extend for three years, without revision, the FR Y-12. In addition, the Federal Reserve proposes to implement a companion reporting form, the FR Y-12A, effective December 31, 2006. The proposed FR Y-12A is intended to provide the Federal Reserve with data concerning merchant banking investments that are approaching the end of the holding period permissible under Regulation Y. A financial holding company generally would have to submit a FR Y-12A if it holds a merchant banking investment for longer than eight years (or thirteen years in the case of an investment held through a qualifying private equity fund). Board of Governors of the Federal Reserve System, August 28,2006. Jennifer J. Johnson, Secretary of the Board. [FR Doc. E6-21915 Filed 12-21-06; 8:45 am] BILLING CODE 6210-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-07-07AE] Proposed Data Collections Submitted for Public Comment and Recommendations 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 Centers for Disease Control and Prevention

(CDC)will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 and send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to *omb@cdc.gov* . *Comments are invited on:*

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

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

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

(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project Division of Oral Health Program Evaluation—NEW—National Center for Chronic Disease and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description In 2000, the Surgeon General published the first ever report on oral health in America to alert Americans to the full meaning of oral health and its importance to general health and wellbeing. Included in the framework for action was the charge to build an effective oral health infrastructure that meets the oral health needs of all Americans and integrates oral health effectively into overall health planning. In response, the CDC awarded funds for cooperative agreements to 12 state demonstration sites and 1 territory in two phases for the planning and implementation of oral health capacity, infrastructure building and demonstration delivery programs. Building infrastructure enables the demonstration states to develop the capacity to achieve Healthy People 2010 objectives and reach many more Americans than a single local program could reach by sustaining health gains beyond the funding cycle. Infrastructure development encompasses many activities, each of which can be accomplished in a myriad of methods by the grantees. To evaluate and summarize program processes and accomplishments, a 4-site case study is proposed. Obtaining uniform data of performance will allow the construction of summary reports to assist future sites and not-yet-funded oral health infrastructure development programs. Case study information would describe the implementation of each site's infrastructure model in relation to environmental context and state characteristics as well as the impacts of core infrastructure components for the purpose of program improvement. The results would provide information for the essential implementation strategies for effective infrastructure development as defined by the consensus-based Association of State and Territorial Dental Directors' (ASTDD) 2000 model. The results would be used to structure flexible guidelines for infrastructure development and identify high-priority activities enabling additional sites to efficiently plan and implement cost-effective oral health improvement activities. Additionally, this project will assist in the development of objectives and indicators of sustainability—the ability of these demonstration programs to meet the needs of their constituents beyond the seed-funding period. The objectives of the case study project are to: ☐ Evaluate the progress made by programs in achieving national and program-specific goals and objectives as well as documenting reach and impact. ☐ Identify successful and innovative strategies and public health interventions to reduce the burden of oral diseases. ☐ Disseminate and share information among all grantees. ☐ Monitor the use of federal funds ☐ Evaluate and report on the overall effectiveness and implementation characteristics of the grantees. ☐ Promote positive infrastructure growth among funded and non-funded sites. The above objectives will be attained through a case-study method using interviews designed to evaluate demographic, extent, and culture climate of infrastructure development activities. Up to 15 respondents from each site will be asked to participate in a one to two hour interview. Participation is voluntary for funded sites. 4 of 12 funded states will be asked to participate in the case-study interview project. Information obtained through the case-study interviews will be supported by documentation already submitted through routine reporting practices by all 12 funded states. There are no costs to respondents except their time to participate in the interview. Estimated Annualized Burden Hours Respondents Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden (in hours) Dental Directors 4 1 2 8 Program staff 20 1 2 40 Coalition Leader/members 12 1 2 24 Program Key informant 24 1 2 48 Total 120 Dated: December 15, 2006. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E6-21931 Filed 12-21-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60 Day-07-0557] Proposed Data Collections Submitted for Public Comment and Recommendations 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 Centers for Disease Control and Prevention

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

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

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

(PHF)to develop performance standards for public health systems based on the essential services of public health. In 2005, CDC reconvened workgroups with these same organizations to revise the data collection instruments, in order to ensure the standards remain current and improve user friendliness. There is no cost to the respondents other than their time. Estimate of Annualized Burden Hours Respondents Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden hours State Public Health Systems 8 1 12 96 Dated: December 15, 2006. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E6-21932 Filed 12-21-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-07-0555] Proposed Data Collections Submitted for Public Comment and Recommendations 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 Centers for Disease Control and Prevention

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

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

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

(PHF)to develop performance standards for public health systems based on the essential services of public health. In 2005, CDC reconvened workgroups with these same organizations to revise the data collection instruments, in order to ensure the standards remain current and improve user friendliness. There are no costs to the respondent other than their time. Estimate of Annualized Burden Hours Respondents Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden hours Local Public Health Systems 350 1 16 5,600 Dated: December 15, 2006. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E6-21933 Filed 12-21-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-07-0580] Proposed Data Collections Submitted for Public Comment and Recommendations 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 Centers for Disease Control and Prevention

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

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

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

(PHF)to develop performance standards for public health systems based on the essential services of public health. In 2005, CDC reconvened workgroups with these same organizations to revise the data collection instruments, in order to ensure the standards remain current and improve user friendliness. There is no cost to the respondent, other than their time. Estimate of Annualized Burden Hours Respondents No. of respondents No. of responses per respondent Average burden per response (in hours) Total burden hours Local Board of Health 175 1 5 875 Dated: December 15, 2006. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E6-21935 Filed 12-21-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-43, CMS-4040 & 4040-SP, CMS-10179, CMS-R-142, and CMS-10210] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:

(1)The necessity and utility of the proposed information collection for the proper performance of the Agency's function;

(2)the accuracy of the estimated burden;

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

(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Application for Hospital Insurance Benefits for individuals with End Stage Renal Disease; *Use:* 42 CFR 406.13 outlines the requirements for entitlement to Medicare Part A (hospital insurance [HI]) and Part B (supplementary medical insurance [SMI]) for individuals with End Stage Renal Disease (ESRD). 42 CFR 406.7 lists the CMS-43 form, Application for Hospital Insurance Benefits for Individuals with End Stage Renal Disease, as the application to be used by individuals applying for Medicare under the ESRD provisions of the Social Security Act. The form CMS-43 elicits the information that the Social Security Administration and the Centers for Medicare & Medicaid Services need to determine entitlement to Medicare based on the ESRD requirements of the law and regulations. *Form Number:* CMS-43 (OMB:# 0938-0800); *Frequency:* Reporting—Once; *Affected Public:* Individuals or households; *Number of Respondents:* 60,000; *Total Annual Responses:* 60,000; *Total Annual Hours:* 25,989.60. 2. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Request for Enrollment in Supplementary Medical Insurance; *Use:* 42 CFR 407.10 list the alternative requirements for enrollment in Part B for any individual who is not entitled to hospital insurance under Part A but has attained age 65 and is either a citizen of the United States or an alien lawfully admitted for permanent residence who has lived in the United States continually for 5 years. 42 CFR 407.11 lists the CMS-4040 form, Request for Enrollment in Supplementary Medical Insurance, as the application to be used by individuals not eligible for monthly benefits or free Part A. Form CMS-4040 elicits the information that the Social Security Administration and Centers for Medicare & Medicaid Services need to determine entitlement to Part B only. *Form Number:* CMS-4040, 4040-SP (OMB:# 0938-0245); *Frequency:* Reporting—Once; *Affected Public:* Individuals or households; *Number of Respondents:* 10,000; *Total Annual Responses:* 10,000; *Total Annual Hours:* 25,000. 3. *Type of Information Collection Request:* New Collection; *Title of Information Collection:* Requests by Hospitals for an Alternative Cost-to-Charge Ration Instead of the Statewide Average Cost-to-Charge Ratio; *Use:* Because of the extensive gaming of outlier payments, CMS implemented new regulations in § 412.84(i)(2) of the Code of Federal Regulations for Inpatient Prospective Payment System

(IPPS)hospitals and §§ 412.525(a)(4)(ii) and 412.529(c)(5)(ii) of the Code of Federal Regulations for Long Term Care Hospitals

(LTCH)to allow a hospital to contact its FI to request that its cost-to-charge ratio

(CCR)(operating and/or capital CCR for IPPS hospitals or the total (combined operating and capital) CCR for LTCHs), otherwise applicable, be changed if the hospital presents substantial evidence that the ratios are inaccurate for IPPS hospitals. Any such requests would have to be approved by the CMS RO with jurisdiction over that FI. *Form Number:* CMS-10179 (OMB:# 0938-NEW); *Frequency:* Reporting—On occasion; *Affected Public:* Business or other for-profit and Not-for-profit institutions and Federal government; *Number of Respondents:* 18; *Total Annual Responses:* 18; *Total Annual Hours:* 144. 4. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Examination and Treatment for Emergency Medical Conditions and Women in Labor Act (EMTALA) and Supporting Regulations in 42 CFR 482.12, 488.18, 489.20, and 489.24; *Use:* As mandated by Congress, the information collection requirements found in supporting regulations in 42 CFR 482.12, 488.18, 489.20, and 489.24, aim to prevent hospitals from inappropriately transferring individuals with emergency medical conditions. These requirements are supported by two other current statutes. Section 1861(e)(9) of the Act permits the Secretary to impose on hospitals such other requirements as he finds necessary in the interests of the health and safety of individuals who are furnished services in the institution. It is under this authority that the Secretary has obligated hospitals that participate in Medicare to report when they receive patients that have been inappropriately transferred. Under section 1866(b)(2)(A) and

(B)of the Social Security Act (the Act), the Secretary may terminate the provider agreement of a hospital that is not complying substantially with the statute and regulations under title XVIII or that no longer substantially meets the provisions of section 1861 of the Act. *Form Number:* CMS-R-142 (OMB#: 0938-0667); *Frequency:* Recordkeeping and Reporting—On occasion; * Affected Public: * Individuals or households, Business or other for-profit, Not-for-profit, State, Local or Tribal Governments, Federal Government; *Number of Respondents:* 5,600; *Total Annual Responses:* 5,600; *Total Annual Hours:* 1. 5. *Type of Information Collection Request:* New collection; *Title of Information Collection:* Hospital Reporting Initiative—Hospital Quality Measures (Surgical Care Improvement

(SCIP)Measures/Mortality Measures; *Use:* The purpose of this information collection request is to collect data to produce valid, reliable, comparable and salient quality measures to provide a potent stimulus for clinicians and providers to improve the quality of care they provide. The reporting of Surgical Care Improvement

(SCIP)measures is currently being collected from hospitals for activities associated with the Quality Improvement Organization

(QIO)Program. Section 5001(a) of Pub. L. 109-171 of the Deficit Reduction Act

(DRA)sets out new requirements under the Reporting Hospital Quality Data for Annual Payment Update program. This program was initially established under section 501(b) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, which offers monetary incentives for hospitals participating in the reporting of quality data. The DRA requires that we expand the existing “starter set” of 10 quality measures that we have used since 2003. Although, this effort increases the volume of data currently reported into the QIO Clinical Data Warehouse; it however, does not place a substantial data collection burden on hospitals. A substantial percentage of hospitals are voluntarily submitting these SCIP measures currently. In contrast to the SCIP quality measures, no additional data collection from hospitals will be required from the mortality measures. All three mortality measures can be calculated based on Medicare inpatient and outpatient claims data that are already reported to the Medicare program for payment purposes. *Form Number:* CMS-10210 (OMB#: 0938-NEW); *Frequency:* Recordkeeping, Reporting, Third-Party Disclosure—Quarterly; *Affected Public:* Business or other for-profit, Not-for-profit; *Number of Respondents:* 3,700; *Total Annual Responses:* 3,700; *Total Annual Hours:* 587,500. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS Web site address at *http://www.cms.hhs.gov/PaperworkReductionActof1995* , or E-mail your request, including your address, phone number, OMB number, and CMS document identifier, to *Paperwork@cms.hhs.gov* , or call the Reports Clearance Office on

(410)786-1326. Written comments and recommendations for the proposed information collections must be mailed or faxed within 30 days of this notice directly to the OMB desk officer: OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, New Executive Office Building, Room 10235, Washington, DC 20503. Fax Number:

(202)395-6974. Dated: December 18, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6-21916 Filed 12-21-06; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier CMS 10098 and CMS-10114] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services

(CMS)is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:

(1)The necessity and utility of the proposed information collection for the proper performance of the agency's functions;

(2)the accuracy of the estimated burden;

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

(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* 1-800-MEDICARE Beneficiary Satisfaction Survey; *Use:* The Centers for Medicare & Medicaid Services will use the survey information for performance evaluation of the contractor. The information gathered will also be used to validate the quality of service delivered, and or direct the contractor to performance improvement; *Form Number:* CMS-10098 (OMB#: 0938-0919); *Frequency:* Reporting—Weekly, Monthly and Yearly; *Affected Public:* Individuals or households; *Number of Respondents:* 18,000; *Total Annual Responses:* 18,000; *Total Annual Hours:* 2,250. *Type of Information Collection Request:* Revision of a currently approved collection; *Title of Information Collection:* National Provider Identifier

(NPI)Application and Update Form and Supporting Regulations in 45 CFR 142.408, 45 CFR 162.406, 45 CFR 162.408; *Use:* The National Provider Identifier

(NPI)Application and Update Form is used by health care providers to apply for NPIs and furnish updates to the information they supplied on their initial applications. The form is also used to deactivate their NPIs if necessary. The NPI Application/Update form has been revised to further assist in uniquely identifying health care providers and provide additional guidance on how to accurately complete the form. The form captures additional data elements that will assist with unique identification. It also includes more detailed instructions. *Form Number:* CMS-10114 (OMB:# 0938-0931); *Frequency:* Reporting—On occasion, one-time; *Affected Public:* Business or other for-profit, Not-for-profit institutions, and Federal government; *Number of Respondents:* 325,608; *Total Annual Responses:* 325,608; *Total Annual Hours:* 108,560. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS' Web site address at *http://www.cms.hhs.gov/PaperworkReductionActof1995* , or E-mail your request, including your address, phone number, OMB number, and CMS document identifier, to *Paperwork@cms.hhs.gov* , or call the Reports Clearance Office on

(410)786-1326. To be assured consideration, comments and recommendations for the proposed information collections must be received at the address below, no later than 5 p.m. on February 20, 2007. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development—B, *Attention:* William N. Parham, III, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Dated: December 18, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6-21917 Filed 12-21-06; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1327-N] Medicare Program; First Biannual Meeting of the Advisory Panel on Ambulatory Payment Classification Groups—March 7, 8, and 9, 2007 AGENCY: Centers for Medicare & Medicaid Services, Department of Health and Human Services. ACTION: Notice. SUMMARY: In accordance with section 10(a) of the Federal Advisory Committee Act

(FACA)(5 U.S.C. Appendix 2), this notice announces the first biannual meeting of the Advisory Panel on Ambulatory Payment Classification

(APC)Groups (the Panel) for 2007. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services

(CMS)(the Administrator) concerning the clinical integrity of the APC groups and their associated weights. CMS will consider the Panel's advice as we prepare the proposed and final rules that update the hospital Outpatient Prospective Payment System

(OPPS)for CY 2008. *Meeting Dates:* We are scheduling the first biannual meeting in 2007 for the following dates and times: • Wednesday, March 7, 2007, 1 p.m. to 5 p.m. (e.s.t.) • Thursday, March 8, 2007, 8 a.m. to 5 p.m. (e.s.t.) • Friday, March 9, 2007, 8 a.m. to 12 noon (e.s.t.) 1 1 The times listed above are approximate times; consequently, the meetings may last longer than listed above, but will not begin before the posted times. Note: We anticipate that there will be a meeting on Friday, March 9, 2007. However, if the business of the Panel concludes on Thursday, March 8, 2007, there will be no meeting on March 9, 2007. Deadlines *Deadline for Hardcopy Comments/Suggested Agenda Topics* —5 p.m. (e.s.t.), Wednesday, February 7, 2007 *Deadline for Hardcopy Presentations* —5 p.m. (e.s.t.), Wednesday, February 7, 2007 *Deadline for Attendance Registration* —5 p.m. (e.s.t.), Wednesday, February 28, 2007 *Deadline for Special Accommodations* —5 p.m. (e.s.t.), Wednesday, February 28, 2007 Submission of Materials to the Designated Federal Officer

(DFO)Because of staffing and resource limitations, we cannot accept written comments and presentations by FAX, nor can we print written comments and presentations received electronically for dissemination at the meeting. Only hardcopy comments and presentations can be reproduced for public dissemination. All hardcopy presentations *must be accompanied by Form CMS-20017* . The form is now available through the CMS Forms Web site. The URL for linking to this form is as follows: *http://www.cms.hhs.gov/cmsforms/downloads/cms20017.pdf* . We are also requiring electronic versions of the written comments and presentations (in addition to the hardcopies), so we can send them electronically to the Panel members for their review before the meeting. Consequently, *you must send BOTH electronic and hardcopy versions of your presentations and written comments by the prescribed deadlines.* (Send electronic transmissions to the e-mail address below. Mail (or send by courier) hardcopies, accompanied by Form CMS-20017, to the DFO, as specified in the FOR FURTHER INFORMATION CONTACTS section of this notice.) ADDRESSES: The meeting will be held in the Auditorium, 1st Floor, CMS Central Office, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. FOR FURTHER INFORMATION CONTACT: • For further information, contact: Shirl Ackerman-Ross, DFO, CMS, CMM, HAPG, DOC, 7500 Security Boulevard, Mail Stop C4-05-17, Baltimore, MD 21244-1850. Phone:

(410)786-4474*. *Note: Please advise couriers of the following: When delivering hardcopies of presentations to CMS, if no one answers at the above phone number, please call

(410)786-4532. • E-mail address for comments, presentations, and registration requests is *CMS_APCPanel@cms.hhs.gov.* • News media representatives must contact our Public Affairs Office at

(202)690-6145. Advisory Committees' Information Lines The phone numbers for the CMS Federal Advisory Committee Hotline are 1-877-449-5659 (toll free) and

(410)786-9379 (local). Web Sites Please search the CMS Web site at *http://www.cms.hhs.gov/FACA/05_AdvisoryPanelonAmbulatoryPaymentClassificationGroups.asp#TopOfPage* in order to obtain the following: • Additional information on the APC meeting agenda topics, • Updates to the Panel's activities, • Copies of the current Charter, and • Membership requirements. SUPPLEMENTARY INFORMATION: I. Background The Secretary is required by section 1833(t)(9)(A) of the Act, as amended and redesignated by sections 201(h) and 202(a)(2) of the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999

(BBRA)(Pub. L. 106-113), respectively, to establish and consult with an expert, outside advisory panel on APC groups. The APC Panel meets up to three times annually to review the APC groups and to provide technical advice to the Secretary and the Administrator concerning the clinical integrity of the groups and their associated weights. All Panel members must have technical expertise that enables them to participate fully in the work of the Panel. The expertise encompasses hospital payment systems, hospital medical-care delivery systems, outpatient payment requirements, APCs, Current Procedural Terminology

(CPT)codes, and the use and payment of drugs and medical devices in the outpatient setting, as well as other forms of relevant expertise. Details regarding membership requirements for the APC Panel can be found on the CMS Web site as listed above. The Panel presently consists of the following members: • E.L. Hambrick, M.D., J.D., Chair. • Marilyn Bedell, M.S., R.N., O.C.N. • Gloryanne Bryant, B.S., R.H.I.A., R.H.I.T., C.C.S. • Albert Brooks Einstein, Jr., M.D., F.A.C.P. • Hazel Kimmel, R.N., C.C.S. • Sandra J. Metzler, M.B.A., R.H.I.A., C.P.H.Q. • Thomas M. Munger, M.D., F.A.C.C. • Frank G. Opelka, M.D., F.A.C.S. • Louis Potters, M.D., F.A.C.R. • James V. Rawson, M.D. • Lou Ann Schraffenberger, M.B.A., R.H.I.A., C.C.S.-P. • Judie S. Snipes, R.N., M.B.A., F.A.C.H.E. • Timothy Gene Tyler, Pharm.D. • Kim Allan Williams, M.D., F.A.C.C., F.A.B.C. • Robert Matthew Zwolak, M.D., Ph.D., F.A.C.S. II. Agenda The agenda for the March 2007 meeting will provide for discussion and comment on the following topics as designated in the Panel's Charter: • Reconfiguring APCs (for example, splitting of APCs, moving Healthcare Common Procedure Coding System [HCPCS] codes from one APC to another and moving HCPCS codes from new technology APCs to clinical APCs). • Evaluating APC weights. • Packaging device and drug costs into APCs: methodology, effect on APCs, and need for reconfiguring APCs based upon device and drug packaging. • Removing procedures from the inpatient list for payment under the OPPS. • Using single and multiple procedure claims data. • Addressing other APC structure technical issues. The subject matter before the Panel shall be limited to these and related topics. Issues related to calculation of the OPPS conversion factor, charge compression, pass-through payments, or wage adjustments are not related to the subject matter that the Panel reviews. The Panel may use data collected or developed by entities and organizations, other than DHHS and CMS, in conducting its review. Organizations are urged to submit data to CMS for review. III. Written Comments and Suggested Agenda Topics Send hardcopy written comments and suggested agenda topics to the DFO at the address indicated above. The DFO must receive these items by 5 p.m. (e.s.t.), Wednesday, February 7, 2007. The written comments and suggested agenda topics for the March 2007 APC Panel meeting must fall within the subject categories outlined in the Panel's Charter and as listed in the Agenda section of this notice. IV. Oral Presentations Individuals or organizations wishing to make 5-minute oral presentations must submit hardcopies of their presentations to the DFO by 5 p.m. (e.s.t.), Wednesday, February 7, 2007, for consideration. The number of oral presentations may be limited by the time available. Oral presentations should not exceed 5 minutes in length for an individual or organization. The Chair may further limit time allowed for presentations due to the number of oral presentations, if necessary. V. Presenter and Presentation Information All presenters must submit Form CMS-20017. Hardcopies are required for oral presentations; however, electronic submissions of Form CMS-20017 are optional. The DFO must receive the following information from those wishing to make oral presentations: • Form CMS-20017 completed with all pertinent information identified on the first page of the presentation. • One hardcopy of presentation. • Electronic copy of presentation. • Personal registration information as described in the Meeting Attendance section below. (Those persons wishing to submit comments only must send hard-copy and electronic versions of their comments, but they are not required to submit Form CMS-20017.) VI. Oral Comments In addition to formal oral presentations, there will be opportunity during the meeting for public oral comments, which will be limited to 1 minute for each individual and a total of 3 minutes per organization. VII. Meeting Attendance The meeting is open to the public; however, attendance is limited to space available. Attendance will be determined on a first-come, first-served basis. Persons wishing to attend this meeting, which is located on Federal property, must e-mail the Panel DFO to register in advance no later than 5 p.m. (e.s.t.), Wednesday, February 28, 2007. A confirmation will be sent to the requester(s) via return e-mail. The following personal information must be e-mailed or telephoned to the DFO by the date and time above: • Name(s) of attendee(s), • Title(s), • Organization, • E-mail address(es), and • Telephone number(s). VIII. Security, Building, and Parking Guidelines Persons attending the meeting must present photographic identification to the Federal Protective Service or Guard Service personnel before they will be allowed to enter the building. Security measures will include inspection of vehicles, inside and out, at the entrance to the grounds. In addition, all persons entering the building must pass through a metal detector. All items brought to CMS, including personal items such as desktops, cell phones, palm pilots, etc., are subject to physical inspection. *Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting* . Note: Presenters must register for the meeting. The public may enter the building 30 to 45 minutes before the meeting convenes each day. All visitors must be escorted in areas other than the lower and first-floor levels in the Central Building. Parking permits and instructions are issued upon arrival by the guards at the main entrance. IX. Special Accommodations Individuals requiring sign-language interpretation or other special accommodations must send a request for these services to the DFO by 5 p.m. (e.s.t.), Wednesday, February 28, 2007. Authority: Section 1833(t)(9) of the Act (42 U.S.C. 1395l(t)). The Panel is governed by the provisions of Pub. L. 92-463, as amended (54 U.S.C. Appendix 2). (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare-Hospital Insurance; and Program No. 93.774, Medicare-Supplementary Medical Insurance Program). Dated: December 7, 2006. Leslie V. Norwalk, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E6-21736 Filed 12-21-06; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-7002-N] Medicare Program; Meeting of the Advisory Panel on Medicare Education, January 24, 2007 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice of meeting. SUMMARY: In accordance with the Federal Advisory Committee Act, 5 U.S.C. Appendix 2, section 10(a) (Pub. L. 92-463), this notice announces a meeting of the Advisory Panel on Medicare Education (the Panel) on January 24, 2007. The Panel advises and makes recommendations to the Secretary of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. This meeting is open to the public. DATES: *Meeting Date:* January 24, 2007 from 9 a.m. to 3:30 p.m., e.s.t.Deadline for *Meeting Registration, Presentations, and Written Comments:* January 17, 2007, 12 noon, e.s.t. *Deadline for Requesting Special Accommodations:* January 9, 2007, 12 noon, e.s.t. ADDRESSES: *Meeting Location:* Marriott Metro Center Hotel, 775 12th Street, NW., Washington, DC 20005,

(202)737-2200. Meeting Registration, Presentations, and Written Comments: Lynne Johnson, Health Insurance Specialist, Division of Partnership Development, Office of External Affairs, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mail stop S1-05-06, Baltimore, MD 21244-1850 or contact Ms. Johnson via e-mail at *Lynne.Johnson@cms.hhs.gov.* Meeting Registration: The meeting is open to the public, but attendance is limited to the space available. Persons wishing to attend this meeting must register by contacting Lynne Johnson at the address listed in the ADDRESSES section of this notice or by telephone at

(410)786-0090, by 12 noon, e.s.t., on January 17, 2007. FOR FURTHER INFORMATION CONTACT: Lynne Johnson,

(410)786-0090. Please refer to the CMS Advisory Committees' Information Line (1-877-449-5659 toll free)/(410-786-9379 local) or the Internet ( *http://www.cms.hhs.gov/FACA/04_APME.asp* ) for additional information and updates on committee activities. Press inquiries are handled through the CMS Press Office at

(202)690-6145. SUPPLEMENTARY INFORMATION: Section 222 of the Public Health Service Act (42 U.S.C. 217a), as amended, grants to the Secretary the authority to establish an advisory panel if the Secretary finds the panel necessary and in the public interest. The Secretary signed the charter establishing this Panel on January 21, 1999 and approved the renewal of the charter on January 14, 2005. The establishment of the charter and renewal of the charter were announced in the February 17, 1999 **Federal Register** (64 FR 7899), and the January 28, 2005 **Federal Register** (70 FR 4129), respectively. The Panel advises and makes recommendations to the Secretary and the Administrator of the Centers for Medicare & Medicaid Services

(CMS)on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. The goals of the Panel are as follows: • To develop and implement a national Medicare education program that describes the options for selecting a health plan under Medicare. • To enhance the Federal Government's effectiveness in informing the Medicare consumer, including the appropriate use of public-private partnerships. • To expand outreach to vulnerable and underserved communities, including racial and ethnic minorities, in the context of a national Medicare education program. • To assemble an information base of best practices for helping consumers evaluate health plan options and build a community infrastructure for information, counseling, and assistance. The current members of the Panel are: Anita B. Boles, Executive Director, Partnership for Clear Health Communications; Gwendolyn T. Bronson, SHINE/SHIP Counselor, Massachusetts SHINE Program; Dr. Yanira Cruz, President and Chief Executive Officer, National Hispanic Council on Aging; Clayton Fong, President and Chief Executive Officer, National Asian Pacific Center on Aging; Nan Kirsten-Forte, Executive Vice President, Consumer Services, WebMD; Dr. Jessie C. Gruman, President and Chief Executive Officer, Center for the Advancement of Health; Betty L. Kennard, Vice President, Government Programs and Compliance, Health First Health Plans; Dr. David Lansky, Director, Health Program, Markle Foundation; Dr. Daniel Lyons, Senior Vice President, Government Programs, Independence Blue Cross; Dr. Frank B. McArdle, Manager, Hewitt Research Office, Hewitt Associates; Traci McClellan, J.D., Executive Director, National Indian Council on Aging; Dr. Keith Mueller, Professor and Section Head, Health Services Research and Rural Health Policy, University of Nebraska; Lee Partridge, Senior Health Policy Advisor, National Partnership for Women and Families; Myisha M. Patterson, National Health Coordinator, National Association for the Advancement of Colored People; Susan O. Raetzman, Associate Director, Public Policy Institute, American Association of Retired Persons; Rebecca Snead, Executive Vice President/Chief Executive Officer, National Alliance of State Pharmacy Associations; William A. Steel, President, The National Grange; Marvin Tuttle, Jr., CAE, Executive Director and Chief Executive Officer, Financial Planning Association; Catherine Valenti, Chairperson and Chief Executive Officer, Caring Voice Coalition; and Grant Wedner, Manager, Business Development Team, Cosmix Corporation. The agenda for the January 24, 2007 meeting will include the following: • Recap of the previous (October 17, 2006) meeting. • Centers for Medicare & Medicaid Services Update. • Medicare Preventive Benefits and Quality. • Medicare Prescription Drug Benefit Update. • Public Comment. • Listening Session with CMS Leadership. • Next Steps. Individuals or organizations that wish to make a 5-minute oral presentation on an agenda topic should submit a written copy of the oral presentation to Lynne Johnson at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice. The number of oral presentations may be limited by the time available. Individuals not wishing to make a presentation may submit written comments to Ms. Johnson at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice. Individuals requiring sign language interpretation or other special accommodations should contact Ms. Johnson at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice. Authority: Sec. 222 of the Public Health Service Act (42 U.S.C. 217a) and sec.10(a) of Pub. L. 92-463 (5 U.S.C. App. 2, 10(a) and 41 CFR 102-3). Dated: November 30, 2006. (Catalog of Federal Domestic Assistance Program No. 93.733, Medicare—Hospital Insurance Program; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program). Leslie V. Norwalk, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. E6-21434 Filed 12-21-06; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1382-N] Medicare Program; Town Hall Meeting on the Fiscal Year 2008 Applications for New Medical Services and Technologies and Informational Workshop on Payment for New Technologies Under the Inpatient Prospective Payment System

(IPPS)and the Outpatient Prospective Payment System (OPPS), Processes for Diagnosis-Related Group

(DRG)Assignment; and Requesting New International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) Codes Under the IPPS—February 22, 2007 (CMS-1382-N) AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice of meetings. SUMMARY: This notice announces a Town Hall Meeting to discuss fiscal year

(FY)2008 applications for add-on payments for new medical services and technologies under the Inpatient Prospective Payment System (IPPS). Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2008 new medical services and technologies applications meet the substantial clinical improvement criteria. Additionally, we will hold an Informational Workshop for all interested parties on the application process and criteria for new medical services and technologies add-on payments under the IPPS, the transitional pass-through payment and new technology ambulatory payment classification

(APC)assignment application processes under the Outpatient Prospective Payment System

(OPPS)and the processes of Diagnosis-Related Group

(DRG)assignment and requesting new ICD-9 codes under the IPPS. DATES: *Meeting and Informational Workshop Date:* Both the Town Hall Meeting and Informational Workshop will be held on Thursday, February 22, 2007. The Informational Workshop will begin at 9 a.m. e.s.t. The Town Hall Meeting will begin at 1:30 p.m. e.s.t. *Registration Deadline for All Participants for the Town Hall Meeting and the Informational Workshop:* All participants must register by February 15, 2007. *Registration Deadline for Presenters of the Town Hall Meeting:* All presenters for the Town Hall Meeting, whether attending in person or by phone, must register and submit their agenda item(s) by February 6, 2007. *Comment Deadline for the Town Hall Meeting:* Written comments for discussion at the Town Hall Meeting must be received by February 6, 2007. All other written comments on whether the service or technology represents a substantial clinical improvement must be received by March 9, 2007 for consideration before publication of the FY 2008 IPPS proposed rule. *Agenda Item(s) Deadline for the Town Hall Meeting:* Agenda items for the Town Hall Meeting must be received by February 6, 2007. ADDRESSES: *Meeting Location:* The Information Workshop and Town Hall Meeting will be held in the auditorium in the central building of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850. *Registration and Special Accommodations:* Individuals wishing to participate or who need special accommodations or both must register by completing the on-line registration located at *newtech@cms.hhs.gov* or by contacting Tiffany Swygert

(410)786-4642 or Michael Treitel at

(410)786-4552. Registration information may also be mailed to the New Technology Team, Division of Acute Care, Center for Medicare Management, Centers for Medicare & Medicaid Services, Mail stop C4-08-06, 7500 Security Boulevard, Baltimore, MD 21244-1850 or faxed to the New Technology Team at

(410)786-0169. *Written Comments for the Town Hall Meeting:* We will accept written questions or other statements, not to exceed three single-spaced, typed pages that are received by the date specified in the “ DATES ” section. Written comments may be sent electronically to *newtech@cms.hhs.gov* (please make the subject of the e-mail new technology comments); sent via mail to the New Technology Team, Division of Acute Care, Center for Medicare Management, Centers for Medicare & Medicaid Services, Mail stop C4-08-06, 7500 Security Boulevard, Baltimore, MD 21244-1850; or sent via fax to the New Technology Team at

(410)786-0169. *Agenda Item(s) for the Town Hall Meeting:* Agenda items for the Town Hall Meeting regarding whether a FY 2008 application meets the substantial clinical improvement criteria may be sent by mail, fax, or electronically. Agenda items must be received by the date specified in the “ DATES ” section. Agenda item(s) may be sent electronically to *newtech@cms.hhs.gov* (please make the subject of the e-mail new technology agenda item(s)); sent via mail to the attention of the New Technology Team, Division of Acute Care, Center for Medicare Management, Centers for Medicare & Medicaid Services, Mail stop C4-08-06, 7500 Security Boulevard, Baltimore, MD 21244-1850; or faxed to the New Technology Team at

(410)786-0169. FOR FURTHER INFORMATION CONTACT: Tiffany Swygert,

(410)786-4642, *tiffany.swygert@cms.hhs.gov* . Michael Treitel,

(410)786-4552, *michael.treitel@cms.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background Sections 1886(d)(5)(K) and

(L)of the Act require the Secretary to establish a process of identifying and ensuring adequate payments for new medical services and technologies under Medicare. Effective for discharges beginning on or after October 1, 2001, section 1886(d)(5)(K)(i) required the Secretary to establish (after notice and opportunity for public comment) a mechanism to recognize the costs of new services and technologies under the inpatient prospective payment system (IPPS). In addition, section 1886(d)(5)(K)(vi) of the Act specifies that a medical service or technology will be considered “new” if it meets criteria established by the Secretary (after notice and opportunity for public comment). (See the FY 2002 IPPS proposed (66 FR 22693, May 4, 2001) and final rules (66 FR 46912, September 7, 2001) for a more detailed discussion.) In addition, we have further discussed our application of the criteria in the IPPS proposed and final rules for FYs 2003, 2004, 2005, 2006 and 2007. (See 67 FR 31427, May 9, 2002; 67 FR 50009, August 1, 2002; 68 FR 27184, May 19, 2003; 68 FR 45385, August 1, 2003; 69 FR 28236, May 18, 2004; 69 FR 49000, August 11, 2004; 70 FR 23353, May 5, 2005; 70 FR 47341, August 12, 2005; and 71 FR 47994, August 18, 2006 respectively). In the September 7, 2001 final rule (66 FR 46914), we noted that we evaluate a request for special payment for a new medical service or technology against the following criteria in order to determine if the new technology meets the substantial clinical improvement requirement: • The device offers a treatment option for a patient population unresponsive to, or ineligible for, currently available treatments. • The device offers the ability to diagnose a medical condition in a patient population where that medical condition is currently undetectable or offers the ability to diagnose a medical condition earlier in a patient population than allowed by currently available methods. There must also be evidence that use of the device to make a diagnosis affects the management of the patient. • Use of the device significantly improves clinical outcomes for a patient population as compared to currently available treatments. Some examples of outcomes that are frequently evaluated in studies of medical devices are the following: ‡ Reduced mortality rate with use of the device. ‡ Reduced rate of device-related complications. ‡ Decreased rate of subsequent diagnostic or therapeutic interventions (for example, due to reduced rate of recurrence of the disease process). ‡ Decreased number of future hospitalizations or physician visits. ‡ More rapid beneficial resolution of the disease process treatment because of the use of the device. ‡ Decreased pain, bleeding, or other quantifiable symptoms. ‡ Reduced recovery time. In addition, we indicated that the requester is required to submit evidence that the technology meets one or more of these criteria. Section 503 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003

(MMA)revised the process for evaluating new medical services and technology applications by requiring the Secretary to do the following: • Provide for public input regarding whether a new service or technology represents an advance in medical technology that substantially improves the diagnosis or treatment of Medicare beneficiaries. • Make public and periodically update a list of all the services and technologies for which an application is pending. • Accept comments, recommendations, and data from the public regarding whether the service or technology represents a substantial improvement. • Provide for a meeting at which organizations representing hospitals, physicians, manufacturers and any other interested parties may present comments, recommendations, and data to the clinical staff of CMS whether the service or technology represents a substantial improvement. The opinions and alternatives provided during this meeting will assist us as we evaluate the new medical services and technology applications for FY 2008. In addition, they will help us to evaluate our policy on the IPPS new technology add-on payment process. We note that for applications for add-on payments for new technologies for FY 2008, we initially set a deadline of October 15, 2006 for an applicant to submit a formal request, including a full description of the clinical applications of the medical service, evidence that the new medical service or technology represents a substantial clinical improvement, and a significant sample of data demonstrating that the medical service or technology meets the high-cost threshold. As announced on our Web site, *http://www.cms.hhs.gov/AcuteInpatientPPS/08_newtech.asp* , we extended the October 15, 2006 deadline to December 30, 2006. Applicants must also submit a complete database demonstrating that the medical service or technology meets the high-cost threshold by December 30, 2006. II. Informational Workshop and Town Hall Meeting Format In addition to, the statutorily-required Town Hall Meeting on whether an IPPS new technology application meets the substantial clinical improvement criteria, we will be holding an Informational Workshop on applying for special payment for new medical services and technologies under the IPPS and OPPS. Specifically, for new technology add-on payments under the IPPS, we will discuss each criterion in detail along with other information that will be helpful in guiding an applicant through the new technology add-on payment process. We will also discuss the processes of DRG assignment and requesting new ICD-9 codes under the IPPS. (Information on DRGs can be found on the IPPS Web site at *http://www.cms.hhs.gov/AcuteInpatientPPS/01_overview.asp#TopOfPage* and information on ICD-9-CM coding can be found on our Web site at *http://www.cms.hhs.gov/ICD9ProviderDiagnosticCodes/02_newrevisedcodes.asp* .) In addition, to facilitate the public's knowledge of OPPS new technology application processes, the Informational Workshop will also include information on several processes for applying for special payment under the OPPS. One topic concerns the process and criteria for applying for a new category of devices for pass-through payment. Interested parties may apply for a new device category, in accordance with section 1833(t)(6) of the Act. As background information, we have posted application and process background information on our Web site at *http://www.cms.hhs.gov/HospitalOutpatientPPS/Downloads/catapp.pdf.* Furthermore, under section 1833(t)(6) of the Act interested parties may also apply for transitional pass-through payment for certain new drugs, biological or radiopharmaceutical agents. As background information, we have posted application and process background information on our Web site, *http://www.cms.hhs.gov/HospitalOutpatientPPS/Downloads/drugapplication.pdf* . Finally, we provide the opportunity for the public to apply for new services to be placed in new technology APC groups in the OPPS, in accordance with our criteria and discussion in our November 30, 2001 final rule (66 FR 59897). We plan to discuss all three of these OPPS application processes at the Informational Workshop that will be held on February 22, 2007. The Informational Workshop is open to all interested parties including organizations representing hospitals, physicians and manufacturers. We encourage all interested parties to attend, especially those who are not familiar with these processes. Individuals who want to attend this Informational Workshop must register by the date specified in the “ DATES ” section of this notice. Registration information is available below. For participants who cannot come to CMS for the meeting, an open toll-free phone line,

(888)577-8990, has been made available. If you are calling in, the operator will ask you for the conference code. The conference code is “New Tech.” We are required to provide for a Town Meeting at which organizations representing hospitals, physicians, manufacturers and any other interested party may present comments, recommendations, and data to the clinical staff of CMS whether the service or technology for which an application has been submitted for new technology add-on treatment under the IPPS represents a substantial improvement. This meeting will allow for a discussion of the substantial clinical improvement criteria to each of the FY 2008 new medical services and technology add-on payment applications. Information regarding the applications can be found on our Web site at *http://www.cms.hhs.gov/AcuteInpatientPPS/08_newtech.asp#TopOfPage.* The majority of the meeting will be reserved for comments, recommendations, and data from registered presenters. The time for each presenter's comments will be approximately 10 to 15 minutes and will be based on the number of registered presenters. Presenters will be scheduled to speak in the order in which they register and grouped by new technology applicant. Therefore, individuals who want to be presenters must register and submit their agenda item(s) by the date specified in the “ DATES ” section. Once the agenda is completed, it will be posted on the IPPS Web site at *http://www.cms.hhs.gov/AcuteInpatientPPS/08_newtech.asp#TopOfPage* . Comments from participants will be heard (time permitting) after the completion of the presentations. For presenters or participants who cannot come to CMS for the meeting, an open toll-free phone line,

(888)577-8990, has been made available. If you are calling in, the operator will ask you for the conference code. The conference code is “New Tech.” In addition, written comments will also be accepted and presented at the meeting if they are received by the date specified in the “ DATES ” section. Written comments may also be submitted after the meeting. If the comments are to be considered before the publication of the proposed rule, the comments must be received by the date specified in the “ DATES ” section. III. Registration Instructions The Division of Acute Care in CMS is coordinating the meeting registration for both the Informational Workshop and Town Hall Meeting. While there is no registration fee, individuals must register to attend the Town Hall Meeting on substantial clinical improvement and for the Informational Workshop (two separate registrations). Individuals may present their comments for the Town Hall Meeting either in person or by phone. These individuals must register and submit their agenda item(s) by the date specified in the “ DATES ” section. All other participants for the Town Hall Meeting must register by the date specified in the “ DATES ” section. All registrants will receive confirmation with instructions for arrival at the CMS complex (persons who register on-line will receive this confirmation upon completion of registration process and should print the confirmation and bring it with them to the meeting). Because of limited meeting space and our desire to maintain an accurate count of registrants who plan to come to CMS, we prefer that these persons register on-line. In addition, we would prefer that registrants who plan to participate by phone register by phone or fax. A. On-line Registration Registration may be completed on-line at the following Web address: *http://www.cms.hhs.gov/AcuteInpatientPPS/08_newtech.asp#TopOfPage* . Select the link “Register to Attend the New Technology Town Hall Meeting” and/or “Register to attend the New Technology Informational Workshop.” After completing the registration, on-line registrants should print the confirmation page and bring it with them to the meeting(s). B. Registration by Phone, Fax or Mail Registration for both meetings may also be completed by contacting Tiffany Swygert at

(410)786-4642 or Michael Treitel at

(410)786-4552. Registration may also be completed by fax to the attention of the New Technology Team at

(410)786-0169. If registration is completed by phone fax or mail, please provide your name, address, and telephone number, meetings, which you are registering for Town Hall Meeting and/or Informational Workshop and, if available, e-mail address and fax number. Please send mail in registration to address specified in the “ADDRESSES” section. IV. Security Information Because this meeting will be located on Federal property, for security reasons, any persons wishing to attend this Informational Workshop and Town Meeting must register by close of business on February 15, 2007. Individuals who have not registered in advance will not be allowed to enter the building to attend the meeting. Seating capacity is limited to the first 250 registrants. The on-site check-in for visitors will begin at 8:30 a.m. Please allow sufficient time to go through the security checkpoints. It is suggested that you arrive at central building by 8:30 a.m. so that you will have enough time to check-in before the session begins. Individuals that will only attend the Town Hall Meeting must check-in at 1 p.m. Security measures will include inspection of vehicles, inside and out, at the entrance to the grounds. In addition, all persons entering the building must check in by name, provide a government-issued identification, and pass through a metal detector. All items brought to CMS, whether personal or for the purpose of demonstration or to support a presentation, including items such as laptops, cell phones, and palm pilots, are subject to physical inspection. Participants attending the Informational Workshop will be able to attend the Town Hall meeting without an additional check-in unless they exit the building. In this case, a participant will need to repeat the security check-in and procedures. Authority: Section 503 of Public Law 108-173. (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program) Dated: November 30, 2006. Leslie V. Norwalk, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 06-9838 Filed 12-20-06; 8:45 am]

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