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FR
FR-2006-05-01/E6-6522
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25575] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6522] [[Page 25575]] ----------------------------------------------------------------------- DEPARTMENT OF EDUCATION Submission for OMB Review; Comment Request AGENCY: Department of Education. SUMMARY: The IC Clearance Official, Regulatory Information Management Services, Office of Management invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995. DATES: Interested persons are invited to submit comments on or before May 31, 2006. ADDRESSES: Written comments should be addressed to the Office of Information and Regulatory Affairs, Attention: Rachel Potter, Desk Officer, Department of Education, Office of Management and Budget, 725 17th Street, NW., Room 10222, New Executive Office Building, Washington, DC 20503 or faxed to (202) 395-6974. SUPPLEMENTARY INFORMATION: Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget (OMB) provide interested Federal agencies and the public an early opportunity to comment on information collection requests. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The IC Clearance Official, Regulatory Information Management Services, Office of Management, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested, e.g. new, revision, extension, existing or reinstatement; (2) Title; (3) Summary of the collection; (4) Description of the need for, and proposed use of, the information; (5) Respondents and frequency of collection; and (6) Reporting and/or Recordkeeping burden. OMB invites public comment. Dated: April 25, 2006. Angela C. Arrington, IC Clearance Official, Regulatory Information Management Services, Office of Management. Office of Postsecondary Education Type of Review: Revision. Title: Higher Education Act (HEA) Title II Reporting Forms on Teacher Quality and Preparation. Frequency: Annually. Affected Public: State, Local, or Tribal Gov't, SEAs or LEAs; not- for-profit institutions. Reporting and Recordkeeping Hour Burden: Responses: 1,309. Burden Hours: 121,632. Abstract: The Higher Education Act of 1998 calls for annual reports from states and institutions of higher education (IHE) on the quality of teacher education and related matters (Pub. L. 105-244, section 207:20 U.S.C. 1027). The purpose of the reports is to provide greater accountability in the preparation of America's teaching forces and to provide information and incentives for its improvement. Most IHEs that have teacher preparation programs must report annually to their states on the performance of their program completers on teacher certification tests. States, in turn, must report test performance information, institution by institution, to the Secretary of Education, along with institution rankings. They must also report on their requirements for licensing teachers, state standards, alternative routes to certifications, waivers, and related items. Requests for copies of the information collection submission for OMB review may be accessed from http://edicsweb.ed.gov, by selecting the ``Browse Pending Collections'' link and by clicking on link number 2975. When you access the information collection, click on ``Download Attachments'' to view. Written requests for information should be addressed to U.S. Department of Education, 400 Maryland Avenue, SW., Potomac Center, 9th Floor, Washington, DC 20202-4700. Requests may also be electronically mailed to IC [email protected] or faxed to 202-245- 6623. Please specify the complete title of the information collection when making your request. Comments regarding burden and/or the collection activity requirements should be electronically mailed to IC [email protected]. Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339. [FR Doc. E6-6522 Filed 4-28-06; 8:45 am] BILLING CODE 4000-01-P
usgpo
2024-10-08T14:08:34.140892
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6522.htm" }
FR
FR-2006-05-01/E6-6526
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25575-25577] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6526] ----------------------------------------------------------------------- DEPARTMENT OF EDUCATION Notice of Proposed Information Collection Requests AGENCY: Department of Education. SUMMARY: The Director, Regulatory Information Management Services, Office of Management, invites comments on the proposed information collection requests as required by the Paperwork Reduction Act of 1995. DATES: Interested persons are invited to submit comments on or before June 30, 2006. SUPPLEMENTARY INFORMATION: Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget (OMB) provide interested Federal agencies and the public an early opportunity to comment on information collection requests. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The Director, Regulatory Information Management Services, Office of Management, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested, e.g. new, revision, extension, existing or reinstatement; (2) Title; (3) Summary of the collection; (4) Description of the need for, and proposed use of, the information; (5) Respondents and frequency of collection; and (6) Reporting and/or Recordkeeping burden. OMB invites public comment. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Dated: April 25, 2006. Jeanne Van Vlandren, Director, Regulatory Information Management Services, Office of Management. Office of Planning, Evaluation, and Policy Development. Type of Review: Regular. Title: Annual Mandatory Collection of Elementary and Secondary Education Data for the Education Data Exchange Network (EDEN). Frequency: Annually. [[Page 25576]] Affected Public: State, Local, or Tribal Gov't, SEAs or LEAs. Reporting and Recordkeeping Hour Burden: Responses: 6,052. Burden Hours: 476,234. Abstract: The Education Data Exchange Network (EDEN) is in the implementation phase of a multiple year effort to consolidate the collection of education information about States, Districts, and Schools in a way that improves data quality and reduces paperwork burden for all of the national education partners. To minimize the burden on the data providers, EDEN seeks the transfer of the proposed data as soon as it has been processed for State, District, and School use. These data will then be stored in EDEN and accessed by federal education program managers and analysts as needed to make program management decisions. This process will eliminate redundant data collections while providing for the timeliness of data submission and use. Additional Information: The Department of Education (ED) is specifically requesting the data providers in each the State Education Agency (SEA) to review the proposed data elements to determine which of these data can be provided for the upcoming 2006-2007 school year and which data would be available in later years (2007-2008 or 2008-2009) and which data, if any, is never expected to be available from the SEA. If information for a data group is not available, please provide information beyond the fact that it is not available. Are there specific impediments to providing this data that you can describe? Is the definition for the data group unclear or ambiguous? Do the requested code sets not align with the way your state collects the data? This is very important information because ED intends to make the collection of these data mandatory. ED also seeks to know if the SEA data definitions are consistent and compatible with the EDEN definitions and accurately reflect the way data is stored and used for education by the States, Districts, and Schools. The answers to these questions by the data providers will influence the timing and content of the final EDEN proposal for the collection of this elementary and secondary data. In addition to overall public comments, ED would also like state education data providers to consider and respond to a number of specific questions that were developed during the recent data definition cycle for EDEN 2006-07 data. While most of these questions address the ability of states to provide information, some speak to the potential burden on states associated with overall changes in EDEN. When responding to these questions, please include the question number in your response. 1. Some of the EDEN data groups require additional information in order to interpret it properly; this is loosely described as metadata. For example, state proficiency levels and the levels that make up proficient and higher differ from one state to the next. Similarly, there are numerous data groups that collect information on state- defined items such as truants, persistently dangerous schools, and definition of school year. For all of these examples, additional information is needed in order to fully understand the reported data as well as to understand whether comparisons across the state are (or are not) appropriate. We are currently considering several ways to collect this information including web-based forms and a separate state-level submission file. What would be the most convenient way for your state to initially provide and subsequently update this information? 2. As EDEN matures, we are weighing the costs/benefits of standardizing the naming conventions of the data groups in order to align them more closely with the Federal Enterprise Architecture. We anticipate this effort would result in changes to approximately \1/3\ of data group names and we would provide a crosswalk between the old name and the new name of each data group. The numbers assigned to the data groups would not change. What impact would data group name changes have on the burden associated with producing and submitting EDEN data files in your state? If we do elect to make these changes, what tools can ED provide to you to lessen your paperwork burden? 3. For the 2006-07 EDEN data set, we added a new topic area: Finance. This change was based on an understanding that in many states, data for files that include financial information come from a source that is separate from the rest of the EDEN data files. So far, we have moved the following data groups to this new topic area: 574--Federal Funding Allocation Table, 614--REAP Alternative Funding Indicator, 615--RLIS Program Table, 616--Transfer Funds Indicator, plus the two new data groups: Funds Spent on Supplemental Services and Funds Spent on School Choice. Is this conceptual change helpful in your state? Are there other data groups that you recommend that we move to this new topic area? 4. As part of the merge between NCES' Common Core of Data (CCD) and EDEN, we would like to modify the way the CCD ID code for schools and districts are submitted in EDEN data files. The CCD ID code is made up of 3 components (a 2 digit FIPS code, a 5 digit district ID code, and a 5 digit school ID code). CCD collects all 3 of these components separately meaning that for schools, there are 3 ID codes that, together, make a unique identifier. EDEN collects a single 7 digit CCD District ID (FIPS thru District) and a single 12 digit CCD school ID (FIPS thru District thru School). What impact would there be on your state's ability to provide EDEN data files if EDEN changed to the CCD methodology for NCES IDs? 5. For Magnet School Status (at the school level) CCD collects only (1) Yes and (2) No. EDEN is set up to collect 4 categories of information regarding Magnet Schools: (1) Magnet All Students, (2) Magnet Not All Students, (3) Not Magnet, and (4) Not Collected by State. At what level of detail does your state collect information on Magnet Schools? What is the burden to your state to provide the data EDEN is requesting? 6. OSEP has historically collected placement information for school age children by age ranges (6-11, 12-17, and 18-21). For 2006-07, USED is proposing to collect this information using discrete ages (instead of the previously used age ranges). This change would take place in EDEN data group 74, Children with Disabilities (IDEA), in the category set that now contains Educational Environment (IDEA), Disability Category (IDEA), and Age Group (Placement). The comparable data group for early childhood (Data Group 613) already collects placement information by discrete age. How does this change affect your state's reporting ability and burden? 7. How do states track dropouts within each state? Would states be able to report dropout data by age or is this information only available by grade? 8. EDEN currently collects dropout data by grade for students in grades 7-12 but will be adding ungraded as an option for the 2006-07 reporting year. Does your state have a significant number of dropouts in grades other than 7-12 (e.g., a student in grade 6 who reaches the age where dropping out is an option)? Can you report this count as a single number (e.g., total dropouts below 7th grade)? 9. Please examine the two new data groups--Funds Spent on Supplemental Services and Funds Spent on School Choice. What information does your state ask LEAs to report on this subject? Can you provide the information requested? If you cannot provide data for these new data groups for 2006-07, [[Page 25577]] when will you be able to provide this data? Requests for copies of the proposed information collection request may be accessed from http://edicsweb.ed.gov, by selecting the ``Browse Pending Collections'' link and by clicking on link number 03017. When you access the information collection, click on ``Download Attachments'' to view. Written requests for information should be addressed to U.S. Department of Education, 400 Maryland Avenue, SW., Potomac Center, 9th Floor, Washington, DC 20202-4700. Requests may also be electronically mailed to [email protected] or faxed to 202-245- 6623. Please specify the complete title of the information collection when making your request. Comments regarding burden and/or the collection activity requirements should be electronically mailed to [email protected]. Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339. [FR Doc. E6-6526 Filed 4-28-06; 8:45 am] BILLING CODE 4000-01-P
usgpo
2024-10-08T14:08:34.151630
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6526.htm" }
FR
FR-2006-05-01/E6-6528
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25577-25580] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6528] ----------------------------------------------------------------------- DEPARTMENT OF EDUCATION Office of Elementary and Secondary Education, Overview Information; Enhanced Assessment Instruments; Notice Inviting Applications for New Awards for Fiscal Year (FY) 2005 Catalog of Federal Domestic Assistance (CFDA) Number: 84.368. Dates: Applications Available: May 1, 2006. Deadline for Transmittal of Applications: June 15, 2006. Eligible Applicants: State educational agencies (SEAs); consortia of SEAs. Estimated Available Funds: $11,680,000 in FY 2005 funds. Estimated Range of Awards: $500,000 to $2,000,000. Estimated Average Size of Awards: $1,460,000. Estimated Number of Awards: 8. Note: The Department is not bound by any estimates in this notice. Project period: Up to 18 months. Full Text of Announcement I. Funding Opportunity Description Purpose of Program: To enhance the quality of assessment instruments and systems used by States for measuring the achievement of all students. Priorities: This application includes four absolute and three competitive preference priorities. In accordance with 34 CFR 75.105(b)(2)(iv), the absolute priorities are from section 6112 of the Elementary and Secondary Education Act of 1965, as amended (ESEA). The competitive preference priorities are from Appendix E to the notice of final requirements for optional State consolidated applications submitted under section 9302 of the ESEA, published in the Federal Register on May 22, 2002 (67 FR 35967). Absolute Priorities: For FY 2005, these priorities are absolute priorities. Under 34 CFR 75.105(c)(3) we consider only applications that address one or more of these priorities. These priorities are: a. Collaborate with institutions of higher education, other research institutions, or other organizations to improve the quality, validity, and reliability of State academic assessments beyond the requirements for these assessments described in section 1111(b)(3) of the ESEA; b. Measure student academic achievement using multiple measures of student academic achievement from multiple sources; c. Chart student progress over time; and d. Evaluate student academic achievement through the development of comprehensive academic assessment instruments, such as performance and technology-based academic assessments. Competitive Preference Priorities: For FY 2005, these priorities are competitive preference priorities. Under 34 CFR 75.105(c)(2)(i) we will award up to an additional 35 points to an application, depending on the extent to which the application meets these priorities. These priorities are: Test accommodations and alternate assessments (up to 15 points), collaborative efforts (up to 10 points), and dissemination (up to 10 points). Note: The full text of these priorities is included in the notice of final requirements published in the Federal Register on May 22, 2002 (67 FR 35967) and in the application package. Program Authority: 20 U.S.C. 7842 and 7301a. Applicable Regulations: (a) The Education Department General Administrative Regulations (EDGAR) in 34 CFR parts 74, 75, 77, 80, 81, 82, 84, 85, 86, 97, 98, and 99. (b) The notice of final requirements published in the Federal Register on May 22, 2002 (67 FR 35967). II. Award Information Type of Award: Discretionary grants. Estimated Available Funds: $11,680,000 in FY 2005 funds. Estimated Range of Awards: $500,000 to $2,000,000. Estimated Average Size of Awards: $1,460,000. Estimated Number of Awards: 8. Note: The Department is not bound by any estimates in this notice. Project period: Up to 18 months. III. Eligibility Information 1. Eligible Applicants: SEAs; consortia of SEAs. 2. Cost Sharing or Matching: This competition does not involve cost sharing or matching. 3. Other: An application from a consortium of SEAs must designate one SEA as the fiscal agent. IV. Application and Submission Information 1. Address to Request Application Package: Zollie Stevenson, Jr., Student Achievement and School Accountability Program, U.S. Department of Education, 400 Maryland Avenue, SW., Room 3W226, Washington, DC 20202-6132. Telephone: (202) 260-1824 or by e-mail: [email protected]. If you use a telecommunications device for the deaf (TDD), you may call the Federal Relay Service (FRS) at 1-800-877-8339. Individuals with disabilities may obtain a copy of the application package in an alternative format (e.g., Braille, large print, audiotape, or computer diskette) by contacting the program contact person listed in this section. 2. Content and Form of Application Submission: Requirements concerning the content of an application, together with the forms you must submit, are in the application package for this competition. Page Limit: The application narrative (Part III of the application) is where you, the applicant, address the selection criteria that reviewers use to evaluate your application. You must limit Part III to the equivalent of no more than 40 pages, using the following standards: A ``page'' is 8.5'' x 11'', on one side only with 1 margins at the top, bottom, and both sides. Double space (no more than three lines per vertical inch) all text in the application narrative, including titles, headings, footnotes, quotations, and captions as well as all text in charts, tables, figures, and graphs. Use a font that is either 12 point or larger or no smaller than 10 pitch (characters per inch). The page limit does not apply to the cover sheet, budget section (chart and [[Page 25578]] narrative), assurances and certifications, response regarding research activities involving human subjects, GEPA 427 response, one-page abstract, personnel resumes, and letters of support; however, discussion of how the application meets the absolute priorities, how well the application meets the competitive preference priorities, and how well the application addresses each of the selection criteria must be included within the page limit. Our reviewers will not read any pages of your application if-- You apply these standards and exceed the page limit; or You apply other standards and exceed the equivalent of the page limit. 3. Submission Dates and Times: Applications Available: May 1, 2006. Deadline for Transmittal of Applications: June 15, 2006. Applications for grants under this competition must be submitted electronically using the Grants.gov Apply site (Grants.gov). For information (including dates and times) about how to submit your application electronically or by mail or hand delivery if you qualify for an exception to the electronic submission requirement, please refer to section IV. 6. Other Submission Requirements in this notice. We do not consider an application that does not comply with the deadline requirements. 4. Intergovernmental Review: This competition is not subject to Executive Order 12372 and the regulations in 34 CFR part 79. 5. Funding Restrictions: We reference regulations outlining funding restrictions in the Applicable Regulations section of this notice. 6. Other Submission Requirements: Applications for grants under this competition must be submitted electronically unless you qualify for an exception to this requirement in accordance with the instructions in this section. a. Electronic Submission of Applications. Applications for grants under the Enhanced Assessment Instruments- CFDA Number 84.368 must be submitted electronically using the Grants.gov Apply site at http://www.grants.gov. Through this site, you will be able to download a copy of the application package, complete it offline, and then upload and submit your application. You may not e- mail an electronic copy of a grant application to us. We will reject your application if you submit it in paper format unless, as described elsewhere in this section, you qualify for one of the exceptions to the electronic submission requirement and submit, no later than two weeks before the application deadline date, a written statement to the Department that you qualify for one of these exceptions. Further information regarding calculation of the date that is two weeks before the application deadline date is provided later in this section under Exception to Electronic Submission Requirement. You may access the electronic grant application for Enhanced Assessment Instruments at: http://www.grants.gov. You must search for the downloadable application package for this program by the CFDA number. Do not include the CFDA number's alpha suffix in your search. Please note the following: When you enter the Grants.gov site, you will find information about submitting an application electronically through the site, as well as the hours of operation. Applications received by Grants.gov are time and date stamped. Your application must be fully uploaded and submitted, and must be date/time stamped by the Grants.gov system no later than 4:30 p.m., Washington, DC time, on the application deadline date. Except as otherwise noted in this section, we will not consider your application if it is date/time stamped by the Grants.gov system later than 4:30 p.m., Washington, DC time, on the application deadline date. When we retrieve your application from Grants.gov, we will notify you if we are rejecting your application because it was date/time stamped after 4:30 p.m., Washington, DC time, on the application deadline date. The amount of time it can take to upload an application will vary depending on a variety of factors including the size of the application and the speed of your Internet connection. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the application process through Grants.gov. You should review and follow the Education Submission Procedures for submitting an application through Grants.gov that are included in the application package for this competition to ensure that you submit your application in a timely manner to the Grants.gov system. You can also find the Education Submission Procedures pertaining to Grants.gov at http://eGrants.ed.gov/help/GrantsgovSubmissionProcedures.pdf. To submit your application via Grants.gov, you must complete all of the steps in the Grants.gov registration process (see http://www.Grants.gov/GetStarted). These steps include (1) registering your organization, (2) registering yourself as an Authorized Organization Representative (AOR), and (3) getting authorized as an AOR by your organization. Details on these steps are outlined in the Grants.gov 3-Step Registration Guide (see http://www.grants.gov/assets/GrantsgovCoBrandBrochure8X11.pdf). You also must provide on your application the same D-U-N-S Number used with this registration. Please note that the registration process may take five or more business days to complete, and you must have completed all registration steps to allow you to successfully submit an application via Grants.gov. You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you qualify for an exception to the electronic submission requirement, as described elsewhere in this section, and submit your application in paper format. You must submit all documents electronically, including all information typically included on the Application for Federal Education Assistance (ED 424), Budget Information--Non-Construction Programs (ED 524), and all necessary assurances and certifications. You must attach any narrative sections of your application as files in a .DOC (document), .RTF (rich text), or .PDF (Portable Document) format. If you upload a file type other than the three file types specified above or submit a password protected file, we will not review that material. Your electronic application must comply with any page limit requirements described in this notice. After you electronically submit your application, you will receive an automatic acknowledgement from Grants.gov that contains a Grants.gov tracking number. The Department will retrieve your application from Grants.gov and send you a second confirmation by e- mail that will include a PR/Award number (an ED-specified identifying number unique to your application). We may request that you provide us original signatures on forms at a later date. Application Deadline Date Extension in Case of Technical Issues with the Grants.gov System: If you are prevented from electronically submitting your application on the application deadline date because of technical problems with the Grants.gov system, we will grant you an extension until 4:30 p.m., [[Page 25579]] Washington, DC time, the following business day to enable you to transmit your application electronically, or by hand delivery. You may also mail your application by following the mailing instructions as described elsewhere in this notice. If you submit an application after 4:30 p.m., Washington, DC time, on the deadline date, please contact the person listed elsewhere in this notice under FOR FURTHER INFORMATION CONTACT, and provide an explanation of the technical problem you experienced with Grants.gov, along with the Grants.gov Support Desk Case Number (if available). We will accept your application if we can confirm that a technical problem occurred with the Grants.gov system and that that problem affected your ability to submit your application by 4:30 p.m., Washington, DC time, on the application deadline date. The Department will contact you after a determination is made on whether your application will be accepted. Note: Extensions referred to in this section apply only to the unavailability of or technical problems with the Grants.gov system. We will not grant you an extension if you failed to fully register to submit your application to Grants.gov before the deadline date and time or if the technical problem you experienced is unrelated to the Grants.gov system. Exception to Electronic Submission Requirement: You qualify for an exception to the electronic submission requirement, and may submit your application in paper format, if you are unable to submit an application through the Grants.gov system because-- You do not have access to the Internet; or You do not have the capacity to upload large documents to the Grants.gov system; and No later than two weeks before the application deadline date (14 calendar days or, if the fourteenth calendar day before the application deadline date falls on a Federal holiday, the next business day following the Federal holiday), you mail or fax a written statement to the Department, explaining which of the two grounds for an exception prevent you from using the Internet to submit your application. If you mail your written statement to the Department, it must be postmarked no later than two weeks before the application deadline date. If you fax your written statement to the Department, we must receive the faxed statement no later than two weeks before the application deadline date. Address and mail or fax your statement to: Zollie Stevenson, Jr., U.S. Department of Education, 400 Maryland Avenue, SW., Room 3W226, Washington, DC 20202-6132. FAX: (202) 260-7764. Your paper application must be submitted in accordance with the mail or hand delivery instructions described in this notice. b. Submission of Paper Applications by Mail. If you qualify for an exception to the electronic submission requirement, you may mail (through the U.S. Postal Service or a commercial carrier), your application to the Department. You must mail the original and two copies of your application, on or before the application deadline date, to the Department at the applicable following address: By mail through the U.S. Postal Service: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.368), 400 Maryland Avenue, SW., Washington, DC 20202-4260; or By mail through a commercial carrier: U.S. Department of Education, Application Control Center--Stop 4260, Attention: (CFDA Number 84.368), 7100 Old Landover Road, Landover, MD 20785-1506. Regardless of which address you use, you must show proof of mailing consisting of one of the following: (1) A legibly dated U.S. Postal Service postmark, (2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service, (3) A dated shipping label, invoice, or receipt from a commercial carrier, or (4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education. If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing: (1) A private metered postmark, or (2) A mail receipt that is not dated by the U.S. Postal Service. If your application is postmarked after the application deadline date, we will not consider your application. Note: The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office. c. Submission of Paper Applications by Hand Delivery. If you qualify for an exception to the electronic submission requirement, you (or a courier service) may deliver your paper application to the Department by hand. You must deliver the original and two copies of your application by hand, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.368), 550 12th Street, SW., Room 7041, Potomac Center Plaza, Washington, DC 20202-4260. The Application Control Center accepts hand deliveries daily between 8 a.m. and 4:30 p.m., Washington, DC time, except Saturdays, Sundays and Federal holidays. Note for Mail or Hand Delivery of Paper Applications: If you mail or hand deliver your application to the Department: (1) You must indicate on the envelope and--if not provided by the Department--in Item 4 of the Application for Federal Education Assistance (ED 424) the CFDA number--and suffix letter, if any--of the competition under which you are submitting your application. (2) The Application Control Center will mail a grant application receipt acknowledgment to you. If you do not receive the grant application receipt acknowledgment within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at (202) 245-6288. V. Application Review Information Selection Criteria: The selection criteria for this competition are from Appendix E to the notice of final requirements published in the Federal Register on May 22, 2002 (67 FR 35967) and are listed in the application package. VI. Award Administration Information 1. Award Notices: If your application is successful, we notify your U.S. Representative and U.S. Senators and send you a Grant Award Notice (GAN). We may also notify you informally. If your application is not evaluated or not selected for funding, we notify you. 2. Administrative and National Policy Requirements: We identify administrative and national policy requirements in the application package and reference these and other requirements in the Applicable Regulations section of this notice. We reference the regulations outlining the terms and conditions of an award in the Applicable Regulations section of this notice and include these and other specific conditions in the GAN. The GAN also incorporates your approved application as part of your binding commitments under the grant. 3. Reporting: At the end of your project period, you must submit a final performance report, including financial information as directed by the Secretary. If you receive a multi-year award, you [[Page 25580]] must submit an annual performance report that provides the most current performance and financial expenditure information as specified by the Secretary in 34 CFR 75.118. 4. Performance Measures: Under the Government Performance and Results Act (GPRA), the Department has developed three measures for evaluating the effectiveness of the Enhanced Assessment Instruments program: (1) The number of States that participated in pilot activities described in each proposal; (2) the number of States that participated in Enhanced Assessment grant projects funded by the current or prior competitions; and (3) the number of presentations at national conferences sponsored by professional education organizations and papers submitted for publication in refereed journals. All grantees will be expected to submit an annual performance report documenting their success in addressing the performance measures. VII. Agency Contact FOR FURTHER INFORMATION CONTACT: Sue Rigney, U.S. Department of Education, 400 Maryland Avenue, SW., Room 3C139, Washington, DC 20202- 6132. Telephone: (202) 260-0931, or by e-mail: [email protected]. If you use a telecommunications device for the deaf (TDD), you may call the Federal Relay Service (FRS) at 1-800-877-8339. Individuals with disabilities may obtain this document in an alternative format (e.g., Braille, large print, audiotape, or computer diskette) on request to the program contact person listed in this section. VIII. Other Information Electronic Access to This Document: You may view this document, as well as all other documents of this Department published in the Federal Register, in text or Adobe Portable Document Format (PDF) on the Internet at the following site: http://www.ed.gov/news/fedregister. To use PDF you must have Adobe Acrobat Reader, which is available free at this site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO), toll free, at 1-888-293-6498; or in the Washington, DC, area at (202) 512-1530. Note: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available on GPO Access at: http://www.gpoaccess.gov/nara/index.html. Dated: April 25, 2006. Henry L. Johnson, Assistant Secretary for Elementary and Secondary Education. [FR Doc. E6-6528 Filed 4-28-06; 8:45 am] BILLING CODE 4000-01-P
usgpo
2024-10-08T14:08:34.184505
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6528.htm" }
FR
FR-2006-05-01/E6-6531
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25580-25584] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6531] ----------------------------------------------------------------------- DEPARTMENT OF EDUCATION Office of Elementary and Secondary Education; Overview Information; Teacher Incentive Fund; Notice Inviting Applications for New Awards for Fiscal Year (FY) 2006 Catalog of Federal Domestic Assistance (CFDA) Number: 84.374A. Dates: Applications Available: May 1, 2006. Deadline for Notice of Intent to Apply: June 15, 2006. Deadline for Transmittal of Applications: July 31, 2006. Deadline for Intergovernmental Review: September 28, 2006. Eligible Applicants: Local educational agencies (LEAs), including charter schools that are LEAs in their State; State educational agencies (SEAs); or partnerships of (a) an LEA, an SEA, or both, and (b) at least one non-profit organization. Estimated Available Funds: $94,050,000. The funds appropriated for this program become available on July 1, 2006 for a period of 15 months. Therefore, we anticipate making awards using FY 2006 funds early in FY 2007. Contingent upon the availability of funds and the receipt of a sufficient number of high-quality applications, we may make additional awards, using FY 2007 funds, from the rank-ordered list of unfunded applications from this competition. Estimated Range of Awards: $300,000-$12,000,000. Estimated Average Size of Awards: $8,000,000. Estimated Number of Awards: 10-15. Note: The Department is not bound by any estimates in this notice. Project Period: Up to 60 months. Full Text of Announcement I. Funding Opportunity Description Purpose of Program: The purpose of the Teacher Incentive Fund, authorized as part of the FY 2006 Department of Education Appropriations Act, Public Law 109-149, is to support programs that develop and implement performance-based teacher and principal compensation systems in high-need schools. The specific goals of the Teacher Incentive Fund include: Improving student achievement by increasing teacher and principal effectiveness; reforming teacher and principal compensation systems so that teachers and principals are rewarded for increases in student achievement; increasing the number of effective teachers teaching poor, minority, and disadvantaged students in hard-to-staff subjects; and creating sustainable performance-based compensation systems. Priorities: We are establishing these priorities for the FY 2006 grant competition (including any awards we make, using FY 2007 funds, from the list of unfunded applications from this competition), in accordance with section 437(d)(1) of the General Education Provisions Act. Absolute Priority: For the FY 2006 grant competition (including any awards we make, using FY 2007 funds, from the list of unfunded applications from this competition), this priority is an absolute priority. Under 34 CFR 75.105(c)(3) we consider only applications that meet this priority. Consistent with the program purpose, the grantee must establish a system that provides teachers and principals, or principals only, serving in high-need schools with differentiated levels of compensation based primarily on student achievement gains at the school and classroom levels. This performance-based compensation system must also (a) consider classroom evaluations conducted multiple times during each school year and (b) provide educators with incentives to take on additional responsibilities and leadership roles. Competitive Preference Priorities: For the FY 2006 grant competition (including any awards we make, using FY 2007 funds, from the list of unfunded applications from this competition), these priorities are competitive preference priorities. Under 34 CFR 75.105(c)(2)(i) we award up to an additional 5 points to an application, depending on the extent to which the application meets the priority. These priorities are: Competitive Preference Priority 1: We will award up to an additional 5 points depending on the extent to which the applicant documents or provides a plan to establish ongoing support for and commitment to the performance-based compensation system from a significant proportion of the teachers, the principal, and the community, including the applicable governing authority or LEA, for each participating high-need school. Competitive Preference Priority 2: We will award up to an additional 5 points depending on the extent to which the applicant will provide differentiated [[Page 25581]] levels of compensation, which may include incentives, to recruit or retain effective teachers and principals (as measured by student achievement gains) in high-need urban and rural schools, and/or in hard-to-staff subject areas such as mathematics and science. Definitions: The following definitions apply: A high-need school means a school with more than 30 percent of its enrollment from low-income families, based on eligibility for free and reduced price lunch subsidies or other poverty measures that the State permits the LEAs to use. A middle or high school may be determined to meet this definition on the basis of poverty data from feeder elementary schools. Waiver of Proposed Rulemaking: Under the Administrative Procedure Act (5 U.S.C. 553), the Department generally offers interested parties the opportunity to comment on proposed priorities, definitions, cost- sharing requirements, selection criteria, and performance measures. Section 437(d)(1) of the General Education Provisions Act (20 U.S.C. 1232(d)(1)), however, allows the Secretary to exempt from rulemaking requirements regulations governing the first grant competition under a new or substantially revised program authority. This is the first grant competition for this program authorized as part of the FY 2006 Department of Education Appropriations Act, Public Law 109-149, and therefore these rules qualify for this exemption. To ensure timely grant awards, the Secretary has decided, under section 437(d)(1), to forego public comment on the priorities, definitions, cost-sharing requirements, selection criteria, and performance measures. These priorities, definitions, cost-sharing requirements, selection criteria, and performance measures will apply to the FY 2006 grant competition (including any awards we make, using FY 2007 funds, from the list of unfunded applications from this competition). Program Authority: Pub. L. 109-149, 119 Stat. 2864-65. Applicable Regulations: The Education Department General Administrative Regulations (EDGAR) in 34 CFR parts 74, 75, 77, 79, 80, 81, 81, 82, 84, 85, 97, 98, and 99. II. Award Information Type of Award: Discretionary grant. Estimated Available Funds: $94,050,000. The funds appropriated for this program become available on July 1, 2006 for a period of 15 months. Therefore, we anticipate making awards using FY 2006 funds in early FY 2007. Contingent upon the availability of funds and the receipt of a sufficient number of high-quality applications, we may make additional awards, using FY 2007 funds, from the rank-ordered list of unfunded applications from this competition. Estimated Range of Awards: $300,000-$12,000,000. Estimated Average Size of Awards: $8,000,000. Estimated Number of Awards: 10-15. Note: The Department is not bound by any estimates in this notice. Project Period: Up to 60 months. III. Eligibility Information 1. Eligible Applicants: LEAs, including charter schools that are LEAs in their State; SEAs; or partnerships of (a) an LEA, an SEA, or both, and (b) at least one non-profit organization. 2. Cost-Sharing: The grantee must ensure that, in each applicable budget year, an increasing share of funds from sources other than this grant will be used to pay for earned differential compensation costs as they are phased in during the performance period. In the final year of the performance period, the grantee must ensure that at least 75 percent of the differentiated compensation costs are not paid from this grant. IV. Application and Submission Information 1. Address to Request Application Package: Education Publications Center (ED Pubs), P.O. Box 1398, Jessup, MD 20794-1398. Telephone (toll free): 1-877-433-7827. FAX: (301) 470-1244. If you use a telecommunications device for the deaf (TDD), you may call (toll free): 1-877-576-7734. You may also contact ED Pubs at its Web site: www.ed.gov/pubs/edpubs.html or you may contact ED Pubs at its e-mail address: [email protected]. If you request an application from ED Pubs, be sure to identify this competition as follows: CFDA number 84.374A. Individuals with disabilities may obtain a copy of the application package in an alternative format (e.g., Braille, large print, audiotape, or computer diskette) by contacting one of the individuals listed under For Further Information Contact in section VII. of this notice. 2. Content and Form of Application Submission: Requirements concerning the content of an application, together with the forms you must submit, are in the application package for this competition. Notice of Intent to Apply: We will be able to develop a more efficient process for reviewing grant applications if we have a better understanding of the number of entities that intend to apply for funding. Therefore, we strongly encourage each potential applicant to send a notification of its intent to apply for funding to the following email address: [email protected]. The notification of intent to apply for funding is optional and should not include information regarding the proposed application. Page Limit: Applicants are strongly encouraged to limit their application to 40 pages. 3. Submission Dates and Times: Applications Available: May 1, 2006. Deadline for Notice of Intent to Apply: June 15, 2006. Deadline for Transmittal of Applications: July 31, 2006. Applications for grants under this competition may be submitted electronically using the Grants.gov Apply site (Grants.gov), or in paper format by mail or hand delivery. For information (including dates and times) about how to submit your application electronically, or by mail or hand delivery, please refer to section IV. 6. Other Submission Requirements in this notice. We do not consider an application that does not comply with the deadline requirements. Deadline for Intergovernmental Review: September 28, 2006. 4. Intergovernmental Review: This competition is subject to Executive Order 12372 and the regulations in 34 CFR part 79. Information about Intergovernmental Review of Federal Programs under Executive Order 12372 is in the application package for this competition. 5. Funding Restrictions: We reference regulations outlining funding restrictions in the Applicable Regulations section in this notice. 6. Other Submission Requirements: Applications for grants under this competition may be submitted electronically or in paper format by mail or hand delivery. a. Electronic Submission of Applications. We have been accepting applications electronically through the Department's e-Application system since FY 2000. In order to expand on those efforts and comply with the President's Management Agenda, we are continuing to participate as a partner in the new government-wide Grants.gov Apply site in FY 2006. Teacher Incentive Fund-CFDA Number 84.374A is one of the programs included in this [[Page 25582]] project. We request your participation in Grants.gov. If you choose to submit your application electronically, you must use the Grants.gov Apply site at http://www.Grants.gov. Through this site, you will be able to download a copy of the application package, complete it offline, and then upload and submit your application. You may not e-mail an electronic copy of a grant application to us. You may access the electronic grant application for Teacher Incentive Fund at: http://www.grants.gov. You must search for the downloadable application package for this program by the CFDA number. Do not include the CFDA number's alpha suffix in your search. Please note the following: Your participation in Grants.gov is voluntary. When you enter the Grants.gov site, you will find information about submitting an application electronically through the site, as well as the hours of operation. Applications received by Grants.gov are time and date stamped. Your application must be fully uploaded and submitted, and must be date/time stamped by the Grants.gov system no later than 4:30 p.m., Washington, DC time, on the application deadline date. Except as otherwise noted in this section, we will not consider your application if it is date/time stamped by the Grants.gov system later than 4:30 p.m., Washington, DC time, on the application deadline date. When we retrieve your application from Grants.gov, we will notify you if we are rejecting your application because it was date/time stamped by the Grants.gov system after 4:30 p.m., Washington, DC time, on the application deadline date. The amount of time it can take to upload an application will vary depending on a variety of factors, including the size of the application and the speed of your Internet connection. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the application process through Grants.gov. You should review and follow the Education Submission Procedures for submitting an application through Grants.gov that are included in the application package for this competition to ensure that you submit your application in a timely manner to the Grants.gov system. You can also find the Education Submission Procedures pertaining to Grants.gov at http://e-Grants.ed.gov/help/GrantsgovSubmissionProcedures.pdf To submit your application via Grants.gov, you must complete all of the steps in the Grants.gov registration process (see http://www.Grants.gov/GetStarted). These steps include (1) registering your organization, (2) registering yourself as an Authorized Organization Representative (AOR), and (3) getting authorized as an AOR by your organization. Details on these steps are outlined in the Grants.gov 3-Step Registration Guide (see http://www.grants.gov/assests/GrantsgovCoBrandBrochure8X11.pdf). You must also provide on your application the same D-U-N-S Number used with this registration. Please note that the registration process may take five or more business days to complete, and you must have completed all registration steps to allow you to successfully submit an application via Grants.gov. You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you submit your application in paper format. You may submit all documents electronically, including all information typically included on the Application for Federal Education Assistance (SF 424), Budget Information--Non-Construction Programs (ED 524), and all necessary assurances and certifications. If you choose to submit your application electronically, you must attach any narrative sections of your application as files in a .DOC (document), .RTF (rich text), or .PDF (Portable Document) format. If you upload a file type other than the three file types specified above or submit a password protected file, we will not review that material. Your electronic application must comply with any page limit requirements described in this notice. After you electronically submit your application, you will receive an automatic acknowledgment from Grants.gov that contains a Grants.gov tracking number. The Department will retrieve your application from Grants.gov and send you a second confirmation by e- mail that will include a PR/Award number (an ED-specified identifying number unique to your application). We may request that you provide us original signatures on forms at a later date. Application Deadline Date Extension in Case of System Unavailability If you are prevented from electronically submitting your application on the application deadline date because of technical problems with the Grants.gov system, we will grant you an extension until 4:30 p.m., Washington, DC time, the following business day to enable you to transmit your application electronically, or by hand delivery. You also may mail your application by following the mailing instructions as described elsewhere in this notice. If you submit an application after 4:30 p.m., Washington, DC time, on the deadline date, please contact the person listed elsewhere in this notice under For Further Information Contact, and provide an explanation of the technical problem you experienced with Grants.gov, along with the Grants.gov Support Desk Case Number (if available). We will accept your application if we can confirm that a technical problem occurred with the Grants.gov system and that that problem affected your ability to submit your application by 4:30 p.m., Washington, DC time, on the application deadline date. The Department will contact you after a determination is made on whether your application will be accepted. Note: Extensions referred to in this section apply only to the unavailability of or technical problems with the Grants.gov system. We will not grant you an extension if you failed to fully register to submit your application to Grants.gov before the deadline date and time or if the technical problem you experienced is unrelated to the Grants.gov system. b. Submission of Paper Applications by Mail. If you submit your application in paper format by mail (through the U.S. Postal Service or a commercial carrier), you must mail the original and two copies of your application, on or before the application deadline date, to the Department at the applicable following address: By mail through the U.S. Postal Service: U.S. Department of Education, Application Control Center, Attention: CFDA Number 84.374A, 400 Maryland Avenue, SW., Washington, DC 20202-4260; or By mail through a commercial carrier: U.S. Department of Education, Application Control Center--Stop 4260, Attention: CFDA Number 84.374A, 7100 Old Landover Road, Landover, MD 20785-1506. Regardless of which address you use, you must show proof of mailing consisting of one of the following: (1) A legibly dated U.S. Postal Service postmark, (2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service, (3) A dated shipping label, invoice, or receipt from a commercial carrier, or (4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education. [[Page 25583]] If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing: (1) A private metered postmark, or (2) A mail receipt that is not dated by the U.S. Postal Service. If your application is postmarked after the application deadline date, we will not consider your application. Note: The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office. c. Submission of Paper Applications by Hand Delivery. If you submit your application in paper format by hand delivery, you (or a courier service) must deliver the original and two copies of your application by hand, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: CFDA Number 84.374A, 550 12th Street, SW., Room 7041, Potomac Center Plaza, Washington, DC 20202-4260. The Application Control Center accepts hand deliveries daily between 8 a.m. and 4:30 p.m., Washington, DC time, except Saturdays, Sundays and Federal holidays. Note for Mail or Hand Delivery of Paper Applications: If you mail or hand deliver your application to the Department: (1) You must indicate on the envelope and--if not provided by the Department--in Item 4 of the Application for Federal Education Assistance (SF 424) the CFDA number--and suffix letter, if any--of the competition under which you are submitting your application. (2) The Application Control Center will mail a grant application receipt acknowledgment to you. If you do not receive the grant application receipt acknowledgment within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at (202) 245-6288. V. Application Review Information Selection Criteria: The selection criteria for this competition are as follows: (a) Need (5 points). The extent to which the applicant describes the scope and size of the project and the need for the project, including information on student academic achievement and the quality of the teachers and principals in the LEA(s) and high-need schools that will be served by the project. (b) Project Design (50 points). (1) The extent to which the performance-based compensation system will reward teachers and principals who raise student academic achievement. (2) The extent to which the applicant describes the performance- based teacher and principal compensation system that the applicant proposes to develop, implement, or expand, including the extent to which the applicant will build the capacity of teachers and principals through activities such as professional development to raise student achievement and to provide students with greater access to rigorous coursework. (3) The extent to which the applicant's proposed project includes valid and reliable measures of student achievement--including statewide assessment scores as appropriate for this purpose--as the primary indicator of teacher and principal effectiveness in the proposed performance-based compensation system. (4) The extent to which the applicant proposes to develop and implement a fair, rigorous and objective process to evaluate teacher and principal performance multiple times throughout the school year. (c) Adequacy of Resources (20 points). (1) The extent to which the applicant provides a thorough explanation of how the applicant will use funds awarded under the grant together with the required matching funds to carry out the program purpose. (2) The extent to which the applicant provides a detailed plan, including documentation of resources, for sustaining its performance- based compensation system after the grant period ends. (3) The extent to which the applicant includes a thorough description of its current data-management capacity and proposed areas of data management development in order to implement a performance- based compensation system in which differentiated compensation is based primarily on student academic achievement. (d) Quality of the Management Plan and Key Personnel (15 points). (1) The adequacy of the management plan to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, milestones, and processes for continuous improvement to accomplish project tasks. (2) The qualifications, including experience, education, and training of proposed key personnel. (e) Evaluation (10 points). (1) The extent to which the applicant's evaluation plan includes the use of objective measures that are clearly related to the goals of the project to raise student achievement and increase teacher effectiveness, including the extent to which the evaluation will produce quantitative and qualitative data. (2) The extent to which the applicant includes adequate evaluation procedures for ensuring feedback and continuous improvement in the operation of the proposed project. (3) The extent to which the applicant commits to participating in a rigorous national evaluation that will provide a common design methodology, data collection instruments, and performance measures for all grantees funded under this competition. VI. Award Administration Information 1. Award Notices: If your application is successful, we notify your U.S. Representative and U.S. Senators and send you a Grant Award Notification (GAN). We may also notify you informally. If your application is not evaluated or not selected for funding, we notify you. 2. Administrative and National Policy Requirements: We identify administrative and national policy requirements in the application package and reference these and other requirements in the Applicable Regulations section of this notice. We reference the regulations outlining the terms and conditions of an award in the Applicable Regulations section of this notice and include these and other specific conditions in the GAN. The GAN also incorporates your approved application as part of your binding commitments under the grant. 3. Reporting: At the end of the project period, recipients must submit a final performance report, including financial information, as directed by the Secretary. If you receive a multi-year award, you must submit an annual performance report that provides the most current performance and financial expenditure information as specified by the Secretary in 34 CFR 75.118. 4. Performance Measures: Pursuant to the Government Performance and Results Act (GPRA), the Department has established the following performance measures that it will use to evaluate the overall effectiveness of the grantee's project, as well as the TIF program as a whole: (1) Changes in LEA personnel deployment practices, as measured by changes over time in the percentage of teachers and principals in high- need schools who have a record of effectiveness; and (2) Changes in teacher and principal compensation systems in participating [[Page 25584]] LEAs, as measured by the percentage of a district's personnel budget that is used for performance-related payments to effective (as measured by student achievement gains) teachers and principals. All grantees will be expected to submit an annual performance report documenting their success in addressing these performance measures. The Department will use the applicant's performance data for program management and administration, in such areas as determining new and continuation funding and planning technical assistance. VII. Agency Contacts For Further Information Contact: Margaret McNeely, U.S. Department of Education, 400 Maryland Avenue, SW., room 3W103, Washington, DC 20202-6200, or Sheila Sjolseth, Department of Education, 400 Maryland Avenue, SW., room 3W237, Washington, DC 20202-6200. Or by phone at (202) 205-5224. Or by e-mail: [email protected] or by Internet at the following Web site: http://www.ed.gov/programs/teacherincentive/index.html. If you use a telecommunications device for the deaf (TDD), you may call the Federal Relay Service (FRS) at 1-800-877-8339. Individuals with disabilities may obtain this document in an alternative format (e.g., Braille, large print, audiotape, or computer diskette) on request to the individuals listed in this section. VIII. Other Information Electronic Access to This Document: You may view this document, as well as all other documents of this Department published in the Federal Register, in text or Adobe Portable Document Format (PDF) on the Internet at the following site: www.ed.gov/news/fedregister. To use PDF you must have Adobe Acrobat Reader, which is available free at this site. If you have questions about using PDF, call the U.S. Government Printing Office (GPO), toll free, at 1-888-293-6498; or in the Washington, DC, area at (202) 512-1530. Note: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available on GPO Access at: www.gpoaccess.gov/nara/index.html. Dated: April 26, 2006. Henry L. Johnson, Assistant Secretary for Elementary and Secondary Education. [FR Doc. E6-6531 Filed 4-28-06; 8:45 am] BILLING CODE 4000-01-P
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FR
FR-2006-05-01/E6-6524
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25584] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6524] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF ENERGY Environmental Management Site-Specific Advisory Board, Paducah AGENCY: Department of Energy (DOE). ACTION: Notice of open meeting. ----------------------------------------------------------------------- SUMMARY: This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Paducah. The Federal Advisory Committee Act (Pub. L. No. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the Federal Register. DATES: Thursday, May 18, 2006, 5:30 p.m.-9 p.m. ADDRESSES: 111 Memorial Drive, Barkley Centre, Paducah, Kentucky 42001. FOR FURTHER INFORMATION CONTACT: William E. Murphie, Deputy Designated Federal Officer, Department of Energy Portsmouth/Paducah Project Office, 1017 Majestic Drive, Suite 200, Lexington, Kentucky 40513, (859) 219-4001. SUPPLEMENTARY INFORMATION: Purpose of the Board: The purpose of the Board is to make recommendations to DOE in the areas of environmental restoration, waste management and related activities. Tentative Agenda: 5:30 p.m.--Informal Discussion 6 p.m.--Call to Order Introductions Review of Agenda Approval of April Minutes 6:15 p.m.--Deputy Designated Federal Officer's Comments 6:35 p.m.--Federal Coordinator's Comments 6:40 p.m.--Ex-officios' Comments 6:50 p.m.--Public Comments and Questions 7 p.m.--Task Forces/Presentations Land Acquisition Study Statement of Work Water Disposition/Water Quality Task Force--End State Maps 8 p.m. Public Comments and Questions 8:10 p.m. Break 8:20 p.m. Administrative Issues Preparation for June Presentation Budget Review Review of Work Plan Review of Next Agenda 8:30 p.m. Review of Action Items 8:35 p.m. Subcommittee Report Executive Committee--Chairs Meeting Review 8:50 p.m. Final Comments 9 p.m. Adjourn Public Participation: The meeting is open to the public. Written statements may be filed with the Board either before or after the meeting. Individuals who wish to make oral statements pertaining to agenda items should contact David Dollins at the address listed below or by telephone at (270) 441-6819. Requests must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comment will be provided a maximum of five minutes to present their comments. Minutes: The minutes of this meeting will be available for public review and copying at the U.S. Department of Energy's Freedom of Information Public Reading Room, 1E-190, Forrestal Building, 1000 Independence Avenue, SW., Washington, DC 20585 between 9 a.m. and 4 p.m., Monday-Friday, except Federal holidays. Minutes will also be available at the Department of Energy's Environmental Information Center and Reading Room at 115 Memorial Drive, Barkley Centre, Paducah, Kentucky between 8 a.m. and 5 p.m. on Monday through Friday or by writing to David Dollins, Department of Energy, Paducah Site Office, Post Office Box 1410, MS-103, Paducah, Kentucky 42001 or by calling him at (270) 441-6819. Issued at Washington, DC on April 25, 2006. Rachel M. Samuel, Deputy Advisory Committee Management Officer. [FR Doc. E6-6524 Filed 4-28-06; 8:45 am] BILLING CODE 6450-01-P
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{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6524.htm" }
FR
FR-2006-05-01/E6-6527
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25584-25585] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6527] ----------------------------------------------------------------------- DEPARTMENT OF ENERGY Energy Information Administration Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Energy Information Administration (EIA), Department of Energy (DOE). ACTION: Agency Information Collection Activities: Proposed Collection; Comment Request. ----------------------------------------------------------------------- SUMMARY: The EIA is soliciting comments on the proposed three-year [[Page 25585]] extension to the DOE-887, ``DOE Customer Surveys,'' to the Office of Management and Budget (OMB) for review and a three-year extension under section 3507(h)(1) of the Paperwork Reduction Act of 1995 (Pub. L. 104- 13) (44 U.S.C. 3501 et seq.). DATES: Comments must be filed by June 30, 2006. If you anticipate difficulty in submitting comments within that period, contact the person listed below as soon as possible. ADDRESSES: Send comments to Kara Norman. To ensure receipt of the comments by the due date, submission by FAX (202-287-1705) or e-mail ([email protected]) is recommended. The mailing address is Statistics and Methods Group (EI-70), Forrestal Building, U.S. Department of Energy, Washington, DC 20585-0670. Alternatively, Kara Norman may be contacted by telephone at 202-287-1902. FOR FURTHER INFORMATION CONTACT: Requests for additional information or copies of any forms and instructions should be directed to Kara Norman at the address listed above. SUPPLEMENTARY INFORMATION: I. Background II. Current Actions III. Request for Comments I. Background The Federal Energy Administration Act of 1974 (Pub. L. 93-275, 15 U.S.C. 761 et seq.) and the DOE Organization Act (Pub. L. 95-91, 42 U.S.C. 7101 et seq.) require the EIA to carry out a centralized, comprehensive, and unified energy information program. This program collects, evaluates, assembles, analyzes, and disseminates information on energy resource reserves, production, demand, technology, and related economic and statistical information. This information is used to assess the adequacy of energy resources to meet near and longer term domestic demands. The EIA, as part of its effort to comply with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35), provides the general public and other Federal agencies with opportunities to comment on collections of energy information conducted by or in conjunction with the EIA. Any comments received help the EIA to prepare data requests that maximize the utility of the information collected, and to assess the impact of collection requirements on the public. Also, the EIA will later seek approval by the Office of Management and Budget (OMB) under Section 3507(a) of the Paperwork Reduction Act of 1995. On September 11, 1993, the President signed Executive Order No. 12862 aimed at ``* * * ensuring the Federal government provides the highest quality service possible to the American people.'' The Order discusses surveys as a means for determining the kinds and qualities of service desired by Federal Government customers and for determining satisfaction levels for existing services. These voluntary customer surveys will be used to ascertain customer satisfaction with the Department of Energy in terms of services and products. Respondents will be individuals and organizations that are the recipients of the Department's services and products. Previous customer surveys have provided useful information to the Department for assessing how well the Department is delivering its services and products and for making improvements. The results are used internally and summaries are provided to the Office of Management and Budget on an annual basis, and are used to satisfy the requirements and the spirit of Executive Order No. 12862. II. Current Actions The request to OMB will be for a three-year extension of the expiration date of approval for the Form DOE-887 ``DOE Customer Surveys''. Examples of previously conducted customer surveys are available upon request. Our planned activities in the next three years reflect our increased emphasis on and expansion of these activities, including an increased use of electronic means for obtaining customer input (World Wide Web). III. Request for Comments Prospective respondents and other interested parties should comment on the actions discussed in item II. The following guidelines are provided to assist in the preparation of comments. General Issues A. Is the proposed collection of information necessary for the proper performance of the functions of the agency and does the information have practical utility? Practical utility is defined as the actual usefulness of information to or for an agency, taking into account its accuracy, adequacy, reliability, timeliness, and the agency's ability to process the information it collects. B. What enhancements can be made to the quality, utility, and clarity of the information to be collected? As a Potential Respondent to the Request for Information A. What actions could be taken to help ensure and maximize the quality, objectivity, utility, and integrity of the information to be collected? B. Are the instructions and definitions clear and sufficient? If not, which instructions need clarification? C. Can the information be submitted by the due date? D. Public reporting burden for this collection is estimated to average .25 hours per response. The estimated burden includes the total time necessary to provide the requested information. In your opinion, how accurate is this estimate? E. The agency estimates that the only cost to a respondent is for the time it will take to complete the collection. Will a respondent incur any start-up costs for reporting, or any recurring annual costs for operation, maintenance, and purchase of services associated with the information collection? F. What additional actions could be taken to minimize the burden of this collection of information? Such actions may involve the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. G. Does any other Federal, State, or local agency collect similar information? If so, specify the agency, the data element(s), and the methods of collection. As a Potential User of the Information To Be Collected A. What actions could be taken to help ensure and maximize the quality, objectivity, utility, and integrity of the information disseminated? B. Is the information useful at the levels of detail to be collected? C. For what purpose(s) would the information be used? Be specific. D. Are there alternate sources for the information and are they useful? If so, what are their weaknesses and/or strengths? Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of the form. They also will become a matter of public record. Statutory Authority: Section 3507(h)(1) of the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35). Issued in Washington, DC, April 19, 2006. Jay H. Casselberry, Agency Clearance Officer, Energy Information Administration. [FR Doc. E6-6527 Filed 4-28-06; 8:45 am] BILLING CODE 6450-01-P
usgpo
2024-10-08T14:08:34.274920
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6527.htm" }
FR
FR-2006-05-01/E6-6529
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25586-25587] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6529] [[Page 25586]] ----------------------------------------------------------------------- DEPARTMENT OF ENERGY Energy Information Administration Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Energy Information Administration (EIA), Department of Energy (DOE). ACTION: Agency information collection activities: proposed collection; comment request. ----------------------------------------------------------------------- SUMMARY: The EIA is soliciting comments on the proposed changes and three-year extension to the Form EIA-851A, ``Domestic Uranium Production Report (Annual),'' Form EIA-851Q, ``Domestic Uranium Production Report (Quarterly),'' and Form EIA-858, ``Uranium Marketing Annual Survey.'' DATES: Comments must be filed by June 30, 2006. If you anticipate difficulty in submitting comments within that period, contact the person listed below as soon as possible. ADDRESSES: Send comments to Douglas Bonnar. To ensure receipt of the comments by the due date, submission by FAX (202-287-1944) or e-mail ([email protected]) is recommended. The mailing address is U.S. Department of Energy, EI-52, Forrestal Building, U.S. Department of Energy, telephone at (202-287-1911). FOR FURTHER INFORMATION CONTACT: Requests for additional information or copies of any forms and instructions should be directed to Douglas Bonnar at the address listed above. SUPPLEMENTARY INFORMATION: I. Background II. Current Actions III. Request for Comments I. Background The Federal Energy Administration Act of 1974 (Pub. L. 93-275, 15 U.S.C. 761 et seq.) and the DOE Organization Act (Pub. L. 95-91, 42 U.S.C. 7101 et seq.) require the EIA to carry out a centralized, comprehensive, and unified energy information program. This program collects, evaluates, assembles, analyzes, and disseminates information on energy resource reserves, production, demand, technology, and related economic and statistical information. This information is used to assess the adequacy of energy resources to meet near and longer term domestic demands. The EIA, as part of its effort to comply with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35), provides the general public and other Federal agencies with opportunities to comment on collections of energy information conducted by or in conjunction with the EIA. Any comments received help the EIA to prepare data requests that maximize the utility of the information collected, and to assess the impact of collection requirements on the public. Also, the EIA will later seek approval by the Office of Management and Budget (OMB) under Section 3507(a) of the Paperwork Reduction Act of 1995. Form EIA-851A collects data on uranium milling and processing, uranium feed sources, employment, drilling, expenditures (for drilling, production, and land/other), and uranium mining. Currently, the reporting burden is estimated to average 2 hours per response. The data are used by public and private analysts and policy makers to monitor the domestic uranium mining and milling industry. Form EIA-851A is completed by uranium producers and firms with uranium exploration, drilling, mining, and reclamation activities in the U.S. (that is, within the 50 States, District of Columbia, Puerto Rico, the Virgin Islands, Guam, and other U.S. possessions) during the survey year. Published data appear on the EIA Web site at http://www.eia.doe.gov/cneaf/nuclear/dupr/dupr.html. Form EIA-851Q collects data on monthly uranium production and sources (mines and other). Currently, the reporting burden is estimated to average 0.75 hours per response. The data are used by public and private analysts, the Department of Commerce's International Trade Administration and policy makers to monitor the domestic uranium mining industry. U.S. uranium producers report on the EIA-851Q. Published data appear in the EIA Web site on http://www.eia.doe.gov/cneaf/nuclear/dupr/qupd.html. Form EIA-858 collects data on contracts, deliveries (during the report year and projected for the next ten years), enrichment services purchased, inventories, use in fuel assemblies, feed deliveries to enrichers (during the report year and projected for the next ten years), and unfilled market requirements for the next ten years. Currently, the reporting burden is estimated to average 14 hours per response. The data are used by public and private analysts and policy makers to monitor the domestic uranium market. Form EIA-858 is completed by uranium suppliers and owners and operators of U.S. civilian nuclear power reactors firms and individuals that were involved in the U.S. uranium industry (that is, within the 50 States, District of Columbia, Puerto Rico, the Virgin Islands, Guam, and other U.S. possessions) during the survey year. Published data appear in the EIA Web site on http://www.eia.doe.gov/cneaf/nuclear/umar/umar.html. II. Current Actions EIA will be requesting a three-year extension of approval to its 3 uranium surveys with the following 2 survey changes. Form EIA-851A ``Domestic Uranium Production Report (Annual)'': EIA proposes slightly increasing the collection of details related to four of the seven current data items, (Item 1: Facility Information; Item 2: Milling and Processing; Item 3: Feed Source; Item 4: Mine Production; Item 5: Employment; Item 6: Drilling; and Item 7: Expenditures.) The annual burden associated with the collection of this additional detail would be increased by 1 hour for an estimated average 3 hours per response. Specifically, EIA proposes the additional detail of mine production by mine name, by type, by capacity, by State, and by owner in Item 4; employment by State in Item 5; by exploration drilling and by development drilling in Item 6; and land, exploration, and reclamation expenditures in Item 7. These details were not collected previously because of the small U.S. production industry, and this increase in burden is minimal. Items 1 through 3 will not collect additional detail information. Form EIA-858 ``Uranium Marketing Annual Survey'': EIA proposes collecting one new data price (Average-Price per Separative Work Unit (SWU)) in Item 2: Enrichment Services Purchased by Owners and Operators of Civilian Nuclear Power Reactors. The annual burden would be increased by 1 hour for an estimated average 15 hours per response. The term ``SWU'' stands for ``Separative Work Unit''. It is a measure of the amount of work (energy) that is required to separate raw uranium into two components--a valuable component (U235) and a waste component (U238). Generally speaking, the more SWUs that are expended in the separation process, the greater the degree of efficiency of separation; and the less valuable material (U235) that is lost in the U238 waste stream. However, the energy that goes into separating uranium has a cost associated with it. EIA already collects information on raw uranium price and quantities purchased. However, this provides only a partial picture of the market. EIA now proposes to collect average SWU price data from nuclear electric utilities on an [[Page 25587]] annual basis because this information is critical to understanding the overall dynamics and underlying fundamentals of the current nuclear fuels market and utility choices. III. Request for Comments Prospective respondents and other interested parties should comment on the actions discussed in item II. The following guidelines are provided to assist in the preparation of comments. Please indicate to which form(s) your comments apply. General Issues A. Is the proposed collection of information necessary for the proper performance of the functions of the agency and does the information have practical utility? Practical utility is defined as the actual usefulness of information to or for an agency, taking into account its accuracy, adequacy, reliability, timeliness, and the agency's ability to process the information it collects. B. What enhancements can be made to the quality, utility, and clarity of the information to be collected? As a Potential Respondent to the Request for Information A. What actions could be taken to help ensure and maximize the quality, objectivity, utility, and integrity of the information to be collected? B. Are the instructions and definitions clear and sufficient? If not, which instructions need clarification? C. Can the information be submitted by the due date? D. Public reporting burden for this collection is estimated to average 3 hours per response for Form EIA-851A, 0.75 hours per response for Form EIA-851Q, and 15 hours per response for Form EIA-858. The estimated burden includes the total time necessary to provide the requested information. In your opinion, how accurate is this estimate? E. The agency estimates that the only cost to a respondent is for the time it will take to complete the collection. Will a respondent incur any start-up costs for reporting, or any recurring annual costs for operation, maintenance, and purchase of services associated with the information collection? F. What additional actions could be taken to minimize the burden of this collection of information? Such actions may involve the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. G. Does any other Federal, State, or local agency collect similar information? If so, specify the agency, the data element(s), and the methods of collection. As a Potential User of the Information To Be Collected A. What actions could be taken to help ensure and maximize the quality, objectivity, utility, and integrity of the information disseminated? B. Is the information useful at the levels of detail to be collected? C. For what purpose(s) would the information be used? Be specific. D. Are there alternate sources for the information and are they useful? If so, what are their weaknesses and/or strengths? Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of the form. They also will become a matter of public record. Statutory Authority: Section 3507(h)(1) of the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35). Issued in Washington, DC, April 19, 2006. . Jay H. Casselberry, Agency Clearance Officer, Energy Information Administration. [FR Doc. E6-6529 Filed 4-28-06; 8:45 am] BILLING CODE 6450-01-P
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2024-10-08T14:08:34.303026
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6529.htm" }
FR
FR-2006-05-01/E6-6539
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25587-25589] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6539] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [FRL-8163-9] Ambient Air Monitoring Reference and Equivalent Methods: Designation of Five New Reference or Equivalent Methods AGENCY: Environmental Protection Agency. ACTION: Notice of the designation of five new reference or equivalent methods for monitoring ambient air quality. ----------------------------------------------------------------------- SUMMARY: Notice is hereby given that the Environmental Protection Agency (EPA) has designated two new reference methods for measuring concentrations of nitrogen dioxide (NO2) and carbon monoxide (CO) in the ambient air, and three new equivalent methods for measuring concentrations of sulfur dioxide (SO2) and ozone (O3) in the ambient air. FOR FURTHER INFORMATION CONTACT: Elizabeth Hunike, Human Exposure and Atmospheric Sciences Division (MD-D205-03), National Exposure Research Laboratory, U.S. EPA, Research Triangle Park, North Carolina 27711. Phone: (919) 541-3737, e-mail: [email protected]. SUPPLEMENTARY INFORMATION: In accordance with regulations at 40 CFR part 53, the EPA evaluates various methods for monitoring the concentrations of those ambient air pollutants for which EPA has established National Ambient Air Quality Standards (NAAQSs) as set forth in 40 CFR part 50. Monitoring methods that are determined to meet specific requirements for adequacy are designated by the EPA as either reference methods or equivalent methods (as applicable), thereby permitting their use under 40 CFR part 58 by States and other agencies for determining attainment of the NAAQSs. The EPA hereby announces the designation of two new reference methods for measuring concentrations of NO2 and CO in the ambient air, and three new equivalent methods for measuring concentrations of SO2 and O3 in the ambient air. These designations are made under the provisions of 40 CFR part 53, as amended on July 18, 1997 (62 FR 38764). The new reference method for NO2 is an automated method (analyzer) that utilizes the measurement principle (gas phase chemiluminescence) and calibration procedure specified in appendix F of 40 CFR part 50. This newly designated NO2 reference method is identified as follows: RFNA-0506-0157, ``Horiba Instruments Incorporated Model APNA-370 Ambient NOX Monitor,'' standard specification, operated with a full scale fixed measurement range of 0-0.50 ppm with the automatic range switching off, at any ambient temperature in the range of 20 [deg]C to 30 [deg]C, and with a 0.3 micrometer sample particulate filter installed. The new reference method for CO is an automated method (analyzer) that utilizes the measurement principle (non-dispersive infra-red absorption photometry) and calibration procedure specified in appendix C of 40 CFR part 50. This newly designated CO reference method is identified as follows: RFCA-0506-158, ``Horiba Instruments Incorporated Model APMA-370 Ambient CO Monitor,'' operated with a full scale fixed measurement range of 0-50 ppm, with the automatic range switching off, at any environmental temperature in the range of 20 [deg]C to 30 [deg]C. The new equivalent method for SO2 is an automated method (analyzer) that utilizes a measurement principle based on ultraviolet fluorescence. This newly designated SO2 equivalent method is identified as follows: EQSA-0506-159, ``Horiba Instruments Incorporated Model APSA-370 Ambient SO22 Monitor,'' operated with a full scale fixed measurement range of 0-0.50 ppm, with the automatic range switching off, at [[Page 25588]] any environmental temperature in the range of 20 [deg]C to 30 [deg]C. The two new equivalent methods for O3 are automated methods (analyzers) that utilize a measurement principle based on absorption of ultraviolet light by ozone at a wavelength of 254 nm. These newly designated equivalent methods are identified as follows: EQOA-0506-160, ``Horiba Instruments Incorporated APOA-370 Ambient O3 Monitor,'' standard specification, operated with a full-scale fixed measurement range of 0-0.5 ppm, with the automatic range switching off, at any temperature in the range of 20 to 30 [deg]C. EQOA-0506-161, ``Seres OZ 2000 G Ozone Ambient Air Analyzer,'' operated with a full scale range of 0-0.5 ppm, at any temperature in the range of 20 [deg]C to 30 [deg]C, and with or without either of the following options: Internal ozone generator, teletransmission interface. Applications for the Horiba reference and equivalent method determinations were received by the EPA on August 23 (2), September 9, and September 23, 2005. The Horiba methods are available commercially from the applicant, Horiba Instruments Incorporated, 17671 Armstrong Avenue, Irvine, CA 92614 (http://www.horiba.com). The Seres equivalent method application was received by the EPA on November 9, 2005, and the Seres method is available commercially from the applicant, Seres, 360, Rue Louis de Broglie, La Duranne BP 87000, 13793 Aix en Provence, Cedex 3, France (http://www.seres-france.com). A test analyzer representative of each of these methods has been tested in accordance with the applicable test procedures specified in 40 CFR part 53 (as amended on July 18, 1997). After reviewing the results of those tests and other information submitted by the applicants in the respective applications, EPA has determined, in accordance with part 53, that each of these methods should be designated as a reference or equivalent method, as applicable. The information submitted by the applicants in their respective applications will be kept on file, either at EPA's National Exposure Research Laboratory, Research Triangle Park, North Carolina 27711 or in an approved archive storage facility, and will be available for inspection (with advance notice) to the extent consistent with 40 CFR part 2 (EPA's regulations implementing the Freedom of Information Act). As a designated reference or equivalent method, each of these methods is acceptable for use by states and other air monitoring agencies under the requirements of 40 CFR part 58, Ambient Air Quality Surveillance. For such purposes, the method must be used in strict accordance with the operation or instruction manual associated with the method and subject to any specifications and limitations (e.g., configuration or operational settings) specified in the applicable designation method description (see the identifications of the methods above). Use of each method should also be in general accordance with the guidance and recommendations of applicable sections of the ``Quality Assurance Handbook for Air Pollution Measurement Systems, Volume I,'' EPA/600/R-94/038a and ``Quality Assurance Handbook for Air Pollution Measurement Systems, Volume II, Part 1,'' EPA-454/R-98-004 (available at http://www.epa.gov/ttn/amtic/qabook.html). Vendor modifications of a designated reference or equivalent method used for purposes of part 58 are permitted only with prior approval of the EPA, as provided in part 53. Provisions concerning modification of such methods by users are specified under section 2.8 (Modifications of Methods by Users) of appendix C to 40 CFR part 58. In general, a method designation applies to any sampler or analyzer which is identical to the sampler or analyzer described in the application for designation. In some cases, similar samplers or analyzers manufactured prior to the designation may be upgraded or converted (e.g., by minor modification or by substitution of the approved operation or instruction manual) so as to be identical to the designated method and thus achieve designated status. The manufacturer should be consulted to determine the feasibility of such upgrading or conversion. Part 53 requires that sellers of designated reference or equivalent method analyzers or samplers comply with certain conditions. These conditions are specified in 40 CFR 53.9 and are summarized below: (a) A copy of the approved operation or instruction manual must accompany the sampler or analyzer when it is delivered to the ultimate purchaser. (b) The sampler or analyzer must not generate any unreasonable hazard to operators or to the environment. (c) The sampler or analyzer must function within the limits of the applicable performance specifications given in 40 CFR parts 50 and 53 for at least one year after delivery when maintained and operated in accordance with the operation or instruction manual. (d) Any sampler or analyzer offered for sale as part of a reference or equivalent method must bear a label or sticker indicating that it has been designated as part of a reference or equivalent method in accordance with part 53 and showing its designated method identification number. (e) If such an analyzer has two or more selectable ranges, the label or sticker must be placed in close proximity to the range selector and indicate which range or ranges have been included in the reference or equivalent method designation. (f) An applicant who offers samplers or analyzers for sale as part of a reference or equivalent method is required to maintain a list of ultimate purchasers of such samplers or analyzers and to notify them within 30 days if a reference or equivalent method designation applicable to the method has been canceled or if adjustment of the sampler or analyzer is necessary under 40 CFR 53.11(b) to avoid a cancellation. (g) An applicant who modifies a sampler or analyzer previously designated as part of a reference or equivalent method is not permitted to sell the sampler or analyzer (as modified) as part of a reference or equivalent method (although it may be sold without such representation), nor to attach a designation label or sticker to the sampler or analyzer (as modified) under the provisions described above, until the applicant has received notice under 40 CFR 53.14(c) that the original designation or a new designation applies to the method as modified, or until the applicant has applied for and received notice under 40 CFR 53.8(b) of a new reference or equivalent method determination for the sampler or analyzer as modified. Aside from occasional breakdowns or malfunctions, consistent or repeated noncompliance with any of these conditions should be reported to: Director, Human Exposure and Atmospheric Sciences Division (MD- E205-01), National Exposure Research Laboratory, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711. Designation of these new reference and equivalent methods is intended to assist the States in establishing and operating their air quality surveillance systems under 40 CFR part 58. Questions concerning the commercial availability or technical aspects of the [[Page 25589]] method should be directed to the applicant. Lawrence W. Reiter, Director, National Exposure Research Laboratory. [FR Doc. E6-6539 Filed 4-28-06; 8:45 am] BILLING CODE 6560-50-P
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2024-10-08T14:08:34.338663
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6539.htm" }
FR
FR-2006-05-01/E6-6540
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25589] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6540] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [FRL-8164-1] National Advisory Council for Environmental Policy and Technology AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of meeting. ----------------------------------------------------------------------- SUMMARY: Under the Federal Advisory Committee Act, P.L. 92463, EPA gives notice of a meeting of the National Advisory Council for Environmental Policy and Technology (NACEPT). NACEPT provides advice to the EPA Administrator on a broad range of environmental policy, technology, and management issues. The Council is a panel of individuals who represent diverse interests from academia, industry, non-governmental organizations, and local, state, and tribal governments. The purpose of this meeting is to discuss the FY06-07 NACEPT agenda, including sustainable water infrastructure, environmental stewardship, cooperative conservation, energy and the environment, environmental technology, EPA's 2006-2011 Draft Strategic Plan, and environmental indicators. A copy of the agenda for the meeting will be posted at http://www.epa.gov/ocem/nacept/cal-nacept.htm. DATES: NACEPT will hold a two day open meeting on Thursday, May 18, from 8:30 a.m. to 5:30 p.m. and Friday, May 19, from 9:30 a.m. to 2 p.m. ADDRESSES: The meeting will be held at The Madison Hotel, 1177 15th Street, NW., Washington, DC 20005. The meeting is open to the public, with limited seating on a first-come, first-served basis. FOR FURTHER INFORMATION CONTACT: Sonia Altieri, Designated Federal Officer, [email protected], (202) 233-0061, U.S. EPA, Office of Cooperative Environmental Management (1601E), 1200 Pennsylvania Avenue, NW., Washington, DC 20460. SUPPLEMENTARY INFORMATION: Requests to make oral comments or to provide written comments to the Council should be sent to Sonia Altieri, Designated Federal Officer, at the contact information above. The public is welcome to attend all portions of the meeting. Meeting Access: For information on access or services for individuals with disabilities, please contact Sonia Altieri at 202-233- 0061 or [email protected]. To request accommodation of a disability, please contact Sonia Altieri, preferably at least 10 days prior to the meeting, to give EPA as much time as possible to process your request. Dated: April 17, 2006. Sonia Altieri, Designated Federal Officer. [FR Doc. E6-6540 Filed 4-28-06; 8:45 am] BILLING CODE 6560-50-P
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2024-10-08T14:08:34.354571
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6540.htm" }
FR
FR-2006-05-01/E6-6537
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25589] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6537] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [FRL-8163-6] SES Performance Review Board; Membership AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: Notice is hereby given of the membership of the EPA Performance Review Board. DATES: This is effective on May 1, 2006. FOR FURTHER INFORMATION CONTACT: Judith M. King, Director, Executive Resources Staff, 3611A, Office of Human Resources, Office of Administration and Resources Management, Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460 (202) 564- 0400. SUPPLEMENTARY INFORMATION: Section 4314(c)(1) through (5) of Title 5, U.S.C., requires each agency to establish in accordance with regulations prescribed by the Office of Personnel Management, one or more SES performance review boards. This board shall review and evaluate the initial appraisal of a senior executive's performance by the supervisor, along with any recommendations to the appointment authority relative to the performance of the senior executive. Members of the EPA Performance Review Board are: William G. Laxton (Chair), Acting Director, Office of Human Resources, Office of Administration and Resources Management George W. Alapas, Deputy Director for Management, National Center for Environmental Assessment, Office of Research and Development Gerald M. Clifford, Deputy Assistant Administrator, Office of International Affairs Kerrigan G. Clough, Deputy Regional Administrator, Region 8 Howard F. Corcoran, Director, Office of Grants and Debarment, Office of Administration and Resources Management Nanci E. Gelb, Deputy Director, Office of Ground Water and Drinking Water, Office of Water Robin L. Gonzalez, Director, National Technology Services Division-RTP, Office of Environmental Information Gregory A. Green, Deputy Director, Office of Air Quality Planning and Standards, RTP, Office of Air and Radiation Sally C. Gutierrez, Director, National Risk Management Research Laboratory, Cincinnati, Office of Research and Development Susan B. Hazen, Principal Deputy Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances Karen D. Higgenbotham (Ex-Officio), Director, Office of Civil Rights, Office of the Administrator Nancy J. Marvel, Regional Counsel, Region 9, Office of Enforcement and Compliance Assurance Kathleen S. O'Brien, Deputy Director, Office of Planning, Analysis, and Accountability, Office of the Chief Financial Officer James T. Owens III, Director, Office of Administration and Resources Management, Region 1 George Pavlou, Director, Emergency and Remedial Response Division, Region 2 Stephen G. Pressman, Associate General Counsel (Civil Rights), Office of General Counsel Elizabeth Southerland, Director, Assessment and Remediation Division, Office of Solid Waste and Emergency Response Cecilia M. Tapia, Director, Superfund Division, Region 7 Louise P. Wise, Principal Deputy Associate Administrator for Policy, Economics and Innovation, Office of the Administrator Judith King (Executive Secretary), Acting Director, Executive Resources Staff, Office of Human, Resources, Office of Administration and Resources Management Dated: April 21, 2006. Sherry A. Kaschak, Acting Assistant Administrator for Administration and Resources Management. [FR Doc. E6-6537 Filed 4-28-06; 8:45 am] BILLING CODE 6560-50-P
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2024-10-08T14:08:34.383820
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6537.htm" }
FR
FR-2006-05-01/06-4101
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25590] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 06-4101] [[Page 25590]] ======================================================================= ----------------------------------------------------------------------- EXPORT-IMPORT BANK OF THE UNITED STATES Sunshine Act Meeting AGENCY: Export-Import Bank of the United States. ACTION: Cancellation of a Government in the Sunshine Meeting. ----------------------------------------------------------------------- Original Time and Place: Thursday, April 27, 2006 at 9:30 a.m. Place: Room 1143, 811 Vermont Avenue, NW., Washington, DC 20571. The Export-Import Bank of the United States has cancelled the Government in the Sunshine meeting which was scheduled for April 27, 2006. The Bank will reschedule this meeting at a future date. Earlier announcement of this cancellation was not possible. FOR FURTHER INFORMATION CONTACT: For further information, contact: Office of the Secretary, 811 Vermont Avenue, NW., Washington, DC 20571 (Tele. No. 202-565-3957). Howard A. Schweitzer, General Counsel (Acting). [FR Doc. 06-4101 Filed 4-26-06; 4:08 am] BILLING CODE 6690-01-M
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2024-10-08T14:08:34.395708
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/06-4101.htm" }
FR
FR-2006-05-01/E6-6530
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25590] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6530] ======================================================================= ----------------------------------------------------------------------- FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisition of Shares of Bank or Bank Holding Companies The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and Sec. 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)). The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the office of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than May 16, 2006. A. Federal Reserve Bank of Kansas City (Donna J. Ward, Assistant Vice President) 925 Grand Avenue, Kansas City, Missouri 64198-0001: 1. Biegert Family Trust, Laramie, Wyoming, its trustees, Larry R. Cox; Henderson, Nebraska, Judith Ackland, Geneva, Nebraska, and Larry R. Cox, individually; Charles Flaming, individually, and as owner of Sadle Cattle Company, Inc., both of Paxton, Nebraska; Alan Janzen, Christopher Vanderneck, Matthew D. Siebert, Fredrick Regier, Arvid Janzen, and Brian Janzen, all of Henderson, Nebraska; Ronald Preheim, Aurora, Nebraska; Jeff Pribbeno, Imperial, Nebraska; and Wesley Kroeker, Enid, Oklahoma; and thereby indirectly acquire shares of Henderson State Company, Henderson, Nebraska, of Henderson State Bank, Henderson, Nebraska. Board of Governors of the Federal Reserve System, April 26, 2006. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E6-6530 Filed 4-28-06; 8:45 am] BILLING CODE 6210-01-S
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2024-10-08T14:08:34.415777
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6530.htm" }
FR
FR-2006-05-01/E6-6492
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25590] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6492] ----------------------------------------------------------------------- FEDERAL RESERVE SYSTEM Federal Open Market Committee; Domestic Policy Directive of March 27 and 28, 2006 In accordance with Sec. 271.25 of its rules regarding availability of information (12 CFR part 271), there is set forth below the domestic policy directive issued by the Federal Open Market Committee at its meeting held on March 27 and 28, 2006.\1\ --------------------------------------------------------------------------- \1\ Copies of the Minutes of the Federal Open Market Committee Meeting on March 27 and 28, 2006, which includes the domestic policy directive issued at the meeting, are available upon request to the Board of Governors of the Federal Reserve System, Washington, DC 20551. The minutes are published in the Federal Reserve Bulletin and in the Board's annual report. --------------------------------------------------------------------------- The Federal Open Market Committee seeks monetary and financial conditions that will foster price stability and promote sustainable growth in output. To further its long-run objectives, the Committee in the immediate future seeks conditions in reserve markets consistent with increasing the federal funds rate to an average of around 4\3/4\ percent. The vote encompassed approval of the paragraph below for inclusion in the statement to be released shortly after the meeting: ``The Committee judges that some further policy firming may be needed to keep the risks to the attainment of both sustainable economic growth and price stability roughly in balance. In any event, the Committee will respond to changes in economic prospects as needed to foster these objectives.'' By order of the Federal Open Market Committee, April 20, 2006. Vincent R. Reinhart, Secretary, Federal Open Market Committee. [FR Doc. E6-6492 Filed 4-28-06; 8:45 am] BILLING CODE 6210-01-P
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2024-10-08T14:08:34.437427
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6492.htm" }
FR
FR-2006-05-01/E6-6501
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25590-25591] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6501] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-06-0222] 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 [email protected]. 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 Questionnaire Design Research Laboratory (QDRL) 2007-2009, (OMB No. 0920-0222)--Extension--National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Questionnaire Design Research Laboratory (QDRL) conducts questionnaire pre-testing and evaluation activities for CDC surveys (such as the NCHS National Health Interview [[Page 25591]] Survey, OMB No. 0920-0214) and other federally sponsored surveys. The QDRL conducts cognitive interviews, focus groups, mini field-pretests, and experimental research in laboratory and field settings, both for applied questionnaire evaluation and more basic research on response errors in surveys. The most common questionnaire evaluation method is the cognitive interview. In a cognitive interview, a questionnaire design specialist interviews a volunteer participant. The interviewer administers the draft survey questions as written, but also probes the participant in depth about interpretations of questions, recall processes used to answer them, and adequacy of response categories to express answers, while noting points of confusion and errors in responding. Interviews are generally conducted in small rounds of 10-15 interviews; ideally, the questionnaire is re-worked between rounds and revisions are tested iteratively until interviews yield relatively few new insights. When possible, cognitive interviews are conducted in the survey's intended mode of administration. For example, when testing telephone survey questionnaires, participants often respond to the questions via a telephone in a laboratory room. Under this condition, the participant answers without face-to-face interaction. QDRL staff watch for response difficulties from an observation room, and then conduct a face-to-face debriefing with in-depth probes. Cognitive interviewing provides useful data on questionnaire performance at minimal cost and respondent burden. Similar methodology has been adopted by other federal agencies, as well as by academic and commercial survey organizations. NCHS is requesting 3 years of OMB Clearance for the project. There are no costs to respondents other than their time. Estimated Annualized Burden ---------------------------------------------------------------------------------------------------------------- Number of Number of Avg. burden Respondents respondents responses/ response (in Total burden per year respondent hours) hours ---------------------------------------------------------------------------------------------------------------- 2007 test volunteers............................ 500 1 1.2 600 ---------------------------------------------------------------------------------------------------------------- Dated: April 25, 2006. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E6-6501 Filed 4-28-06; 8:45 am] BILLING CODE 4163-18-P
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2024-10-08T14:08:34.454183
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6501.htm" }
FR
FR-2006-05-01/E6-6457
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25591] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6457] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2003N-0273] (formerly 03N-0273) Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Research Study Complaint Form AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Research Study Complaint Form'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482. SUPPLEMENTARY INFORMATION: In the Federal Register of December 16, 2005 (70 FR 74817), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910-0579. The approval expires on March 31, 2009. A copy of the supporting statement for this information collection is available on the Internet at http://www.fda.gov/ohrms/dockets. Dated: April 24, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-6457 Filed 4-28-06; 8:45 am] BILLING CODE 4160-01-S
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2024-10-08T14:08:34.472044
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6457.htm" }
FR
FR-2006-05-01/E6-6461
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25591-25593] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6461] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N-0166] Agency Emergency Processing Under the Office of Management and Budget Review; MedWatch--The Food and Drug Administration Safety Information and Adverse Event Reporting Program; Proposal to Survey MedWatch Partners Organizations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995 (the PRA). This notice solicits comments on a proposal for the MedWatch program to deploy and conduct a web-based customer satisfaction survey of certain health care professional trade and specialty organizations that voluntarily have chosen to participate in the FDA MedWatch's Partners program. The survey will solicit information about the utility of the FDA MedWatch safety alerts and monthly safety labeling changes that are posted on the MedWatch Web site and disseminated to partner organizations for sharing with members of the organizations. DATES: Fax written comments on the collection of information by May 31, 2006. FDA is requesting approval of this emergency processing by May 31, 2006. ADDRESSES: OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. To ensure that comments on the information collection are received, OMB recommends that comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for FDA, Fax: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Karen Nelson, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482. SUPPLEMENTARY INFORMATION: FDA has requested emergency processing of this [[Page 25592]] proposed collection of information under section 3507(j) of the PRA (44 U.S.C. 3507(j)) and 5 CFR 1320.13. This information is needed immediately so that the agency can effectively assess and re-evaluate its FDA MedWatch risk communication efforts in drug safety as part of a broader center level (the Center for Drug Evaluation and Research (CDER)) reorganization action to enhance its risk communication activities for CDER-regulated products, and address public expectations for timely dissemination of clinically useful safety information to both providers and their patients at the point of care. With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. MedWatch--The FDA Safety Information and Adverse Event Reporting Program; Proposal to Survey MedWatch Partners Organizations The MedWatch Partners program is an FDA outreach effort directed at health care provider professional organizations. The effort facilitates the timely dissemination of clinically important new safety information on the drugs, devices, and other human medical care products regulated by FDA and prescribed, dispensed, or used by the membership of these professional societies. In voluntarily agreeing to work with FDA MedWatch, these partner organizations disseminate this important safety information to their members and their members' patients so that medical products necessary to efforts to improve a patient's health may be used more safely and reduce the risk of harm. Risk communication is one of the essential elements in the risk management paradigm accepted as a framework within CDER since described in the ``Report to the FDA Commissioner from the Task Force on Risk Management'' in May 1999. As an agency that regulates a broad range of clinical medical products--drugs, therapeutic biologics, blood products, medical devices, and dietary supplements--FDA's public health mission includes the timely dissemination of new safety information identified during post-marketing surveillance activities. This information includes class 1 recalls, public health advisories, notice of counterfeit drug product, and labeling changes such as new black box warnings or contraindications to drug product use. In recent years, there has been a public commitment to actively disseminating this new safety information, both to health care providers and their patients, and to leveraging this risk communication activity by developing partnerships and alliances with non-governmental organizations. This commitment was explicitly identified as an objective in the strategic plan for ``Improving Patient Safety'' of former Commissioner of Food and Drugs, Mark McClellan. That objective states that FDA will ``take appropriate actions to communicate risks and correct problems associated with medical products'' and ``will identify new ways to inform physicians, pharmacists, nurses, and patients about the safety of FDA-regulated products.'' The MedWatch program is currently located in the Office of Drug Safety, CDER. MedWatch disseminates safety information on FDA-regulated medical products to both health care professional and consumer/patient audiences. MedWatch maintains a comprehensive Web site at http://www.fda.gov/medwatch for this purpose. The FDA MedWatch program has about 120 Partner organizations that represent clinical care providers (doctors, nurses, pharmacists, etc.). As a ``Partner,'' the organization has agreed to support the goals of the MedWatch program: Participating in the dissemination of FDA-approved safety information and promoting the voluntary reporting to FDA of adverse events. In order to communicate quickly with MedWatch Partner organizations, a listserve, supported by the National Institutes of Health, is maintained, with contacts for each MedWatch Partner group. Partner organizations have voluntarily agreed to receive these FDA MedWatch safety alerts and monthly safety labeling changes. Each organization receives e-mail notification of two types of FDA MedWatch safety information at the time it is added to the MedWatch Web site--safety alerts for individual products and, once a month, a listing of the 30 to 60 drugs that have had safety labeling changes for that month. The FDA MedWatch program, in order to implement this safety information dissemination process effectively, needs to evaluate satisfaction of these customer groups so that FDA MedWatch can improve the dissemination process and content of this safety information and increase its use and application to direct patient care and to the public's health. The purpose of the survey is to fulfill phase one of Executive Order 12862, ``Setting Customer Service Standards,'' which directs agencies to continually reform their management practices and operations to provide service to the public that matches or exceeds the best service available in the private sector. There is no duplication of effort. The MedWatch program is the only one planning to perform this survey. By actively gathering this survey information from MedWatch partner customers, the agency will achieve a better understanding customer satisfaction with this program, and be able to direct limited resources to produce an improved program that is most useful to both health care provider customers and, secondarily, their patients. FDA estimates the burden of this collection of information as follows: Table 1.--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- No. of Annual Frequency Total Annual Hours per Respondents per Response Responses Response Total Hours -------------------------------------------------------------------------------------------------------------------------------------------------------- Partner Organizations 120 1 120 .5 60 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\There are no capital costs or operating and maintenance costs associated with this collection of information. This burden estimate of total hours was developed by using: (1) The number of known MedWatch partner health care organizations, (2) the number of times the survey will be deployed, and (3) the expected time to complete the response [[Page 25593]] based on internal pilot testing of the survey instrument at the agency. Dated: April 24, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-6461 Filed 4-28-06; 8:45 am] BILLING CODE 4160-01-S
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2024-10-08T14:08:34.498147
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6461.htm" }
FR
FR-2006-05-01/E6-6508
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25593] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6508] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Research Review Subcommittee of the Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public. Name of the Subcommittee: Research Review Subcommittee of the Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues. Date and Time: The meeting will be held on May 19, 2006, from 8 a.m. to 4:30 p.m. Location: Hilton Hotel, Washington DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877. Contact Person: Christine Walsh or Denise Royster, Center for Biologics Evaluation and Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443- 0572 in the Washington, DC area), code 3014512391. Please call the Information Line for up-to-date information on this meeting. Agenda: On May 19, 2006, the subcommittee will listen to presentations about the research program at the Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER). The program is intended to provide dynamic, responsive, cutting edge research to contribute to OVRR's regulatory mission and facilitate development of safe and effective biological products. The subcommittee will discuss the program and make recommendations to the Vaccines and Related Biological Products Advisory Committee at a future open meeting of the full committee. Information regarding CBER's scientific program is outlined in its Strategic Plan of 2004 and is available to the public on the Internet at: http://www.fda.gov/cber/inside/mission.htm. Information regarding FDA's Critical Path to New Medical Products is available to the public on the Internet at: http://www.fda.gov/oc/initiatives/criticalpath/ criticalpath/. Procedure: On May 19, 2006, from 8 a.m. to 1 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by May 12, 2006. Oral presentations from the public will be scheduled between approximately 12 p.m. to 1 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before May 12, 2006, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. Closed Committee Deliberations: On May 19, 2006, from 2 p.m. to 4:30 p.m., the meeting will be closed to the public. The meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6) and to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4). The subcommittee will discuss internal research programs in the Office of Vaccines Research and Review, CBER. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Christine Walsh or Denise Royster at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: April 21, 2006. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. E6-6508 Filed 4-28-06; 8:45 am] BILLING CODE 4160-01-S
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2024-10-08T14:08:34.536596
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6508.htm" }
FR
FR-2006-05-01/E6-6509
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25593-25594] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6509] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues. Date and Time: The meeting will be held on May 18, 2006, from 9 a.m. to 4:45 p.m. Location: Hilton Hotel, Washington DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877. Contact Person: Christine Walsh or Denise Royster, Center for Biologics Evaluation and Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443- 0572 in the Washington, DC area), code 3014512391. Please call the Information Line for up-to-date information on this meeting. Agenda: The committee will hear presentations and make recommendations on the safety and efficacy of GARDASIL (Human Papillomavirus [Types 6,11,16,18] Recombinant Vaccine) manufactured by Merck. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by May 11, 2006. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral [[Page 25594]] presentations should notify the contact person before May 11, 2006, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Christine Walsh or Denise Royster at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: April 24, 2006. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. E6-6509 Filed 4-28-06; 8:45 am] BILLING CODE 4160-01-S
usgpo
2024-10-08T14:08:34.550149
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6509.htm" }
FR
FR-2006-05-01/E6-6458
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25594-25595] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6458] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D-0401] Guidance for Industry and Food and Drug Administration Staff: Compliance With the Medical Device User Fee and Modernization Act of 2002, as amended--Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Compliance With Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended-- Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices.'' The Medical Device User Fee and Modernization Act 2002 (MDUFMA), as amended by the Medical Device User Fee Stabilization Act of 2005 (MDUFSA), requires that FDA issue guidance identifying the circumstances in which the name, abbreviation, or symbol of the manufacturer of an original device is not ``prominent and conspicuous.'' MDUFSA requires that FDA issue guidance no later than 180 days after the date of enactment (August 1, 2005). DATES: Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies on a 3.5'' diskette of the guidance document entitled ``Compliance With Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended--Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices'' to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-443-8818. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Casper E. Uldriks, Center for Devices and Radiological Health (HFZ-300), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240-276-0106. SUPPLEMENTARY INFORMATION: I. Background MDUFMA (Public Law 107-250) amended section 502 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 352) to require a device, or an attachment to the device, to bear prominently and conspicuously the name of the manufacturer, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying the manufacturer. This labeling provision applied to all devices and all device manufacturers. On August 1, 2005, MDUFSA (Public Law 109-43) amended section 502(u) of the act by limiting the provision to reprocessed single-use devices (SUDs) and the manufacturers who reprocess them. Therefore, section 502(u) of the act, as amended by MDUFSA, no longer sets forth requirements for original equipment manufacturers, unless they also reprocess SUDs. Under the amended provision, if an original device or an attachment to it does not prominently and conspicuously bear the name of the manufacturer of the original device, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying such manufacturer, the manufacturer who reprocesses the SUD may identify itself using a detachable label on the packaging of the device. Section 2(c)(2) of MDUFSA requires that FDA issue guidance not later than 180 days after the date of its enactment to identify the circumstances under which the identifying mark of a manufacturer of an original device is not ``prominent and conspicuous,'' as used in section 502(u) of the act. On October 11, 2005, FDA issued draft guidance describing the circumstances under which the agency would not consider a manufacturer's mark to be prominent and conspicuous. FDA received several comments on the draft guidance, all of which were considered in finalizing the guidance. II. Significance of Guidance This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on ``Compliance With Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended-- Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices.'' It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. III. Electronic Access To receive `` Compliance With Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended--Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices'' by fax, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number (1217) followed by the pound sign (). Follow the remaining voice prompts to complete your request. Persons interested in obtaining a copy of the guidance may also do so by using the Internet. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, [[Page 25595]] Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH web site may be accessed at http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also available on the Division of Dockets Management Internet site at http://www.fda.gov/ohrms/dockets. IV. Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The collection(s) of information in this guidance were approved under OMB control number 0910-0577. V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES), written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Comments received may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: April 24, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-6458 Filed 4-28-06; 8:45 am] BILLING CODE 4160-01-S
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2024-10-08T14:08:34.579833
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6458.htm" }
FR
FR-2006-05-01/E6-6493
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25595-25597] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6493] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 276-1243. Project: Strategic Prevention Framework State Incentive Grant (SPF SIG) Program--New The Substance Abuse and Mental Health Services Administration's (SAMHSA) Center for Substance Abuse Prevention (CSAP) is responsible for the Evaluation of the Strategic Prevention Framework State Incentive Grant (SPF SIG) Program. The program is a major national initiative designed to: (1) Prevent the onset and reduce the progression of substance abuse, including childhood and underage drinking; (2) reduce substance abuse-related problems in communities; and, (3) build prevention capacity and infrastructure at the State/ territory and community levels. Five steps comprise the SPF: [ssbox] Step 1: Profile population needs, resources, and readiness to address needs and gaps. [ssbox] Step 2: Mobilize and/or build capacity to address needs. [ssbox] Step 3: Develop a comprehensive strategic plan. [ssbox] Step 4: Implement evidence-based prevention programs, policies, and practices. [ssbox] Step 5: Monitor, evaluate, sustain, and improve or replace those that fail. Under a contract with CSAP, an evaluation team will implement a multi-method quasi-experimental evaluation at national, State, and community levels. Evaluation data will be collected from 26 states receiving grants in 2004 and 2005 and as many as 32 non-grantee states that will serve as a comparison group. The primary evaluation objective is to determine the impact of SPF SIG on the SAMHSA National Outcome Measures (NOMs). This notice invites comment on state-level and community-level data collection instruments. The instruments for assessing state-level change will be included in an OMB review package submitted immediately after the expiration of the comment period and are the main focus of this announcement. These instruments will be reviewed first by OMB to ensure that state-level data collection occurs as specified in the evaluation plan (on or before June 30, 2006). Because the states have not awarded community-level funding, the evaluators will not initiate community-level data collection until late in 2006. Thus, the community-level survey will be submitted as an addendum approximately one month after the comment period expires. However, the instrument is described in this notice and comments on the instrument are invited. State-Level Data Collection Two instruments were developed for assessing state-level effects. Both instruments are guides for telephone interviews that will be conducted by trained interviewers three to four times over the life of the SPF SIG award. The Strategic Prevention Framework Index will be used to assess the relationship between SPF implementation and change in the national outcome measures. The State Infrastructure Index will capture data to assess infrastructure change and to test the relationship of this change to outcomes. Prevention infrastructure refers to the organizational features of the system that delivers prevention services, including all procedures related to planning, data management systems, workforce development, intervention implementation, evaluation and monitoring, financial management, and sustainability. The estimated annual burden for state-level data collection is displayed below in the table. State Level Burden Estimate [Year 1] -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Number of Hourly burden Total hourly Interview guide Content description respondents responses per response burden -------------------------------------------------------------------------------------------------------------------------------------------------------- SPF Implementation Index....................... SEW activities, indicators for each SPF 26 1 3 78 step, including cultural competence throughout all five steps. [[Page 25596]] State Infrastructure Index..................... Assessment of a state's progress over 26 1 6 156 time toward the implementation of these best practices. --------------------------------------------------------------- Total State Level.......................... ....................................... 26 .............. .............. 234 -------------------------------------------------------------------------------------------------------------------------------------------------------- Community-Level Data Collection The Community Level Index is a two-part, web-based survey for capturing information about SPF SIG implementation at the community level. Part 1 of the survey focuses on the five SPF SIG steps and efforts to ensure cultural competency throughout the SPF SIG process. Part 2 will capture data on the specific intervention(s) implemented at the community level including both individual-focused and environmental prevention strategies. Community partners receiving SPF SIG awards will be required to complete the survey every six months, using a secure password system. The survey data will be analyzed in conjunction with state and community outcome data to determine the relationship, if any, between the SPF process and substance use outcomes. This survey will be submitted as an addendum to the forthcoming OMB package approximately one month after the expiration of the comment period. The estimated annual burden for community-level data collection is displayed below. Note that the total burden assumes an average of 15 community-level sub-grantees per state (a total of 390 respondents) and two survey administrations per year. Note also that some questions will be addressed only once and the responses will be used to pre-fill subsequent surveys. In addition, as community partners work through the SPF steps, they will report only on step-related activities. For example, needs assessment activities will likely precede monitoring and evaluation activities. Thus, respondents will answer questions related to needs assessment in the first few reports but will not need to address monitoring and evaluation items until later in the implementation process. Community Level Burden Estimate ---------------------------------------------------------------------------------------------------------------- Number of Responses per Burden per Community-level instrument section/domain respondents respondent response Total burden ---------------------------------------------------------------------------------------------------------------- Year 1 ---------------------------------------------------------------------------------------------------------------- Part I, 1-11 State Responses.................... 26 1 0.08 2.08 Part I, 12-20 Contact Information and Reporting 390 1 0.08 31.20 Period......................................... Part I, 21-26 Organization Type and Funding..... 390 1 0.08 31.20 Part I, 27-33 Cultural Competence, 390 2 0.17 132.60 Sustainability, and Framework Progress......... Part I, 34-66 Needs and Resources Assessments... 390 2 0.50 390.00 Part I, 67-159 Capacity Building Activities..... 390 2 0.50 390.00 Part I, 160-178 Strategic Plan Development...... 390 2 0.50 390.00 Part I, 198-216 Systems and Contextual Factors 390 2 1.00 780.00 and Closing Questions.......................... Part I, subform 217-231 Coalition Organizational 390 1 0.17 66.30 Information.................................... Part II 1-40; 45 Intervention Specific 390 3 1.00 1,170.00 Information and Adaptations.................... Review of past responses........................ 390 2 0.50 390.00 Preparation and gathering of supporting 390 2 2.00 1,560.00 materials...................................... State Review of Community Responses............. 26 2 1.00 52.00 --------------------------------------------------------------- Total Year 1 Burden--State-level............ 26 .............. .............. 54.08 --------------------------------------------------------------- Total Year 1 Burden--Community-level........ 390 .............. .............. 5,331 ---------------------------------------------------------------------------------------------------------------- Year 2 ---------------------------------------------------------------------------------------------------------------- Part I, 27-33 Cultural Competence, 390 2 0.17 132.60 Sustainability, and Framework Progress......... Part I, 67-15 Capacity Building Activities...... 390 2 0.50 390.00 Part I, 160-178 Strategic Plan Development...... 390 2 0.50 390.00 Part I, 179-184 Intervention Implementation..... 390 2 0.17 132.60 Part I, 198-216 Systems and Contextual Factors 390 2 1.00 780.00 and Closing Questions.......................... Part II 1-40; 45 Intervention Specific 390 3 1.00 1,170.00 Information and Adaptations.................... Part II 41-44 Intervention Outcomes............. 390 6 0.17 397.80 Part II subforms Intervention Component 390 6 1.00 2,340.00 Information.................................... Review of past responses........................ 390 2 0.50 390.00 Preparation and gathering of supporting 390 2 2.00 1,560.00 materials...................................... State Review of Community Responses............. 26 2 1.00 52.00 Total Year 2 Burden--State-level............ 26 .............. .............. 52.00 --------------------------------------------------------------- [[Page 25597]] Total Year 2 Burden--Community-level........ 390 .............. .............. 7,683 ---------------------------------------------------------------------------------------------------------------- Year 3 ---------------------------------------------------------------------------------------------------------------- Part I, 27-33 Cultural Competence, 390 2 0.17 132.60 Sustainability, and Framework Progress......... Part I, 67-159 Capacity Building Activities..... 390 2 0.50 390.00 Part I, 179-184 Intervention Implementation..... 390 2 0.17 132.60 Part I, 185-197 Monitoring and Evaluation....... 390 2 0.33 257.40 Part I, 198-216 Systems and Contextual Factors 390 2 1.00 780.00 and Closing Questions.......................... Part II 1-40; 45 Intervention Specific 390 3 1.00 1,170.00 Information and Adaptations.................... Part II 41-44 Intervention Outcomes............. 390 6 0.17 397.80 Part II subforms Intervention Component 390 6 1.00 2,340.00 Information.................................... Review of past responses........................ 390 2 0.50 390.00 Preparation and gathering of supporting 390 2 2.00 1,560.00 materials...................................... State Review of Community Responses............. 26 2 1.00 52.00 --------------------------------------------------------------- Total Year 3 Burden--State-level............ 26 .............. .............. 52.00 --------------------------------------------------------------- Total Year 3 Burden--Community-level........ 390 .............. .............. 7,550.00 --------------------------------------------------------------- Total Average Annual Burden--Slate-level.... 26 .............. .............. 53.00 --------------------------------------------------------------- Total Average Annual Burden--Community-level 390 .............. .............. 6,855.00 ---------------------------------------------------------------------------------------------------------------- Written comments and recommendations concerning the proposed information collection should be sent by May 31, 2006 to: SAMHSA Desk Officer, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503; due to potential delays in OMB's receipt and processing of mail sent through the U.S. Postal Service, respondents are encouraged to submit comments by fax to: 202-395-6974. Dated: April 24, 2006. Anna Marsh, Director, Office of Program Services. [FR Doc. E6-6493 Filed 4-28-06; 8:45 am] BILLING CODE 4162-20-P
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2024-10-08T14:08:34.598216
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6493.htm" }
FR
FR-2006-05-01/E6-6496
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25597-25598] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6496] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Proposed Collection; Comment Request In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on (240) 276-1243. Comments are invited on: (a) Whether the proposed collections of information are 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. Proposed Project: Opioid Treatment Data Systems for Disaster Planning Project (Pilot)--New The Substance Abuse and Mental Health Services Administration's (SAMHSA), Center for Substance Abuse Treatment (CSAT), has identified a critical need for Opioid Treatment Programs (OTPs, also commonly known as Methadone Clinics) to be able to access limited but specific patient dosage data for patients displaced due to service disruptions affecting the OTP from which they regularly receive treatment (the patient's 'Home OTP'). Service disruptions in home OTPs have ranged in cause from events such as the September 11th terrorist attacks or more recently, Hurricanes Katrina and Rita, to more common events such as snow storms or electrical black-outs. The proposed system will ensure that, in such circumstances, patients displaced from their home OTPs will still be able to obtain safe and effective treatment at an alternative OTP (referred to in this project as a 'Guest OTP'). In reviewing past events involving OTP service disruptions and their impact on patients, SAMHSA, in tandem with numerous stakeholders, established four basic principles that would guide creation of a deliberately simple, centralized Web-based system to house patient data. Such a system would facilitate guest OTPs in providing safe and effective continuity of treatment for patients temporarily unable to obtain treatment from their Home OTPs due to any form of service disruption. The proposed centralized data system is known as the Opioid Treatment Data Systems for Disaster. Subsequently, in a small sample study of five (5) OTPs, SAMHSA tested a protocol and data collection instrument for use in determining functional requirements for the proposed system. In Fall 2005, SAMHSA provided funding for the current project, to support creation of the necessary infrastructure for a pilot system, to be followed by testing on a regional basis. This pilot project will focus on creating the means by which vital dosage data for OTP patients can be made accessible to guest OTPs called [[Page 25598]] upon to treat patients of other programs in the event of service disruptions, most specifically, in disaster scenarios, so that patients are not forced during such circumstances to forgo or discontinue treatment. Ultimately, the pilot system will be reviewed to determine its effectiveness and ability to support a national implementation, should funding for such a system become available. This notice is being provided for a survey to be distributed to OTPs in the region(s) selected by SAMHSA to gather information regarding their present data collection and reporting capabilities and practices. Technical information from the surveys will be used exclusively for development of the overall system and to help inform selection of sites best suited for participation as pilot sites for testing of the Opioid Treatment Data Systems for Disaster Planning. OTP respondents will have the option of completing an on-line or paper version of the survey. The survey consists of approximately 25 questions predominantly formatted as yes/no responses with one to two words fill in the blank responses. The estimated maximum annual response burden to collect this information is as follows: ------------------------------------------------------------------------ Number of Responses per Burden/response Annual burden facilities (OTPs) facility (hours) (hours) ------------------------------------------------------------------------ 200 1 1.0 200 ------------------------------------------------------------------------ Send comments to Summer King, SAMHSA Reports Clearance Officer, Room 7-1044, One Choke Cherry Road, Rockville, MD 20857. Written comments should be received within 60 days of this notice. Dated: April 25, 2006. Anna Marsh, Director, Office of Program Services. [FR Doc. E6-6496 Filed 4-28-06; 8:45 am] BILLING CODE 4162-20-P
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2024-10-08T14:08:34.617979
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6496.htm" }
FR
FR-2006-05-01/E6-6459
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25598-25599] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6459] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HOMELAND SECURITY Coast Guard [CGD08-06-012] Implementation of Sector Upper Mississippi River AGENCY: Coast Guard, DHS. ACTION: Notice of organizational change. ----------------------------------------------------------------------- SUMMARY: The Coast Guard announces the stand-up of Sector Upper Mississippi River. Sector Upper Mississippi River is an internal reorganization that combines Group Upper Mississippi River and Marine Safety Office St. Louis into a single command. The Coast Guard has established a continuity of operations order whereby all previous practices and procedures will remain in effect until superseded by an authorized Coast Guard official or document. DATES: This notice is effective April 27, 2006. ADDRESSES: Documents indicated in this preamble as being available in the docket are part of docket CGD08-06-012 and are available for inspection or copying at Commander (dmpl), Eighth Coast Guard District, 500 Poydras Street, New Orleans, Louisiana 70130-3310 between 7:30 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays. FOR FURTHER INFORMATION CONTACT: Lieutenant Michael Roschel, Eighth District Planning Office at 504-589-6293. SUPPLEMENTARY INFORMATION: Discussion of Notice The single command center for Sector Upper Mississippi River is located at 1222 Spruce Street, Ste. 8.104E, St. Louis, MO 63103-2825. Sector Upper Mississippi River is composed of a Response Department, Prevention Department, and Logistics Department. Effective April 27, 2006, all existing missions and functions performed by Group Upper Mississippi River and Marine Safety Office St. Louis will be performed by Sector Upper Mississippi River. Group Upper Mississippi River and Marine Safety Office St. Louis will no longer exist as organizational entities. Sector Upper Mississippi River will be responsible for all Coast Guard Missions in the Sector Upper Mississippi River Marine Inspection zone and Captain of the Port zone. This area of responsibility includes all of Wyoming except for Sweetwater County; Colorado; North Dakota; South Dakota; Kansas; Nebraska; Iowa; all of Missouri with the exception of Perry, Cape Girardeau, Scott, Mississippi, New Madrid, Dunklin, and Pemiscot Counties; that part of Minnesota south of latitude 46[deg]20' N; that part of Wisconsin south of latitude 46[deg]20' N, and west of longitude 90[deg]00' W; that part of Illinois west of longitude 90[deg]00' W and north of latitude 41[deg]00' N; and that part of Illinois south of latitude 41[deg]00' N, except for Jackson, Williamson, Saline, Gellatin, Union, Johnson, Pope, Hardin, Alexander, Pulaski, and Massac Counties; that part of the Upper Mississippi River above mile 109.9, including both banks, and that part of the Illinois River below latitude 41[deg]00' N. The boundary changes associated with the implementation of Sector Upper Mississippi River will not affect any of the rights, responsibilities, duties, and authorities of the commanders over the units described in this notice and all previous practices and procedures will remain in effect. The Sector Upper Mississippi River Commander is vested with all the rights, responsibilities, duties, and authority of a Group Commander and Commanding Officer Marine Safety Office, as provided for in Coast Guard regulations, and is the successor in command to the Commanding Officers of Group Upper Mississippi River and Marine Safety Office St. Louis. The Sector Upper Mississippi River Commander is designated: (a) Captain of the Port (COTP) for the Upper Mississippi River COTP zone; (b) Federal Maritime Security Coordinator (FMSC); (c) Federal On Scene Coordinator (FOSC) for the Upper Mississippi River COTP zone, consistent with the National Contingency Plan; (d) Officer in Charge of Marine Inspection (OCMI) for the Upper Mississippi River Marine Inspection Zone; and (e) Search and Rescue Mission Coordinator (SMC). The Deputy Sector Commander is designated alternate COTP, FMSC, FOSC, SMC, and Acting OCMI. A continuity of operations order has been issued ensuring that all previous Group Upper Mississippi River and Marine Safety Office St. Louis practices and procedures remain in effect until superseded by Commander, Sector Upper Mississippi River. This continuity of operations order addresses existing COTP regulations, orders, directives, and policies. Following is a list of updated command titles, addresses and points of contact to facilitate requests from the public and assist with entry into security or safety zones: Name: Sector Upper Mississippi River. [[Page 25599]] Address: Commander, U.S. Coast Guard Sector Upper Mississippi River, 1222 Spruce Street, Ste. 8.104E, St. Louis, MO 63103-2825. Contact: General Number, (314) 269-2500, Sector Commander: Captain Suzanne Englebert; Deputy Sector Commander: Lieutenant Commander Frank Kulhawick. Chief, Prevention Department: (314) 269-2560, Chief, Response Department: (314) 269-2540, Chief, Logistics Department: (314) 269- 2510. Dated: April 19, 2006. R.F. Duncan, Rear Admiral, U.S. Coast Guard Commander, Eight Coast Guard District. [FR Doc. E6-6459 Filed 4-28-06; 8:45 am] BILLING CODE 4910-15-P
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2024-10-08T14:08:34.629320
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6459.htm" }
FR
FR-2006-05-01/E6-6467
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25599] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6467] ----------------------------------------------------------------------- DEPARTMENT OF HOMELAND SECURITY Bureau of Customs and Border Protection Proposed Collection; Comment Request Deferral of Duty on Large Yachts Imported for Sale AGENCY: Customs and Border Protection (CBP), Department of Homeland Security. ACTION: Notice and request for comments. ----------------------------------------------------------------------- SUMMARY: As part of its continuing effort to reduce paperwork and respondent burden, CBP invites the general public and other Federal agencies to comment on an information collection requirement concerning the Deferral of Duty on Large Yachts Imported for Sale. This request for comment is being made pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13; 44 U.S.C. 3505(c)(2)). DATES: Written comments should be received on or before June 30, 2006, to be assured of consideration. ADDRESSES: Direct all written comments to Tracey Denning, Bureau of Customs and Border Protection, Information Services Group, Room 3.2.C, 1300 Pennsylvania Avenue, NW., Washington, DC 20229. FOR FURTHER INFORMATION CONTACT: Requests for additional information should be directed to Bureau of Customs and Border Protection, Attn.: Tracey Denning, Room 3.2.C, 1300 Pennsylvania Avenue, NW., Washington, DC 20229, Tel. (202) 344-1429. SUPPLEMENTARY INFORMATION: CBP invites the general public and other Federal agencies to comment on proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13; 44 U.S.C. 3505(c)(2)). The comments should address: (1) Whether the 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 estimates of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden including the use of automated collection techniques or the use of other forms of information technology; and (e) the annual costs burden to respondents or record keepers from the collection of information (a total capital/startup costs and operations and maintenance costs). The comments that are submitted will be summarized and included in the CBP request for Office of Management and Budget (OMB) approval. All comments will become a matter of public record. In this document CBP is soliciting comments concerning the following information collection: Title: Deferral of Duty on Large Yachts Imported for Sale. OMB Number: 1651-0080. Form Number: N/A. Abstract: Section 2406(a) of the Miscellaneous Trade and Technical Corrections Act of 1999 provides that an otherwise dutiable ``large yacht'' may be imported without the payment of duty if the yacht is imported with the intention to offer for sale at a boat show in the U.S. Current Actions: There are no changes to the information collection. This submission is being submitted to extend the expiration date. Type of Review: Extension (without change). Affected Public: Business or other for-profit institutions, and non-profit institutions. Estimated Number of Respondents: 100. Estimated Time Per Respondent: 1 hour. Estimated Total Annual Burden Hours: 100. Estimated Total Annualized Cost on the Public: N/A. Dated: April 24, 2006. Tracey Denning, Agency Clearance Officer, Information Services Branch. [FR Doc. E6-6467 Filed 4-28-06; 8:45 am] BILLING CODE 9111-14-P
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2024-10-08T14:08:34.660594
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6467.htm" }
FR
FR-2006-05-01/E6-6541
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25599-25600] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6541] ----------------------------------------------------------------------- DEPARTMENT OF HOMELAND SECURITY [Docket No. USCBP-2006-0023] Departmental Advisory Committee on Commercial Operations of Customs and Border Protection and Related Functions (COAC) AGENCY: Customs and Border Protection, DHS. ACTION: Notice of meeting. ----------------------------------------------------------------------- SUMMARY: The Departmental Advisory Committee on Commercial Operations of Customs and Border Protection and Related Functions (COAC) will meet in open session. DATES: Tuesday, May 16, 2006, 9 a.m. to 1 p.m. ADDRESSES: The meeting will be held in the Horizon Ballroom of the Ronald Reagan Building, 1300 Pennsylvania Avenue, NW., Washington, DC. If you desire to submit comments, they must be submitted by May 15, 2006. Comments must be identified by USCBP-2006-0023 and may be submitted by one of the following methods: Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. E-mail: [email protected] Include docket number in the subject line of the message. Mail: Ms. Wanda Tate, Office of Trade Relations, Customs and Border Protection, Department of Homeland Security, Washington, DC 20229. Facsimile: 202-344-1969. Instructions: All submissions received must include the words ``Department of Homeland Security'' and the docket number for this action. Comments received will be posted without alteration at www.regulations.gov, including any personal information provided. Docket: For access to the docket to read background documents or comments received by the COAC, go to http://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Ms. Wanda Tate, Office of Trade Relations, Customs and Border Protection, Department of Homeland Security, Washington, DC 20229, telephone 202-344-1440; facsimile 202- 344-1969. SUPPLEMENTARY INFORMATION: The sixth meeting of the ninth term of the Departmental Advisory Committee on Commercial Operations of Customs and Border Protection and Related Functions (COAC) will be held at the date, time and location specified above. This notice also announces the expected agenda for that meeting below. [[Page 25600]] This meeting is open to the public; however, participation in COAC deliberations is limited to COAC members, Homeland Security and Treasury Department officials, and persons invited to attend the meeting for special presentations. Since seating is limited, all persons attending this meeting should provide notice, preferably by close of business Thursday, May 11, 2006, to Ms. Wanda Tate, Office of Trade Relations, Customs and Border Protection, Department of Homeland Security, Washington, DC 20229, telephone 202-344-1440; facsimile 202- 344-1969. For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, contact Ms. Wanda Tate as soon as possible. Draft Agenda 1. Introductory Remarks. 2. Container Security Issues. 3. WCO (World Customs Organization)/Implementation. 4. Update on HSPD-13/NMSAC (Homeland Security Presidential Directive-13 & National Maritime Security Advisory Committee). 5. Update on Security and Prosperity Partnership (SPP). 6. Security Subcommittee: C-TPAT (Customs-Trade Partnership Against Terrorism). 7. Green Lane Task Force. 8. Textiles & Apparel Entry Processing. 9. E-Manifest for Trucks. 10. ACE (Automated Commercial Environment)/ITDS (International Trade Data System). 11. Radiation Portal Monitoring. 12. Staffing: Import Specialists. 13. Pre-Entry Information. 14. New Action Items. 15. Adjourn. Dated: April 26, 2006. Stewart A. Baker, Assistant Secretary, Office of Policy , United States Department of Homeland Security. [FR Doc. E6-6541 Filed 4-28-06; 8:45 am] BILLING CODE 9111-14-P
usgpo
2024-10-08T14:08:34.689438
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6541.htm" }
FR
FR-2006-05-01/E6-6499
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25600-25601] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6499] ----------------------------------------------------------------------- DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Federal Emergency Management Agency, Department of Homeland Security. ACTION: Notice and request for comments. ----------------------------------------------------------------------- SUMMARY: The Federal Emergency Management Agency, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a proposed continuing information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments on the cancellation of Federal assistance loans to any local government. SUPPLEMENTARY INFORMATION: The Community Disaster Loan (CDL) Program is authorized by section 417 of the Disaster Relief Act of 1974 (Pub. L. 93-288), as amended by the Robert T. Stafford Disaster Relief and Emergency Act of 1988 (Pub. L. 100-707), and implemented by FEMA regulation 44 CFR, subpart K. Community Disaster Loans, section 206.366. The CDL Program offers loans to local governments that have suffered a substantial loss of tax or other revenues as a result of a major disaster or emergency and demonstrates a need for Federal financial assistance in order to perform their governmental functions. The loan must be justified on the basis of need and be based on the actual and projected expenses, as a result of the disaster, for the fiscal year in which the disaster occurred and the three succeeding fiscal years. Collection of Information Title: Application for Community Disaster Loan Cancellation. Type of Information Collection: Extension of a currently approved collection. OMB Number: 1660-0082. Form Numbers: FEMA Form 90-5. Abstract: Local governments may submit an Application for Loan Cancellation through the Governor's Authorized Representative to the FEMA Regional Director prior to the expiration date of the loan. FEMA has the authority to cancel repayment of all or part of a Community Disaster Loan to the extent that a determination is made that revenues of the local government during the three fiscal years following the disaster are insufficient to meet the operating budget of that local government because of disaster-related revenue losses and additional unreimbursed disaster-related municipal operating expenses. Operating budget means actual revenues and expenditures of the local government as published in the official financial statements of the local government. Affected Public: State, local or tribal governments. Estimated Total Annual Burden Hours: 1. Number of Respondents: 1. Frequency of Response: On occasion. Hour Burden Per Response: 1 hour. Annual Burden Hours ---------------------------------------------------------------------------------------------------------------- Project/Activity (Survey, Form(s), Focus Group, Worksheet, Number of Frequency of Burden hours Annual Total annual etc.) respondents responses per respondent responses burden hours (A) (B) (C) (A x B) (A x B x C) ---------------------------------------------------------------------------------------------------------------- FF-90-5......................... 1 1 1 1 1 Total....................... 1 1 1 1 1 ---------------------------------------------------------------------------------------------------------------- Estimated Cost: $15.00 per hour times 1 burden hour equals $15.00. Comments: Written comments are solicited to (a) evaluate whether the proposed data collection is necessary for the proper performance of the agency, including whether the information shall have practical utility; (b) evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) enhance the quality, utility, and clarity of the information to be collected; and (d) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Comments must be submitted on or before June 30, 2006. [[Page 25601]] ADDRESSES: Interested persons should submit written comments to Chief, Records Management Section, Information Resources Management Branch, Information Technology Services Division, Federal Emergency Management Agency, 500 C Street, SW., Room 316, Washington, DC 20472. FOR FURTHER INFORMATION CONTACT: Contact Mr. Gerald Connelly, (202) 646-3638 for additional information regarding this information collection. . You may contact the Records Management Branch for copies of the proposed collection of information at facsimile number (202) 646-3347 or e-mail address: [email protected]. Dated: April 7, 2006. Deborah Moradi, Acting Chief, Information Resources Management Branch, Information Technology Services Division. [FR Doc. E6-6499 Filed 4-28-06; 8:45 am] BILLING CODE 9110-11-P
usgpo
2024-10-08T14:08:34.718392
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6499.htm" }
FR
FR-2006-05-01/E6-6500
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25601] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6500] ----------------------------------------------------------------------- DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Federal Emergency Management Agency, Department of Homeland Security. ACTION: Notice and request for comments. ----------------------------------------------------------------------- SUMMARY: The Federal Emergency Management Agency (FEMA) has submitted the following information collection to the Office of Management and Budget (OMB) for review and clearance in accordance with the requirements of the Paperwork Reduction Act of 1995. The submission describes the nature of the information collection, the categories of respondents, the estimated burden (i.e., the time, effort and resources used by respondents to respond) and cost, and includes the actual data collection instruments FEMA will use. Title: Flood Mitigation Assistance--Flood Mitigation Plan. OMB Number: 1660-0075. Form Numbers: None. Abstract: States and communities must have a FEMA approved flood mitigation plan before FEMA will award project grant assistance to a State or community applicant. FEMA and the States will use local community flood mitigation plans to identify the need to provide technical assistance to local governments lacking sufficient resources to complete FEMA grant applications. Secondly, and more importantly, the local or State government that develops the plan will use it to make land use decisions, implement zoning changes, encourage smarter development, and implement projects to reduce the impact of flooding on insurable structures. Affected Public: State, Local or Tribal Government. Number of Respondents: 240. Estimated Time per Respondent: 2080 hours to develop a new Mitigation Plan and 8 hours to review submitted plans. Estimated Total Annual Burden Hours: 250,560. Frequency of Response: Once. Comments: Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs at OMB, Attention: Desk Officer for the Department of Homeland Security/FEMA, Docket Library, Room 10102, 725 17th Street, NW., Washington, DC 20503, or facsimile number (202) 395-7285. Comments must be submitted on or before May 31, 2006. FOR FURTHER INFORMATION CONTACT: Requests for additional information or copies of the information collection should be made to Chief, Records Management, FEMA, 500 C Street, SW., Room 316, Washington, DC 20472, facsimile number (202) 646-3347, or e-mail address [email protected]. Dated: April 11, 2006. Deborah Moradi, Acting Branch Chief, Information Resources Management Branch, Information Technology Services Division. [FR Doc. E6-6500 Filed 4-28-06; 8:45 am] BILLING CODE 9110[dash]13-P
usgpo
2024-10-08T14:08:34.743821
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6500.htm" }
FR
FR-2006-05-01/E6-6471
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25601-25602] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6471] ----------------------------------------------------------------------- DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1636-DR] Arkansas; Major Disaster and Related Determinations AGENCY: Federal Emergency Management Agency, Department of Homeland Security. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This is a notice of the Presidential declaration of a major disaster for the State of Arkansas (FEMA-1636-DR), dated April 12, 2006, and related determinations. DATES: Effective Date: April 12, 2006. FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705. SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter dated April 12, 2006, the President declared a major disaster under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act), as follows: I have determined that the damage in certain areas of the State of Arkansas resulting from severe storms and tornadoes during the period of April 1-3, 2006, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act). Therefore, I declare that such a major disaster exists in the State of Arkansas. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses. You are authorized to provide Individual Assistance and Hazard Mitigation in the designated areas and any other forms of assistance under the Stafford Act you may deem appropriate. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation and Other Needs Assistance will be limited to 75 percent of the total eligible costs. If Public Assistance is later requested and warranted, Federal funds provided under that program will also be limited to 75 percent of the total eligible costs. Further, you are authorized to make changes to this declaration to the extent allowable under the Stafford Act. The time period prescribed for the implementation of section 310(a), Priority to Certain Applications for Public Facility and Public Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed six months after the date of this declaration. The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Acting Director, Department of Homeland Security, under Executive Order 12148, as amended, Carlos Mitchell, of FEMA is appointed to act as the Federal Coordinating Officer for this declared disaster. I do hereby determine the following areas of the State of Arkansas to have been affected adversely by this declared major disaster: Conway, Cross, Fulton, Greene, Lawrence, Randolph, and White Counties for Individual Assistance. [[Page 25602]] Conway, Cross, Fulton, Greene, Lawrence, Randolph, and White Counties within the State of Arkansas are eligible to apply for assistance under the Hazard Mitigation Grant Program. (The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis Counseling; 97.033, Disaster Legal Services Program; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance; 97.048, Individual and Household Housing; 97.049, Individual and Household Disaster Housing Operations; 97.050, Individual and Household Program--Other Needs; 97.036, Public Assistance Grants; 97.039, Hazard Mitigation Grant Program.) R. David Paulison, Acting Director, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. E6-6471 Filed 4-28-06; 8:45 am] BILLING CODE 9110-10-P
usgpo
2024-10-08T14:08:34.772418
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6471.htm" }
FR
FR-2006-05-01/E6-6474
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25602] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6474] ----------------------------------------------------------------------- DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1633-DR] Illinois; Amendment No. 2 to Notice of a Major Disaster Declaration AGENCY: Federal Emergency Management Agency, Department of Homeland Security. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice amends the notice of a major disaster declaration for the State of Illinois (FEMA-1633-DR), dated March 28, 2006, and related determinations. DATES: Effective Date: April 13, 2006. FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705. SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration for the State of Illinois is hereby amended to include the following area among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of March 28, 2006: Randolph County for Public Assistance. (The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis Counseling; 97.033, Disaster Legal Services Program; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance; 97.048, Individuals and Households Housing; 97.049, Individuals and Households Disaster Housing Operations; 97.050 Individuals and Households Program--Other Needs; 97.036, Public Assistance Grants; 97.039, Hazard Mitigation Grant Program.) R. David Paulison, Acting Director, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. E6-6474 Filed 4-28-06; 8:45 am] BILLING CODE 9110-10-P
usgpo
2024-10-08T14:08:34.807601
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6474.htm" }
FR
FR-2006-05-01/E6-6468
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25602] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6468] ----------------------------------------------------------------------- DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1638-DR] Kansas; Major Disaster and Related Determinations AGENCY: Federal Emergency Management Agency, Department of Homeland Security. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This is a notice of the Presidential declaration of a major disaster for the State of Kansas (FEMA-1638-DR), dated April 13, 2006, and related determinations. DATES: Effective Date: April 13, 2006. FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705. SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter dated April 13, 2006, the President declared a major disaster under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act), as follows: I have determined that the damage in certain areas of the State of Kansas resulting from severe storms, tornadoes, and straight line winds during the period of March 12-13, 2006, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act). Therefore, I declare that such a major disaster exists in the State of Kansas. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses. You are authorized to provide Public Assistance in the designated areas, Hazard Mitigation throughout the State, and any other forms of assistance under the Stafford Act you may deem appropriate. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Public Assistance and Hazard Mitigation will be limited to 75 percent of the total eligible costs. If Other Needs Assistance under section 408 of the Stafford Act is later requested and warranted, Federal funding under that program will also be limited to 75 percent of the total eligible costs. Further, you are authorized to make changes to this declaration to the extent allowable under the Stafford Act. The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Acting Director, under Executive Order 12148, as amended, Thomas J. Costello, of FEMA is appointed to act as the Federal Coordinating Officer for this declared disaster. I do hereby determine the following areas of the State of Kansas to have been affected adversely by this declared major disaster: Douglas and Wyandotte Counties for Public Assistance. All counties within the State of Kansas are eligible to apply for assistance under the Hazard Mitigation Grant Program. (The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis Counseling; 97.033, Disaster Legal Services Program; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance; 97.048, Individuals and Households Housing; 97.049, Individuals and Households Disaster Housing Operations; 97.050, Individuals and Households Program--Other Needs; 97.036, Public Assistance Grants; 97.039, Hazard Mitigation Grant Program.) R. David Paulison, Acting Director, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. E6-6468 Filed 4-28-06; 8:45 am] BILLING CODE 9110-10-P
usgpo
2024-10-08T14:08:34.824250
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6468.htm" }
FR
FR-2006-05-01/E6-6465
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25602-25603] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6465] ----------------------------------------------------------------------- DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1635-DR] Missouri; Amendment No. 1 to Notice of a Major Disaster Declaration AGENCY: Federal Emergency Management Agency, Department of Homeland Security. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice amends the notice of a major disaster declaration for the State of Missouri (FEMA-1635-DR), dated April 5, 2006, and related determinations. DATES: Effective Date: April 17, 2006. [[Page 25603]] FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705. SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration for the State of Missouri is hereby amended to include the following areas among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of April 5, 2006: Butler, Dunklin, St. Francois, and Stoddard Counties for Individual Assistance. Andrew and Pettis Counties for Individual Assistance (already designated for debris removal and emergency protective measures [Categories A and B] under the Public Assistance program.) Pemiscot County for Public Assistance [Categories C-G] (already designated for debris removal and emergency protective measures [Categories A and B] under the Public Assistance program.) (The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis Counseling; 97.033, Disaster Legal Services Program; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance; 97.048, Individuals and Households Housing; 97.049, Individuals and Households Disaster Housing Operations; 97.050 Individuals and Households Program--Other Needs; 97.036, Public Assistance Grants; 97.039, Hazard Mitigation Grant Program.) R. David Paulison, Acting Director, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. E6-6465 Filed 4-28-06; 8:45 am] BILLING CODE 9110-10-P
usgpo
2024-10-08T14:08:34.833908
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6465.htm" }
FR
FR-2006-05-01/E6-6473
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25603] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6473] ----------------------------------------------------------------------- DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1631-DR] Missouri; Amendment No. 3 to Notice of a Major Disaster Declaration AGENCY: Federal Emergency Management Agency, Department of Homeland Security. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice amends the notice of a major disaster declaration for the State of Missouri (FEMA-1631-DR), dated March 16, 2006, and related determinations. DATES: Effective Date: April 12, 2006. FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705. SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration for the State of Missouri is hereby amended to include the following areas among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of March 16, 2006: Bollinger, Daviess, and Ray Counties for Public Assistance. Benton, Boone, Carroll, Cedar, Greene, Henry, Hickory, Iron, Morgan, Perry, Pettis, Putnam, Randolph, Saline, St. Clair, Webster, and Wright Counties for Public Assistance (already designated for Individual Assistance.) Bates, Christian, Howard, Monroe, and Montgomery Counties for Public Assistance [Categories C-G] (already designated for Individual Assistance and debris removal and emergency protective measures [Categories A and B] under the Public Assistance program). Washington County for Public Assistance [Categories C-G] (already designated for debris removal and emergency protective measures [Categories A and B] under the Public Assistance program). (The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis Counseling; 97.033, Disaster Legal Services Program; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance; 97.048, Individuals and Households Housing; 97.049, Individuals and Households Disaster Housing Operations; 97.050, Individuals and Households Program--Other Needs; 97.036, Public Assistance Grants; 97.039, Hazard Mitigation Grant Program.) R. David Paulison, Acting Director, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. E6-6473 Filed 4-28-06; 8:45 am] BILLING CODE 9110-10-P
usgpo
2024-10-08T14:08:34.860604
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6473.htm" }
FR
FR-2006-05-01/E6-6466
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25603-25604] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6466] ----------------------------------------------------------------------- DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1637-DR] Oklahoma; Major Disaster and Related Determinations AGENCY: Federal Emergency Management Agency, Department of Homeland Security. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This is a notice of the Presidential declaration of a major disaster for the State of Oklahoma (FEMA-1637-DR), dated April 13, 2006, and related determinations. DATES: Effective Date: April 13, 2006. FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705. SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter dated April 13, 2006, the President declared a major disaster under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act), as follows: I have determined that the damage in certain areas of the State of Oklahoma resulting from severe storms and tornadoes on March 12, 2006, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act). Therefore, I declare that such a major disaster exists in the State of Oklahoma. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses. You are authorized to provide Individual Assistance and Hazard Mitigation in the designated areas and any other forms of assistance under the Stafford Act you may deem appropriate. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation and Other Needs Assistance will be limited to 75 percent of the total eligible costs. If Public Assistance is later requested and warranted, Federal funds provided under that program will also be limited to 75 percent of the total eligible costs. Further, you are authorized to make changes to this declaration to the extent allowable under the Stafford Act. The time period prescribed for the implementation of section 310(a), Priority to Certain Applications for Public Facility and Public Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed six months after the date of this declaration. The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Acting Director, under Executive Order 12148, as amended, Philip Parr, of FEMA is appointed to act as the Federal Coordinating Officer for this declared disaster. I do hereby determine the following areas of the State of Oklahoma to have been affected adversely by this declared major disaster: Delaware County for Individual Assistance. Delaware County within the State of Oklahoma is eligible to apply for assistance under the Hazard Mitigation Grant Program. [[Page 25604]] (The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis Counseling; 97.033, Disaster Legal Services Program; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance; 97.048, Individuals and Households Housing; 97.049, Individuals and Households Disaster Housing Operations; 97.050, Individuals and Households Program--Other Needs; 97.036, Public Assistance Grants; 97.039, Hazard Mitigation Grant Program.) R. David Paulison, Acting Director, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. E6-6466 Filed 4-28-06; 8:45 am] BILLING CODE 9110-10-P
usgpo
2024-10-08T14:08:34.898615
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6466.htm" }
FR
FR-2006-05-01/E6-6469
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25604] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6469] ----------------------------------------------------------------------- DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1634-DR] Tennessee; Amendment No. 3 to Notice of a Major Disaster Declaration AGENCY: Federal Emergency Management Agency, Department of Homeland Security. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice amends the notice of a major disaster declaration for the State of Tennessee (FEMA-1634-DR), dated April 5, 2006, and related determinations. DATES: Effective Date: April 17, 2006. FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705. SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration for the State of Tennessee is hereby amended to include the following areas among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of April 5, 2006: Benton, Cannon, Carroll, Cheatham, Cumberland, Davidson, Dickson, Maury, Sumner, Warren, and Weakley Counties for Individual Assistance. Fayette County for Individual Assistance (already designated for Public Assistance.) Haywood County for Individual Assistance and Public Assistance. (The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis Counseling; 97.033, Disaster Legal Services Program; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance; 97.048, Individuals and Households Housing; 97.049, Individuals and Households Disaster Housing Operations; 97.050, Individuals and Households Program--Other Needs; 97.036, Public Assistance Grants; 97.039, Hazard Mitigation Grant Program.) R. David Paulison, Acting Director, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. E6-6469 Filed 4-28-06; 8:45 am] BILLING CODE 9110-10-P
usgpo
2024-10-08T14:08:34.916548
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6469.htm" }
FR
FR-2006-05-01/E6-6470
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25604] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6470] ----------------------------------------------------------------------- DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1634-DR] Tennessee; Amendment No. 2 to Notice of a Major Disaster Declaration AGENCY: Federal Emergency Management Agency, Department of Homeland Security. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice amends the notice of a major disaster declaration for the State of Tennessee (FEMA-1634-DR), dated April 5, 2006, and related determinations. DATES: Effective Date: April 12, 2006. FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705. SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration for the State of Tennessee is hereby amended to include the Public Assistance Program and the Hazard Mitigation Grant Program for the following areas among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of April 5, 2006: Fayette County for Public Assistance. Dyer and Gibson Counties for Public Assistance (already designated for Individual Assistance). All counties in the State of Tennessee are eligible to apply for assistance under the Hazard Mitigation Grant Program. (The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis Counseling; 97.033, Disaster Legal Services Program; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance; 97.048, Individuals and Households Housing; 97.049, Individuals and Households Disaster Housing Operations; 97.050, Individuals and Households Program--Other Needs; 97.036, Public Assistance Grants; 97.039, Hazard Mitigation Grant Program.) R. David Paulison, Acting Director, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. E6-6470 Filed 4-28-06; 8:45 am] BILLING CODE 9110-10-P
usgpo
2024-10-08T14:08:34.933969
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6470.htm" }
FR
FR-2006-05-01/E6-6472
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25604-25605] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6472] ----------------------------------------------------------------------- DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [FEMA-1624-DR] Texas; Amendment No. 4 to Notice of a Major Disaster Declaration AGENCY: Federal Emergency Management Agency, Department of Homeland Security. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice amends the notice of a major disaster declaration for the State of Texas (FEMA-1624-DR), dated January 11, 2006, and related determinations. DATES: Effective Date: April 17, 2006. FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Recovery Division, Federal Emergency Management Agency, Washington, DC 20472, (202) 646-2705. SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration for the State of Texas is hereby amended to include the following area among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of January 11, 2006: Potter County for Individual Assistance (already designated for Public Assistance Category B (emergency protective measures), subject to subsequent designation by FEMA for reimbursement.) (The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund Program; 97.032, Crisis Counseling; 97.033, Disaster Legal Services Program; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance; 97.048, Individuals and Households Housing; 97.049, Individuals and Households Disaster Housing Operations; 97.050, Individuals and Households Program--Other Needs; 97.036, Public [[Page 25605]] Assistance Grants; 97.039, Hazard Mitigation Grant Program.) R. David Paulison, Acting Director, Federal Emergency Management Agency, Department of Homeland Security. [FR Doc. E6-6472 Filed 4-28-06; 8:45 am] BILLING CODE 9110-10-P
usgpo
2024-10-08T14:08:34.962474
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6472.htm" }
FR
FR-2006-05-01/E6-6495
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25605] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6495] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF THE INTERIOR Bureau of Land Management [AK-964-1410-KC-P; AA-12581] Alaska Native Claims Selection AGENCY: Bureau of Land Management, Interior. ACTION: Notice of decision approving lands for conveyance. ----------------------------------------------------------------------- SUMMARY: As required by 43 CFR 2650.7(d), notice is hereby given that an appealable decision approving lands for conveyance pursuant to the Alaska Native Claims Settlement Act will be issued to Chugach Alaska Corporation for lands located in the vicinity of the Prince William Sound, Alaska. Notice of the decision will also be published four times in the Anchorage Daily News. DATES: The time limits for filing an appeal are: 1. Any party claiming a property interest which is adversely affected by the decision shall have until May 31, 2006 to file an appeal. 2. Parties receiving service of the decision by certified mail shall have 30 days from the date of receipt to file an appeal. Parties who do not file an appeal in accordance with the requirements of 43 CFR part 4, subpart E, shall be deemed to have waived their rights. ADDRESSES: A copy of the decision may be obtained from: Bureau of Land Management, Alaska State Office, 222 West Seventh Avenue, 13, Anchorage, Alaska 99513-7599. FOR FURTHER INFORMATION CONTACT: The Bureau of Land Management by phone at 907-271-5960, or by e-mail at [email protected]. Persons who use a telecommunication device (TTD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8330, 24 hours a day, seven days a week, to contact the Bureau of Land Management. Dina L. Torres, Land Law Examiner, Branch of Adjudication II (964). [FR Doc. E6-6495 Filed 4-28-06; 8:45 am] BILLING CODE 4310-$$-P
usgpo
2024-10-08T14:08:34.981300
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6495.htm" }
FR
FR-2006-05-01/E6-6494
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25605] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6494] ----------------------------------------------------------------------- DEPARTMENT OF THE INTERIOR Bureau of Land Management [AK-964-1410-KC-P; AA-6706-A, AA-6706-E, AA-6706-F, and AA-6706-A2] Alaska Native Claims Selection AGENCY: Bureau of Land Management, Interior. ACTION: Notice of decision approving lands for conveyance. ----------------------------------------------------------------------- SUMMARY: As required by 43 CFR 2650.7(d), notice is hereby given that an appealable decision approving lands for conveyance pursuant to the Alaska Native Claims Settlement Act will be issued to Twin Hills Native Corporation, for lands in the vicinity of Twin Hills, Alaska, and located in: Seward Meridian, Alaska T. 12 S., R. 64 W., Secs. 8, 9, and 16; Secs. 17, 20, and 21. Containing 2,624.18 acres. T. 14 S., R. 65 W., Secs. 4, 5, and 8; Secs. 9, 16, and 17; Secs. 20, 21, and 28; Sec. 29. Containing approximately 5,518 acres. T. 13 S., R. 66 W., Sec. 6. Containing approximately 160 acres. Total aggregating approximately 8,302 acres. Notice of the decision will also be published four times in the Anchorage Daily News. DATES: The time limits for filing an appeal are: 1. Any party claiming a property interest which is adversely affected by the decision shall have until May 31, 2006 to file an appeal. 2. Parties receiving service of the decision by certified mail shall have 30 days from the date of receipt to file an appeal. Parties who do not file an appeal in accordance with the requirements of 43 CFR part 4, Subpart E, shall be deemed to have waived their rights. ADDRESSES: A copy of the decision may be obtained from: Bureau of Land Management, Alaska State Office, 222 West Seventh Avenue, 13, Anchorage, Alaska 99513-7599. FOR FURTHER INFORMATION CONTACT: The Bureau of Land Management by phone at 907-271-5960, or by e-mail at [email protected]. Persons who use a telecommunication device (TTD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8330, 24 hours a day, seven days a week, to contact the Bureau of Land Management. Eileen Ford, Land Law Examiner, Branch of Adjudication II. [FR Doc. E6-6494 Filed 4-28-06; 8:45 am] BILLING CODE 4310-$$-P
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2024-10-08T14:08:35.008399
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6494.htm" }
FR
FR-2006-05-01/E6-6491
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25605-25606] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6491] ----------------------------------------------------------------------- DEPARTMENT OF THE INTERIOR Bureau of Land Management [CO-921-06-1320-EL; COC 69631] Notice of Invitation for Coal Exploration License Application, CAM-Colorado LLC. COC 69631; Colorado AGENCY: Bureau of Land Management, Interior. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: Pursuant to the Mineral Leasing Act of February 25, 1920, as amended, and to Title 43, Code of Federal Regulations, Subpart 3410, members of the public are hereby invited to participate with CAM- Colorado, LLC, in a program for the exploration of unleased coal deposits owned by the United States of America containing approximately 13,646.04 acres in Garfield and Mesa Counties, Colorado. DATES: Written Notice of Intent to Participate should be addressed to the attention of the following persons and must be received by them by May 31, 2006. ADDRESSES: Karen Zurek, CO-921, Solid Minerals Staff, Division of Energy, Lands and Minerals, Colorado State Office, Bureau of Land Management, 2850 Youngfield Street, Lakewood, Colorado 80215; and, CAM- Colorado LLC, P.O. Box 98, Loma, Colorado 81524. FOR FURTHER INFORMATION, CONTACT: Karen Zurek at (303) 239-3795. SUPPLEMENTARY INFORMATION: The application for coal exploration license is available for public inspection during normal business hours under serial number COC 69631 at the Bureau of Land Management, Colorado State Office, 2850 Youngfield Street, Lakewood, Colorado 80215, and at the Grand Junction Field Office, 2815 H Road, Grand Junction, Colorado 81506. Any party electing to participate in this program must share all costs on a pro rata basis with CAM-Colorado LLC, and [[Page 25606]] with any other party or parties who elect to participate. Karen Zurek, Solid Minerals Staff, Division of Energy, Lands and Minerals. [FR Doc. E6-6491 Filed 4-28-06; 8:45 am] BILLING CODE 4310-JB-P
usgpo
2024-10-08T14:08:35.020203
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6491.htm" }
FR
FR-2006-05-01/E6-6490
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25606] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6490] ----------------------------------------------------------------------- DEPARTMENT OF THE INTERIOR Bureau of Land Management [MT-921-06-1320-EL-P; MTM 95451] Notice of Invitation--Coal Exploration License Application MTM 95451 AGENCY: Bureau of Land Management, Interior. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: Members of the public are hereby invited to participate with Western Energy Company in a program for the exploration of coal deposits owned by the United States of America in lands located in Treasure and Rosebud Counties, Montana, encompassing 548.17 acres. FOR FURTHER INFORMATION CONTACT: Robert Giovanini, Mining Engineer, or Connie Schaff, Land Law Examiner, Branch of Solid Minerals (MT-921), Bureau of Land Management (BLM), Montana State Office, Billings, Montana 59101-4669, telephone (406) 896-5084 or (406) 896-5060, respectively. SUPPLEMENTARY INFORMATION: The lands to be explored for coal deposits are described as follows: T. 2 N., R. 38 E., P.M.M. Sec. 14: E\1/2\. T. 1 N., R. 39 E., P.M.M. Sec. 4: Lots 1, 2, 4. T. 2 N., R. 39 E., P.M.M. Sec. 34: W\1/2\SW\1/4\ Any party electing to participate in this exploration program shall notify, in writing, both the State Director, BLM, 5001 Southgate Drive, Billings, Montana 59101-4669, and Western Energy Company, P.O. Box 99, Colstrip, Montana 59323. Such written notice must refer to serial number MTM 95451 and be received no later than 30 calendar days after publication of this Notice in the Federal Register or 10 calendar days after the last publication of this Notice in the Independent Press newspaper, whichever is later. This Notice will be published once a week for two (2) consecutive weeks in the Independent Press, Forsyth, Montana. The proposed exploration program is fully described, and will be conducted pursuant to an exploration plan to be approved by the Bureau of Land Management. The exploration plan, as submitted by Western Energy Company, is available for public inspection at the BLM, 5001 Southgate Drive, Billings, Montana, during regular business hours (9 a.m. to 4 p.m.), Monday through Friday. Dated: February 16, 2006. Rebecca Spurgin, Acting Chief, Branch of Solid Minerals. [FR Doc. E6-6490 Filed 4-28-06; 8:45 am] BILLING CODE 4310-$$-P
usgpo
2024-10-08T14:08:35.041098
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6490.htm" }
FR
FR-2006-05-01/E6-6485
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25606-25607] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6485] ----------------------------------------------------------------------- DEPARTMENT OF THE INTERIOR National Park Service Notice of Availability of the Record of Decision for the Environmental Impact Statement on the Falls Creek Hydroelectric Project and Land Exchange, Glacier Bay National Park and Preserve, Alaska AGENCY: National Park Service, Interior. ACTION: Notice of Availability of the Record of Decision for the Environmental Impact Statement on the Falls Creek Hydroelectric Project and Land Exchange, Glacier Bay National Park and Preserve, Alaska. ----------------------------------------------------------------------- SUMMARY: The National Park Service (NPS) announces the availability of the Record of Decision (ROD) for the Falls Creek Hydroelectric Project and Land Exchange, Glacier Bay National Park and Preserve, Alaska. This ROD documents the decision by the NPS on behalf of the Secretary of Interior (Secretary) to implement applicable portions of the Glacier Bay National Park Boundary Adjustment Act of 1998 (Pub. L. 105-317) (Act). The Act mandated the Secretary implement specific actions once certain provisions were met. In this ROD the NPS addresses its decision to: Exchange land presently in Glacier Bay National Park (Glacier Bay) to the State of Alaska (state); Add state land to Klondike Gold Rush National Historical Park (Klondike Gold Rush); Designate an island in Blue Mouse Cove and Cenotaph Island in Glacier Bay as wilderness; and Adjust national park and wilderness boundaries as necessary to compensate for the land exchange. By addressing these actions the NPS will fulfill the Department of Interior's responsibility under the Act. This ROD follows the Federal Energy Regulatory Commission's (FERC) October 29, 2004 decision to issue a license to Gustavus Electric Company allowing the construction and operation of the Falls Creek Hydroelectric Project (FERC No. 11659). It also follows the FERC Order Denying Rehearing on March 24, 2005 and FERC's June 17, 2005 denial of a request to reconsider the March 24, 2005 Order. This record of decision does not address any of FERC's responsibility under the Act nor does it address any aspect of the licensing process and decision as discussed in the final environmental impact statement (final EIS) and the FERC Order Issuing License and the subsequent rehearing denials. The NPS has decided to adopt the Preferred Alternative as presented in the final EIS. This will result in conveying approximately 1,034 acres in Glacier Bay to the State of Alaska and in exchange receiving approximately 1,040 acres in Klondike Gold Rush. Included is the designation of 1,069 acres in Glacier Bay as wilderness and deletion of 1040 acres of wilderness in Glacier Bay. The National Park and National Wilderness boundaries will be adjusted. The ROD briefly discusses the Act and background of the hydroelectric project and land exchange, summarizes public involvement during the planning process, states the decision and discusses the basis for it, describes other alternatives considered, specifies the environmentally preferable alternative, identifies measures adopted to minimize potential environmental harm, and provides a non-impairment determination. ADDRESSES: The ROD can be found online at the http://www.nps.gov/glba. Copies of the ROD are available on request from: Bruce Greenwood, National Park Service, Alaska Regional Office, 240 West 5th Avenue, Anchorage, Alaska 99501. Telephone: (907) 644-3503. FOR FURTHER INFORMATION CONTACT: Bruce Greenwood, Project Manager, National Park Service, Alaska Region, 240 West 5th Avenue, Anchorage, Alaska 99501. Telephone: (907) 644-3503. SUPPLEMENTARY INFORMATION: The NPS prepared a final EIS, as required, under the National Environmental Policy Act of 1969 and Council of Environmental Quality regulations (40 Code of Federal Regulations (CFR) Part 1500). A Notice of Intent to prepare an environmental impact statement, published in the Federal Register on July 5, 2002 (67 FR 129), formally initiated the environmental impact statement (EIS) process. A draft EIS was issued on November 7, 2003 (68 FR 216) for a 60-day public comment period, that ended January 6, 2004. A Federal Register notice announcing the availability of the final EIS was [[Page 25607]] published by the U.S. Environmental Protection Agency on July 9, 2004 (69 FR 41476), commencing the required 30-day no-action period. The final EIS describes and analyzes the environmental impacts of four action alternatives and a no-action alternative. The NPS has decided to adopt the Preferred Alternative as presented in the final EIS. This will result in conveyance of 1,034 acres to the state of Alaska. The Preferred Alternative is a slight variation of the final EIS Maximum Boundary Alternative. The Maximum Boundary Alternative included the entire 1,145 acres of Glacier Bay park land identified in the Act as potentially available for exchange and the development of a hydroelectric power project. Because 95 acres in the upper portion of the Falls Creek area was not needed for construction of the hydroelectric power project, the Maximum Boundary Alternative was reduced by this amount. To compensate for the 1,034 acres in Glacier Bay that will be exchanged to the state of Alaska, the state of Alaska will transfer to NPS, approximately 1,040 acres of Chilkoot parcels within Klondike Gold Rush. This land will be administered as part of the historical park. Upon completion of the exchange of land under this Act, the Secretary shall adjust, as necessary, the boundaries of Glacier Bay to exclude the land exchanged to the State of Alaska and at Klondike Gold Rush to include the land acquired from the State of Alaska. In accordance with Section 2(b) of the Boundary Act, to compensate for the 1,034 acres deleted from the National Wilderness Preservation System at Glacier Bay, the unnamed island near Blue Mouse Cove and Cenotaph Island, totaling 1,069 acres, will be designated as wilderness. The wilderness boundaries in the Falls Creek, Blue Mouse Cove, and Cenotaph Island areas will be adjusted accordingly. Dated: March 21, 2006. Marcia Blaszak, Regional Director, Alaska. [FR Doc. E6-6485 Filed 4-28-06; 8:45 am] BILLING CODE 4312-HX-P
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2024-10-08T14:08:35.060947
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6485.htm" }
FR
FR-2006-05-01/06-4047
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25607] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 06-4047] ----------------------------------------------------------------------- DEPARTMENT OF THE INTERIOR National Park Service Notice of Inventory Completion: American Museum of Natural History, New York, NY AGENCY: National Park Service, Interior. ACTION: Notice. ----------------------------------------------------------------------- Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains in the possession of the American Museum of Natural History, New York, NY. The human remains were collected from Morton and Oliver Counties, ND, and Hughes County, SD. This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003 (d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains. The National Park Service is not responsible for the determinations in this notice. A detailed assessment of the human remains was made by American Museum of Natural History professional staff in consultation with representatives of the Three Affiliated Tribes of the Fort Berthold Reservation, North Dakota. Prior to 1877, human remains representing a minimum of one individual were collected from a village site, Fort Lincoln, Morton County, ND, on the Missouri River. The human remains were collected by an unknown person. It is unclear how the museum received the remains. No known individual was identified. No associated funerary objects are present. The individual has been identified as Native American based on museum documentation that describes the remains as ``Hidatsa?'' The human remains have not been dated, but originated from an area occupied during the early postcontact period by the Mandan people, who are now part of the Three Affiliated Tribes of the Fort Berthold Reservation, North Dakota. Given the description of their geographic origin, the human remains may have come from On-a-Slant Village, a Mandan settlement abandoned in 1781. In 1916, human remains representing a minimum of one individual were collected from Old Fort Clark in Oliver County, ND, by Rev. Gilbert L. Wilson. The American Museum of Natural History purchased the human remains from Rev. Wilson in 1917. No known individual was identified. No associated funerary objects are present. The individual has been identified as Native American based on geographic origin. The location of the human remains is consistent with the postcontact territory of the Three Affiliated Tribes of the Fort Berthold Reservation, North Dakota. In 1827, most of the Arikara and some of the Mandan people settled near Fort Clark. An Arikara cemetery is present at Fort Clark. Based on the association of the human remains with historic Fort Clark, the remains are most likely postcontact. In 1939, human remains representing a minimum of six individuals were collected from the Arzberger site, Hughes County, SD, by Columbia University. The American Museum of Natural History acquired the human remains as a gift from Columbia University in 1964. No known individuals were identified. No associated funerary objects are present. The individuals have been identified as Native American based on geographic origin, mortuary practices, and catalog records. The catalog indicates the remains are ``probably Arikara.'' Flexed inhumations on elevated land forms immediately outside villages are consistent with late precontact and postcontact Arikara mortuary practices. Officials of the American Museum of Natural History have determined that, pursuant to 25 U.S.C. 3001 (9-10), the human remains described above represent the physical remains of eight individuals of Native American ancestry. Officials of the American Museum of Natural History also have determined that, pursuant to 25 U.S.C. 3001 (2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and the Three Affiliated Tribes of the Fort Berthold Reservation, North Dakota. Representatives of any other Indian tribe that believes itself to be culturally affiliated with the human remains should contact Nell Murphy, Director of Cultural Resources, American Museum of Natural History, Central Park West at 79th Street, New York, NY 10024-5192, telephone (212) 769-5837, before May 31, 2006. Repatriation of the human remains to the Three Affiliated Tribes of the Fort Berthold Reservation, North Dakota may proceed after that date if no additional claimants come forward. The American Museum of Natural History is responsible for notifying the Three Affiliated Tribes of the Fort Berthold Reservation, North Dakota that this notice has been published. Dated: March 24, 2006. Sherry Hutt, Manager, National NAGPRA Program. [FR Doc. 06-4047 Filed 4-28-06; 8:45 am] BILLING CODE 4312-50-S
usgpo
2024-10-08T14:08:35.089397
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/06-4047.htm" }
FR
FR-2006-05-01/E6-6484
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25608] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6484] [[Page 25608]] ----------------------------------------------------------------------- DEPARTMENT OF THE INTERIOR National Park Service Notice of Inventory Completion: American Museum of Natural History, New York, NY AGENCY: National Park Service, Interior. ACTION: Notice. ----------------------------------------------------------------------- Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains in the possession of the American Museum of Natural History, New York, NY. The human remains were collected from Sioux County, ND. This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003 (d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains. The National Park Service is not responsible for the determinations in this notice. A detailed assessment of the human remains was made by American Museum of Natural History professional staff in consultation with representatives of the Assiniboine and Sioux Tribes of the Fort Peck Indian Reservation, Montana; Cheyenne River Sioux Tribe of the Cheyenne River Reservation, South Dakota; Crow Creek Sioux Tribe of the Crow Creek Reservation, South Dakota; Flandreau Santee Sioux Tribe of South Dakota; Lower Brule Sioux Tribe of the Lower Brule Reservation, South Dakota; Lower Sioux Indian Community in the State of Minnesota; Oglala Sioux Tribe of the Pine Ridge Reservation, South Dakota; Prairie Island Indian Community in the State of Minnesota; Rosebud Sioux Tribe of the Rosebud Indian Reservation, South Dakota; Santee Sioux Nation, Nebraska; Shakopee Mdewakanton Sioux Community of Minnesota; Sisseton- Wahpeton Oyate of the Lake Traverse Reservation, South Dakota; Spirit Lake Tribe, North Dakota; Standing Rock Sioux Tribe of North & South Dakota; Upper Sioux Community, Minnesota; and Yankton Sioux Tribe of South Dakota. In 1885, human remains representing a minimum of one individual were collected from Fort Yates, Standing Rock Indian Reservation, Sioux County, ND, by Mr. DeCost Smith. In 1902, the American Museum of Natural History acquired the human remains as a gift from Mr. Smith. No known individual was identified. No associated funerary objects are present. The individual has been identified as Native American based on museum documentation that describes the human remains as ``Dakota.'' The human remains were collected from the Standing Rock Reservation, which is inhabited by Standing Rock Sioux Indians. Although the lands from which the human remains were collected are currently under the jurisdiction of the U.S. Department of the Interior, Bureau of Indian Affairs, the American Museum of Natural History has control of the human remains since their removal from tribal land predates the permit requirements established by the Antiquities Act of 1906. Officials of the American Museum of Natural History have determined that, pursuant to 25 U.S.C. 3001 (9-10), the human remains described above represent the physical remains of one individual of Native American ancestry. Officials of the American Museum of Natural History also have determined that, pursuant to 25 U.S.C. 3001 (2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and the Standing Rock Sioux Tribe of North & South Dakota. Representatives of any other Indian tribe that believes itself to be culturally affiliated with the human remains should contact Nell Murphy, Director of Cultural Resources, American Museum of Natural History, Central Park West at 79th Street, New York, NY 10024-5192, telephone (212) 769-5837, before May 31, 2006. Repatriation of the human remains to the Standing Rock Sioux Tribe of North & South Dakota may proceed after that date if no additional claimants come forward. The American Museum of Natural History is responsible for notifying the Assiniboine and Sioux Tribes of the Fort Peck Indian Reservation, Montana; Cheyenne River Sioux Tribe of the Cheyenne River Reservation, South Dakota; Crow Creek Sioux Tribe of the Crow Creek Reservation, South Dakota; Flandreau Santee Sioux Tribe of South Dakota; Lower Brule Sioux Tribe of the Lower Brule Reservation, South Dakota; Lower Sioux Indian Community in the State of Minnesota; Oglala Sioux Tribe of the Pine Ridge Reservation, South Dakota; Prairie Island Indian Community in the State of Minnesota; Rosebud Sioux Tribe of the Rosebud Indian Reservation, South Dakota; Santee Sioux Nation, Nebraska; Shakopee Mdewakanton Sioux Community of Minnesota; Sisseton-Wahpeton Oyate of the Lake Traverse Reservation, South Dakota; Spirit Lake Tribe, North Dakota; Standing Rock Sioux Tribe of North & South Dakota; Upper Sioux Community, Minnesota; and Yankton Sioux Tribe of South Dakota that this notice has been published. Dated: March 29, 2006. Sherry Hutt, Manager, National NAGPRA Program. [FR Doc. E6-6484 Filed 4-28-06; 8:45 am] BILLING CODE 4312-50-S
usgpo
2024-10-08T14:08:35.113239
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6484.htm" }
FR
FR-2006-05-01/06-4048
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25608-25609] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 06-4048] ----------------------------------------------------------------------- DEPARTMENT OF THE INTERIOR National Park Service Notice of Inventory Completion: Sheboygan County Historical Museum, Sheboygan, WI AGENCY: National Park Service, Interior. ACTION: Notice. ----------------------------------------------------------------------- Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains in the possession of Sheboygan County Historical Museum, Sheboygan, WI. The human remains were removed from Sheboygan County, WI. This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003 (d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains. The National Park Service is not responsible for the determinations in this notice. A detailed assessment of the human remains was made by Sheboygan County Historical Museum professional staff in consultation with representatives of the Citizen Potawatomi Nation, Oklahoma; Forest County Potawatomi Community, Wisconsin; Hannahville Indian Community, Michigan; Menominee Indian Tribe of Wisconsin; and Prairie Band of Potawatomi Nation, Kansas. In 1938, human remains representing a minimum of one individual were removed from the Sheboygan Marsh in Sheboygan County, WI, during the building of the Sheboygan dam, a Works Progress Administration project. The human remains were kept in private possession until they were donated by Mr. Charles Luksis of Sheboygan, WI, to the Sheboygan County Historical Museum in 1985. It is unknown if Mr. Luksis was the collector. No known individual was identified. No associated funerary objects are present. [[Page 25609]] The human remains are assumed to be of Native American ancestry because of the presence of other Native American sites, including a mound, in the immediate vicinity of the Sheboygan dam where the human remains were most likely recovered. There are no known historic or European burials in the area. The Sheboygan County Historical Museum has determined that the human remains are likely culturally affiliated with the Hannahville Indian Community, Michigan based on judicially established land areas of the Indian Claims Commission 1978. Finally, oral history and historic accounts of the presence of the tribe in the area by the tribal representative, independently verified by the staff of the Sheboygan County Historical Museum and the Sheboygan County Historical Research Center, also support the cultural affiliation to the Hannahville Indian Community, Michigan. On an unknown date, human remains representing a minimum of four individuals were removed from the Kraemer property in the Town of Rhine, Sheboygan County, WI, by an unknown person. The human remains were taken to the Sheboygan County Historical Museum and donated to the collection on February 11, 1936, by Mr. Charles E. Broughton, President of the Sheboygan County Historical Society. No known individuals were identified. No associated funerary objects are present. According to museum records, the human remains were excavated from a mound, which indicates that the human remains are Native American in origin. The Sheboygan County Historical Museum has determined that the human remains are most likely culturally affiliated with the Hannahville Indian Community, Michigan, based on an Indian Claims Commission decision (Land Claims Map ID 15). Furthermore, historic accounts of the presence of the tribe in the area by the tribal representative, independently verified by the staff of the Sheboygan County Historical Museum and the Sheboygan County Historical Research Center, also support the cultural affiliation to the Hannahville Indian Community, Michigan. Officials of the Sheboygan County Historical Museum have determined that, pursuant to 25 U.S.C. 3001 (9-10), the human remains described above represent the physical remains of five individuals of Native American ancestry. Officials of the Sheboygan County Historical Museum also have determined that, pursuant to 25 U.S.C. 3001 (2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and the Hannahville Indian Community, Michigan. Representatives of any other Indian tribe that believes itself to be culturally affiliated with the human remains should contact Casandra Karl, Registrar, Sheboygan County Historical Museum, 3110 Erie Avenue, Sheboygan, WI 53081, telephone (920) 458-1103, before May 31, 2006. Repatriation of the human remains to the Hannahville Indian Community, Michigan may proceed after that date if no additional claimants come forward. The Sheboygan County Historical Museum is responsible for notifying the Citizen Potawatomi Nation, Oklahoma; Forest County Potawatomi Community, Wisconsin; Hannahville Indian Community, Michigan; Menominee Indian Tribe of Wisconsin; and Prairie Band of Potawatomi Nation, Kansas that this notice has been published. Dated: March 22, 2006. Sherry Hutt, Manager, National NAGPRA Program. [FR Doc. 06-4048 Filed 4-28-06; 8:45 am] BILLING CODE 4312-50-S
usgpo
2024-10-08T14:08:35.138080
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/06-4048.htm" }
FR
FR-2006-05-01/E6-6361
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25609-25611] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6361] ======================================================================= ----------------------------------------------------------------------- INTERNATIONAL TRADE COMMISSION [Investigation No. 731-TA-702 (Second Review)] Ferrovanadium and Nitrided Vanadium from Russia AGENCY: International Trade Commission. ACTION: Institution of a five-year review concerning the antidumping duty order on ferrovanadium and nitrided vanadium from Russia. ----------------------------------------------------------------------- SUMMARY: The Commission hereby gives notice that it has instituted a review pursuant to section 751(c) of the Tariff Act of 1930 (19 U.S.C. 1675(c)) (the Act) to determine whether revocation of the antidumping duty order on ferrovanadium and nitrided vanadium from Russia would be likely to lead to continuation or recurrence of material injury. Pursuant to section 751(c)(2) of the Act, interested parties are requested to respond to this notice by submitting the information specified below to the Commission; \1\ to be assured of consideration, the deadline for responses is June 20, 2006. Comments on the adequacy of responses may be filed with the Commission by July 14, 2006. For further information concerning the conduct of this review and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A through E (19 CFR part 201), and part 207, subparts A, D, E, and F (19 CFR part 207). --------------------------------------------------------------------------- \1\ No response to this request for information is required if a currently valid Office of Management and Budget (OMB) number is not displayed; the OMB number is 3117-0016/USITC No. 06-5-152, expiration date June 30, 2008. Public reporting burden for the request is estimated to average 10 hours per response. Please send comments regarding the accuracy of this burden estimate to the Office of Investigations, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436. --------------------------------------------------------------------------- DATES: Effective Date: May 1, 2006. FOR FURTHER INFORMATION CONTACT: Mary Messer (202-205-3193), Office of Investigations, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205- 1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (http://www.usitc.gov). The public record for this review may be viewed on the Commission's electronic docket (EDIS) at http://edis.usitc.gov. SUPPLEMENTARY INFORMATION: Background. On July 10, 1995, the Department of Commerce issued an antidumping duty order on imports of ferrovanadium and nitrided vanadium from Russia (60 FR 35550). Following five-year reviews by Commerce and the Commission, effective June 7, 2001, Commerce issued a continuation of the antidumping duty order on imports of ferrovanadium and nitrided vanadium from Russia (66 FR 30694). The Commission is now conducting a second review to determine whether revocation of the order would be likely to lead to continuation or recurrence of material injury to the domestic industry within a reasonably foreseeable time. It will assess the adequacy of interested party responses to this notice of institution to determine whether to conduct a full review or an expedited review. The Commission's determination in any expedited review will be based on the facts available, which may include information provided in response to this notice. Definitions. The following definitions apply to this review: [[Page 25610]] (1) Subject Merchandise is the class or kind of merchandise that is within the scope of the five-year review, as defined by the Department of Commerce. (2) The Subject Country in this review is Russia. (3) The Domestic Like Product is the domestically produced product or products which are like, or in the absence of like, most similar in characteristics and uses with, the Subject Merchandise. In its original determination, the Commission found one Domestic Like Product including both ferrovanadium and nitrided vanadium. Noting in its full five-year review determination that nitrided vanadium had not been produced in the United States since 1992, the Commission determined that, based on the record, the product most like ferrovanadium and most similar in characteristics and uses to nitrided vanadium that was produced in the United States at that time was ferrovanadium. Accordingly, the Commission found one Domestic Like Product consisting of ferrovanadium. One Commissioner defined the Domestic Like Product differently in the first five-year review determination. (4) The Domestic Industry is the U.S. producers as a whole of the Domestic Like Product, or those producers whose collective output of the Domestic Like Product constitutes a major proportion of the total domestic production of the product. In its original determination, the Commission found one Domestic Industry consisting of ferrovanadium and nitrided vanadium producers, including certain toll-producers. In its full five-year review determination, the Commission found one Domestic Industry consisting of ferrovanadium producers, including a toll- producer of the Domestic Like Product. The Commission, however, did not include tollees Gulf and USV in the Domestic Industry because those firms produced vanadium pentoxide, an intermediate product, not ferrovanadium, the Domestic Like Product. Two Commissioners defined the Domestic Industry differently in the first five-year review determination. (5) An Importer is any person or firm engaged, either directly or through a parent company or subsidiary, in importing the Subject Merchandise into the United States from a foreign manufacturer or through its selling agent. Participation in the review and public service list. Persons, including industrial users of the Subject Merchandise and, if the merchandise is sold at the retail level, representative consumer organizations, wishing to participate in the review as parties must file an entry of appearance with the Secretary to the Commission, as provided in section 201.11(b)(4) of the Commission's rules, no later than 21 days after publication of this notice in the Federal Register. The Secretary will maintain a public service list containing the names and addresses of all persons, or their representatives, who are parties to the review. Former Commission employees who are seeking to appear in Commission five-year reviews are reminded that they are required, pursuant to 19 CFR 201.15, to seek Commission approval if the matter in which they are seeking to appear was pending in any manner or form during their Commission employment. The Commission is seeking guidance as to whether a second transition five-year review is the ``same particular matter'' as the underlying original investigation for purposes of 19 CFR 201.15 and 18 U.S.C. 207, the post employment statute for Federal employees. Former employees may seek informal advice from Commission ethics officials with respect to this and the related issue of whether the employee's participation was ``personal and substantial.'' However, any informal consultation will not relieve former employees of the obligation to seek approval to appear from the Commission under its rule 201.15. For ethics advice, contact Carol McCue Verratti, Deputy Agency Ethics Official, at 202-205-3088. Limited disclosure of business proprietary information (BPI) under an administrative protective order (APO) and APO service list. Pursuant to section 207.7(a) of the Commission's rules, the Secretary will make BPI submitted in this review available to authorized applicants under the APO issued in the review, provided that the application is made no later than 21 days after publication of this notice in the Federal Register. Authorized applicants must represent interested parties, as defined in 19 U.S.C. 1677(9), who are parties to the review. A separate service list will be maintained by the Secretary for those parties authorized to receive BPI under the APO. Certification. Pursuant to section 207.3 of the Commission's rules, any person submitting information to the Commission in connection with this review must certify that the information is accurate and complete to the best of the submitter's knowledge. In making the certification, the submitter will be deemed to consent, unless otherwise specified, for the Commission, its employees, and contract personnel to use the information provided in any other reviews or investigations of the same or comparable products which the Commission conducts under Title VII of the Act, or in internal audits and investigations relating to the programs and operations of the Commission pursuant to 5 U.S.C. Appendix 3. Written submissions. Pursuant to section 207.61 of the Commission's rules, each interested party response to this notice must provide the information specified below. The deadline for filing such responses is June 20, 2006. Pursuant to section 207.62(b) of the Commission's rules, eligible parties (as specified in Commission rule 207.62(b)(1)) may also file comments concerning the adequacy of responses to the notice of institution and whether the Commission should conduct an expedited or full review. The deadline for filing such comments is July 14, 2006. All written submissions must conform with the provisions of sections 201.8 and 207.3 of the Commission's rules and any submissions that contain BPI must also conform with the requirements of sections 201.6 and 207.7 of the Commission's rules. The Commission's rules do not authorize filing of submissions with the Secretary by facsimile or electronic means, except to the extent permitted by section 201.8 of the Commission's rules, as amended, 67 FR 68036 (November 8, 2002). Also, in accordance with sections 201.16(c) and 207.3 of the Commission's rules, each document filed by a party to the review must be served on all other parties to the review (as identified by either the public or APO service list as appropriate), and a certificate of service must accompany the document (if you are not a party to the review you do not need to serve your response). Inability to provide requested information. Pursuant to section 207.61(c) of the Commission's rules, any interested party that cannot furnish the information requested by this notice in the requested form and manner shall notify the Commission at the earliest possible time, provide a full explanation of why it cannot provide the requested information, and indicate alternative forms in which it can provide equivalent information. If an interested party does not provide this notification (or the Commission finds the explanation provided in the notification inadequate) and fails to provide a complete response to this notice, the Commission may take an adverse inference against the party pursuant to section 776(b) of the Act in making its determination in the review. Information to Be Provided in Response to this Notice of Institution: [[Page 25611]] As used below, the term ``firm'' includes any related firms. (1) The name and address of your firm or entity (including World Wide Web address if available) and name, telephone number, fax number, and E-mail address of the certifying official. (2) A statement indicating whether your firm/entity is a U.S. producer of the Domestic Like Product, a U.S. union or worker group, a U.S. importer of the Subject Merchandise, a foreign producer or exporter of the Subject Merchandise, a U.S. or foreign trade or business association, or another interested party (including an explanation). If you are a union/worker group or trade/business association, identify the firms in which your workers are employed or which are members of your association. (3) A statement indicating whether your firm/entity is willing to participate in this review by providing information requested by the Commission. (4) A statement of the likely effects of the revocation of the antidumping duty order on the Domestic Industry in general and/or your firm/entity specifically. In your response, please discuss the various factors specified in section 752(a) of the Act (19 U.S.C. 1675a(a)) including the likely volume of subject imports, likely price effects of subject imports, and likely impact of imports of Subject Merchandise on the Domestic Industry. (5) A list of all known and currently operating U.S. producers of the Domestic Like Product. Identify any known related parties and the nature of the relationship as defined in section 771(4)(B) of the Act (19 U.S.C. 1677(4)(B)). (6) A list of all known and currently operating U.S. importers of the Subject Merchandise and producers of the Subject Merchandise in the Subject Country that currently export or have exported Subject Merchandise to the United States or other countries after 2000. (7) If you are a U.S. producer of the Domestic Like Product, provide the following information on your firm's operations on that product during calendar year 2005 (report quantity data in pounds of contained vanadium and value data in U.S. dollars, f.o.b. plant). If you are a union/worker group or trade/business association, provide the information, on an aggregate basis, for the firms in which your workers are employed/which are members of your association. (a) Production (quantity) and, if known, an estimate of the percentage of total U.S. production of the Domestic Like Product accounted for by your firm's(s') production; (b) The quantity and value of U.S. commercial shipments of the Domestic Like Product produced in your U.S. plant(s); and (c) The quantity and value of U.S. internal consumption/company transfers of the Domestic Like Product produced in your U.S. plant(s). (8) If you are a U.S. importer or a trade/business association of U.S. importers of the Subject Merchandise from the Subject Country, provide the following information on your firm's(s') operations on that product during calendar year 2005 (report quantity data in pounds of contained vanadium and value data in U.S. dollars). If you are a trade/ business association, provide the information, on an aggregate basis, for the firms which are members of your association. (a) The quantity and value (landed, duty-paid but not including antidumping duties) of U.S. imports and, if known, an estimate of the percentage of total U.S. imports of Subject Merchandise from the Subject Country accounted for by your firm's(s') imports; (b) The quantity and value (f.o.b. U.S. port, including antidumping duties) of U.S. commercial shipments of Subject Merchandise imported from the Subject Country; and (c) The quantity and value (f.o.b. U.S. port, including antidumping duties) of U.S. internal consumption/company transfers of Subject Merchandise imported from the Subject Country. (9) If you are a producer, an exporter, or a trade/business association of producers or exporters of the Subject Merchandise in the Subject Country, provide the following information on your firm's(s') operations on that product during calendar year 2005 (report quantity data in pounds of contained vanadium and value data in U.S. dollars, landed and duty-paid at the U.S. port but not including antidumping duties). If you are a trade/business association, provide the information, on an aggregate basis, for the firms which are members of your association. (a) Production (quantity) and, if known, an estimate of the percentage of total production of Subject Merchandise in the Subject Country accounted for by your firm's(s') production; and (b) The quantity and value of your firm's(s') exports to the United States of Subject Merchandise and, if known, an estimate of the percentage of total exports to the United States of Subject Merchandise from the Subject Country accounted for by your firm's(s') exports. (10) Identify significant changes, if any, in the supply and demand conditions or business cycle for the Domestic Like Product that have occurred in the United States or in the market for the Subject Merchandise in the Subject Country after 2000, and significant changes, if any, that are likely to occur within a reasonably foreseeable time. Supply conditions to consider include technology; production methods; development efforts; ability to increase production (including the shift of production facilities used for other products and the use, cost, or availability of major inputs into production); and factors related to the ability to shift supply among different national markets (including barriers to importation in foreign markets or changes in market demand abroad). Demand conditions to consider include end uses and applications; the existence and availability of substitute products; and the level of competition among the Domestic Like Product produced in the United States, Subject Merchandise produced in the Subject Country, and such merchandise from other countries. (11) (OPTIONAL) A statement of whether you agree with the above definitions of the Domestic Like Product and Domestic Industry; if you disagree with either or both of these definitions, please explain why and provide alternative definitions. Authority: This review is being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.61 of the Commission's rules. Issued: April 24, 2006. By order of the Commission. Marilyn R. Abbott, Secretary to the Commission. [FR Doc. E6-6361 Filed 4-28-06; 8:45 am] BILLING CODE 7020-02-P
usgpo
2024-10-08T14:08:35.156699
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6361.htm" }
FR
FR-2006-05-01/06-4060
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25611-25612] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 06-4060] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Office of Justice Programs Agency Information Collection Activities; Proposed Collection; Comments Requested ACTION: 30-Day Notice of Information Collection Under Review: Reinstatement, without Change of a previously approved collection for which Approvals has expired. Budget Detail Worksheet. ----------------------------------------------------------------------- The Department of Justice (DOJ), Office of Justice Programs (OJP) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. [[Page 25612]] The proposed collection information is published to obtain comments from the public and affected agencies. This proposed information collection was previously published in the Federal Register Volume 71, Number 24, page 6096 on February 6, 2006, allowing for a 60 day comment period. The purpose of this notice is to allow for an additional 30 days for public comment until May 31, 2006. This process is conducted in accordance with 5 CFR 1320.10. Written comments and/or suggestions regarding the items contained in this notice, especially the estimated public burden and associated response time, should be directed to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20503. Additionally, comments may be submitted to OMB via facsimile to (202) 395-5806. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points: --Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; --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; --Enhance the quality, utility, and clarity of the information to be collected; and --Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of this information collection: (1) Type of Information Collection: Reinstatement, without Change of a previously approved collection for which approval has expired. (2) Title of the Form/Collection: Budget Detail Worksheet (3) Agency form number, if any, and the applicable component of the Department of Justice sponsoring the collection: Forms: Not-applicable (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: All potential grantee partners who are possible recipient of our discretionary grant programs. The eligible recipients include state and local government, Indian tribes, profit entities, non-profit entities, educational institutions, and individuals. The form is not mandatory and is recommended as guide to assist the recipient in preparing the budget narrative as authorized in 28 CFR parts 66 and 70. (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond/reply: It is estimated that 2,500 respondents will complete a 4-hour form. (6) An estimate of the total public burden (in hours) associated with the collection: The estimated total public burden hours associated with this collection is 4,609 hours. If additional information is required contact: Robert B. Briggs, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Patrick Henry Building, Suite 1600, 601 D Street, NW., Washington, DC 20530. Dated: April 24, 2006 Robert B. Briggs, Department Clearance Officer, Department of Justice. [FR Doc. 06-4060 Filed 4-28-06; 8:45am] BILLING CODE 4410-18-M
usgpo
2024-10-08T14:08:35.173046
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/06-4060.htm" }
FR
FR-2006-05-01/E6-6513
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25612] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6513] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF LABOR Office of the Secretary Submission for OMB Review: Comment Request April 19, 2006. The Department of Labor (DOL) has submitted the following public information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35). A copy of this ICR, with applicable supporting documentation, may be obtained by calling the Department of Labor. To obtain documentation contact Ira Mills on 202-693-4122 (this is not a toll-free number) or E-Mail: [email protected]. These documents can also be accessed online at: http://www.doleta.gov/Performance/guidance/OMBControlNumber.cfm. Comments should be sent to Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for ETA, Office of Management and Budget, Room 10235, Washington, DC 20503, 202-395-7316 (this is not a toll free number), within 30 days from the date of this publication in the Federal Register. The OMB is particularly interested in comments which: Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; 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; Enhance the quality, utility and clarity of the information to be collected; and Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Agency: Employment and Training Administration (ETA). Type of Review: Extension of a currently approved collection. Title: Standard Job Corps Request for Proposal and Related Contractor Information Gathering. OMB Number: 1205-0219. Frequency: Annually; quarterly; monthly; and weekly. Affected Public: Business or other for-profit; not-for profit institutions; Federal Government; State, Local, or Tribal gov't. Type of Response: Recordkeeping and reporting. Number of Respondents: 122. Annual Responses: 232,212. Average Response time: 4 hours 11 minutes. Total Annual Burden Hours: 62,525. Total Annualized Capital/Startup Costs: 0. Total Annual Costs (operating/maintaining systems or purchasing services): 0. Description: Standard Request for Proposal for the operation of a Job Corps Center completed by prospective contractors for competitive procurement and Federal paperwork requirements for contract operators of such centers. Ira L. Mills, Departmental Clearance Officer, Team Leader. [FR Doc. E6-6513 Filed 4-28-06; 8:45 am] BILLING CODE 4510-30-P
usgpo
2024-10-08T14:08:35.195611
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6513.htm" }
FR
FR-2006-05-01/E6-6505
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25613] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6505] [[Page 25613]] ======================================================================= ----------------------------------------------------------------------- NUCLEAR REGULATORY COMMISSION [Docket No. 030-34437] Notice of Availability of Environmental Assessment and Finding of No Significant Impact for License Amendment for DGI Biotechnologies, LLC's Facility in Edison, NJ AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Availability. ----------------------------------------------------------------------- FOR FURTHER INFORMATION CONTACT: Joseph Nick, Commercial and R&D Branch, Division of Nuclear Materials Safety, Region I, 475 Allendale Road, King of Prussia, Pennsylvania 19406, telephone (610) 337-5056, fax (610) 337-5269; or by e-mail: [email protected]. SUPPLEMENTARY INFORMATION: I. Introduction The U.S. Nuclear Regulatory Commission (NRC) is considering the issuance of a license amendment to DGI Biotechnologies, LLC (DGI) for Materials License No. 29-30389-01, to authorize release of its facility in Edison, New Jersey for unrestricted use and terminate the license. NRC has prepared an Environmental Assessment (EA) in support of this proposed action in accordance with the requirements of 10 CFR part 51. Based on the EA, the NRC has concluded that a Finding of No Significant Impact (FONSI) is appropriate. The amendment will be issued following the publication of this Notice. II. EA Summary The purpose of the proposed action is to authorize the release of the licensee's Edison, New Jersey facility for unrestricted use and terminate the license. DGI was authorized by NRC from 1997 to use radioactive materials for research and development purposes at the site. In 2003, DGI ceased operations with licensed materials at the Edison site and the DGI facility was taken over by Antyra, Inc. (Antyra). On September 28, 2005, Antyra requested that NRC release the facility for unrestricted use. Antyra has conducted surveys of the facility and provided information to the NRC to demonstrate that the site meets the license termination criteria in subpart E of 10 CFR part 20 for unrestricted release. The NRC staff has prepared an EA in support of the license amendment. The facility was remediated and surveyed prior to the licensee requesting the license amendment. The NRC staff has reviewed the information and final status survey submitted by Antyra. Based on its review, the staff has determined that there are no additional remediation activities necessary to complete the proposed action. Therefore, the staff considered the impact of the residual radioactivity at the facility and concluded that since the residual radioactivity meets the requirements in subpart E of 10 CFR part 20, a Finding of No Significant Impact is appropriate. III. Finding of No Significant Impact The staff has prepared the EA (summarized above) in support of the license amendment to terminate the license and release the facility for unrestricted use. The NRC staff has evaluated Antyra's request and the results of the surveys and has concluded that the completed action complies with the criteria in subpart E of 10 CFR part 20. The staff has found that the radiological environmental impacts from the action are bounded by the impacts evaluated by NUREG-1496, Volumes 1-3, ``Generic Environmental Impact Statement in Support of Rulemaking on Radiological Criteria for License Termination of NRC-Licensed Facilities'' (ML042310492, ML042320379, and ML042330385). Additionally, no non-radiological or cumulative impacts were identified. On the basis of the EA, the NRC has concluded that there are no significant environmental impacts from the proposed action, and has determined not to prepare an environmental impact statement for the proposed action. IV. Further Information Documents related to this action, including the application for the license amendment and supporting documentation, are available electronically at the NRC's Electronic Reading Room at http://www.nrc.gov/reading-rm/adams.html. From this site, you can access the NRC's Agencywide Document Access and Management System (ADAMS), which provides text and image files of NRC's public documents. The ADAMS accession numbers for the documents related to this Notice are: Environmental Assessment Related to Issuance of a License Amendment of U.S. Nuclear Regulatory Commission Materials License No. 29-30389-01, DGI Biotechnologies, LLC in Edison, New Jesey (ML061070474); and Final Status Survey Results for DGI Biotechnologies, LLC Facility, 40 Talmadge Road, Edison, New Jersey (ML052840126). Persons who do not have access to ADAMS or who encounter problems in accessing the documents located in ADAMS, should contact the NRC PDR Reference staff by telephone at (800) 397-4209 or (301) 415-4737, or by e-mail to [email protected]. Documents related to operations conducted under this license not specifically referenced in this Notice may not be electronically available and/or may not be publicly available. Persons who have an interest in reviewing these documents should submit a request to NRC under the Freedom of Information Act (FOIA). Instructions for submitting a FOIA request can be found on the NRC's Web site at http://www.nrc.gov/reading-rm/foia/foia-privacy.html. Dated at King of Prussia, Pennsylvania this 20th day of April, 2006. For the Nuclear Regulatory Commission. James P. Dwyer, Chief, Commercial and R&D Branch, Division of Nuclear Materials Safety, Region I. [FR Doc. E6-6505 Filed 4-28-06; 8:45 am] BILLING CODE 7590-01-P
usgpo
2024-10-08T14:08:35.207836
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6505.htm" }
FR
FR-2006-05-01/06-4070
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25613-25614] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 06-4070] ======================================================================= ----------------------------------------------------------------------- OFFICE OF MANAGEMENT AND BUDGET Executive Office of the President; Acquisition Advisory Panel; Notification of Upcoming Meetings of the Acquisition Advisory Panel AGENCY: Office of Management and Budget, Executive Office of the President. ACTION: Notice of Federal Advisory Committee Meetings. ----------------------------------------------------------------------- SUMMARY: The Office of Management and Budget announces five meetings of the Acquisition Advisory Panel (AAP or ``Panel'') established in accordance with the Services Acquisition Reform Act of 2003. DATES: There are five meetings announced in this Federal Register Notice. Public meetings of the Panel will be held on May 18th, May 31st, June 14th, July 7th and July 21st 2006. All meetings will begin at 9 a.m. Eastern Time and end no later than 5 p.m. ADDRESSES: Except for the July 7th meeting, all public meetings will be held at the Small Business Administration (SBA), 409 Third Street, SW., Washington, DC, 2nd Floor Eisenhower Conference Room (Metro stop at building: Federal Center Southwest, Orange or Blue Lines). The July 7th meeting will be held at the new FDIC Building, 3501 N. Fairfax Drive, Arlington, VA 22226, Room 203. This facility is a quarter of a block off of the Orange Line metro stop for Virginia Square. The public must pre-register [[Page 25614]] one week in advance for all meetings due to security and/or seating limitations (see below for information on pre-registration). FOR FURTHER INFORMATION CONTACT: Members of the public wishing further information concerning these meetings or the Panel itself, or to pre- register for the meetings, should contact Ms. Laura Auletta, Designated Federal Officer (DFO), at: [email protected], phone/voice mail (202) 208-7279, or mail at: General Services Administration, 1800 F. Street, NW., Room 4006, Washington, DC 20405. Members of the public wishing to reserve speaking time must contact Mr. Emile Monette, AAP Staff Analyst, in writing at: [email protected] or by Fax at 202- 501-3341, or mail at the address given above for the DFO. Requests must be received no later than one week prior to the meeting for which speaking time is desired. SUPPLEMENTARY INFORMATION: (a) Background: The purpose of the Panel is to provide independent advice and recommendations to the Office of Federal Procurement Policy and Congress pursuant to Section 1423 of the Services Acquisition Reform Act of 2003. The Panel's statutory charter is to review Federal contracting laws, regulations, and governmentwide policies, including the use of commercial practices, performance-based contracting, performance of acquisition functions across agency lines of responsibility, and governmentwide contracts. Interested parties are invited to attend the meetings. Opportunity for public comments will be provided at the meetings. Any change will be announced in the Federal Register. All Meetings--While the Panel may hear from additional invited speakers, the focus of these meetings will be discussions of and voting on working group findings and recommendations from selected working groups, established at the February 28, 2005 and May 17, 2005 public meetings of the AAP (see http://acquisition.gov/comp/aap/index.html for a list of working groups). The Panel welcomes oral public comments at these meetings and has reserved one-half hour for this purpose at each meeting. Members of the public wishing to address the Panel during the meeting must contact Mr. Monette, in writing, as soon as possible to reserve time (see contact information above). (b) Posting of Draft Reports: Members of the public are encouraged to regularly visit the Panel's web site for draft reports. Currently, the working groups are staggering the posting of various sections of their draft reports at http://acquisition.gov/comp/aap/index.html under the link for ``Working Group Reports.'' The most recent posting is from the Commercial Practices Working Group. The public is encouraged to submit written comments on any and all draft reports. (c) Adopted Recommendations: The Panel has adopted recommendations presented by the Small Business, Interagency Contracting, and Performance-Based Acquisition Working Groups as of the date of this notice. While additional recommendations from some of these working groups are likely and adopted recommendations from other working groups will be posted as recommendations are adopted, the public is encouraged to review and comment on the recommendations adopted by the Panel to date by going to http://acquisition.gov/comp/aap/index.html and selecting the link for ``Panel Recommendations To Date.'' (d) Availability of Meeting Materials: Please see the Panel's Web site for any available materials, including draft agendas and minutes. Questions/issues of particular interest to the Panel are also available to the public on this Web site on its front page, including ``Questions for Government Buying Agencies,'' ``Questions for Contractors that Sell Commercial Goods or Services to the Government,'' ``Questions for Commercial Organizations,'' and an issue raised by one Panel member regarding the rules of interpretation and performance of contracts and liabilities of the parties entitled ``Revised Commercial Practices Proposal for Public Comment.'' The Panel encourages the public to address any of these questions/issues when presenting either oral public comments or written statements to the Panel. (e) Procedures for Providing Public Comments: It is the policy of the Panel to accept written public comments of any length, and to accommodate oral public comments whenever possible. The Panel Staff expects that public statements presented at Panel meetings will be focused on the Panel's statutory charter and working group topics, and not be repetitive of previously submitted oral or written statements, and that comments will be relevant to the issues under discussion. Oral Comments: Speaking times will be confirmed by Panel staff on a ``first-come/first-served'' basis. To accommodate as many speakers as possible, oral public comments must be no longer than 10 minutes. Because Panel members may ask questions, reserved times will be approximate. Interested parties must contact Mr. Emile Monette, in writing (via mail, e-mail, or fax identified above for Mr. Monette) at least one week prior to the meeting in order to be placed on the public speaker list for the meeting. Oral requests for speaking time will not be taken. Speakers are requested to bring extra copies of their comments and/or presentation slides for distribution to the Panel at the meeting. Speakers wishing to use a Power Point presentation must e- mail the presentation to Mr. Monette one week in advance of the meeting. Written Comments: Although written comments are accepted until the date of the meeting (unless otherwise stated), written comments should be received by the Panel Staff at least one week prior to the meeting date so that the comments may be made available to the Panel for their consideration prior to the meeting. Written comments should be supplied to the DFO at the address/contact information given in this FR Notice in one of the following formats (Adobe Acrobat, WordPerfect, Word, or Rich Text files, in IBM-PC/Windows 98/2000/XP format). Please note: Because the Panel operates under the provisions of the Federal Advisory Committee Act, as amended, all public presentations will be treated as public documents and will be made available for public inspection, up to and including being posted on the Panel's Web site. (f) Meeting Accommodations: Individuals requiring special accommodation to access the public meetings listed above should contact Ms. Auletta at least five business days prior to the meeting so that appropriate arrangements can be made. Laura Auletta, Designated Federal Officer (Executive Director), Acquisition Advisory Panel. [FR Doc. 06-4070 Filed 4-28-06; 8:45 am] BILLING CODE 3110-01-P
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FR
FR-2006-05-01/E6-6536
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25614-25615] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6536] ======================================================================= ----------------------------------------------------------------------- OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE Generalized System of Preferences (GSP): Notice of Closure of Case 012-CP-05, Protection of Worker Rights in Swaziland and Closure of Case 015-CP-05, Protection of Intellectual Property in Kazakhstan, in the 2005 Annual Country Practice Review AGENCY: Office of the United States Trade Representative. ACTION: Notice. ----------------------------------------------------------------------- [[Page 25615]] SUMMARY: This notice announces closure of the review for cases 012-CP- 05, Protection of Worker Rights in Swaziland and 015-CP-05, Protection of Intellectual Property in Kazakhstan. FOR FURTHER INFORMATION, CONTACT: Marideth Sandler, Executive Director of the GSP Program, Office of the United States Trade Representative (USTR), Room F-220, 1724 F Street, NW., Washington, DC 20508. The telephone number is (202) 395-6971 and the facsimile number is (202) 395-9481. SUPPLEMENTARY INFORMATION: The GSP program provides for the duty-free importation of designated articles when imported from beneficiary developing countries. The GSP program is authorized by Title V of the Trade Act of 1974 (19 U.S.C. 2461, et seq.), as amended (the ``Trade Act''), and is implemented in accordance with Executive Order 11888 of November 24, 1975, as modified by subsequent Executive Orders and Presidential Proclamations. In the 2005 Annual Review, the GSP Subcommittee of the Trade Policy Staff Committee (TPSC) is reviewing petitions concerning the country practices of certain beneficiary developing countries of the GSP program. As a result of that review, the TPSC has decided to close the review for case 012-CP-05 regarding protection of worker rights in Swaziland and case 015-CP-05, protection of intellectual property rights in Kazakhstan. The Petitioners were the AFL-CIO and the International Intellectual Property Alliance (IIPA), respectively. The results of other ongoing country practice reviews in the 2005 Annual Review will be announced in the Federal Register at a later date. Marideth J. Sandler, Executive Director, GSP Program. [FR Doc. E6-6536 Filed 4-28-06; 8:45 am] BILLING CODE 3190-W6-P
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2024-10-08T14:08:35.246387
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6536.htm" }
FR
FR-2006-05-01/06-4049
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25615-25616] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 06-4049] ======================================================================= ----------------------------------------------------------------------- OFFICE OF PERSONNEL MANAGEMENT Personnel Demonstration Project; Alternative Personnel Management System for the U.S. Department of Commerce AGENCY: Office of Personnel Management. ACTION: Notice of modification to the Department of Commerce Personnel Management Demonstration Project. ----------------------------------------------------------------------- SUMMARY: The Office of Personnel Management (OPM) has authority to conduct demonstration projects that experiment with new and different human resources management concepts to determine whether changes in policies and procedures result in improved Federal human resources management. OPM approved a demonstration project covering several operating units of the U.S. Department of Commerce (DoC). OPM must approve modifications to demonstration project plans. This notice rescinds the demonstration project's independent authority pertaining to recruitment and retention payments. By so doing, it allows the demonstration project to take advantage of the expanded recruitment and retention flexibilities applicable to General Schedule and other employees. DATES: This notice modifying the DoC Demonstration Project may be implemented upon publication. FOR FURTHER INFORMATION CONTACT: Department of Commerce: Joan Jorgenson, U.S. Department of Commerce, 14th and Constitution Avenue, NW., Room 5004, Washington, DC 20230, (202) 482-4233. Office of Personnel Management: Jill Rajaee, U.S. Office of Personnel Management, 1900 E Street, NW., Washington, DC 20415, (202) 606-0836. SUPPLEMENTARY INFORMATION: 1. Background The Office of Personnel Management (OPM) approved the Department of Commerce (DOC) Demonstration Project and published the final plan in the Federal Register Volume 62, Number 247, Part II, on Wednesday, December 24, 1997. The project was implemented on March 29, 1998, and modified in the Federal Register on Thursday, September 30, 1999, Volume 64, Number 189 [Notices] [Pages 52810-52812], and on Tuesday, August 12, 2003, Volume 68, Number 155 [Notices] [Pages 47948-47949]. OPM approved a request to extend the DOC Demonstration Project for five years as stated in an administrative letter from OPM, dated February 14, 2003. The project was approved for expansion in the Federal Register Volume 68, Number 180 [Notices] [Pages 54505-54507], on Wednesday, September 17, 2003, to include an additional 1,505 employees. The demonstration project was again modified on Tuesday, July 5, 2005, Volume 70, Number 127 [Notices] [Pages 38732-38733]. This notice rescinds the demonstration project's independent authority pertaining to recruitment and retention payments. By so doing, it allows the demonstration project to take advantage of the expanded recruitment and retention flexibilities under 5 U.S.C. 5753 and 5754, and subparts A and C of 5 CFR part 575. Authority: 5 U.S.C. 4703; 5 CFR 470.315 Office of Personnel Management. Linda M. Springer, Director. Table of Contents I. Executive Summary II. Basis for Project Plan Modification III. Changes to the Project Plan I. Executive Summary The Department of Commerce (DOC) Demonstration Project utilizes many features similar to those implemented by the National Institute of Standards and Technology (NIST) Demonstration Project in 1988. The DOC Demonstration Project supports several key objectives: To simplify the classification system for greater flexibility in classifying work and paying employees; to establish a performance management and rewards system for improving individual and organizational performance; and to improve recruitment and retention to attract highly qualified candidates. The project is designed to test whether the interventions of the NIST project, which is now a permanent alternative personnel system, could be successful in other DOC environments. The current participating organizations include the Office of the Chief Financial Officer and Assistant Secretary for Administration (CFO/ASA), the Technology Administration, the Bureau of Economic Analysis, the Institute for Telecommunication Sciences, and units of the National Oceanic and Atmospheric Administration: Office of Oceanic and Atmospheric Research, National Marine Fisheries Service, and the National Environmental Satellite, Data, and Information Service. II. Basis for Project Plan Modification As part of the Commerce Demonstration Project plan, as published in the Federal Register notice (62 FR 67434), the recruitment bonus and retention allowance authorities under 5 U.S.C. 5753 and 5754, and subparts A and C of 5 CFR part 575, were waived for the DOC Demonstration Project and replaced with an independent authority to pay recruitment and retention payments. Based on independent evaluations, the recruitment and retention payment flexibilities have been underutilized in the demonstration project. The changes in statute made by section 101 of the Federal Workforce Flexibility Act of 2004 (Pub. L. 108-411, October 30, 2004) provide robust recruitment and retention incentives in an effort to [[Page 25616]] address challenges such as labor market competition and skill gap issues. However, because of the previous waivers, the demonstration project is precluded from taking advantage of these tools to address recruitment and retention concerns. This notice removes the demonstration project's independent authority to pay recruitment and retention payments, thereby allowing the project to use the recruitment and retention incentive authorities in 5 U.S.C. 5753 and 5754, and subparts A and C of 5 CFR part 575. This will provide managers in the demonstration project the same flexibilities now available to General Schedule and other employees under title 5. The demonstration project needs to be able to take advantage of legislative changes to title 5 when appropriate. It should be noted that since the demonstration project did not waive 5 U.S.C. 5753 or subpart B of 5 CFR part 575 pertaining to relocation bonuses, the demonstration project could use the relocation incentive flexibilities provided by the Federal Workforce Flexibility Act of 2004 and implementing regulations prior to this notice. This notice continues to allow the demonstration project to use the title 5 relocation incentive authority. III. Changes to the Project Plan This notice modifies the Commerce demonstration plan by rescinding its independent authority related to recruitment and retention payments, thereby providing authority to use recruitment and retention incentive authorities under 5 U.S.C. 5753 and 5754, and subparts A and C of 5 CFR part 575. The following discussion refers readers to the substantive changes to the project plan. The following page numbers refer to the pages in the final plan, published in the Federal Register on December 24, 1997. (1) Page 67451: Remove Paragraph B.12, ``Recruitment and Retention Payments,'' and renumber Paragraphs B.13, ``Travel Expenses,'' and B.14, ``Promotion,'' as Paragraphs B.12 and B.13, respectively. (2) Page 67463: In section X, ``Authorities and Waiver of Laws and Regulations Required,'' remove the following waivers: --``5 U.S.C. 5753-5754 Recruitment and relocation bonuses; Retention allowances (except that relocation bonuses under Section 5753 continue to apply),'' --``Part 575, Subpart A, Recruitment bonuses,'' and --``Part 575, Subpart C, Retention allowances.'' (3) Page 67463: In section X, ``Authorities and Waiver of Laws and Regulations Required,'' add the following new waivers: --Before the waiver for ``Section 7512(3),'' insert ``Section 5753 and 5754 Recruitment, Relocation and Retention Incentives. This waiver applies only to the extent necessary to allow employees and positions under the demonstration project to be treated as employees and positions under the General Schedule or the SL/ST pay plan.'' --Before the waiver for ``Section 752.401(a)(3),'' insert ``Part 575, Subparts A, B and C, Recruitment, Relocation and Retention Incentives. This waiver applies only to the extent necessary to allow employees and positions under the demonstration project to be treated as employees and positions under the General Schedule or the SL/ST pay plan.'' [FR Doc. 06-4049 Filed 4-28-06; 8:45 am] BILLING CODE 6325-43-P
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{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/06-4049.htm" }
FR
FR-2006-05-01/E6-6481
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25616-25620] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6481] ======================================================================= ----------------------------------------------------------------------- SECURITIES AND EXCHANGE COMMISSION [Investment Company Act Release No. 27292; 812-13214] Frank Russell Investment Company, et al.; Notice of Application April 25, 2006. AGENCY: Securities and Exchange Commission (``Commission''). ACTION: Notice of an application for an order under (a) section 6(c) of the Investment Company Act of 1940 (``Act'') granting an exemption from sections 18(f) and 21(b) of the Act; (b) section 12(d)(1)(J) of the Act granting an exemption from section 12(d)(1) of the Act; (c) sections 6(c) and 17(b) of the Act granting an exemption from sections 17(a)(1) and 17(a)(3) of the Act; and (d) section 17(d) of the Act and rule 17d- 1 under the Act to permit certain joint transactions. ----------------------------------------------------------------------- Summary of the Application: Applicants request an order that would permit certain registered open-end management investment companies to participate in a joint lending and borrowing facility. Applicants: Frank Russell Investment Company and Russell Investment Funds (each, a ``Trust'' and collectively, the ``Trusts''), and Frank Russell Investment Management Company (``FRIMCo''). Filing Dates: The application was filed on July 19, 2005 and amended on April 13, 2006. Applicants have agreed to file an amendment during the notice period, the substance of which is reflected in the notice. Hearing or Notification of Hearing: An order granting the application will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving applicants with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on May 22, 2006, and should be accompanied by proof of service on applicants, in the form of an affidavit or, for lawyers, a certificate of service. Hearing requests should state the nature of the writer's interest, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Commission's Secretary. ADDRESSES: Secretary, U.S. Securities and Exchange Commission, 100 F Street, NE., Washington, DC, 20549-1090. Applicants, c/o Gregory J. Lyons, Esq., Frank Russell Company, 909 A Street, Tacoma, Washington 98402. FOR FURTHER INFORMATION CONTACT: Marilyn Mann, Senior Counsel, at (202) 551-6813 or Mary Kay Frech, Branch Chief, at (202) 551-6821 (Division of Investment Management, Office of Investment Company Regulation). SUPPLEMENTARY INFORMATION: The following is a summary of the application. The complete application may be obtained for a fee at the Commission's Public Reference Desk, 100 F Street, NE., Washington, DC, 20549-0102 (tel. (202) 551-5850). Applicants' Representations 1. Each Trust is organized as a Massachusetts business trust and is registered under the Act as an open-end management investment company. Frank Russell Investment Company consists of 34 separate series (``Funds'') and Russell Investment Funds consists of 5 separate Funds. FRIMCo, a Washington corporation, is registered as an investment adviser under the Investment Advisers Act of 1940, and serves as the investment adviser to each Fund.\1\ An existing Commission order permits the Funds to invest uninvested cash balances in money market Funds that comply with rule 2a-7 under the Act.\2\ --------------------------------------------------------------------------- \1\ All entities that currently intend to rely on the requested relief have been named as applicants. \2\ Frank Russell Investment Company, Investment Company Act Release Nos. 25416 (February 12, 2002) (notice) and 25458 (March 12, 2002) (order). --------------------------------------------------------------------------- 2. Some Funds may lend money to banks or other entities by entering into [[Page 25617]] repurchase agreements or purchasing other short-term investments. Other Funds may borrow money from the same or similar banks for temporary purposes to satisfy redemption requests or to cover unanticipated cash shortfalls such as a trade ``fail'' in which cash payment for a security sold by a Fund has been delayed. Currently, the Funds have entered into a credit agreement with a bank. If a Fund were to borrow money under the credit agreement, it would pay interest on the loan at a rate that is significantly higher than the rate that is earned by other (non-borrowing) Funds on investments in repurchase agreements and other short-term instruments of the same maturity as the loan under the credit agreement. Applicants state that this differential represents the profit the bank would earn on loans under the credit agreement and is not attributable to any material difference in the credit quality or risk of such transactions. 3. Applicants request an order that would permit the Funds to enter into interfund lending agreements (``Interfund Lending Agreements'') under which the Funds would lend and borrow money for temporary purposes directly to and from each other through a credit facility (``Interfund Loan''). Applicants believe that the proposed credit facility would reduce the Funds' borrowing costs and enhance their ability to earn higher interest rates on short-term investments. Although the proposed credit facility would reduce the Funds' need to borrow from banks, the Funds would be free to establish committed lines of credit or other borrowing arrangements with banks. 4. Applicants anticipate that the credit facility would provide a borrowing Fund with significant savings when the cash position of the Fund is insufficient to meet temporary cash requirements. This situation could arise when redemptions exceed anticipated volumes and certain Funds have insufficient cash on hand to satisfy such redemptions. When a Fund liquidates portfolio securities to meet redemption requests which normally are effected immediately, it often does not receive payment in settlement for up to three days (or longer for certain foreign transactions). The credit facility would provide a source of immediate, short-term liquidity pending settlement of the sale of portfolio securities. 5. Applicants also propose using the credit facility when a sale of securities ``fails'' due to circumstances such as a delay in the delivery of cash to a Fund's custodian or improper delivery instructions by the broker effecting the transaction. Sales fails may present a cash shortfall if a Fund has undertaken to purchase securities using the proceeds from the securities sold. Alternatively, the Fund could fail on its intended purchase due to lack of funds from the previous sale, resulting in additional cost to the Fund, or sell a security on a same day settlement basis, earning a lower return on the investment. Use of the credit facility under these circumstances would enable the Fund to have access to immediate short-term liquidity. 6. While bank borrowings generally could supply needed cash to cover unanticipated redemptions and sales fails, under the proposed credit facility a borrowing Fund would pay lower interest rates than those offered by banks on short-term loans. In addition, Funds making short-term cash loans directly to other Funds would earn interest at a rate higher than they otherwise could obtain from investing their cash in repurchase agreements or purchasing shares of a money market Fund. Thus, applicants believe that the proposed credit facility would benefit both borrowing and lending Funds. 7. The interest rate charged to a Fund on any Interfund Loan (``Interfund Loan Rate'') would be the average of the ``Repo Rate'' and the ``Bank Loan Rate,'' both as defined below. The Repo Rate on any day would be the highest rate available to the Funds from investing in overnight repurchase agreements. The Bank Loan Rate on any day would be calculated by FRIMCo each day an Interfund Loan is made according to a formula established by a Fund's board of trustees (``Board'') intended to approximate the lowest interest rate at which bank short-term loans would be available to the Funds. The formula would be based upon a publicly available rate (e.g., Federal funds plus 25 basis points) and would vary with this rate so as to reflect changing bank loan rates. The Board of each Fund would periodically review the continuing appropriateness of using the publicly available rate to determine the Bank Loan Rate, as well as the relationship between the Bank Loan Rate and current bank loan rates that would be available to the Funds. The initial formula and any subsequent modifications to the formula would be subject to the approval of each Fund's Board. 8. The credit facility would be administered by FRIMCo's fund accounting department, an investment professional within FRIMCo who serves as a portfolio manager of money market Funds and a compliance professional within FRIMCo (collectively, the ``Credit Facility Team''). Under the proposed credit facility, the portfolio managers for each participating Fund could provide standing instructions to participate daily as a borrower or lender. The Credit Facility Team on each business day would collect data on the uninvested cash and borrowing requirements of all participating Funds from the Funds' custodian. Once it determined the aggregate amount of cash available for loans and borrowing demand, the Credit Facility Team would allocate loans among borrowing Funds without any further communication from portfolio managers other than the money market Fund portfolio manager on the Credit Facility Team. Applicants expect far more available uninvested cash each day than borrowing demand. All allocations will require the approval of at least one member of the Credit Facility Team who is not a money market Fund portfolio manager. After the Credit Facility Team has allocated cash for Interfund Loans, the Credit Facility Team would invest any remaining cash in accordance with the standing instructions of portfolio managers or return remaining amounts to the Funds. The money market Funds typically would not participate as borrowers because they rarely need to borrow cash to meet redemptions. 9. The Credit Facility Team would allocate borrowing demand and cash available for lending among the Funds on what the Credit Facility Team believes to be an equitable basis, subject to certain administrative procedures applicable to all Funds, such as the time of filing requests to participate, minimum loan lot sizes, and the need to minimize the number of transactions and associated administrative costs. To reduce transaction costs, each Interfund Loan normally would be allocated in a manner intended to minimize the number of participants necessary to complete the loan transaction. The method of allocation and related administrative procedures would be approved by each Fund's Board, including a majority of trustees who are not ``interested persons'' of the Fund, as defined in section 2(a)(19) of the Act (``Independent Trustees''), to ensure that both borrowing and lending Funds participate on an equitable basis. 10. FRIMCo would (a) monitor the Interfund Loan Rate and the other terms and conditions of the loans; (b) limit the borrowings and loans entered into by each Fund to ensure that they comply with the Fund's investment policies and limitations; (c) ensure equitable treatment of each Fund; and (d) make quarterly reports to the Board of each Fund concerning any transactions by [[Page 25618]] the Funds under the credit facility and the Interfund Loan Rate charged. 11. FRIMCo, through the Credit Facility Team, would administer the credit facility under its existing management, advisory, or administrative contract with each Fund and would receive no additional compensation for its services. FRIMCo may collect fees in connection with repurchase and lending transactions generally, including transactions through the credit facility, for pricing and record keeping, bookkeeping and accounting services. These fees would be no higher than those applicable for comparable bank loan transactions. 12. No Fund may participate in the credit facility unless: (a) The Fund has obtained shareholder approval for its participation, if such approval is required by law; (b) the Fund has fully disclosed all material facts concerning the credit facility in its prospectus and/or statement of additional information (``SAI''); and (c) the Fund's participation in the credit facility is consistent with its investment objectives, limitations and organizational documents. 13. In connection with the credit facility, applicants request an order under (a) section 6(c) of the Act granting relief from sections 18(f) and 21(b) of the Act; (b) section 12(d)(1)(J) of the Act granting relief from section 12(d)(1) of the Act; (c) sections 6(c) and 17(b) of the Act granting relief from sections 17(a)(1) and 17(a)(3) of the Act; and (d) under section 17(d) and rule 17d-1 under the Act to permit certain joint arrangements. Applicants' Legal Analysis 1. Section 17(a)(3) generally prohibits any affiliated person, or affiliated person of an affiliated person, from borrowing money or other property from a registered investment company. Section 21(b) generally prohibits any registered management company from lending money or other property to any person if that person controls or is under common control with the company. Section 2(a)(3)(C) of the Act defines an ``affiliated person'' of another person, in part, to be any person directly or indirectly controlling, controlled by, or under common control with, the other person. Applicants state that the Funds may be under common control by virtue of having FRIMCo as their common investment adviser and having a common Board and officers. 2. Section 6(c) provides that an exemptive order may be granted where an exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act. Section 17(b) authorizes the Commission to exempt a proposed transaction from section 17(a) provided that the terms of the transaction, including the consideration to be paid or received, are fair and reasonable and do not involve overreaching on the part of any person concerned, and the transaction is consistent with the policy of the investment company as recited in its registration statement and with the general purposes of the Act. Applicants believe that the proposed arrangements satisfy these standards for the reasons discussed below. 3. Applicants submit that sections 17(a)(3) and 21(b) of the Act were intended to prevent a party with strong potential adverse interests to, and some influence over the investment decisions of, a registered investment company from causing or inducing the investment company to engage in lending transactions that unfairly inure to the benefit of such party and that are detrimental to the best interests of the investment company and its shareholders. Applicants assert that the proposed credit facility transactions do not raise these concerns because: (a) FRIMCo, through the Credit Facility Team, would administer the program as a disinterested fiduciary; (b) all Interfund Loans would consist only of uninvested cash reserves that the Funds otherwise would invest in short-term repurchase agreements or other short-term instruments either directly or through a money market Fund; (c) the Interfund Loans would not involve a greater risk than such other investments; (d) the lending Fund would receive interest at a rate higher than it could obtain through such other investments; and (e) the borrowing Fund would pay interest at a rate lower than otherwise available to it under its bank loan agreements and avoid the up-front commitment fees associated with committed lines of credit. Moreover, applicants believe that the other terms and conditions in the application would effectively preclude the possibility of any Fund obtaining an undue advantage over any other Fund. 4. Section 17(a)(1) generally prohibits an affiliated person of a registered investment company, or an affiliated person of an affiliated person, from selling any securities or other property to the company. Section 12(d)(1) generally makes it unlawful for a registered investment company to purchase or otherwise acquire any security issued by any other investment company except in accordance with the limitations set forth in that section. Applicants state that the obligation of a borrowing Fund to repay an Interfund Loan may constitute a security under sections 17(a)(1) and 12(d)(1). Section 12(d)(1)(J) provides that the Commission may exempt persons or transactions from any provision of section 12(d)(1) if and to the extent such exemption is consistent with the public interest and the protection of investors. Applicants contend that the standards under sections 6(c), 17(b), and 12(d)(1)(J) are satisfied for all the reasons set forth above in support of their request for relief from sections 17(a)(3) and 21(b) and for the reasons discussed below. 5. Applicants state that section 12(d)(1) was intended to prevent the pyramiding of investment companies in order to avoid imposing on investors additional and duplicative costs and fees attendant upon multiple layers of investment companies. Applicants submit that the proposed credit facility does not involve these abuses. Applicants note that there will be no duplicative costs or fees to the Funds or shareholders, and that FRIMCo will receive no additional compensation for its services in administering the credit facility. Applicants also note that the purpose of the proposed credit facility is to provide economic benefits for all of the participating Funds and their shareholders. 6. Section 18(f)(1) prohibits open-end investment companies from issuing any senior security except that a company is permitted to borrow from any bank; provided, that immediately after the borrowing, there is asset coverage of at least 300 per centum for all borrowings of the company. Under section 18(g) of the Act, the term ``senior security'' includes any bond, debenture, note or similar obligation or instrument constituting a security and evidencing indebtedness. Applicants request relief from section 18(f)(1) to the limited extent necessary to implement the credit facility (because the lending Funds are not banks). 7. Applicants believe that granting relief under section 6(c) is appropriate because the Funds would remain subject to the requirement of section 18(f)(1) that all borrowings of a Fund, including combined interfund and bank borrowings, have at least 300% asset coverage. Based on the conditions and safeguards described in the application, applicants also submit that to allow the Funds to borrow from other Funds pursuant to the proposed credit facility is consistent with the purposes and policies of section 18(f)(1). 8. Section 17(d) and rule 17d-1 generally prohibit any affiliated person of a registered investment company, or affiliated persons of an affiliated person, when acting as principal, from effecting [[Page 25619]] any joint transactions in which the company participates unless the transaction is approved by the Commission. Rule 17d-1(b) provides that in passing upon applications filed under the rule, the Commission will consider whether the participation of a registered investment company in a joint enterprise on the basis proposed is consistent with the provisions, policies, and purposes of the Act and the extent to which the company's participation is on a basis different from or less advantageous than that of other participants. 9. Applicants submit that the purpose of section 17(d) is to avoid overreaching by an unfair advantage to investment company insiders. Applicants believe that the credit facility is consistent with the provisions, policies, and purposes of the Act in that it offers both reduced borrowing costs and enhanced returns on loaned funds to all participating Funds and their shareholders. Applicants note that each Fund would have an equal opportunity to borrow and lend on equal terms consistent with its investment policies and fundamental investment limitations. Applicants therefore believe that each Fund's participation in the credit facility will be on terms that are no different from or less advantageous than that of other participating Funds. Applicants' Conditions Applicants agree that any order granting the requested relief will be subject to the following conditions: 1. The Interfund Loan Rate will be the average of the Repo Rate and the Bank Loan Rate. 2. On each business day, the Credit Facility Team will compare the Bank Loan Rate with the Repo Rate and will make cash available for Interfund Loans only if the Interfund Loan Rate is: (a) More favorable to the lending Fund than the Repo Rate and, if applicable, the yield of any money market Fund in which the lending Fund could otherwise invest; and (b) more favorable to the borrowing Fund than the Bank Loan Rate. 3. If a Fund has outstanding borrowings, any Interfund Loans to the Fund: (a) Will be at an interest rate equal to or lower than any outstanding bank loan; (b) will be secured at least on an equal priority basis with at least an equivalent percentage of collateral to loan value as any outstanding bank loan that requires collateral; (c) will have a maturity no longer than any outstanding bank loan (and in any event not over seven days); and (d) will provide that, if an event of default by the Fund occurs under any agreement evidencing an outstanding bank loan to the Fund, that event of default will automatically (without need for action or notice by the lending Fund) constitute an immediate event of default under the Interfund Lending Agreement entitling the lending Fund to call the Interfund Loan (and exercise all rights with respect to any collateral) and that such call will be made if the lending bank exercises its right to call its loan under its agreement with the borrowing Fund. 4. A Fund may make an unsecured borrowing through the proposed credit facility if its outstanding borrowings from all sources immediately after the interfund borrowing total 10% or less of its total assets, provided that if the Fund has a secured loan outstanding from any other lender, including but not limited to another Fund, the Fund's interfund borrowing will be secured on at least an equal priority basis with at least an equivalent percentage of collateral to loan value as any outstanding loan that requires collateral. If a Fund's total outstanding borrowings immediately after an interfund borrowing would be greater than 10% of its total assets, the Fund may borrow through the proposed credit facility only on a secured basis. A Fund may not borrow through the proposed credit facility or from any other source if its total outstanding borrowings immediately after such borrowing would be more than 33\1/3\% of its total assets. 5. Before any Fund that has outstanding interfund borrowings may, through additional borrowings, cause its outstanding borrowings from all sources to exceed 10% of its total assets, the Fund must first secure each outstanding Interfund Loan by the pledge of segregated collateral with a market value at least equal to 102% of the outstanding principal value of the loan. If the total outstanding borrowings of a Fund with outstanding Interfund Loans exceed 10% of its total assets for any other reason (such as a decline in net asset value or because of shareholder redemptions), the Fund will within one business day thereafter: (a) Repay all its outstanding Interfund Loans; (b) reduce its outstanding indebtedness to 10% or less of its total assets; or (c) secure each outstanding Interfund Loan by the pledge of segregated collateral with a market value at least equal to 102% of the outstanding principal value of the loan until the Fund's total outstanding borrowings cease to exceed 10% of its total assets, at which time the collateral called for by this condition 5 shall no longer be required. Until each Interfund Loan that is outstanding at any time that a Fund's total outstanding borrowings exceeds 10% is repaid or the Fund's total outstanding borrowings cease to exceed 10% of its total assets, the Fund will mark the value of the collateral to market each day and will pledge such additional collateral as is necessary to maintain the market value of the collateral that secures each outstanding Interfund Loan at least equal to 102% of the outstanding principal value of the Interfund Loan. 6. No Fund may lend to another Fund through the proposed credit facility if the loan would cause its aggregate outstanding loans through the proposed credit facility to exceed 15% of the lending Fund's current net assets at the time of the loan. 7. A Fund's Interfund Loans to any one Fund shall not exceed 5% of the lending Fund's net assets. 8. The duration of Interfund Loans will be limited to the time required to receive payment for securities sold, but in no event more than seven days. Loans effected within seven days of each other will be treated as separate loan transactions for purposes of this condition. 9. The Fund's borrowings through the proposed credit facility, as measured on the day when the most recent loan was made, will not exceed the greater of 125% of the Fund's total net cash redemptions or 102% of sales fails for the preceding seven calendar days. 10. Each Interfund Loan may be called on one business day's notice by a lending Fund and may be repaid on any day by a borrowing Fund. 11. A Fund's participation in the proposed credit facility must be consistent with its investment objectives, and limitations and organizational documents. 12. The Credit Facility Team will calculate total Fund borrowing and lending demand through the proposed credit facility, and allocate loans on an equitable basis among the Funds, without the intervention of any portfolio manager of the Funds (other than the money market Fund portfolio manager acting in his or her capacity as a member of the Credit Facility Team). All allocations will require the approval of at least one member of the Credit Facility Team who is not the money market Fund portfolio manager. The Credit Facility Team will not solicit cash for the proposed credit facility from any Fund or prospectively publish or disseminate loan demand data to portfolio managers (except to the extent that the money market Fund portfolio manager on the Credit Facility Team has access to loan demand data). The Credit Facility Team will invest any amounts remaining after satisfaction of borrowing demand in accordance with the [[Page 25620]] standing instructions of the portfolio managers or return remaining amounts for investment directly by the portfolio managers of the Funds. 13. FRIMCo will monitor the Interfund Loan Rate and the other terms and conditions of the Interfund Loans and will make a quarterly report to the Trustees of each Trust concerning the participation of the Funds in the proposed credit facility and the terms and other conditions of any extensions of credit under the credit facility. 14. The Board of each Trust, including a majority of the Independent Trustees, will: (a) Review, no less frequently than quarterly, each Fund's participation in the proposed credit facility during the preceding quarter for compliance with the conditions of any order permitting such transactions; (b) Establish the Bank Loan Rate formula used to determine the interest rate on Interfund Loans and review, no less frequently than annually, the continuing appropriateness of the Bank Loan Rate formula; and (c) Review, no less frequently than annually, the continuing appropriateness of each Fund's participation in the proposed credit facility. 15. In the event an Interfund Loan is not paid according to its terms and such default is not cured within two business days from its maturity or from the time the lending Fund makes a demand for payment under the provisions of the Interfund Lending Agreement, FRIMCo will promptly refer such loan for arbitration to an independent arbitrator selected by the Board of each Fund involved in the loan who will serve as arbitrator of disputes concerning Interfund Loans.\3\ The arbitrator will resolve any problem promptly, and the arbitrator's decision will be binding on both Funds. The arbitrator will submit, at least annually, a written report to the Board setting forth a description of the nature of any dispute and the actions taken by the Funds to resolve the dispute. --------------------------------------------------------------------------- \3\ If the dispute involves Funds with different Trustees, the respective Trustees of each Fund will select an independent arbitrator that is satisfactory to each Fund. --------------------------------------------------------------------------- 16. Each Fund will maintain and preserve for a period of not less than six years from the end of the fiscal year in which any transaction by it under the proposed credit facility occurred, the first two years in an easily accessible place, written records of all such transactions setting forth a description of the terms of the transactions, including the amount, the maturity and the Interfund Loan Rate, the rate of interest available at the time on overnight repurchase agreements and commercial bank borrowings, the yield of any money market Fund in which the lending Fund could otherwise invest, and such other information presented to the Fund's Board in connection with the review required by conditions 13 and 14. 17. FRIMCo will prepare and submit to the Board for review an initial report describing the operations of the proposed credit facility and the procedures to be implemented to ensure that all Funds are treated fairly. After the commencement of the proposed credit facility, FRIMCo will report on the operations of the proposed credit facility at the Board's quarterly meetings. In addition, for two years following the commencement of the proposed credit facility, the independent auditors for each Trust shall prepare an annual report that evaluates FRIMCo's assertion that it has established procedures reasonably designed to achieve compliance with the terms and conditions of the order. The report shall be prepared in accordance with the Statements on Standards for Attestation Engagements No. 10 and it shall be filed pursuant to Item 77Q3 of Form N-SAR, as such Statements or Form may be revised, amended, or superseded from time to time. In particular, the report shall address procedures designed to achieve the following objectives: (a) That the Interfund Loan Rate will be higher than the Repo Rate, and, if applicable, the yield of the money market Funds, but lower than the Bank Loan Rate; (b) Compliance with the collateral requirements as set forth in the application; (c) Compliance with the percentage limitations on interfund borrowing and lending; (d) Allocation of interfund borrowing and lending demand in an equitable manner and in accordance with procedures established by the Board; and (e) That the interest rate on any Interfund Loan does not exceed the interest rate on any third-party borrowings of a borrowing Fund at the time of the Interfund Loan. After the final report is filed, each Trust's independent auditors, in connection with their audit examinations of the Funds, will continue to review the operation of the proposed credit facility for compliance with the conditions of the application and their review will form the basis, in part, of the auditor's report on internal accounting controls in Form N-SAR. 18. No Fund will participate in the proposed credit facility upon receipt of requisite regulatory approval unless it has fully disclosed in its prospectus and/or SAI all material facts about its intended participation. 19. The Board of each Trust will satisfy the fund governance standards as defined in rule 0-1(a)(7) under the Act. For the Commission, by the Division of Investment Management, under delegated authority. Jill M. Peterson, Assistant Secretary. [FR Doc. E6-6481 Filed 4-28-06; 8:45 am] BILLING CODE 8010-01-P
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2024-10-08T14:08:35.324883
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6481.htm" }
FR
FR-2006-05-01/06-4099
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25620-25621] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 06-4099] ----------------------------------------------------------------------- SECURITIES AND EXCHANGE COMMISSION Sunshine Act Meeting Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, Public Law 94-409, that the Securities and Exchange Commission will hold the following meeting during the week of May 1, 2006: A closed meeting will be held on Thursday, May 4, 2006 at 2 p.m. Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the closed meeting. Certain staff members who have an interest in the matters may also be present. The General Counsel of the Commission, or his designee, has certified that, in his opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3), (5), (7), (9)(B), and (10) and 17 CFR 200.402(a)(3), (5), (7), (9)(ii) and (10) permit consideration of the scheduled matters at the closed meeting. Commissioner Atkins, as duty officer, voted to consider the items listed for the closed meeting in closed session. The subject matter of the closed meeting scheduled for Thursday, May 4, 2006 will be: Formal orders of investigation; Institution and settlement of injunctive actions; Institution and settlement of administrative proceedings of an enforcement nature; and Resolution of litigation claims. At times, changes in Commission priorities require alterations in the scheduling of meeting items. For further information and to ascertain what, if any, matters have been added, deleted or postponed, please contact: The Office of the Secretary at (202) 551-5400. [[Page 25621]] Dated: April 26, 2006. Nancy M. Morris, Secretary. [FR Doc. 06-4099 Filed 4-26-06; 4:06 pm] BILLING CODE 8010-01-P
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2024-10-08T14:08:35.351699
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/06-4099.htm" }
FR
FR-2006-05-01/E6-6503
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25621-25623] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6503] ----------------------------------------------------------------------- SECURITIES AND EXCHANGE COMMISSION [Release No. 34-53702; File No. SR-NSX-2005-09] Self-Regulatory Organizations; National Stock Exchange; Order Granting Approval of Proposed Rule Change and Notice of Filing and Order Granting Accelerated Approval to Amendment Nos. 1 and 2 Thereto to Amend Exchange Delisting Rules to Conform to Recent Amendments to Commission Rules Regarding Removal from Listing and Withdrawal from Registration April 21, 2006. I. Introduction On October 24, 2005, the National Stock Exchange (``NSX'' or ``Exchange'') filed with the Securities and Exchange Commission (``SEC'' or ``Commission''), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a proposed rule change to amend Exchange delisting rules to conform to recent amendments to Commission rules regarding removal from listing and withdrawal from registration. The proposed rule change was published for comment in the Federal Register on March 22, 2006.\3\ No comments were received regarding the proposal. On March 23, 2006, NSX filed Amendment No. 1 to the proposed rule change.\4\ On April 12, 2006, NSX filed Amendment No. 2 to the proposed rule change.\5\ This order approves the proposed rule change, publishes notice of Amendment Nos. 1 and 2 to the proposed rule change, and grants accelerated approval to Amendment Nos. 1 and 2. --------------------------------------------------------------------------- \1\ 15 U.S.C. 78s(b)(1). \2\ 17 CFR 240.19b-4. \3\ See Securities Exchange Act Release No. 53508 (March 17, 2006), 71 FR 14562. \4\ In Amendment No. 1, NSX added an interpretation and policy to Section 3.2A to Article IV of the NSX Bylaws to: (i) Clarify the effective date of the proposal; (ii) clarify the use of Form 25 as a delisting application; and (iii) state that an issuer that is below the continued listing policies and standards of the Exchange and seeks to voluntarily apply to withdraw a class of securities from listing must disclose that it is no longer eligible for continued listing in its statement of material facts relating to the reason for withdrawal from listing, its public press release, and its Web site notice. \5\ In Amendment No. 2, NSX made technical changes to its Form 19b-4, Exhibit 1, and Exhibits that clarify the changes proposed in Amendment No. 1. --------------------------------------------------------------------------- II. Description of the Proposed Rule Change Section 12 of the Act \6\ and SEC Rule 12d2-2 govern the process for the delisting and deregistration of securities listed on national securities exchanges. Recent amendments to SEC Rule 12d2-2 (``amended SEC Rule 12d2-2'') and other Commission rules require the electronic filing of revised Form 25 \7\ on the Commission's Electronic Data Gathering, Analysis, and Retrieval (``EDGAR'') system by exchanges and issuers for all delistings, other than delistings of standardized options and securities futures, which are exempted.\8\ --------------------------------------------------------------------------- \6\ 15 U.S.C. 78l. \7\ 17 CFR 249.25. \8\ See Securities Exchange Act Release No. 52029 (July 14, 2005), 70 FR 42456 (July 22, 2005) (``SEC Rule 12d2-2 Approval Order''). --------------------------------------------------------------------------- In the case of exchange-initiated delistings, amended SEC Rule 12d2-2(b) states that a national securities exchange may file an application on Form 25 to strike a class of securities from listing and/or withdraw the registration of such securities, in accordance with its rules, if the rules of such exchange, at a minimum, provide for: (i) Notice to the issuer of the exchange's decision to delist its securities; (ii) An opportunity for appeal to the exchange's board of directors, or to a committee designated by the board; and (iii) Public notice of the national securities exchange's final determination to remove the security from listing and/or registration, by issuing a press release and posting notice on its Web site. Public notice must be disseminated no fewer than 10 days before the delisting becomes effective pursuant to amended SEC Rule 12d2-2(d)(1), and must remain posted on its Web site until the delisting is effective. The Exchange's current provisions with respect to the delisting of securities are contained in Article IV, Section 3 of the NSX Bylaws. The Exchange proposes to amend Section 3.1(b) of the Bylaws to comply with new requirements set forth in amended SEC Rule 12d2-2(b). The provisions set forth in current Section 3 of the Bylaws, which provide for notification to the issuer in the event that the Exchange determines to delist the issuer's securities and the right to appeal the Exchange's determination, satisfy the minimum provisions set forth in amended SEC Rule 12d2-2(b)(1)(i)-(ii). NSX rules do not currently provide for public notice of the delisting, as mandated by amended SEC Rule 12d2-2(b)(1)(iii). Therefore, proposed Section 3.1(b) of the Bylaws would require the Exchange to provide public notice, in accordance with amended SEC Rule 12d2-2(b)(1)(iii), of a final determination by the Exchange to strike an issuer's securities from listing and/or withdraw the registration of such securities on the Exchange. The criteria the Exchange would employ for issuers that desire to delist their security from the Exchange are contained in Section 3.2 of the NSX Bylaws. Currently, Section 3.2 of the NSX Bylaws requires that an issuer seeking to voluntarily delist its security submit a certified copy of the issuer's board resolution authorizing withdrawal from listing and registration and a statement of the reasons for the withdrawal and supporting facts. NSX is retaining these provisions. The Exchange proposes to amend Section 3.2 of the NSX Bylaws to add new requirements that an issuer certify that it is in compliance with the Exchange's rules for delisting and applicable state law (in conformity with amended SEC Rule 12d2-2(c)(2)(i)) and certify that the issuer is in compliance with the public notice requirements under amended SEC Rule 12d2-2(c)(2)(iii). The proposed rule filing sets forth a new requirement separate from those set forth in amended SEC Rule 12d2-2(c) that would require the issuer to notify the Exchange in writing that it has filed Form 25 with the SEC simultaneously with such filing. Such notification would include the date the issuer expects the delisting to become effective. In addition, NSX proposes to amend Section 3.2 of the Bylaws to add provisions requiring the issuer to submit written notice that is in conformity with the requirements of amended SEC Rule 12d2- 2(c)(2)(ii) to the Exchange no fewer than ten days before the issuer files its application to delist with the Commission and another notice when such application becomes effective. The proposal would also eliminate the provision in Section 3.2 of the NSX Bylaws that requires the issuer to submit the proposed voluntary delisting of its security to the security holders for their vote in a meeting for which proxies are submitted. The Exchange also proposes in Interpretations and Policies .01 to new Section 3.2A to the NSX Bylaws to require any issuer seeking to voluntarily apply to withdraw a class of securities from listing on the Exchange pursuant to Section 3.2A that has received notice from the Exchange, pursuant to Section 3.1A or otherwise, that it is below the [[Page 25622]] Exchange's continued listing policies and standards, or that is aware that it is below such continued listing policies and standards notwithstanding that it has not received such notice from the Exchange, must disclose that it is no longer eligible for continued listing (including the specific continued listing policies and standards that the issue is below) in: (i) Its statement of all material facts (pursuant to Section 3.2A(d)) relating to the reasons for withdrawal from listing provided to the Exchange along with written notice of its determination to withdraw from listing required by amended SEC Rule12d2-2(c)(2)(ii) under the Act and; (ii) its public press release and web site notice required by amended SEC Rule 12d2-2(c)(2)(iii) under the Act.\9\ --------------------------------------------------------------------------- \9\ See Amendment No. 1, supra note 4. --------------------------------------------------------------------------- Finally, the Exchange has made changes in its rules to clarify that the Form 25 serves as the application to remove a security from listing and/or registration and to specify that the proposed changes will be effective as of April 24, 2006 as required by amended SEC Rule 12d2-2. III. Discussion The Commission finds that the proposed rule change, as amended, is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange \10\ and, in particular, the requirements of Section 6 of the Act.\11\ Specifically, as discussed below, the Commission finds that the proposal, as amended, is consistent with Section 6(b)(5) of the Act,\12\ which requires, in part, that the rules of an exchange be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in regulating, clearing, settling, and processing information with respect to, and facilitating transactions in securities, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, to protect investors and the public interest. Further, as noted in more detail below, the changes being adopted by the NSX meet the requirements of amended SEC Rule 12d2-2. --------------------------------------------------------------------------- \10\ In approving this proposal, the Commission has considered the proposed rule's impact on efficiency, competition, and capital formation. See 15 U.S.C. 78c(f). \11\ 15 U.S.C. 78f. \12\ 15 U.S.C. 78f(b)(5). --------------------------------------------------------------------------- A. Exchange Delisting Amended SEC Rule 12d2-2(b) states that a national securities exchange may file an application on Form 25 to strike a class of securities from listing and/or withdraw the registration of such securities, in accordance with its rules, if the rules of such exchange, at a minimum, provide for notice to the issuer of the exchange's decision to delist, opportunity for appeal, and public notice of the exchange's final determination to delist. The Commission believes that NSX's current rules and proposal comply with the dictates of amended SEC Rule 12d2-2(b). NSX rules currently provide the requisite issuer notice as well as an opportunity to appeal such action by following Chapter X of the Exchange Rules governing adverse actions.\13\ Specifically, a person who is or will be aggrieved by any action of the Exchange can submit an application for hearing and review to the Secretary of the Exchange, who promptly forwards such request to the Appeals Committee.\14\ The decision of the Appeals Committee is subject to further review by the Board of Directors upon its own motion or upon written request by the aggrieved party.\15\ Finally, the proposed rule change will provide for public notice of the Exchange's final determination to remove the security from listing and/or registration. This should ensure that investors have adequate notice of an exchange delisting and is consistent with the protection of investors under Section 6(b)(5) of the Act.\16\ --------------------------------------------------------------------------- \13\ See Section 3.1 of the NSX By-Laws. \14\ NSX Rule 10.3. \15\ NSX Rule 10.5. \16\ 15 U.S.C. 78f(b)(5). --------------------------------------------------------------------------- B. Issuer Voluntary Delisting The Exchange proposes to set forth in its Exchange rules the general requirements of amended SEC Rule 12d2-2(c) regarding issuer voluntary delisting. In addition, new Section 3.2 of the NSX Bylaws would require the issuer to certify its compliance with Exchange rules for delisting and other applicable laws. Further, the Commission notes that NSX also proposes to amend Section 3.2 of the Bylaws to conform to amended SEC Rule 12d2-2(c) which requires issuers to notify the Exchange in case it elects to delist its securities from the Exchange, and upon such notification, the Exchange would be required to issue a public notice of such determination. The Commission believes that these provisions will inform issuers of the requirements for voluntary delisting of their securities under Exchange rules and federal securities laws and ensure the Exchange and shareholders are adequately notified of an issuer delisting. The proposal also sets forth a new requirement not in amended SEC Rule 12d2-2 that would require an issuer seeking to voluntarily delist its security to notify the Exchange in writing that it has filed Form 25 with the Commission simultaneously with such filing. The issuer would also be required to notify the Exchange in writing immediately after the delisting actually becomes effective. The Commission believes that this requirement will allow the Exchange to be fully informed of the filing of a Form 25 and be prepared to take timely action to delist the security in accordance with the filing of the Form. The Exchange also proposes to add an interpretation and policy to Section 3.2A to the Bylaws to require any issuer seeking to voluntarily apply to withdraw a class of securities from listing on the Exchange pursuant to Section 3.2A that has received notice from the Exchange, pursuant to Section 3.1A or otherwise, that it is below the Exchange's continued listing policies and standards, or that is aware that it is below such continued listing policies and standards notwithstanding that it has not received such notice from the Exchange, must disclose that it is no longer eligible for continued listing (including the specific continued listing policies and standards that the issue is below) in: (i) Its statement of all material facts (pursuant to Section 3.2A (d)) relating to the reasons for withdrawal from listing provided to the Exchange along with written notice of its determination to withdraw from listing required by amended SEC Rule 12d2-2(c)(2)(ii) under the Act and; (ii) its public press release and web site notice required by amended SEC Rule 12d2-2(c)(2)(iii) under the Act.\17\ The Commission believes that this requirement will allow shareholders to be informed and aware that the issuer has failed to meet Exchange listing standards and is voluntarily delisting with the consent of the Exchange. Issuers will therefore not be permitted to delist voluntarily without public disclosure of their noncompliance with Exchange listing standards. --------------------------------------------------------------------------- \17\ See Amendment No. 1, supra note 4. --------------------------------------------------------------------------- C. Accelerated Approval of Amendment Nos. 1 and 2 Pursuant to Section 19(b)(2) of the Act,\18\ the Commission may not approve [[Page 25623]] any proposed rule change, or amendment thereto, prior to the 30th day after the date of publication of notice of the filing thereof, unless the Commission finds good cause for so doing and publishes its reasons for so finding. The Commission hereby finds good cause for approving Amendment Nos. 1 and 2 to the proposal, prior to the 30th day after publishing notice of Amendment Nos. 1 and 2 in the Federal Register. --------------------------------------------------------------------------- \18\ 15 U.S.C. 78s(b)(2). --------------------------------------------------------------------------- As previously discussed, the revisions made to the proposal in Amendment No. 1 \19\ will allow shareholders to be informed and aware that the issuer has failed to meet Exchange listing standards and is voluntarily delisting with the consent of the Exchange. The other revisions in Amendment No. 1 are clarifications. In Amendment No. 2, the Exchange made technical changes that clarify the revisions set forth in Amendment No. 1. The Commission believes that granting accelerated approval of Amendment Nos. 1 and 2 will permit the Exchange to implement these new provisions as expeditiously as possible, to the benefit of investors. Further, no comments were received on the original proposal, as published.\20\ The Commission also believes that accelerating approval of Amendment Nos. 1 and 2 is appropriate because these revisions do not raise new regulatory issues. --------------------------------------------------------------------------- \19\ See Amendment No. 1, supra note 4 and Section III.B herein. \20\ See Securities Exchange Act Release No. 53508, supra note 3. --------------------------------------------------------------------------- Accordingly, pursuant to Section 19(b)(2) of the Act,\21\ the Commission finds good cause to approve Amendment Nos. 1 and 2 prior to the thirtieth day after notice of Amendment Nos. 1 and 2 are published in the Federal Register. --------------------------------------------------------------------------- \21\ 15 U.S.C. 78s(b)(2). --------------------------------------------------------------------------- IV. Solicitation of Comments Interested persons are invited to submit written data, views, and arguments concerning Amendment Nos. 1 and 2, including whether Amendment Nos. 1 and 2 is consistent with the Act. Comments may be submitted by any of the following methods: Electronic Comments Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or Send an e-mail to [email protected]. Please include File No. SR-NSX-2005-09 on the subject line. Paper Comments Send paper comments in triplicate to Nancy M. Morris, Secretary, Securities and Exchange Commission, Station Place, 100 F Street, NE., Washington, DC 20549-1090. All submissions should refer to File Number SR-NSX-2005-09. This file number should be included on the subject line if e-mail is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for inspection and copying in the Commission's Public Reference Room. Copies of such filing also will be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-NSX-2005-09 and should be submitted on or before May 22, 2006. V. Conclusion It is therefore ordered, pursuant to Section 19(b)(2) of the Act,\22\ that the proposed rule change (File No. SR-NSX-2005-09) is approved, and Amendment Nos. 1 and 2 to the proposed rule change are approved on an accelerated basis. --------------------------------------------------------------------------- \22\ 15 U.S.C. 78s(b)(2). For the Commission, by the Division of Market Regulation, pursuant to delegated authority.\23\ --------------------------------------------------------------------------- \23\ 17 CFR 200.30-3(a)(12). --------------------------------------------------------------------------- Jill M. Peterson, Assistant Secretary. [FR Doc. E6-6503 Filed 4-28-06; 8:45 am] BILLING CODE 8010-01-P
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2024-10-08T14:08:35.369314
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6503.htm" }
FR
FR-2006-05-01/E6-6488
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25623] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6488] ======================================================================= ----------------------------------------------------------------------- SMALL BUSINESS ADMINISTRATION [License No. 09/79-0456] Horizon Ventures Fund II, L.P.; Notice Seeking Exemption Under Section 312 of the Small Business Investment Act, Conflicts of Interest Notice is hereby given that Horizon Ventures Fund II, L.P., 4 Main Street, Suite 50, Los Altos, CA 94022, a Federal Licensee under the Small Business Investment Act of 1958, as amended (``the Act''), in connection with the financing of a small concern, has sought an exemption under Section 312 of the Act and Section 107.730, Financings which Constitute Conflicts of Interest of the Small Business Administration (``SBA'') Rules and Regulations (13 CFR 107.730). Horizon Ventures Fund II, L.P. proposes to provide equity/debt security financing to Venturi Wireless, Inc., Sunnyvale Research Plaza, 555 N. Mathilda Avenue, Suite 100, Sunnyvale, California 94085. The financing is contemplated for working capital and general corporate purposes. The financing is brought within the purview of Sec. 107.730(a)(1) of the Regulations because Horizons Ventures Fund I, L.P. and Horizons Ventures Advisors Fund I, L.P., all Associates of Horizon Ventures Fund II, L.P., own more than ten percent of Venturi Wireless, Inc., and therefore Venturi Wireless, Inc. is considered an Associate of Horizon Ventures Fund II as detailed in Sec. 107.50 of the Regulations. Notice is hereby given that any interested person may submit written comments on the transaction to the Associate Administrator for Investment, U.S. Small Business Administration, 409 Third Street, SW., Washington, DC 20416. Dated: April 3, 2006. Jaime Guzm[aacute]n-Fournier, Associate Administrator for Investment. [FR Doc. E6-6488 Filed 4-28-06; 8:45 am] BILLING CODE 8025-01-P
usgpo
2024-10-08T14:08:35.391753
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6488.htm" }
FR
FR-2006-05-01/E6-6489
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25623-25624] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6489] ----------------------------------------------------------------------- SMALL BUSINESS ADMINISTRATION [License No. 09/79-0456] Horizon Ventures Fund II, L.P.; Notice Seeking Exemption Under Section 312 of the Small Business Investment Act, Conflicts of Interest Notice is hereby given that Horizon Ventures Fund II, L.P., 4 Main Street, Suite 50, Los Altos, CA 94022, a Federal Licensee under the Small Business Investment Act of 1958, as amended (``the Act''), in connection with the financing of a small concern, has sought [[Page 25624]] an exemption under Section 312 of the Act and Section 107.730, Financings which Constitute Conflicts of Interest of the Small Business Administration (``SBA'') Rules and Regulations (13 CFR 107.730). Horizon Ventures Fund II, L.P. proposes to provide equity/debt security financing to Invivodata, Inc. 2100 Wharton Street, Suite 505, Pittsburgh, Pennsylvania 15203. The financing is contemplated for working capital and general corporate purposes. The financing is brought within the purview of Sec. 107.730(a)(1) of the Regulations because Horizons Ventures Fund I, L.P. and Horizons Ventures Advisors Fund I, L.P., all Associates of Horizon Ventures Fund II, L.P., own more than ten percent of Invivodata, Inc., and therefore Invivodata is considered an Associate of Horizon Ventures Fund II as detailed in Sec. 107.50 of the Regulations. Notice is hereby given that any interested person may submit written comments on the transaction to the Associate Administrator for Investment, U.S. Small Business Administration, 409 Third Street, SW., Washington, DC 20416. April 3, 2006. Jaime Guzman-Fournier, Associate Administrator for Investment. [FR Doc. E6-6489 Filed 4-28-06; 8:45 am] BILLING CODE 8025-01-P
usgpo
2024-10-08T14:08:35.402023
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6489.htm" }
FR
FR-2006-05-01/E6-6506
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25624-25628] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6506] ----------------------------------------------------------------------- SMALL BUSINESS ADMINISTRATION SBA Lender Risk Rating System Notice and Request for Comments SUMMARY: SBA is proposing for comment a lender risk rating system. The lender risk rating system is an internal tool to assist SBA in assessing the risk of each active 7(a) Lender and Certified Development Company's (``SBA Lender'') SBA loan operations, and loan portfolio, on a uniform basis and for identifying those institutions whose SBA loan operations and portfolio require additional SBA monitoring or other action. It is also a vehicle for assessing the aggregate strength of SBA's 7(a) and 504 portfolios. Under the lender risk rating system, SBA would assign each Lender a composite rating based on certain portfolio performance factors, which may be overridden in some cases due to Lender specific factors that may be indicative of a higher or lower level of risk. SBA Lenders would have access to their own ratings through SBA's Lender Portal. DATES: SBA must receive comments on or before June 15, 2006. ADDRESSES: You may submit comments by any of the following methods (1) E-mail [email protected]; (2) Fax: (202) 205-6831; (3) Mail: John M. White, Deputy Associate Administrator, Office of Lender Oversight, U.S. Small Business Administration, 409 Third Street, SW., Washington, DC 20416; (4) Hand Delivery/Courier: 409 Third Street, SW., Washington, DC 20416, c/o John M. White. FOR FURTHER INFORMATION CONTACT: John M. White, Deputy Associate Administrator, Office of Lender Oversight, U.S. Small Business Administration, 409 Third Street, SW., Washington, DC 20416, (202) 205- 3049. SUPPLEMENTARY INFORMATION: Background SBA is developing an internal risk rating system for assessing an SBA Lender's 7(a) or 504 loan portfolio (i.e., loan portfolio performance). The risk rating system will be an internal tool that will assist SBA in assessing the risk of a Lender's 7(a) and 504 loan performance on a uniform basis and identify those Lenders whose portfolio performance demonstrates the need for additional SBA monitoring or other action. It is not intended to be a Lender grading system. The lender risk rating system will also serve as a vehicle to measure the aggregate strength of SBA's overall 7(a) and 504 loan portfolios and to assist SBA in managing the related risk. SBA will use Lender risk ratings to make more effective use of its on-site and off- site lender review and assessments resources. The proposed risk rating methodology is set forth below. SBA is soliciting comments on the risk rating methodology. During the comment period, SBA will provide Lenders access to their own preliminary risk ratings through SBA's Lender Portal. A more detailed discussion of the risk rating proposal and portal access follows. Risk Rating Proposal Overview Under SBA's proposed risk rating system, SBA would assign all Lenders a composite rating. The composite rating would reflect SBA's assessment of the potential risk to the government of that Lender's SBA portfolio performance. For 7(a) Lenders, SBA would base the composite rating on four common components or factors. The common factors for 7(a) Lenders would be as follows: (i) 12 month actual purchase rate; (ii) problem loan rate; (iii) three month change in the small business predictive score (SBPS), which is a small business credit score on loans in the 7(a) Lender's portfolio; and (iv) projected purchase rate derived from the SBPS. For CDCs, SBA would base the composite rating on three common components or factors. The common factors for CDCs would be as follows: (i) 12 month actual purchase rate; (ii) problem loan rate; and (iii) average SBPS on loans in the 504 Lender's portfolio. The third factor replaces the third and fourth factors used for 7(a) Lenders because it was found, during the testing process, to be more predictive of SBA purchases for 504 Lenders. In general, these factors reflect both historical lender performance and projected future performance. The factors are derived through formulas developed using regression analysis validated and tested by industry experts. SBA would perform quarterly calculations on the common factors for each Lender, so that Lenders' composite risk ratings would be updated on a quarterly basis. Each of the factors is described in more detail in the Rating Components section below. The composite risk rating is a measure of how each Lender's loan performance compares to the loan performance of its peers. Thus, an individual Lender's overall loan performance (using all common factors) would be compared to its peers to derive that Lender's composite risk rating. Lenders whose overall portfolio performance (using all of the common factors) is worse than their peers will receive a worse, or higher score, while Lenders whose overall portfolio performance is better than their peers will receive a better, or lower, score. SBA recognizes that it may be inequitable to compare all Lenders in a risk rating system, without separating them into peer groups, because changes in loan performance would have dramatically different impacts on the portfolio performance of Lenders of different sizes. For example, the purchase of one loan from a Lender would have a much higher impact on the actual purchase rate component of a Lender with a small portfolio than it would on the actual purchase rate of a Lender with a large portfolio. Therefore, SBA has established peer groups to minimize the differences that could result from changes in loan performance for portfolios of different sizes. The peer groups are as follows (based on outstanding SBA guaranteed dollars): [[Page 25625]] ------------------------------------------------------------------------ 7(a) Lender Peer Groups CDC Peer Groups ------------------------------------------------------------------------ $100,000,000 or more............... $100,000,000 or more. $10,000,000-$99,999,999............ $30,000,000-$99,999,999. $4,000,000-$9,999,999.............. $10,000,000-$29,999,999. $1,000,000-$3,999,999.............. $5,000,000-$9,999,999. $0-$999,999 (lenders disbursed at Less than $5,000,000. least one loan in past 12 months). $0-$999,999 (lenders did not disburse at least one loan in past 12 months). ------------------------------------------------------------------------ As noted above, the common components would be used to derive a composite risk rating for each 7(a) and 504 Lender. Under the proposal, no single component factor would normally decide the Lender's composite rating. However, depending upon the size of the peer group, and the variation between a Lender's performance and that of its peers, a single factor could carry a disproportionate weight among the three or four components. Composite Rating SBA would assign a composite rating of 1 to 5 to each Lender based upon their portfolio performance. A rating of 1 would indicate strong portfolio performance, least risk, and the least degree of SBA management oversight is needed (relative to other Lenders in their peer group), while a 5 rating would indicate weak portfolio performance, highest risk, and therefore, the highest degree of SBA management oversight. SBA proposes the following definitions for the composite ratings. Composite 1--The SBA operations of a Lender rated 1 would be considered strong in every respect, and would likely score much better than SBA averages in all or nearly all of the rating components described in this notice. A Lender rated 1 would have relatively stable component factors and overall composite rating from one quarter to the next. Since the component factors measure previous performance, and also attempt to predict future performance, a Lender rated 1 would be more likely to have well below average historical purchase rates, as well as well below average current problem loan rates that would predict lower than average future purchase rates. Overall, loans in the portfolio of a Lender rated 1 would demonstrate highly acceptable credit quality and/or credit trends as measured by credit scores and portfolio performance. A Lender rated 1 would typically also have a well managed SBA loan program as demonstrated through on-site or off- site reviews and assessments (of mid-size and larger Lenders). Based on the strengths outlined in this composite rating, Lenders rated a 1 would present SBA with the least amount of risk, and would thus be subject to the lowest level of SBA oversight compared to other Lenders in the same peer group. Composite 2--The SBA operations of a Lender rated 2 would be considered good, and would likely be above average in all or nearly all of the rating components described in this notice. A Lender rated a 2 would have component factors and a composite rating that would typically be relatively stable from one quarter to the next. A Lender rated 2 would be more likely to have below average previous (historical) purchase rates, as well as below average current problem loan rates that would predict lower than average future purchase rates. Generally, loans in the portfolio of a Lender rated 2 would demonstrate better-than-acceptable credit quality and/or credit trends as measured by credit scores and portfolio performance. A Lender rated 2 would likely have a generally well managed (i.e., a few minor exceptions or findings) SBA loan program as demonstrated through on-site or off-site reviews and assessments (of mid-size and large Lenders). Based on the strengths outlined in this composite rating. Lenders rated a 2 would present SBA with a lower level of risk, and would thus be subject to a lower level of SBA oversight compared to other Lenders in the same peer groups. Composite 3--The SBA operations of a Lender rated 3 would be considered about average in all or nearly all of the rating components described in this notice. A Lender rated a 3 would have, on average, component factors and an overall composite rating that would generally be relatively stable from one quarter to the next. A Lender rated 3 would likely have average previous (historical) purchase rates (as compared to their peers), as well as average current problem loans rates that would predict future purchase rates in line with SBA portfolio averages. Generally, loans in the portfolio of a Lender rated 3 would demonstrate acceptable credit quality and/or credit trends as measured by credit scores and portfolio performance. A Lender rated 3 would have an adequate (i.e., some minor exceptions or findings, but few if any major exceptions or findings, which can be corrected in the normal course of business) SBA loan program as demonstrated through on- site or off-site reviews and assessments (of mid-size and large Lenders). However, Lenders rated a 3 would have room for improvement, should monitor their portfolio closely, and consider methods to improve loan performance. Based on the strengths and weaknesses outlined in this composite rating, Lenders rated a 3 would present SBA with an acceptable level of risk, and would thus be subject to standard SBA oversight compared to other Lenders in the same peer group. Oversight may include requests for corrective action plans. Composite 4--The SBA operations of Lender rated 4 would be considered below average in all or nearly all of the rating components described in this notice. A Lender rated a 4 may have several changes in any of its components factor rates; the component factors and overall composite rating may demonstrate instability or negative performance from one quarter to the next. A Lender rated 4 would be likely have above average previous (historical) purchase rates (as compared to their peers), as well as above average current problem loan rates that would predict future purchase rates above SBA portfolio averages. Generally, loans in the portfolio of a Lender rated 4 would demonstrate somewhat less-than-acceptable credit quality and/or credit trends as measured by credit scores and portfolio performance. A lender rated 4 would likely have a poorly managed (i.e., both minor exceptions or findings, and major exceptions or findings) SBA loan program as demonstrated through on-site or off-site reviews and assessments (of mid-size and large Lenders). Based on the weaknesses outlined in this composite rating, Lenders rated a 4 would present SBA with a less-than- acceptable level of risk, and would thus be subject to greater than normal SBA oversight compared to other Lenders in the same peer group. Oversight measures could include (but are not limited to) additional reviews or assessments, requests for corrective action plans, and/or removal from delegated loan programs, depending [[Page 25626]] upon the level of activity and peer group. Composite 5--The SBA operations of a Lender rated 5 would be considered well below average in all or nearly all of the rating components described in this notice. A Lender rated a 5 is most likely to have changes in any of its component factor rates, and have the greatest likelihood to have their component factors and overall composite rating demonstrate instability or negative performance from one quarter to the next. A Lender rated 5 would be probably have well above average previous (historical) purchase rates, as well as well above average current problem loan rates that would predict future purchase rates above SBA portfolio averages. Generally, loans in the portfolio of a Lender rated 5 would demonstrate less-than-acceptable credit quality and/or credit trends as measured by credit scores and portfolio performance. A Lender rated 5 would likely have a record of significant SBA program compliance issues as demonstrated through on- site or off-site reviews and assessments (of mid-size and large Lenders). Based on the substantial weaknesses outlined in this composite rating, Lenders rated a 5 would present SBA with the highest level of risk, and would thus be subject to extensive SBA oversight compared to other Lenders in the same peer group. Oversight measures could include (but are not limited to) additional reviews or assessments, requests for corrective action plans, and and/or removal from delegated loan programs, depending upon the level of activity and peer group. The descriptions within each Composite rating are not meant as definitions of the ratings, but are given to provide, in general, the characteristics a Lender receiving a particular rating may exhibit. Consequently, a Lender assigned a particular composite rating may not exhibit every characteristic described for that rating, nor would SBA's action be limited to those stated in the descriptions. In some cases, SBA may have reason to believe that a Lender's calculated composite rating may not fully reflect the level of risk that individual Lender presents. In those cases, SBA may override the composite risk rating (either positively or negatively) and assign a different composite score. Should a decision be made to override the composite score, SBA will provide the Lender with an explanation of the reason(s) for the override. More information on overrides of composite ratings is provided in the overriding factors section of this notice. SBA's proposal to base composite ratings on a numeric scale is similar to rating systems used by bank regulators and other federal loan guarantors. For example, SBA's composite rating of 1 is similar to that of a bank regulator in that it is indicative of an institution with strong performance and requiring little management oversight. SBA's rating system is similar to those of other federal loan guarantors because it measures risk and portfolio performance of loan portfolios guaranteed by SBA, rather than measuring the quality of the entire institution. Rating Components The 4 Common Components for 7(a) Lenders: SBA's proposed quantitative risk rating system for 7(a) Lenders features four common component factors. The four common rating components are defined below. (i) Past 12 Month Actual Purchase Rate--The Past 12 Month Actual Purchase Rate is an historical measure of SBA purchases from the Lender in the preceding 12 months. Thus, this component provides a measure of Lender performance and risk as indicated by actual SBA purchases. SBA calculates this ratio by dividing the sum of total gross dollars of the Lender's loans purchased during the past 12 months (numerator) by the sum of total gross outstanding dollars of their SBA loans outstanding at the end of the 12-month period, plus gross dollars purchased during the past 12 months (denominator). (ii) Problem Loan Rate--The Problem Loan Rate provides an indication of current Lender risk. This problem loan indicator helps measure Lender performance and risk by showing current delinquencies and liquidations, as well as predicting potential future purchases by SBA. SBA calculates the problem loan rate by dividing total gross outstanding dollars of a Lender's loans that are 90 days or more delinquent plus gross dollars in liquidation, excluding purchases of active loans, (numerator) by the total gross dollars outstanding (denominator). (iii) 3 Month Change in Small Business Predictive Scores (SBPS)-- The SBPS is a portfolio management (not origination) credit score based upon a borrower's business credit report and principal's consumer credit report. SBPS is a proprietary calculation provided by Dunn & Bradstreet, under contract with SBA, and is compatible with Fair, Isaac & Co.'s ``Liquid Credit'' origination score. This component signals increasing or declining purchase risk by measuring changes in borrower credit trends, and acts as a predictor of possible future loan delinquencies, liquidations, and SBA purchases. The 3 month change in SBPS is calculated by measuring the percentage change, on a dollar- weighted average basis, of the SBPS on all outstanding SBA loans held by the lender, from the previous quarter to the current quarter. (iv) Projected Purchase Rate--The Projected Purchase Rate is a predictive measure of the probability of the amount of SBA guaranteed dollars in a Lender's portfolio that are likely to be purchased by SBA. This factor uses credit bureau data on a Lender's individual SBA loans to project the purchase rate of a Lender's SBA portfolio. It is a 12- month projection of future performance based on the most current credit data on a borrower's payment history. For each of a Lender's SBA loans outstanding, SBA multiplies the amount of guaranteed loan dollars outstanding by the probability of its purchase (as determined by the SBPS of the individual loan) and totals the sum of each individual loan outstanding. This total (numerator) is then divided by the Lender's total SBA-guaranteed dollars outstanding (denominator). The 3 Common Components for CDCs: SBA's proposed quantitative risk rating system for 504 Lenders features three common component factors. The three common rating components are defined below. (i) Past 12 Month Actual Purchase Rate--The Past 12 Month Actual Purchase Rate is an historical measure of SBA purchases from the CDC in the preceding 12 months. Thus, this component provides a measure of CDC performance and risk as indicated by actual SBA purchases. SBA calculates this ratio by dividing the sum of total SBA gross dollars of the CDC's loans purchased during the past 12 months (numerator) by the sum of total SBA gross dollars of their SBA loans outstanding at the end of the 12-month period, plus total SBA gross dollars purchased during the past 12 months (denominator). (ii) Problem Loan Rate--The Problem Loan Rate provides an indication of current CDC risk. This problem loan indicator helps measure CDC performance and risk by showing current delinquencies and liquidations, as well as predicting potential future purchases by SBA. SBA calculates the problem loan rate by dividing the total SBA gross dollars of a CDC's loans that are 90 days or more delinquent plus total SBA gross dollars of a CDC's loans [[Page 25627]] in liquidation (numerator), by the total SBA gross dollars outstanding (denominator). (iii) Average Small Business Predictive Scores (SBPS)--The SBPS is a portfolio management (not origination) credit score based upon a borrower's business credit report and principal's consumer credit report. SBPS is a proprietary calculation provided by Dunn & Bradstreet, under contract with SBA, and is compatible with Fair, Isaac & Co.'s ``Liquid Credit'' origination score. This component provides an indication of the relative credit quality of the loans in a CDC's SBA portfolio. The score is calculated from the average SBPS score of the loans in a CDC's portfolio, weighted by each loan's guaranteed loan dollars outstanding. Each of the common components described above would reflect a different means of measuring a Lender's risk to SBA in terms of loan purchase data. Loan purchase metrics provide a core gauge of SBA lending success and program risk. SBA believes a risk rating system emphasizing purchase indicators would be a good measure of SBA lending risk because purchases are a strong indicator of the cost to SBA, and predictive of final charge offs and loan recoveries. In addition, loan purchases are resource intensive and an administrative expense to SBA that reduces SBA's ability to provide assistance to small businesses. Finally, SBA is a ``gap'' lender, and purchases are a prime indicator of the failure of the financing to assist in the growth and development of small businesses. Overriding Factors In addition to the common components calculated through the use of loan performance factors, the proposed risk rating system allows for consideration of additional factors. The occurrence of these factors may lead SBA to conclude that an individual lender's composite rating is not fully reflective of its true risk. Therefore, the proposed risk rating system would provide for the consideration of overriding factors, which may only apply to a particular Lender or group of Lenders, and permit SBA to adjust a Lender's overall composite rating. The allowance of overriding factors in helping determine a Lender's risk rating would enable SBA to use key risk factors that are not necessarily applicable to all Lenders, but indicate a greater or lower level of risk from a particular Lender than that which the calculated score provides. One of the most important overriding factors would be a Lender's on-site risk-based reviews/assessments usually performed on SBA's relatively large Lenders, or that may (under extraordinary circumstances) be performed on other Lenders whose performance demonstrates a highly unusual deviation from their peer group. SBA conducts on-site reviews of large Lenders, performs safety and soundness reviews of SBA Supervised Lenders, and uses certain off-site evaluation measures for less active Lenders. Consequently, these assessments, as a factor, may only be available for a fraction of SBA's approximately 5200 Lenders. Examples of other overriding factors that may be considered are: Early loan default trends; purchase rate or projected purchase rate trends; abnormally high default, purchase or liquidation rates; denial of liability occurrences; lending concentrations; rapid growth of SBA lending; inadequate, incomplete, or untimely reporting to SBA or inaccurate submission of required fees to SBA; and enforcement actions of regulators or other authority. This list is not all inclusive; however, SBA does not expect any of the overriding factors to affect a significant number of composite scores. Request for Comments SBA is undertaking a deliberative development of the Lender risk rating system. The proposed risk rating system utilizes predictive modeling and behavioral scoring systems developed by private sector industry leaders in credit risk analysis. SBA has and will continue to perform annual validation testing on the risk rating system, and will further refine the system as necessary to improve the predictability of its risk scoring. SBA is requesting comments from the public on all aspects of the proposed risk rating system. To facilitate written comments on the proposed risk rating system, SBA will provide Lenders access to their own preliminary risk ratings, as well as average peer and portfolio performance information. SBA will provide Lenders access to this information through the use of the Lender Portal developed for SBA's Loan and Lender Monitoring System (L/ LMS). Once the risk rating system is finalized, Lenders will have access to their final quarterly ratings through the portal. Additional guidance on portal access follows. Lender Portal Overview SBA intends to communicate Lender performance to Lenders through the use of SBA's Lender Portal. The portal will allow Lenders to view their own quarterly performance data, including their most current composite risk rating. Lenders can also access data on peer group and portfolio averages. Consequently, a Lender will be able to gauge its performance relative to its peer group and the portfolio norm. While Lenders can view their ratings, their performance indicators, and peer and portfolio averages, they will not be able to view the individual ratings and performance indicators of other Lenders. The quarterly performance data will be overwritten on a quarterly basis; therefore, SBA recommends that Lenders save their performance data for their own tracking and trend analysis purposes. Portal Data SBA plans to update portal data quarterly approximately six to eight weeks after a calendar quarter ends. Lenders will only be able to access the most recent quarterly data. Lenders will not be able to access previous quarters' data following an update. Correcting Portal Data Portal data includes both summary performance and credit quality data. Because summary performance data is largely derived from data that Lenders provide to SBA through 1502 and 172 Reports, Lenders bear much of the responsibility for ensuring data accuracy. If a Lender reviews its performance components and they do not comport with its own data records, the Lender should confirm the accuracy of the underlying data. If the Lender determines that the data is inaccurate, it should seek to amend any incorrect data through SBA's normal processing channels (for example--for loan performance data, Lender should contact SBA's fiscal and transfer agent). Credit quality data used to help establish certain component scores is derived from credit bureau reports of the borrower business and its principals/guarantors. To the extent that credit quality data relies on information that a Lender provides on the business, its principals, and guarantors contained in the loan application and as required to be updated by the Lender, the Lender must take responsibility for ensuring this information is correct, complete, and updated. SBA recognizes that underlying borrower credit data cannot be changed by SBA or a Lender. Therefore, any changes to data provided to credit bureaus must be reported directly to Dunn & Bradstreet or Trans Union, as appropriate, by the borrower. All corrections to portal data (both summary performance and credit quality data) will be reflected in the [[Page 25628]] quarterly update following the quarter in which the correction is entered. Portal Access Lenders with at least one outstanding SBA loan will be able to apply for portal access. SBA will issue only one portal user account per Lender. Lenders must submit initial requests for a portal user account (or requests to switch or terminate a user) by regular or overnight mail to SBA at the following address: Office of Lender Oversight--Capital Access, Suite 8200; Mail Code 7011, ATTN: Lender Portal, U.S. Small Business Administration, 409 Third Street, SW., Washington, DC 20416. Lenders must take the following steps in requesting portal access: (1) Request must be made by a senior officer of the Lender (Senior VP or above). (2) Request must be sent via regular or overnight mail to the address provided above. (3) Request must be made using the Lender's stationery. (4) Request must include the user's business card. (4) The stationery and business card should include the Lender's name and address. (5) The request should include the following data: (a) SBA FIRS ID Number(s). (b) Account user's name. (c) Account user's title. (d) Account user's mailing address at the Lender. (e) Account user's telephone number at the Lender. (f) Account user's e-mail address at the Lender. (g) Requesting officer's name. (h) Requesting officer's title. (i) Requesting officer's mailing address at the Lender. (j) Requesting officer's telephone number at the Lender. (k) Requesting officer's e-mail address at the Lender. Once SBA receives and approves the user request, the Agency will forward the approval to SBA's portal contractor for issuance of a user account name and password. The portal contractor will e-mail the user his or her user name and password within approximately two weeks of account approval. The user can then access its data by logging into the Lender portal Web page at https://pdp.dnb.com/pdpsba/pdplogin.asp. Lender Portal Responsibilities Lenders are responsible for complying with SBA's requirements in obtaining and maintaining the portal user accounts and passwords as set forth below and as published from time to time. Lenders are also responsible for timely informing SBA to terminate or switch an account if the person to whom it was issued no longer holds that responsibility for the Lender. Upon accessing the lender portal, Lenders must take full responsibility for protecting the confidentiality of the user password and lender risk rating information and for ensuring the security of the data. Confidentiality Agreement By clicking on the Portal log-in button to access the SBA Lender Information Portal (``Portal''), Lender will agree to use the Confidential Information (defined in the Portal) contained in the Portal only for confidential use within its own immediate corporate organization, and to hold and maintain the Confidential Information in confidence in accordance with the terms of the Agreement. Lender will agree to restrict access to the Confidential Information to those of its officers and employees who have a legitimate need to know such information for the purpose of assisting the Lender in improving the Lender's 7(a) or 504 program operations in conjunction with SBA's Lender Oversight Program and SBA's portfolio management (each referred to as a ``permitted party''), and to those for whom SBA has approved access by prior written consent and for whom access is required by applicable law or legal process. If such law or process requires Lender to disclose the Confidential Information to any person other than a permitted party, Lender will agree to promptly notify SBA and SBA's Information Provider (defined below) in writing so that SBA and the Information Provider have, within their sole discretion, the opportunity to seek appropriate relief such as an injunction or protective order prior to Lender's disclosure. In addition, Lender will agree to ensure that each permitted party is aware of the requirements of the Agreement and to ensure that each such permitted party agrees to the terms and conditions. Lender will agree not to disclose, and will agree to protect from disclosure, Lender's password to enter the Portal. Further, any disclosure of Confidential Information other than as permitted by the Agreement may result in appropriate action as authorized by law. Lender also will agree to indemnify and hold harmless each of SBA and any provider of the Confidential Information from and against any and all claims, demands, suits, actions, and liabilities to any degree based upon or resulting from the unauthorized use or disclosure of the Confidential Information. ``Information Provider'' means Dun & Bradstreet. (Mail Provider Information notice to Dun & Bradstreet, Legal Department, 103 JFK Parkway, Short Hills, NJ 07078.) No information contained in the Portal shall be relied upon for any purpose other than SBA's lender oversight and SBA's portfolio management purposes. In addition, Lender will acknowledge and agree that the Confidentiality Agreement is for the benefit not only of the SBA but also of any party providing the Confidential Information. Any such party shall have the right and standing to pursue all legal and equitable remedies against the Lender in the event of unauthorized use or disclosure. Portal Inquiries For general inquiries, a Lender may submit its e-mail to [email protected]. If a Lender needs to speak to an individual on a non-technical matter, it may contact Paul Bishop at 202-205-7516. SBA advises a Lender to state upfront its Lender name, address, FIRS number, and user name to expedite processing of all inquiries. Dated: April 26, 2006. Michael W. Hager, Associate Deputy Administrator, Office of Capital Access. [FR Doc. E6-6506 Filed 4-28-06; 8:45 am] BILLING CODE 8025-01-P
usgpo
2024-10-08T14:08:35.436323
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6506.htm" }
FR
FR-2006-05-01/06-4037
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25628-25629] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 06-4037] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Notice of Intent To Prepare an Environmental Impact Statement; Port Columbus International Airport, Columbus, OH AGENCY: Federal Aviation Administration, Department of Transportation ACTION: Notice of Intent; notice of scoping meetings. ----------------------------------------------------------------------- SUMMARY: The Federal Aviation Administration (FAA) is issuing this Notice of Intent to announce publicly that an Environmental Impact Statement (EIS) will be prepared and considered for the proposed construction of a replacement runway, proposed terminal development, ancillary development, and air traffic procedures developed in the Part 150 Study for the replacement runway. Associated improvements involved with the proposed project are described below. FOR FURTHER INFORMATION CONTACT: Ms. Katherine S. Jones, Federal Aviation Administration, Detroit Airports District Office, 11677 South Wayne Road, Suite [[Page 25629]] 107, Romulus, Michigan 48174, (734) 229-2958. Project Web site: http://www.airportsites.net/CMH-EIS. SUPPLEMENTARY INFORMATION: This notice announces that the FAA, in cooperation with the Columbus Regional Airport Authority (CRAA), will prepare an EIS for a proposed project to replace Runway 10R/28L at the Port Columbus International Airport, approximately 700 feet south of the existing Runway 10R/28L; new terminal facilities in the midfield area; ancillary in support of the replacement runway and midfield terminal; and noise abatement air traffic procedures developed for the replacement runway. The replacement runway would be 10,113 feet long. This length would maintain the airport's ability to accommodate current and projected airport operations. Existing Runway 10R/28L would be decommissioned as a runway and converted into a taxiway upon commissioning of the replacement runway. In addition, a south taxiway and north parallel taxiways to proposed Runway 10R/28L would be constructed. To meet future aircraft parking and passenger processing requirements, new midfield terminal facilities are needed. The EIS will assess a development envelope that is defined as an area large enough to encompass Phase I and II of the CRAA terminal development program. The number of gates, approximate square footage, approximate curb frontage, and the number of passengers that the terminal would accommodate will be discussed throughout the process. Ancillary facilities in support of the replacement runway and midfield terminal would be constructed . The facilities include roadway relocations and construction; parking improvements; property acquisition; and relocation of residences, businesses, and farms, as necessary. The CRAA is in the process of preparing a 14 CFR part 150 Noise Compatibility Study Update (Part 150 Update) to address the current and future noise conditions. The Part 150 Update will include an analysis of the potential noise and land use impacts resulting from the proposed development of relocating Runway 10R/28L to the south, as well as possible mitigation options. Any noise abatement air traffic options recommended through the Part 150 Update will be included in the EIS as part of the part of the proposed project. In addition, any land use mitigation that is recommended in the Part 150 Update for the proposed project will be included in the EIS. The EIS will include the evaluation of a no action alternative and other reasonable alternatives that may be identified during the agency and public scoping meetings. The EIS will determine all environmental impacts, such as and not limited to, noise impacts, impacts on air and water quality, wetlands, ecological resources, floodplains, historic resources, hazardous wastes, socioeconomics, and economic factors. Scoping: To resure that the full range of issues related to the proposed project is addressed and that all significant issues are identified, comments and suggestions are invited from all interested parties. Public and agency scoping meetings will be conducted to identify any significant issues associated with the proposed project. An agency scoping meeting for all Federal, state, and local environmental regulatory agencies will be held on May 31, 2006. This meeting will take place at 10 a.m. in the Emergency Operations Center at the Port Columbus International Airport, 4600 International Gateway, Columbus, Ohio 43219. Two public scoping meetings for the general public will be held on the evenings of May 31, 2006 and June 1, 2006. The meetings will be conducted at two locations, one at the Holiday Inn, 750 Stelzer Road, Columbus, OH 43219 and the other at the Ramda Inn, 4801 East Broad Street, Columbus, Ohio 43213. Both meetings will be held between 5 p.m. and 8 p.m. Written comments may be mailed to the Informational contact listed above within 30 days following the scoping meetings. Questions may be directed to the individual named above under the heading, FOR FURTHER INFORMATION CONTACT. Issued in Romulus, Michigan, April 21, 2006. Irene R. Porter, Manager, Detroit Airports District Office, FAA, Great Lakes Region. [FR Doc. 06-4037 Filed 4-28-06; 8:45 am] BILLING CODE 4910-13-M
usgpo
2024-10-08T14:08:35.461611
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/06-4037.htm" }
FR
FR-2006-05-01/06-4038
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25629] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 06-4038] ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Sixth Meeting: RTCA Special Committee 203/Minimum Performance Standards for Unmanned Aircraft Systems and Unmanned Aircraft AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of RTCA Special Committee 203, Minimum Performance Standards for Unmanned Aircraft Systems and Unmanned Aircraft. ----------------------------------------------------------------------- SUMMARY: The FAA is issuing this notice to advise the public of a meeting of RTCA Special Committee 203, Minimum Performance Standards for Unmanned Aircraft Systems and Unmanned Aircraft and Working Groups 1-3 and Sub-Groups 1-3. DATES: The meeting will be held May 16-19, 2006, starting at 9 a.m. ADDRESSES: The meeting will be held at RTCA, 1828 L Street, NW., Suite 805, Washington, DC 20036. FOR FURTHER INFORMATION CONTACT: (1) RTCA Secretariat, 1828 L Street, NW., Suite 805, Washington, DC 20036; telephone (202) 833-9339; fax (202) 833-9434; Web site http:www.rtca.org SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., Appendix 2), notice is hereby given for a Special Committee 203 meeting. The agenda will include: May 16: Sub-Group 1, 2 & 3 Writing Teams in working sessions. May 17: Opening Plenary Session (Welcome and Introductory Remarks, Approval of Fifth Plenary Summary, Review SC-203 Progress Since Fifth Plenary, Other Business, Prepare for Plenary 7, Plenary Adjourns). Sub-Group Writing Teams in working sessions. May 18: Sub-Group 1, 2 & 3 Writing Teams continue in working sessions. Working Groups 2 & 3 Teams in working session. May 19: Sub-Group 1, 2, & 3 Writing Teams in working sessions. Working Groups 2 & 3 in working session. Attendance is open to the interested public but limited to space availability. With the approval of the chairmen, members of the public may present oral statements at the meeting. Persons wishing to present statements or obtain information should contact the person listed in the FOR FURTHER INFORMATION CONTACT section. Members of the public may present a written statement to the committee at any time. Issued in Washington, DC, on April 18, 2006. Francisco Estrada C., RTCA Advisory Committee. [FR Doc. 06-4038 Filed 4-28-06; 8:45 am] BILLING CODE 4910-13-M
usgpo
2024-10-08T14:08:35.479337
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/06-4038.htm" }
FR
FR-2006-05-01/06-4039
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25630] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 06-4039] [[Page 25630]] ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Second Meeting: Special Committee 209, Air Traffic Control Radar Beacon Systems (ATCRBS)Mode S Transponder AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of RTCA Special Committee 209, ATCRBS/Mode S Transponder. ----------------------------------------------------------------------- SUMMARY: The FAA is issuing this notice to advise the public of a meeting of RTCA Special Committee 209, Air Traffic Control Radar Beacon Systems (ATCRBS)/Mode S Transponder. DATES: The meeting will be held May 23, 2006, from 9 a.m.-5 p.m., and May 24, from 9 a.m.-4 p.m. ADDRESSES: The meeting will be held at L-3/Titan Group, 5218 Atlantic Avenue, 3rd floor, Mays Landing, NJ 08330. FOR FURTHER INFORMATION CONTACT: RTCA Secretariat, 1828 L Street, NW., Suite 805, Washington, DC 20036; telephone (202) 833-9339; fax (202) 833-9434; Web site http://www.rtca.org. Host Contact: Gary Furr (609) 625-5669; e-mail [email protected]. SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., Appendix 2), notice is hereby given for a Special Committee 209 meeting. The agenda will include: May 23-24: Opening Plenary Session (Welcome, Introductions, and Administrative Remarks, Review/Approval of Agenda, Review/Approval of Minutes from Meeting 1). Report from Team reviewing the ADLP MOPS, DO-218B. Report from Team reworking DO-181C. Report from Team reviewing the udpate of Text Procedures. Status of coordination with WG-49 on Comparison Data Base. Review Status of Action Items. Closing Plenary Session (Other Business, Discussion of Agenda for Next Meeting, Date, Place and Time of Future Meeting, Adjourn). Attendance is open to the interested public but limited to space availability. With the approval of the chairmen, members of the public may present oral statements at the meeting. Persons wishing to present statements or obtain information should contact the person listed in the FOR FURTHER INFORMATION CONTACT section. Members of the public may present a written statement to the committee at any time. Issued in Washington, DC, on April 24, 2006. Francisco Estrada C., RTCA Advisory Committee. [FR Doc. 06-4039 Filed 4-28-06; 8:45 am] BILLING CODE 4910-13-M
usgpo
2024-10-08T14:08:35.502083
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/06-4039.htm" }
FR
FR-2006-05-01/06-4090
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25630-25631] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 06-4090] ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Federal Highway Administration Notice of Final Federal Agency Actions on Proposed Highways in South Carolina AGENCY: Federal Highway Administration (FHWA), DOT. ACTION: Notice of Limitation on Claims for Judicial Review of Actions by FHWA and Other Federal Agencies. ----------------------------------------------------------------------- SUMMARY: This notice announces actions taken by the FHWA and other Federal agencies that are final within the meaning of 23 U.S.C. 139(l)(1). The actions relate to various proposed highway projects in the State of South Carolina. Those actions grant licenses, permits, and approvals for the projects. DATES: By this notice, the FHWA is advising the public of final agency actions subject to 23 U.S.C. 139(l)(1). A claim seeking judicial review of the Federal agency actions on any of the listed highway projects will be barred unless the claim is filed on or before October 30, 2006. If the Federal law that authorizes judicial review of a claim provides a time period of less than 180 days for filing such claim, then that shorter time period still applies. FOR FURTHER INFORMATION CONTACT: Mr. Robert L. Lee, Division Administrator, Federal Highway Administration, 1835 Assembly Street, Suite 1270, Columbia, SC 29201; Telephone: (803) 765-5411; e-mail: [email protected]. The FHWA South Carolina Division Office's normal business hours are 7 a.m. to 4:30 p.m. (eastern time). You may also contact Mr. J. Berry Still, P.E., South Carolina Department of Transportation, 955 Park Street, P.O. Box 191, Columbia, SC 29202-0191; Telephone: (803) 737-9967; e-mail: [email protected]. SUPPLEMENTARY INFORMATION: Notice is hereby given that the FHWA and other Federal agencies have taken final agency actions by issuing licenses, permits, and approvals for the highway project in the State of South Carolina that is listed below. The project will improve safety on US 17 from US 21 in Gardens Corner to SC 64 in Jacksonboro while preserving community values and protecting the natural and scenic environment of the ACE Basin. The actions by the Federal agencies on a project, and the laws under which such actions were taken, are described in the documented environmental assessment (EA) and Finding of Significant Impact (FONSI) issued in connection with the project, and in other documents in the FHWA administrative record for the project. The EA, FONSI and other documents from the FHWA administrative record files for the listed project are available by contacting the FHWA or the SCDOT at the addresses provided above. This notice applies to all Federal agency decisions on the listed project as of the issuance date of this notice and all laws under which such actions were taken, including but not limited to: 1. General: National Environmental Policy Act (NEPA) [42 U.S.C. 4321-4351]; Federal-Aid Highway Act [23 U.S.C. 109]. 2. Air: Clean Air Act, 42 U.S.C. 7401-7671(q). 3. Land: Section 4(f) of the Department of Transportation Act of 1966 [49 U.S.C. 303]; Landscaping and Scenic Enhancement (Wildflowers), 23 U.S.C. 319. 4. Wildlife: Endangered Species Act [16 U.S.C. 1531-1544 and Section 1536], Marine Mammal Protection Act [16 U.S.C. 1361], Anadromous Fish Conservation Act [16 U.S.C. 757(a)-757(g)], Fish and Wildlife Coordination Act [16 U.S.C. 661-667(d)], Migratory Bird Treaty Act [16 U.S.C. 703-712], Magnuson-Stevenson Fishery Conservation and Management Act of 1976, as amended [16 U.S.C. 1801 et seq.]. 5. Historic and Cultural Resources: Section 106 of the National Historic Preservation Act of 1966, as amended [16 U.S.C. 470(f) et seq.]; Archaeological Resources Protection Act of 1977 [16 U.S.C. 470(aa)-11]; Archaeological and Historic Preservation Act [16 U.S.C. 469-469(c)]; Native American Grave Protection and Repatriation Act (NAGPRA) [25 U.S.C. 3001-3013]. 6. Social and Economic: Civil Rights Act of 1964 [42 U.S.C. [2000(d)-2000(d)(1)]; American Indian Religious Freedom Act [42 U.S.C. 1996]; Farmland Protection Policy Act (FPPA) [7 U.S.C. 4201-4209]. 7. Wetlands and Water Resources: Clean Water Act, [33 U.S.C.] 1251- 1377 (Section 404, Section 401, Section 319); Coastal Barrier Resources Act, 16 U.S.C. 3501-3510; Coastal Zone Management Act, 16 U.S.C. 1451- 1465; Land and Water Conservation Fund (LWCF), 16 U.S.C. 4601-4604; Safe Drinking Water Act (SDWA), 42 U.S.C. 300(f)-300(j)(6); Rivers and Harbors Act of 1899, 33 U.S.C. 401-406; Wild and Scenic Rivers [[Page 25631]] Act, 16 U.S.C. 1271-1287; Emergency Wetlands Resources Act, 16 U.S.C. 3921, 3931; TEA-21 Wetlands Mitigation, 23 U.S.C. 103(b)(6)(m), 133(b)(11); Flood Disaster Protection Act, 42 U.S.C. 4001-4128. 8. Hazardous Materials: Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), 42 U.S.C. 9601-9675; Superfund Amendments and Reauthorization Act of 1986 (SARA); Resource Conservation and Recovery Act (RCRA), 42 U.S.C. 6901-6992(k). 9. Executive Orders: E.O. 11990 Protection of Wetlands; E.O. 11988 Floodplain Management; E.O. 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations; E.O. 11593 Protection and Enhancement of Cultural Resources; E.O. 13007 Indian Sacred Sites; E.O. 13287 Preserve America; E.O. 13175 Consultation and Coordination with Indian Tribal Governments; E.O. 11514 Protection and Enhancement of Environmental Quality; E.O. 13112 Invasive Species. The project subject to this notice is: Project Location: US-17--Beaufort and Colleton Counties, US-17--ACE Basin Widening between Gardens Corner and Jacksonboro. The project proposes a combination of alignment shifts to avoid and minimize environmental impacts as much as practicable while maintaining the safety and scenic nature of roadway. An EA was issued on September 16, 2005 and a FONSI was issued on April 7, 2006. (Catalog of Federal Domestic Assistance Program Number 20.205, Highway Planning and Construction. The regulation implementing Executive Order 12372 regarding intergovernmental consultation of Federal programs and activities apply to this program.) Authority: 23 U.S.C. 1391(l)(1). Issued on: April 25, 2006. Robert Lee, Division Administrator, FHWA-SC Division, Columbia, SC. [FR Doc. 06-4090 Filed 4-28-06; 8:45 am] BILLING CODE 4910-22-M
usgpo
2024-10-08T14:08:35.538102
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/06-4090.htm" }
FR
FR-2006-05-01/E6-6515
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25631] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6515] ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Maritime Administration [Docket Number 2006 24619] Requested Administrative Waiver of the Coastwise Trade Laws AGENCY: Maritime Administration, Department of Transportation. ACTION: Invitation for public comments on a requested administrative waiver of the Coastwise Trade Laws for the vessel BLUE ICE. ----------------------------------------------------------------------- SUMMARY: As authorized by Public Law 105-383 and Public Law 107-295, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.- build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below. The complete application is given in DOT docket 2006-24619 at http://dms.dot.gov. Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with Public Law 105-383 and MARAD's regulations at 46 CFR part 388 (68 FR 23084; April 30, 2003), that the issuance of the waiver will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, a waiver will not be granted. Comments should refer to the docket number of this notice and the vessel name in order for MARAD to properly consider the comments. Comments should also state the commenter's interest in the waiver application, and address the waiver criteria given in Sec. 388.4 of MARAD's regulations at 46 CFR part 388. DATES: Submit comments on or before May 31, 2006. ADDRESSES: Comments should refer to docket number MARAD-2006 24619. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. DOT Dockets, Room PL-401, Department of Transportation, 400 7th St., SW., Washington, DC 20590-0001. You may also send comments electronically via the Internet at http://dmses.dot.gov/submit/. All comments will become part of this docket and will be available for inspection and copying at the above address between 10 a.m. and 5 p.m., E.T., Monday through Friday, except federal holidays. An electronic version of this document and all documents entered into this docket is available on the World Wide Web at http://dms.dot.gov. FOR FURTHER INFORMATION CONTACT: Joann Spittle, U.S. Department of Transportation, Maritime Administration, MAR-830 Room 7201, 400 Seventh Street, SW., Washington, DC 20590. Telephone 202-366-5979. SUPPLEMENTARY INFORMATION: As described by the applicant the intended service of the vessel BLUE ICE is: Intended Use: ``Passenger (6 or fewer).'' Geographic Region: Florida. Dated: April 25, 2006. By order of the Maritime Administrator. Joel C. Richard, Secretary, Maritime Administration. [FR Doc. E6-6515 Filed 4-28-06; 8:45 am] BILLING CODE 4910-81-P
usgpo
2024-10-08T14:08:35.561366
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6515.htm" }
FR
FR-2006-05-01/E6-6514
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25631-25632] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6514] ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Maritime Administration [Docket Number 2006 24620] Requested Administrative Waiver of the Coastwise Trade Laws AGENCY: Maritime Administration, Department of Transportation. ACTION: Invitation for public comments on a requested administrative waiver of the Coastwise Trade Laws for the vessel BLUEBIRD. ----------------------------------------------------------------------- SUMMARY: As authorized by Public Law 105-383 and Public Law 107-295, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.- build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below. The complete application is given in DOT docket 2006-24620 at http://dms.dot.gov. Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with Public Law 105-383 and MARAD's regulations at 46 CFR part 388 (68 FR 23084; April 30, 2003), that the issuance of the waiver will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, a waiver will not be granted. Comments should refer to the docket number of this notice and the vessel name in order for MARAD to properly consider the comments. Comments should also state the commenter's interest in the waiver application, and address the waiver criteria given in Sec. 388.4 of MARAD's regulations at 46 CFR part 388. DATES: Submit comments on or before May 31, 2006. ADDRESSES: Comments should refer to docket number MARAD-2006 24620. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. DOT Dockets, Room PL-401, Department of Transportation, 400 7th [[Page 25632]] St., SW., Washington, DC 20590-0001. You may also send comments electronically via the Internet at http://dmses.dot.gov/submit/. All comments will become part of this docket and will be available for inspection and copying at the above address between 10 a.m. and 5 p.m., E.T., Monday through Friday, except Federal holidays. An electronic version of this document and all documents entered into this docket is available on the World Wide Web at http://dms.dot.gov. FOR FURTHER INFORMATION CONTACT: Joann Spittle, U.S. Department of Transportation, Maritime Administration, MAR-830 Room 7201, 400 Seventh Street, SW., Washington, DC 20590. Telephone 202-366-5979. SUPPLEMENTARY INFORMATION: As described by the applicant the intended service of the vessel BLUEBIRD is: Intended Use: ``Carry passengers for hire.'' Geographic Region: Washington, Oregon, Alaska. Dated: April 25, 2006. By order of the Maritime Administrator. Joel C. Richard, Secretary, Maritime Administration. [FR Doc. E6-6514 Filed 4-28-06; 8:45 am] BILLING CODE 4910-81-P
usgpo
2024-10-08T14:08:35.586896
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6514.htm" }
FR
FR-2006-05-01/E6-6523
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25632] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6523] ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Maritime Administration [Docket Number 2006 24617] Requested Administrative Waiver of the Coastwise Trade Laws AGENCY: Maritime Administration, Department of Transportation. ACTION: Invitation for public comments on a requested administrative waiver of the Coastwise Trade Laws for the vessel JOHN W. ----------------------------------------------------------------------- SUMMARY: As authorized by Public Law 105-383 and Public Law 107-295, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.- build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below. The complete application is given in DOT docket 2006-24617 at http://dms.dot.gov. Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with Public Law 105-383 and MARAD's regulations at 46 CFR part 388 (68 FR 23084; April 30, 2003), that the issuance of the waiver will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, a waiver will not be granted. Comments should refer to the docket number of this notice and the vessel name in order for MARAD to properly consider the comments. Comments should also state the commenter's interest in the waiver application, and address the waiver criteria given in Sec. 388.4 of MARAD's regulations at 46 CFR part 388. DATES: Submit comments on or before May 31, 2006. ADDRESSES: Comments should refer to docket number MARAD 2006 24617. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. DOT Dockets, Room PL-401, Department of Transportation, 400 7th St., SW., Washington, DC 20590-0001. You may also send comments electronically via the Internet at http://dmses.dot.gov/submit/. All comments will become part of this docket and will be available for inspection and copying at the above address between 10 a.m. and 5 p.m., E.T., Monday through Friday, except Federal holidays. An electronic version of this document and all documents entered into this docket is available on the World Wide Web at http://dms.dot.gov. FOR FURTHER INFORMATION CONTACT: Joann Spittle, U.S. Department of Transportation, Maritime Administration, MAR-830 Room 7201, 400 Seventh Street, SW., Washington, DC 20590. Telephone 202-366-5979. SUPPLEMENTARY INFORMATION: As described by the applicant the intended service of the vessel JOHN W is: Intended Use: ``day charter, overnight charter.'' Geographic Region: Albemarle Sound, North Carolina and environs. Dated: April 25, 2006. By order of the Maritime Administrator. Joel C. Richard, Secretary, Maritime Administration. [FR Doc. E6-6523 Filed 4-28-06; 8:45 am] BILLING CODE 4910-81-P
usgpo
2024-10-08T14:08:35.617552
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6523.htm" }
FR
FR-2006-05-01/E6-6520
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25632-25633] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6520] ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Maritime Administration [Docket Number 2006 24616] Requested Administrative Waiver of the Coastwise Trade Laws AGENCY: Maritime Administration, Department of Transportation. ACTION: Invitation for public comments on a requested administrative waiver of the Coastwise Trade Laws for the vessel LEA SCOTIA. ----------------------------------------------------------------------- SUMMARY: As authorized by Public Law 105-383 and Public Law 107-295, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.- build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below. The complete application is given in DOT docket 2006 24616 at http://dms.dot.gov. Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with Public Law 105-383 and MARAD's regulations at 46 CFR part 388 (68 FR 23084; April 30, 2003), that the issuance of the waiver will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, a waiver will not be granted. Comments should refer to the docket number of this notice and the vessel name in order for MARAD to properly consider the comments. Comments should also state the commenter's interest in the waiver application, and address the waiver criteria given in Sec. 388.4 of MARAD's regulations at 46 CFR part 388. DATES: Submit comments on or before May 31, 2006. ADDRESSES: Comments should refer to docket number MARAD 2006 24616. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. DOT Dockets, Room PL-401, Department of Transportation, 400 7th St., SW., Washington, DC 20590-0001. You may also send comments electronically via the Internet at http://dmses.dot.gov/submit/. All comments will become part of this docket and will be available for inspection and copying at the above address between 10 a.m. and 5 p.m., E.T., Monday through Friday, except Federal holidays. An electronic version of this document and all documents entered into this docket is available on the World Wide Web at http://dms.dot.gov. FOR FURTHER INFORMATION CONTACT: Joann Spittle, U.S. Department of Transportation, Maritime Administration, MAR-830 Room 7201, 400 Seventh Street, SW., Washington, DC 20590. Telephone 202-366-5979. SUPPLEMENTARY INFORMATION: [[Page 25633]] As described by the applicant the intended service of the vessel LEA SCOTIA is: Intended Use: ``private charter.'' Geographic Region: Puget Sound, San Juan Islands, West Coast US. Dated: April 25, 2006. By order of the Maritime Administrator. Joel C. Richard, Secretary, Maritime Administration. [FR Doc. E6-6520 Filed 4-28-06; 8:45 am] BILLING CODE 4910-81-P
usgpo
2024-10-08T14:08:35.646757
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6520.htm" }
FR
FR-2006-05-01/E6-6517
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25633] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6517] ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Maritime Administration [Docket Number 2006 24618] Requested Administrative Waiver of the Coastwise Trade Laws AGENCY: Maritime Administration, Department of Transportation. ACTION: Invitation for public comments on a requested administrative waiver of the Coastwise Trade Laws for the vessel SINGAWING. ----------------------------------------------------------------------- SUMMARY: As authorized by Public Law 105-383 and Public Law 107-295, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.- build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below. The complete application is given in DOT docket 2006-24618 at http://dms.dot.gov. Interested parties may comment on the effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. If MARAD determines, in accordance with Public Law 105-383 and MARAD's regulations at 46 CFR part 388 (68 FR 23084; April 30, 2003), that the issuance of the waiver will have an unduly adverse effect on a U.S.-vessel builder or a business that uses U.S.-flag vessels in that business, a waiver will not be granted. Comments should refer to the docket number of this notice and the vessel name in order for MARAD to properly consider the comments. Comments should also state the commenter's interest in the waiver application, and address the waiver criteria given in Sec. 388.4 of MARAD's regulations at 46 CFR part 388. DATES: Submit comments on or before May 31, 2006. ADDRESSES: Comments should refer to docket number MARAD-2006 24618. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. DOT Dockets, Room PL-401, Department of Transportation, 400 7th St., SW., Washington, DC 20590-0001. You may also send comments electronically via the Internet at http://dmses.dot.gov/submit/. All comments will become part of this docket and will be available for inspection and copying at the above address between 10 a.m. and 5 p.m., E.T., Monday through Friday, except Federal holidays. An electronic version of this document and all documents entered into this docket is available on the World Wide Web at http://dms.dot.gov. FOR FURTHER INFORMATION CONTACT: Joann Spittle, U.S. Department of Transportation, Maritime Administration, MAR-830 Room 7201, 400 Seventh Street, SW., Washington, DC 20590. Telephone 202-366-5979. SUPPLEMENTARY INFORMATION: As described by the applicant the intended service of the vessel SINGAWING is: Intended Use: ``6-pack charters.'' Geographic Region: Coastal and inland waters of Washington State. Dated: April 25, 2006. By order of the Maritime Administrator. Joel C. Richard, Secretary, Maritime Administration. [FR Doc. E6-6517 Filed 4-28-06; 8:45 am] BILLING CODE 4910-81-P
usgpo
2024-10-08T14:08:35.679540
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6517.htm" }
FR
FR-2006-05-01/E6-6535
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25633-25640] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6535] ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No. PHMSA-06-24304 (Notice No. 06-2)] Safety Advisory: Manufacture, Marking, and Sale of Untested Compressed Gas Cylinders AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. ACTION: Safety advisory notice. ----------------------------------------------------------------------- SUMMARY: PHMSA was recently notified of the manufacture, marking, and sale of certain high pressure DOT exemption cylinders that were not tested in accordance with applicable regulatory requirements. These cylinders were manufactured and/or distributed by Luxfer, Inc. (Luxfer), Riverside, CA. Luxfer and its independent inspection agency, Arrowhead Industrial Services, Inc. (Arrowhead), reported to PHMSA that 6,325 high pressure cylinders manufactured to the DOT CFFC and FRP-1 standards as authorized in DOT-E 10915, DOT-E 9634, and DOT-E 9894, had been shipped from Luxfer without undergoing the required autofrettage and hydrostatic tests. In a joint effort, Luxfer and Arrowhead have retrieved 2,581 of the untested cylinders. The model numbers and serial numbers of the remaining 3,744 cylinders are listed in this notice. Only cylinders with the listed serial numbers listed are affected. A person with a listed cylinder should discontinue use of the cylinder and return it to Arrowhead at the address below so the autofrettage and hydrostatic test can be completed before its next use. Shippers and compressed gas filling facilities are advised that these cylinders do not meet the requirements of the Hazardous Materials Regulations and may not be offered for transportation or transported until the required testing is completed. FOR FURTHER INFORMATION CONTACT: Wayne E. Chaney, Cylinder Program Manager, Office of Hazardous Materials Enforcement, (202) 366-4700, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, 400 Seventh Street, SW., Room 7104, Washington, DC 20590-0001. SUPPLEMENTARY INFORMATION: Luxfer and its independent inspection agency, Arrowhead Industrial Services, Inc. (Arrowhead), reported to PHMSA that 6,325 high pressure cylinders manufactured to the DOT CFFC and FRP-1 standards as authorized in DOT-E 10915, DOT-E 9634, and DOT-E 9894, had been shipped from Luxfer without undergoing the required autofrettage and hydrostatic tests. In a joint effort, Luxfer and Arrowhead have retrieved 2,581 of the untested cylinders. PHMSA has compiled a list of all model and serial number markings of the remaining cylinders identified by Luxfer and Arrowhead that were not properly tested prior to distribution. Information provided to PHMSA indicates many of these cylinders are being used as self-contained breathing apparatus, in paint ball applications, and in aircraft slide service. Any person possessing a cylinder manufactured by Luxfer and marked with exemption number DOT-E 10915, DOT-E 9634, or DOT-E 9894 and marked with one of the serial numbers listed in this notice should take the cylinder to a qualified refilling station and have the pressure relieved from the cylinder. The cylinder should be returned to Arrowhead Industrial Services for autofrettage and hydrostatic testing before further use. Refilling stations and cylinder requalification facilities are advised that any cylinders marked with DOT-E 10915, DOT- E 9634, or DOT-E 9894 should be checked against the attached [[Page 25634]] list of serial numbers before they are filled or requalified for service. To make arrangements to have an affected cylinder autofrettaged and hydrostatically tested, contact Arrowhead Industrial Services, Inc., 3537 South NC 119, P.O. Box 1000, Graham, NC 27253; telephone (336) 578-2777. This safety advisory covers only the high-pressure DOT exemption cylinders manufactured by Luxfer that have a model number and serial listed on the attached list. Not all cylinders manufactured by Luxfer under DOT-E 10915, DOT-E 9634, and DOT-E 9894 are affected. ---------------------------------------------------------------------------------------------------------------- Model No. ( of cylinders) Serial Nos. ---------------------------------------------------------------------------------------------------------------- LI7A MSA (42).......................................... 6276, 6277, 6278, 6279, 6280, 6281, 6282, 6283, 6284, 6285, 6286, 6287, 6288, 6289, 6290, 6291, 6292, 6293, 6294, 6295, 6296, 6297, 6298, 6299, 6300, 6301, 6302, 6303, 6304, 6305, 6306, 6307, 6308, 6309, 6310, 6311, 6312, 6313, 6314, 6315, 6316, 6317 LI7D SURV (12)......................................... 154, 155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165 LI7M MSA (3)........................................... 1282, 1287, 1307 L45G-1 SURV (38)....................................... 95899, 95900, 95903, 95904, 95905, 95906, 95907, 95908, 95909, 95910, 95911, 95912, 95913, 95914, 95915, 95917, 95918, 95919, 95921, 95922, 95925, 95927, 95928, 95929, 95930, 95931, 95932, 95933, 95934, 95935, 95936, 95938, 95940, 95941, 95942, 95943, 95944, 95945 L45G-2 Scott IJ (108).................................. 111401, 111561, 113303, 111404, 111562, 113305, 111409, 111565, 113307, 111550, 111567, 113310, 111551, 111576, 113311, 111553, 111577, 113313, 111554, 111579, 113316, 111556, 111580, 113317,, 111557, 111581, 113318, 111558, 111582, 113324, 111560, 111585, 113409, 111586, 113445, 111587, 113450, 111588, 113451, 111589, 113452, 111590, 113453, 112470, 113454, 112475, 113455, 112478, 113456, 112479, 113457, 113201, 113459, 113204, 113460, 113219, 113461, 113230, 113462, 113236, 113464, 113241, 113473, 113248, 113474, 113252, 113480, 113254, 113492, 113258, 113498, 113263,, 113532, 113264, 113533, 113265, 113536, 113267,, 113538, 113269, 113542, 113272, 113544, 113273,, 113547, 113274, 113548, 113277, 113550, 113281, 113555, 113282, 113556, 113284, 113564, 113285, 113569, 113286, 113833, 113288, 113867, 113294, 113905, 113298, 114633, 113299, 114671, 113302 L45J-1 SURV (117)...................................... 29576, 29630, 29838, 29577, 29631, 29840, 29578, 29632, 29841, 29579, 29633, 29844, 29580, 29634, 29845, 29581, 29635, 29846, 29582, 29636, 29848, 29583, 29637, 29849, 29584, 29638, 29850, 29586, 29639, 29853, 29587, 29640, 29858, 29588, 29641, 29860, 29589, 29642, 29861, 29590, 29643, 29862, 29591, 29644, 29863, 29592, 29645, 29864, 29593, 29647, 29865, 29594, 29648, 29866, 29595, 29649, 29867, 29596, 29650, 29597, 29651, 29598, 29652, 29599, 29653, 29600, 29654, 29602, 29655, 29603, 29656, 29604, 29657, 29605, 29658, 29606, 29659, 29607, 29660, 29609, 29661, 29610, 29662, 29611, 29663, 29612, 29665, 29613, 29667, 29615, 29668, 29616, 29670, 29617, 29812, 29618, 29815, 29619, 29816, 29620, 29818, 29621, 29822, 29622, 29823, 29623, 29824, 29624, 29832, 29625, 29833, 29626, 29834, 29628, 29836, 29629, 29837 L45J-14 SURV (1)....................................... 42177 L45J-19 SURV (7)....................................... 42986, 42987, 42988, 42989, 42990, 42991, 42992 L45M-44 SCOTT (54)..................................... 49855, 49904, 49856, 49905, 49857, 49906, 49858, 49907, 49859, 49908, 49860, 49861, 49862, 49863, 49864, 49865, 49866, 49867, 49868, 49869, 49870, 49871, 49872, 49873, 49874, 49875, 49876, 49877, 49878, 49879, 49880, 49881, 49882, 49883, 49884, 49885, 49886, 49887, 49888, 49889, 49890, 49891, 49892, 49893, 49894, 49895, 49896, 49897, 49898, 49899, 49900, 49901, 49902, 49903 L45M-1 MSA (73)........................................ 76785, 76786, 76787, 76788, 76789, 76790, 76791, 76792, 76793, 76794, 76795, 76796, 76797, 76798, 76799, 76800, 76801, 76802, 76803, 76804, 76805, 76806, 76807, 76808, 76809, 76810, 76811, 76812, 76813, 76814, 76815, 76816, 76817, 76818, 76819, 76820, 76821, 76822, 76823, 76824, 76825, 76826, 76827, 76828, 76829, 76830, 76831, 76832, 76833, 76834, 76835, 76836, 76837, 76838, 76839, 76840, 77553, 77559, 77560, 77564, 77565, 77568, 77575, 77579, 77580, 77585, 77589, 77596, 77597, 77615, 77634, 77649, 77650 [[Page 25635]] L45M-18 SCOTT (888).................................... 136584, 136585, 136586, 136587, 136588, 136589, 136590, 136591, 136592, 136593, 136594, 136595, 136596, 136597, 136598, 136599, 136600, 136601, 136602, 136603, 136604, 136605, 136606, 136607, 136608, 136609, 136610, 136611, 136612, 136613, 136614, 136615, 136616, 136617, 136618, 136619, 136620, 136621, 136622, 136623, 136624, 136625, 136626, 136627, 136628, 136629, 136630, 136631, 136632, 136633, 136634, 136635, 136636, 136637, 136638, 136639, 136640, 136641, 136809, 136810, 136811, 136812, 136813, 136814, 136815, 136816, 136817, 136818, 136819, 136820, 136821, 136822, 136823, 136824, 136825, 136826, 136827, 136828, 136829, 136830, 136831, 136832, 136833, 136834, 136835, 136836, 136837, 136838, 136839, 136840, 136841, 136842, 136843, 136844, 136845, 136846, 136847, 136848, 136849, 136850, 136851, 136852, 136853, 136854, 136855, 136856, 136857, 136858, 136859, 136860, 136861, 136862, 136863, 136864, 136865, 138145, 138146, 138147, 138148, 138149, 138150, 138151, 138152, 138153, 138154, 138155, 138156, 138157, 138158, 138159, 138160, 138161, 138162, 138163, 138164, 138165, 138166, 138167, 138168, 138169, 138170, 138171, 138172, 138173, 138174, 138175, 138176, 138177, 138178, 138179, 138180, 138181, 138182, 138183, 138184, 138185, 138186, 138187, 138188, 138189, 138190, 138191, 138192, 138193, 138194, 138195, 138196, 138197, 138198, 138199, 138200, 138915, 138916, 138917, 138918, 138919, 138920, 138921, 138922, 138923, 138924, 138925, 138926, 138927, 138928, 138929, 138930, 138931, 138932, 138933, 138934, 138935, 138936, 138937, 138938, 138939, 138940, 138941, 138942, 138943, 138944, 138945, 138946, 138947, 138948, 138949, 138950, 138951, 138952, 138953, 138954, 138955, 138956, 138957, 138958, 138959, 138960, 138961, 138962, 138963, 138964, 138965, 138966, 138967, 138968, 138969, 138970, 138971, 138972, 138973, 138974, 138975, 138976, 138977, 138978, 138979, 138980, 138981, 138982, 138983, 138984, 138985, 138986, 138987, 138988, 138989, 138990, 138991, 138992, 138993, 138994, 138995, 138996, 138997, 138998, 138999, 139000, 139001, 139002, 139003, 139004, 139005, 139006, 139007, 139008, 139009, 139010, 139011, 139012, 139013, 139014, 139015, 139016, 139017, 139018, 139019, 139020, 139021, 139022, 139023, 139024, 139025, 139026, 139027, 139028, 139029, 139030, 139031, 139032, 139033, 139034, 139035, 139036, 139037, 139038, 139039, 140757, 140758, 140759, 140760, 140761, 140762, 140763, 140764, 140765, 140766, 140767, 140768, 140769, 140770, 140771, 140772, 140773, 140774, 140775, 140776, 140799, 140800, 140801, 140802, 140803, 140804, 140805, 140806, 140807, 140808, 140809, 140810, 140811, 140812, 140813, 140814, 140815, 140816, 140817, 140818, 140819, 140820, 140821, 140822, 140823, 140824, 140825, 140826, 140827, 140828, 140829, 140830, 140831, 140832, 140833, 140834, 140835, 140836, 140837, 140838, 140839, 140840, 140841, 140842, 140843, 140844, 140845, 140846, 140847, 140848, 140849, 140850, 140851, 141582, 141583, 141584, 141585, 141585, 141587, 141588, 141589, 141590, 141591, 141592, 141593, 141594, 141595, 141596, 141597, 141598, 141599, 141600, 141601, 141602, 141603, 141604, 141605, 141606, 141607, 141608, 141609, 141610, 141611, 141612, 141613, 141614, 141615, 141616, 141617, 141618, 141619, 141620, 141621, 141622, 141623, 141624, 141625, 141626, 141627, 141628, 141629, 141630, 141631, 141632, 141633, 141634, 141635, 141636, 141637, 141638, 141639, 141640, 141641, 141642, 141643, 141644, 141645, 141646, 141647, 141648, 141649, 141650, 141651, 141652, 141653, 141654, 141655, 141656, 141657, 141658, 141659, 141660, 141661, 143205, 143206, 143207, 143208, 143209, 143210, 143211, 143212, 143213, 143214, 143215, 143216, 143217, 143218, 143219, 143220, 143221, 143222, 143223, 143224, 143225, 143226, 143227, 143228, 143229, 143230, 143231, 143232, 143233, 143234, 143235, 143236, 143237, 143238, 143239, 143240, 143241, 143242, 143243, 143244, 143245, 143246, 143247, 143248, 143249, 143250, 143251, 143252, 143253, 143254, 143255, 143256, 143257, 143258, 143259, 143260, 143261, 143262, 143263, 143264, 143265, 143266, 143267, 143268, 143269, 143270, 143271, 143272, 143273, 143274, 143275, 143276, 143277, 143278, 143279, 143280, 143281, 143282, 143283, 143284, 143285, 143286, 143287, 143288, 143289, 143290, 143291, 143292, 143293, 143294, 143295, 143296, 143297, 143298, 143299, 143300, 143301, 143302, 143303, 143304, 143306, 143307, 143308, 143309, 143310, 143311, 143312, 143313, 143314, 143315, 143316, 143318, 143319, 143320, 143321, 143322, 143323, 143324, 143325, 143326, 143327, 143328, 143329, 143330, 143331, 143332, 143333, 143334, 143335, 143336, 143337, 143338, 143339, 143340, 143341, 143342, 143343, 143344, 143345, 143346, 143347, 143348, 143349, 143350, 143351, 143352, 143353, 143354, 143355, 143356, 143357, 143358, 143359, 143360, 143361, 143362, 143363, 143364, 143365, 143366, 143367, 143368, 143369, 143370, 143371, 143372, 144398, 144399, 144400, 144401, 144402, 144403, 144404, 144405, 144406, 144407, 144408, 144409, 144410, 144411, 144412, 144413, 144414, 144415, 144587, 144588, 144589, 144590, 144591, 144592, 144593, 144594, 144595, 144596, 144597, 144598, 144599, 144600, 144601, 144602, 144603, 144604, 144605, 144606, 144607, 144608, 144609, 144610, 144611, 144612, 144613, 144614, 144616, 144617, 144618, 144619, 144620, 144621, 144622, 144623, 144624, 144625, 144626, 144627, 144628, 144629, 144630, 144631, 144632, 144633, 144634, 144635, 144636, 144637, 144638, 144639, 144640, 144641, 144642, 144643, 144644, 144645, 144646, 144647, 144648, 144649, 144650, 144651, 144652, 144653, 144654, 144655, 144656, 144657, 144658, 144659, 144660, 144661, 144662, 144663, 144664, 144665, 144666, 144667, 144668, 144669, 144670, 144671, 144672, 144673, 144674, 144675, 144676, 144677, 144678, 144679, 144680, 144681, 144682, 144683, 144684, 144685, 144686, 144687, 144688, 144689, 144690, 144691, 144692, 144693, 144694, 144695, 144696, 144697, 144698, 144699, 144700, 144701, 144702, 144703, 144704, 144705, 144706, 144707, 144708, 144709, 144710, 144711, 144712, 144713, 144714, 144715, 144717, 144718, 144719, 144720, 144721, 144722, 144723, 144724, 144725, 145262, 145265, 145270, 145274, 145276, 145278, 145282, 145286, 145289, 145290, 145295, 145297, 145298, 145299, 145301, 145303, 145305, 145308, 145310, 145314, 145317, 145319, 145320, 145321, 145324, 145326, 145329, 145332, 145333, 145337, 145342, 145343, 145348, 145351, [[Page 25636]] 145355, 145360, 145361, 145364, 145365, 145371, 145372, 145375, 145380, 145381, 145383, 145386, 145387, 145388, 145389, 145394, 145395, 145396, 145397, 145398, 145400, 145401, 145402, 145403, 145405, 145407, 145408, 145410, 145411, 145412, 145413, 145416, 145418, 145419, 145420, 145422, 145424, 145425, 145430, 145431, 145432, 145433, 145434, 146104, 146108, 146109, 146110, 146114, 146116, 146120, 146121, 146122, 146127, 146128, 146132, 146134, 146138, 146139, 146140, 146144, 146145, 146146, 146148, 146151, 146152, 146156, 146341, 146352, 146362, 146373, 146374, 146378, 146380, 146386, 146390, 146391, 146392, 146398, 146402, 146403, 146405, 146406, 146408, 146409 L45M-34 MSA (42)....................................... 200900, 200901, 200902, 200903, 200904, 200905, 200906, 200907, 200908, 200909, 200910, 200911, 200912, 200913, 200914, 200915, 200916, 200917, 200918, 200919, 200920, 200921, 200922, 200923, 200924, 200925, 200926, 200927, 200928, 200929, 200930, 200931, 200932, 200933, 200934, 200935, 200936, 200937, 200938, 200939, 200940, 200941 L45S-1 MSA (13)........................................ 112178, 112193, 112212, 114034, 114035, 114042, 114043, 114045, 114048, 114051, 114052, 114055, 114056 L65G-16 MSA (101)...................................... 158662, 158663, 158664, 158665, 158666, 158667, 158668, 158669, 158670, 158673, 158674, 158675, 158677, 158678, 158679, 158680, 158681, 158682, 158683, 158684, 158685, 158686, 158687, 158688, 158689, 158690, 158691, 158692, 158693, 158694, 158695, 158696, 158697, 158698, 158699, 158700, 158865, 158866, 158867, 158868, 158869, 158870, 158871, 158872, 158873, 158874, 158875, 158876, 158877, 158878, 158880, 158881, 158882, 158883, 158884, 158885, 158886, 158887, 158888, 158889, 158890, 158891, 158892, 158894, 158895, 158896, 158897, 158899, 158900, 158901, 158902, 158903, 158904, 158905, 158906, 158907, 158908, 158909, 158911, 158912, 158913, 158914, 158915, 158916, 158918, 158919, 158920, 158921, 158922, 158923, 158924, 159486, 159487, 159495, 159513, 159551, 159558, 159561, 159564, 159585, 159599 L65G-1 SURV (4)........................................ 201492, 201503, 201515, 201526 [[Page 25637]] L65G-2 SCOTT (757)..................................... 216018, 216019, 216020, 216021, 216022, 216023, 216024, 216025, 216026, 216027, 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(22)....................................... 301100, 301101, 301102, 301103, 301104, 301105, 301106, 301107, 301108, 301109, 301110, 301111, 301112, 301113, 301114, 301115, 301116, 301117, 301118, 301119, 301120, 301121 L65G-88 SCOTT (42)..................................... 301752, 301753, 301754, 301755, 301756, 301757, 301758, 301759, 301760, 301761, 301762, 301763, 301764, 301765, 301766, 301767, 301768, 301769, 301770, 301771, 301772, 301773, 301774, 301775, 301776, 301777, 301778, 301779, 301780, 301781, 301782, 301783, 301784, 301785, 301786, 301787, 301788, 301789, 301790, 301791, 301792, 301793 [[Page 25638]] L65M-1 MSA (114)....................................... 57126, 57127, 57128, 57129, 57130, 57131, 57132, 57133, 57134, 57135, 57136, 57137, 57139, 57140, 57141, 57143, 57145, 57146, 57148, 57149, 57150, 57151, 57152, 57153, 57154, 57155, 57156, 57158, 57159, 57161, 57162, 57163, 57164, 57165, 57291, 57292, 57293, 57295, 57296, 57297, 57298, 57299, 57300, 57302, 57303, 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171054, 171055, 171056, 171057, 171058, 171059, 171060, 171061, 171062, 171063, 171064, 171065, 171066, 171067, 171068, 171069, 171070, 171071, 171072, 171073, 171074, 171075 L87G-73 SCOTT (52)..................................... 173000, 173001, 173002, 173003, 173004, 173005, 173006, 173007, 173008, 173009, 173010, 173011, 173012, 173013, 173014, 173015, 173016, 173017, 173018, 173019, 173020, 173021, 173022, 173023, 173024, 173025, 173026, 173027, 173028, 173029, 173030, 173031, 173032, 173033, 173034, 173035, 173036, 173037, 173038, 173039, 173040, 173111, 173112, 173113, 173114, 173115, 173116, 173117, 173118, 173119, 173120, 173121 L87G-74 SCOTT (57)..................................... 174064, 174065, 174066, 174067, 174068, 174069, 174070, 174071, 174072, 174073, 174074, 174075, 174076, 174077, 174078, 174079, 174080, 174081, 174082, 174083, 174084, 174085, 174086, 174087, 174088, 174089, 174090, 174091, 174092, 174093, 174094, 174095, 174096, 174097, 174098, 174099, 174100, 174101, 174102, 174103, 174105, 174106, 174107, 174108, 174109, 174110, 174111, 174112, 174113, 174114, 174115, 174116, 174117, 174118, 174119, 174120, 174121 L87G-75 SCOTT (50)..................................... 175000, 175001, 175002, 175003, 175004, 175005, 175006, 175007, 175008, 175009, 175010, 175011, 175012, 175013, 175014, 175015, 175016, 175017, 175018, 175019, 175020, 175021, 175022, 175023, 175024, 175025, 175026, 175027, 175028, 175029, 175030, 175031, 175032, 175033, 175034, 175035, 175036, 175037, 175038, 175039, 175040, 175041, 175042, 175043, 175044, 175045, 175046, 175047, 175048, 175049 M15B-1 DRAGER (16)..................................... 2570, 2571, 2572, 2577, 2578, 2580, 2595, 2605, 2611, 2612, 2618, 2619, 2623, 2624, 2629, 2630 P07A-4 PMI (105)....................................... 31650, 31651, 31652, 31653, 31654, 31655, 31656, 31657, 31658, 31659, 31660, 31661, 31662, 31663, 31664, 31665, 31666, 31667, 31668, 31669, 31670, 31671, 31672, 31673, 31674, 31675, 31676, 31677, 31678, 31679, 31680, 31681, 31682, 31683, 31684, 31685, 31686, 31687, 31688, 31689, 31690, 31691, 31692, 31693, 31694, 31695, 31696, 31697, 31698, 31699, 31700, 31701, 31702, 31703, 31704, 31705, 31706, 31707, 31708, 31709, 31710, 31711, 31712, 31713, 31714, 31715, 31716, 31717, 31718, 31719, 31720, 31721, 31722, 31723, 31724, 31725, 31726, 31727, 31728, 31729, 31730, 31731, 31732, 31733, 31734, 31735, 31736, 31737, 31738, 31739, 31740, 31741, 31742, 31743, 31744, 31745, 31746, 31747, 31748, 31749, 31750, 31751, 31752, 31753, 31754 P08F-3 PMI (210)....................................... 100234, 100235, 100236, 100237, 100238, 100239, 100240, 100241, 100242, 100243, 100244, 100246, 100247, 100248, 100249, 100250, 100251, 100252, 100253, 100254, 100255, 100256, 100258, 100259, 100260, 100261, 100262, 100263, 100264, 100265, 100266, 100267, 100268, 100269, 100270, 100271, 100272, 100273, 100274, 100275, 100276, 100514, 100515, 100517, 100519, 100520, 100521, 100522, 100523, 100525, 100527, 100528, 100529, 100530, 100531, 100532, 100534, 100535, 100536, 100537, 100538, 100539, 100540, 100541, 100542, 100543, 100546, 100547, 100548, 100550, 100551, 100552, 100553, 100554, 100555, 100556, 100557, 100558, 100559, 100560, 100561, 100562, 100563, 100564, 100565, 100566, 100567, 100568, 100569, 100570, 100571, 100572, 100573, 100574, 100575, 100576, 100577, 100578, 100579, 100580, 100581, 100582, 100583, 100584, 100585, 100586, 100587, 100588, 100589, 100590, 100591, 100592, 100593, 100594, 100595, 100597, 100598, 100599, 100600, 100601, 100602, 100603, 100604, 100605, 100606, 100607, 100608, 100609, 100610, 100611, 100612, 100613, 100614, 100616, 100617, 100618, 100619, 100620, 100621, 100622, 100623, 100624, 100625, 100626, 100627, 100628, 100629, 100630, 100631, 100632, 100633, 100634, 100635, 100636, 100637, 100638, 100639, 100640, 100641, 100642, 100643, 100644, 100645, 100646, 100647, 100649, 100650, 100651, 100652, 100653, 100654, 100655, 100656, 100657, 103005, 103016, 103018, 103026, 103028, 103045, 103052, 103055, 103056, 103067, 103069, 103070, 103074, 103120, 103180, 103219, 103227, 103234, 103261, 103271, 103290, 103310, 103335, 103342, 103391, 103399, 103412, 103563, 103571, 103572, 103573, 103615, 103626, 103665, 103666, 103675 P11F-2 PMI (2)......................................... 123248, 123249 P12A-2 PMI (11)........................................ 21974, 21976, 21977, 21980, 21981, 21985, 21986, 21992, 21993, 21995, 22078 T109A-1 GOODR (37)..................................... 6565, 6566, 6567, 6568, 6569, 6570, 6571, 6572, 6573, 6574, 6575, 6576, 6577, 6578, 6692, 6693, 6694, 6695, 6696, 6697, 6699, 6700, 6701, 6702, 6703, 6704, 6705, 6706, 6707, 6708, 6709, 6710, 6711, 6712, 6713, 6714, 6715 T112A-1 GOODR (25)..................................... 1621, 1622, 1623, 1624, 1625, 1626, 1627, 1628, 1629, 1630, 1631, 1632, 1633, 1634, 1635, 1636, 1637, 1639, 1640, 1641, 1642, 1643, 1644, 1645, 1646 T123-1 GOODR (53)...................................... 1621, 1622, 1623, 1624, 1625, 1626, 1627, 1628, 1629, 1630, 1631, 1632, 1633, 1634, 1635, 1636, 1637, 1639, 1640, 1641, 1642, 1643, 1644, 1645, 1646, 2504, 2505, 2506, 2507, 2508 Total Number (3,858)............................... ---------------------------------------------------------------------------------------------------------------- [?USGPO Galley End:?]?> [[Page 25640]] Issued in Washington, DC, on April 26, 2006. Robert A. McGuire, Associate Administrator for Hazardous Materials Safety. [FR Doc. E6-6535 Filed 4-28-06; 8:45 am] BILLING CODE 4910-60-P
usgpo
2024-10-08T14:08:35.703864
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6535.htm" }
FR
FR-2006-05-01/06-4093
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25640-25644] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 06-4093] ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket Nos. PHMSA-98-4470, PHMSA-2004-18938, and PHMSA-2004-18584] Pipeline Safety: Meetings of the Pipeline Safety Standards Advisory Committees and Two Public Workshops AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), Department of Transportation (DOT). ACTION: Notice of advisory committee meetings and two workshops. ----------------------------------------------------------------------- SUMMARY: This notice announces public meetings of PHMSA's Technical Pipeline Safety Standards Committee (TPSSC) and Technical Hazardous Liquid Pipeline Safety Standards Committee (THLPSSC). The Committees will discuss regulatory issues and vote on two rulemaking proposals: Integrity management program changes and clarifications, and design and construction standards to reduce internal corrosion in gas transmission pipelines. In conjunction with the advisory committee meetings, PHMSA will hold two public workshops. PHMSA will hold a half day public workshop on Hazardous Liquid Low Stress Pipelines to solicit comments on a risk-based approach to protecting unusually sensitive areas from risks associated with low stress lines. PHMSA also will conduct a public workshop to discuss the effectiveness of pipeline control room operations and to obtain comments on ways to enhance the effectiveness of pipeline control room operations and on findings from the Controller Certification Project (CCERT). Dates and Times: PHMSA will hold advisory committee meetings and public workshops on June 26-28, 2006. The dates and times are: Monday, June 26 from 1 p.m. to 5 p.m.--THLPSSC and Public Workshop on Hazardous Liquid Low Stress Pipelines. Tuesday, June 27 from 8 a.m. to 5 p.m.--THLPSSC/TPSSC Public Workshop on Effectiveness of Pipeline Control Room Operations. Wednesday, June 28 from 8 a.m. to 9 a.m.--THLPSSC Meeting to vote on the NPRM to address integrity management modifications. Wednesday, June 28 from 9:30 a.m. to 4:30 p.m.--Joint meetings of the THLPSSC and TPSSC. Wednesday, June 28 from 5 p.m. to 6 p.m.--TPSSC meeting to vote on the NPRM to address internal corrosion in gas transmission pipelines. ADDRESSES: The meetings will be at the Hilton Alexandria Old Town, 1767 King Street, Alexandria, Virginia, 22314. Telephone: 1-703-837-0440, Fax 1-703-837-0454. FOR FURTHER INFORMATION CONTACT: Technical Advisory Committee Meetings: Cheryl Whetsel (202) 366-4431, [email protected]; Hazardous Liquid Low Stress Lines Public Workshop: Dewitt Burdeaux (405) 954-7220, [email protected] or Chris Hoidal (720) 963-3171, [email protected]; and Effectiveness of Pipeline Control Room Operations Public Workshop: Byron Coy (609) 989-2180, [email protected]. SUPPLEMENTARY INFORMATION: General Meeting Details Attendees staying at the hotel must make reservations by Friday, May 26. The phone number for reservations at the hotel is 1-800-HILTONS (445-8667). The hotel will give priority to the Committee members and State Pipeline Safety Representatives for rooms blocked under ``DOT Technical Advisory Committee Meetings.'' PHMSA plans to hold panel discussions during the public workshops. Individuals interested in participating as a panelist/commenter during the workshops should contact the individual listed under FOR FURTHER INFORMATION CONTACT. Members of the public may make short statements on the topics under discussion during the advisory committee sessions. Anyone wishing to make an oral statement should contact one of the individuals listed under FOR FURTHER INFORMATION CONTACT by June 9, with the topic and the estimated time needed to present. The presiding officer at each meeting may deny a request to present an oral statement based on time availability. You may send written comments by mail or deliver them to the Dockets Facility, U.S. Department of Transportation, Room PL-401, 400 Seventh Street, SW., Washington, DC 20590-0001. The Dockets Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except Federal holidays. You also may send written comments to the docket electronically by logging onto the following Internet Web address: http://dms.dot.gov. Click on ``Help & Information'' for instructions on how to file a document electronically. All written comments should reference docket number PHMSA-98-4470 for advisory committee issues; PHMSA-2004-18938 for hazardous liquid low stress line issues; and PHMSA-2004-18584 for controller certification issues. Anyone who would like confirmation of mailed comments must include a self-addressed stamped postcard. These dockets will remain open pending the completion of a rulemaking. Privacy Act Statement: Anyone may search the electronic form of all comments received for any of our dockets. You may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477) or you may visit http://dms.dot.gov. Information on Services for Individuals with Disabilities: For information on facilities or services for individuals with disabilities, or to request special assistance at the meeting, please contact Cheryl Whetsel at (202) 366-4431 by June 2. Background of Technical Advisory Committees The TPSSC and the THLPSSC are statutorily mandated advisory committees advising PHMSA on proposed safety standards, risk assessments, and safety policies for natural gas and hazardous liquid pipelines. These advisory committees are established under section 9(c) (App. 2) of the Federal Advisory Committee Act (Pub. L. 92-463) (5 U.S.C. App. 1). The committees consist of 15 members--five each representing government, industry, and the public. The TPSSC and the THLPSSC determine reasonableness, cost-effectiveness, and practicability of PHMSA's regulatory initiatives. Federal law requires PHMSA to submit cost-benefit analysis and risk assessment information on each proposed safety standard to the advisory committees. The committees evaluate the merits of the data and methods used within the analysis, and when fitting, provide recommendations about the cost-benefit analysis. Hazardous Liquid Low Stress Line Public Workshop June 26 (1 p.m. until 5 p.m.) On Monday, June 26 in conjunction with the THLPSSC meeting, PHMSA will hold a half day public workshop on [[Page 25641]] protecting unusually sensitive areas from hazardous liquid low stress lines. Background on Regulation of Hazardous Liquid Low Stress Lines The original safety regulations for hazardous liquid pipelines did not apply to low stress pipelines. Because of their low operating pressures and minimal accident history, the agency thought low stress hazardous liquid pipelines posed little risk to public safety. Following a prominent accident in 1990 involving the spill of about 500,000 gallons of heating oil from an underwater Exxon pipeline in Arthur Kill Channel in New York, PHMSA began rulemaking on hazardous liquid low stress lines. Further, in the Pipeline Safety Act of 1992, Congress provided guidance for the rulemaking by limiting the authority to exempt a pipeline from regulation solely because it operated at a low stress level. In 1990, PHMSA published an advance notice of proposed rulemaking (ANPRM) on low stress pipelines. (55 FR 45822; October 31, 1990.) In the ANPRM, PHMSA sought information about the costs and benefits of regulating low stress lines. The analysis of the data received in response to the ANPRM showed regulation of all low stress pipelines could impose costs disproportionate to benefits. PHMSA, therefore, focused on those low stress pipelines that posed a higher risk to people and the environment. The risk factors identified were the commodity in transportation and the location of the pipeline. In 1993, PHMSA published an NPRM proposing to apply parts 195 and 199 to low stress transmission pipelines that transport highly volatile liquids, traverse a populated area or traverse a navigable waterway (58 FR 12213; March 3, 2003). In 1994, PHMSA committed to consider regulating rural low stress lines in a future rulemaking based on locations and other risk factors. The agency said that it was developing a better concept of what constitutes an environmentally sensitive area for purposes of pipeline regulation and this would provide the groundwork for the future rulemaking on rural low stress lines. PHMSA said it needed the time to learn the extent to which low stress pipeline spills affect environmentally sensitive areas. It believed the definition used in the part 194 (Response Plans for Onshore Oil Pipelines) was too broad for part 195. In 2000, PHMSA issued a final rule to define unusually sensitive areas (USAs) (65 FR 246). In this rule, PHMSA noted its 1994 decision to defer regulating nonvolatile products in low stress pipelines in rural sensitive areas since there was not a definition. It further noted its intention to reconsider the issue once there was a sensitive area definition. In 2000, PHMSA defined protection of USAs for most hazardous liquid pipelines through its integrity management regulations. This meeting is a crucial step in gathering information needed to complete the protection of USAs from risks of spills from hazardous liquid low stress lines. PHMSA has gathered data from State agencies and industry and evaluated several accidents that involve hazardous liquid low stress lines. Based on its evaluation of data and comments received earlier on this issue, PHMSA would like to consider a risk-based approach to addressing unregulated hazardous liquid low stress lines. PHMSA would require operators of these lines to follow certain safety rules for design, construction, testing, and maximum operating pressure. It would also require these operators to protect the lines from corrosion and excavation damage, provide public education, operator qualification, and report accident and safety-related conditions. Preliminary Agenda--Workshop Questions for Hazardous Liquid Low Stress Lines During the public workshop, PHMSA plans to present its viewpoint and then hold panel discussions. The agency seeks comments on its risk- based approach to addressing unregulated low stress lines. In discussion of concepts, PHMSA asks interested parties to discuss the following agenda topics: Criteria for Applicability of Regulation PHMSA believes it should regulate any pipeline that affects USAs, including those not crossing a public domain. Should low stress lines that remain on leased property or low stress lines not crossing into a public domain be considered a transportation pipeline? Should PHMSA only regulate pipelines that intersect or could affect USAs? Use of Buffer Zones PHMSA is considering using the criteria in part 194 to determine whether a low stress line could affect a USA. In determining whether a low stress line could affect a USA, should PHMSA use criteria similar to the requirements in part 194 or are there other tried and tested criteria, such as buffer zones, we should consider? Physical Pipeline Characteristics PHMSA believes it may be appropriate to regulate pipelines containing a certain amount of product by volume. Throughput: What is the average daily throughput, and type of product transported? Location: Where are low stress lines geographically located? Diameter: What are the diameter ranges for pipelines transporting products through low stress pipelines other than gathering lines? Safety Requirements PHMSA believes that it may be appropriate to apply a limited subset of compliance activities, similar to those prescribed in part 192 for gas gathering lines. Leak Detection: Do hazardous liquid low stress line operators currently employ some type of leak detection techniques? If so, what techniques are used? What is an acceptable margin of error? Are margins determined daily? Operator Qualification: Should we apply Subpart N or a modified approach? If so, what should that modified approach be? Maintenance: Should federal regulations address preventative measures, such as the routine use of corrosion prevention and smart pigs which are capable of detecting corrosion? Do operators routinely run cleaning pigs on its low stress lines? Implementation Timeframes: Are 18-month through 2-year timeframes adequate for operators to address new construction, corrosion, operator qualification and excavation damage; to provide public education; and to report accident and safety-related conditions? Costs/Benefits PHMSA must address cost and benefits in developing all regulatory proposals. PHMSA is gathering cost data to justify a proposal. How many pipelines will be impacted? What is the mileage? What is the average length of those lines? What is the cost of bringing unregulated lines into compliance with part 195? Effectiveness of Pipeline Control Room Management Public Workshop June 27 (8 a.m.-5 p.m.) In conjunction with the Joint Committee meetings, PHMSA will hold a public workshop on opportunities to improve the effectiveness of pipeline [[Page 25642]] control room operations. This workshop will provide the public and industry an opportunity to discuss options for effectiveness of pipeline control room operations and assessing management processes, human fatigue issues, qualification, and other programs affecting pipeline control. Background of Controller Certification Pilot Program In addressing the requirements in the Pipeline Safety Improvement Act (PSIA) of 2002, section 13(b), PHMSA conducted a Controller Certification Pilot Program (CCERT). The purpose of the pilot program was to: (1) Review training programs, qualification requirements, evaluation methods, evaluation criteria, success thresholds, and reevaluation intervals to determine their adequacy and thoroughness in the controller qualification process; (2) evaluate the effectiveness of the practices and administrative processes currently used by operators in the qualification of controllers; (3) examine the thoroughness of operating procedures and practices used by controllers which impact safety and integrity; and (4) explore how these processes and evaluation criteria could be used to develop uniform protocols and acceptance criteria for the validation of pipeline operators' controller qualification processes. Despite differences between natural gas and hazardous liquid pipelines, PHMSA believes controllers for both types of pipelines require similar cognitive and analytical skills. During the same period of time in which PHMSA was conducting the ongoing CCERT Project, the National Transportation Safety Board (NTSB) was conducting a separate study on hazardous liquid pipeline Supervisory Control and Data Acquisition (SCADA) systems (2002-2005). The NTSB study examined how pipeline companies use SCADA systems to monitor and record operating data and to evaluate the role of SCADA systems in leak detection. The impetus of the NTSB study was the number of hazardous liquid accidents the NTSB investigated in which leaks went undetected after the SCADA system indicated the leak. While the NTSB SCADA Safety Study specifically addresses hazardous liquid pipelines, they previously issued about 30 recommendations over the past 30 years either directly or indirectly related to SCADA systems involving both hazardous liquid and natural gas pipeline systems. The NTSB's SCADA Safety Study and the CCERT project yielded many similar findings. PHMSA identified some additional areas of concern. The recommendations from the NTSB's SCADA Safety Study are as follows: Require operators of hazardous liquid pipelines to follow the American Petroleum Institute's Recommended Practice 1165 [API RP 1165] for the use of graphics on the SCADA screens. Require pipeline companies to have a policy for the review/audit of alarms. Require controller training to include simulator or non- computerized simulations for controller recognition of abnormal operating conditions, in particular, leak events. Change the liquid accident reporting form (PHMSA F 7000-1) and require operators to provide data related to controller fatigue. Require operators to install computer-based leak detection systems on all lines unless engineering analysis determined that such a system is not necessary. PHMSA plans to address the first four recommendations listed above within the CCERT Project. PHMSA plans to address the leak detection recommendation separately. The NTSB previously recommended PHMSA address human factors by establishing scientifically based hours of service regulations that set limits on hours of service, provide predictable work and rest schedules, and consider circadian rhythms and human sleep and rest requirements. The NTSB also recommended PHMSA assess the potential safety risks associated with rotating pipeline controller shifts and establish industry guidelines for the development and implementation of pipeline controller work schedules to reduce the likelihood of accidents attributable to controller fatigue. In response, PHMSA held a meeting on fatigue and issued Advisory Bulletin ADB-05-06, ``Countermeasures to Prevent Human Fatigue in the Control Room'' (70 FR 46917; August 11, 2005). This workshop will provide information and promote discussion on the most critical factors emerging from the certification study project and the NTSB recommendations affecting controlling the operation of natural gas and hazardous liquid pipelines. Meetings with state pipeline regulators, pipeline operators, academia, members of the public, parallel industry representatives, vendors and simulator specialists to conduct analyses and evaluations help frame PHMSA's findings. PHMSA is preparing a Report to Congress summarizing its findings regarding pipeline controller training, qualification programs and validation techniques to address the PSIA 2002 section 13(b)(2). PHMSA plans to submit its findings to Congress by the end of the year. In the workshop, PHMSA will first present pilot program initial findings. PHMSA will provide an opportunity to discuss these findings as a basis for potential future regulatory enhancements and other actions to provide further assurance about the effectiveness of pipeline control and the skills and qualifications of controllers. PHMSA is encouraging public participation on the path forward. PHMSA will want to discuss what follow-up action is needed for each topic-- for example, regulation, consensus standard, or advisory. Preliminary Meeting Agenda for CCERT Workshop This workshop will focus on the topics listed below. PHMSA will provide a summary on the critical nature of each topic in validating the effectiveness of pipeline control room operations and controller programs, followed by panel discussions and an opportunity for interested parties to provide comments. Shift Operations The exchange of information between controllers at shift change is critical for the controller going on shift who needs to know about operating conditions that may directly impact pipeline safety. PHMSA believes operators should have formalized procedures to control shift rotation schedules and guide shift change-over practices. What role do shift change procedures have in averting the development of abnormal and emergency situations? Do existing shift rotation schedules, shift length, and hours of service protect against the onset of fatigue? Effectiveness of Pipeline Control Room Operations PHMSA believes operators need to provide clear direction regarding the controller's authority and responsibility to ensure prompt detection and appropriate response to abnormal and emergency operating conditions. Do operators clearly communicate authority and responsibility expectations to their controllers? Fatigue PHMSA believes operators should limit controller shifts and provide periodic training on fatigue issues to controllers. What should be done regarding controller work hour limitations? [[Page 25643]] Should we be concerned about employees' non-work hours that contribute to fatigue? Should PHMSA modify its reporting criteria on accident causes to reflect controller issues? If so, what areas should we address? Management of Change PHMSA believes operators should establish programs to: Periodically audit field data points with SCADA displays; develop integration plans affecting controllers during acquisition and divestitures; ensure including consultation with controllers when considering pipeline hydraulic, SCADA, or configuration changes; and track expedient resolution of controller-oriented changes and repairs. When changes occur in the operating environment affecting controllers, how do we ensure those changes are fully addressed and conveyed to controllers? Alarms and Event Displays Alarms and event displays provide information on potential precursors or indicators of abnormal operating conditions. Controllers should clearly understand displayed information and what specific alarms and event displays indicate. PHMSA believes it is important for operators to routinely review alarms and event displays to identify the need for revisions to alarm and event management systems. How significant are alarm parameters, alarm management, and the periodic review of alarms to pipeline safety and integrity? What impacts do alarm descriptors, display parameters, and the use of color have on providing precise operational information to controllers? Access Control PHMSA believes operators should have measures in place to protect against unauthorized access to SCADA control consoles; configure SCADA systems for individual log-ins; and perform background checks on controllers. Are there additional measures needed to address controller room access to SCADA systems? Qualification of Personnel PHMSA believes simulators and tabletop exercises are valuable tools to help familiarize controllers with the hydraulic response of the pipeline system and improve their recognition of abnormal and emergency conditions. A controller's thorough knowledge of pipeline system hydraulic response is critical to recognizing abnormal operating condition development. PHMSA believes operators should incorporate tabletop exercises, and/or computerized simulations and field visits to enhance controller training. How can computer-based simulator training and tabletop exercises enhance controller skills? What are the benefits of training controllers on specific pipeline hydraulic parameters and response to various abnormal operating conditions? What value can controllers get from facility visits and site-specific emergency issues? Regulating Operating Conditions Incidents, accidents, safety-related condition reports and operator qualification inspections indicate the need for enhanced controller skills on prompt, appropriate response regarding the recognition of abnormal operating conditions and emergency conditions. Parallel industries have identified the need to develop training around combinations of abnormal operating conditions and operating experience. PHMSA believes operators should address abnormal operating conditions occurring frequently and in combinations. How can we better identify and train operators to handle abnormal operating events? What roles can operational events play in identifying emergency operating conditions? How do we plan for and identify multiple contributing causes/factors when incidents and accidents occur? What role do controllers have in reacting and responding to incidents/accidents? Maintaining Personnel Qualifications Operator qualification inspection summaries and CCERT industry review indicate operators frequently do not substantiate re- qualification intervals for controllers. Many operators' programs do not provide guidance to determine when a controller needs refresher training, needs more training, or needs to requalify after disqualification. PHMSA believes these attributes should be incorporated into operators' qualification programs. What process best serves to validate controllers' skills and knowledge? What forms of justification are adequate to substantiate requalification intervals? Should the operator qualification process include documentation of revocation and restoration criteria? Monitoring Performance PHMSA has determined that some operators configure SCADA systems to portray critical information using color alone without verifying the controllers' ability to perceive color. Similar circumstances may exist concerning eyesight and hearing. PHMSA believes that operators should periodically verify that controllers have adequate color perception, eyesight, and hearing. What practical techniques can be used to track ongoing performance and monitor for performance degradation over time? How would a pipeline operator determine and test for adequate color perception, eyesight, and hearing? Path Forward PHMSA believes these findings apply in varying degrees to both hazardous liquid and natural gas pipeline operators. The path forward may include some of the following options: Public workshop discussions, reinforcement of existing regulations, consensus standards development, advisory bulletins, revised inspection guidance, accident/incident form revisions, enhancements to PHMSA incident/accident inspector training, SCADA inspections, or rulemaking. Which of these recommendations should apply to both hazardous liquid and natural gas pipeline operators? What areas should we focus on in addressing the NTSB recommendations and CCERT Project findings? What findings need regulatory action, if any? Are there other types of actions needed, such as consensus standards or advisories? The Technical Hazardous Liquid Pipeline Safety Standards Advisory Committee Wednesday, June 28 (8 a.m. to 9 a.m.) The THLPSSC will meet to discuss and vote on the NPRM, Integrity Management: Program Modifications and Clarifications (70 FR 74265; December 5, 2005). PHMSA proposes revisions to the current Pipeline Safety Regulations for Pipeline Integrity Management in High Consequence Areas. The revisions address a petition from the hazardous liquid pipeline industry. The proposed revisions are to: (1) Allow more flexibility in reassessment intervals for hazardous liquid pipelines by adding an eight-month window to the five-year time frame for operators to complete reassessment; and (2) require both hazardous liquid pipeline and transmission pipeline operators to notify PHMSA whenever they reduce pipeline pressure to make a repair and to provide reasons for pressure reduction. Another notification, [[Page 25644]] including reasons for repair delay, would occur when a pressure reduction exceeds 365 days. Also, PHMSA proposes to correct existing provisions for calculating a pressure reduction when making an immediate repair on a hazardous liquid pipeline. The proposed correction would allow operators to use another acceptable method to calculate reduced operating pressure when a specified formula is not applicable or results in a calculated pressure higher than operating pressure. Finally, PHMSA seeks the submittal of engineering analyses and technical data. These submittals are to provide the basis for modifying the required time periods for remediating certain conditions found during a hazardous liquid pipeline integrity assessment. PHMSA will use this data to evaluate the scope and scale of repair issues to develop an accurate basis for determining if any additional flexibility is needed in the repair schedules. Joint Meetings of the Technical Hazardous Liquid Pipeline Safety Standards Committee and the Technical Pipelines Safety Standards Committee Wednesday, June 28 (9:30 a.m. to 4:30 p.m.) The THLPSSC and TPSSC will hold a joint session from 9:30 am. to 4:30 p.m. to discuss the following regulatory matters. Preliminary Agenda for the Joint Meetings The day's agenda includes these topics: Reauthorization of the Pipeline Safety Act--Discuss status. Data Improvement/Balance Scorecard--Discuss a variety of data quality improvements. Introduce the concept of a company performance scorecard to measure and manage company safety and compliance programs. Performance Measures/Metrics--Discuss continuing efforts to improve pipeline safety by concentrating performance measures on serious incidents as a natural outgrowth of integrity management. Maximum Allowable Operating Pressure--Discuss the waiver process criteria for reconsideration of the maximum allowable operating pressure of pipelines in certain class locations. Operator Qualification--Discuss the comments received from the public meeting on the subject held on December 15, 2005 (70 FR 62162). The meeting provided an opportunity to discuss progress on the operator qualification program and to help PHMSA prepare the Report to Congress and the potential the American Society of Mechanical Engineers consensus standard offers for strengthening operator qualification programs. Controller Certification Pilot Program--Provide a summary of the comprehensive review of existing controller qualification procedures and practices in industry and describe the recommendations drafted for inclusion in the draft report to Congress. Discuss NTSB recommendations on SCADA and human fatigue and report on solutions considered in preparation for the public workshop. Public Education (PANEL)--Discuss the PHMSA Public Education Policy Statement and the status of a national clearinghouse to review updated operator plans. Brief members on the status of the sensitive security information designation of the PHMSA National Pipeline Mapping System availability to the public. Discuss the Common Ground Alliances' status of the Dial 811 initiative and promote the success of the Regional Common Ground Alliances and the need to have one in every state. Technical Pipeline Safety Standards Committee Meeting Wednesday, June 28 (5 p.m. to 6 p.m.) The TPSSC will meet from 5 p.m. to 6 p.m. to address the following two topics: Internal Corrosion--Discuss and vote on ``Design and Construction Standards to Reduce Internal Corrosion in Gas Transmission Pipelines'' (70 FR 74262; 12-15-05). This document proposes regulations on the control of internal corrosion when designing and constructing new and replaced gas transmission pipelines. The proposed rule would require an operator to take steps in design and construction to reduce the risk that liquids collecting within the pipeline could result in failures because of internal corrosion. These changes would ease steps an operator must take in operating and maintaining the pipeline to minimize internal corrosion. Gas Distribution-DIMP/Excess Flow Valves--Provide an update on the regulatory proposal and an update on Gas Pipeline Technology Committee guidance development. PHMSA will post more detailed agendas and any additional information or changes on its Web page (http://phmsa.dot.gov) approximately 15 days before the meeting date. Authority: 49 U.S.C. 60102, 60115. Issued in Washington, DC, on April 26, 2006. Stacey L. Gerard, Associate Administrator for Pipeline Safety. [FR Doc. 06-4093 Filed 4-27-06; 8:45 am] BILLING CODE 4910-60-P
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2024-10-08T14:08:35.732438
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/06-4093.htm" }
FR
FR-2006-05-01/E6-6511
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25644-25645] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6511] ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Research & Innovative Technology Administration [Docket No. RITA-2005-23343] Agency Information Collection; Activity Under OMB Review; Report of Extension of Credit to Political Candidates AGENCY: Research & Innovative Technology Administration (RITA), Bureau of Transportation Statistics (BTS), DOT. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with the Paperwork Reduction Act of 1995, Public Law 104-13, (44 U.S.C. 3501 et seq.) this notice announces that the Information Collection Request, abstracted below, is being forwarded to the Office of Management and Budget for extension of currently approved reporting requirements. Earlier, a Federal Register Notice with a 60- day comment period was published on February 3, 2006 (71 FR 5905). The agency did not receive any comments to its previous notice. DATES: Written comments should be submitted by May 31, 2006. FOR FURTHER INFORMATION CONTACT: Bernie Stankus, Office of Airline Information, RTS-42, Room 4125, RITA, BTS, 400 Seventh Street, SW., Washington, DC 20590-0001, Telephone Number (202) 366-4387, Fax Number (202) 366-3383 or e-mail [email protected]. Comments: Comments should be sent to OMB at the address that appears below and should identify the associated OMB Approval Number 2138-0016 and Docket Number RITA-2005-23343. SUPPLEMENTARY INFORMATION: OMB Approval No.: 2138-0016. Title: Report of Extension of Credit to Political Candidates. Form No.: 183. Type of Review: Extension of a currently approved reporting requirement. Respondents: Certificated air carriers. Number of Respondents: 2 (Monthly Average). Total Annual Burden: 24 hours. Needs and Uses: The Department uses this form as the means to fulfill its [[Page 25645]] obligation under the Federal Election Campaign Act of 1971 (the Act). The Act's legislative history indicates that one of its statutory goals is to prevent candidates for Federal political office from incurring large amounts of unsecured debt with regulated transportation companies (e.g. airlines). This information collection allows the Department to monitor and disclose the amount of unsecured credit extended by airlines to candidates for Federal office. All certificated air carriers are required to submit this information. The Confidential Information Protection and Statistical Efficiency Act of 2002 (44 U.S.C. 3501 note), requires a statistical agency to clearly identify information it collects for non-statistical purposes. BTS hereby notifies the respondents and the public that BTS uses the information it collects under this OMB approval for non-statistical purposes including, but not limited to, publication of both Respondent's identity and its data, submission of the information to agencies outside BTS for review, analysis and possible use in regulatory and other administrative matters. ADDRESSES: Send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 715-17th Street, NW., Washington, DC 20503, Attention RITA Desk Officer. Comments are invited on whether the proposed retention of records is necessary for the proper performance of the functions of the Department of Transportation. Issued in Washington, DC, on April 25, 2006. Donald W. Bright, Assistant Director, Airline Information, Bureau of Transportation Statistics. [FR Doc. E6-6511 Filed 4-28-06; 8:45 am] BILLING CODE 4910-HY-P
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2024-10-08T14:08:35.760967
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6511.htm" }
FR
FR-2006-05-01/E6-6512
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25645] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6512] ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Research & Innovative Technology Administration [Docket No. RITA-2005-23342] Agency Information Collection; Activity Under OMB Review; Part 249 Preservation of Records AGENCY: Research & Innovative Technology Administration (RITA), Bureau of Transportation Statistics (BTS), DOT. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with the Paperwork Reduction Act of 1995, Public Law 104-13, (44 U.S.C. 3501 et seq.) this notice announces that the Information Collection Request, abstracted below, is being forwarded to the Office of Management and Budget for extension of currently approved record retention requirements. Earlier, a Federal Register Notice with a 60-day comment period was published on February 3, 2006 (71 FR 5903). The agency did not receive any comments to its previous notice. DATES: Written comments should be submitted by May 31, 2006. FOR FURTHER INFORMATION CONTACT: Bernie Stankus, Office of Airline Information, RTS-42, Room 4125, RITA, BTS, 400 Seventh Street, SW., Washington, DC 20590-0001, Telephone Number (202) 366-4387, Fax Number (202) 366-3383 or e-mail [email protected]. Comments: Comments should be sent to OMB at the address that appears below and should identify the associated OMB Approval Number 2138-0006 and Docket RITA-2005-23342. SUPPLEMENTARY INFORMATION: OMB Approval No.: 2138-0006. Title: Preservation of Air Carrier Records--14 CFR Part 249 . Form No.: None. Type Of Review: Extension of a currently approved recordkeeping requirement. Respondents: Certificated air carriers and charter operators. Number of Respondents: 120 certificated air carriers. 300 charter operators. Estimated Time per Response: 3 hours per certificated air carrier. 1 hour per charter operator. Total Annual Burden: 660 hours. Needs and Uses: Part 249 requires the retention of records such as: General and subsidiary ledgers, journals and journal vouchers, voucher distribution registers, accounts receivable and payable journals and legers, subsidy records documenting underlying financial and statistical reports to DOT, funds reports, consumer records, sales reports, auditors' and flight coupons, air waybills, etc. Depending on the nature of the document, the carrier may be required to retain the document for a period of 30 days to 3 years. Public charter operators and overseas military personnel charter operators must retain documents which evidence or reflect deposits made by each charter participant and commissions received by, paid to, or deducted by travel agents, and all statements, invoices, bills and receipts from suppliers or furnishers of goods and services in connection with the tour or charter. These records are retained for 6 months after completion of the charter program. Not only is it imperative that carriers and charter operators retain source documentation, but it is critical that we ensure that DOT has access to these records. Given DOT's established information needs for such reports, the underlying support documentation must be retained for a reasonable period of time. Absent the retention requirements, the support for such reports may or may not exist for audit/validation purposes and the relevance and usefulness of the carrier submissions would be impaired, since the data could not be verified to the source on a test basis. ADDRESSES: Send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 715-17th Street, NW., Washington, DC 20503, Attention RITA Desk Officer. Comments are invited on whether the proposed retention of records is necessary for the proper performance of the functions of the Department of Transportation. Issued in Washington, DC, on April 25, 2006. Donald W. Bright, Assistant Director, Airline Information, Bureau of Transportation Statistics. [FR Doc. E6-6512 Filed 4-28-06; 8:45 am] BILLING CODE 4910-HY-P
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2024-10-08T14:08:35.774440
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6512.htm" }
FR
FR-2006-05-01/E6-6533
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25645-25646] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6533] ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Research & Innovative Technology Administration [Docket No.: RITA-2005-23755] Agency Information Collection; Activity Under OMB Review; Passenger Origin-Destination Survey Report AGENCY: Research & Innovative Technology Administration (RITA), Bureau of Transportation Statistics (BTS), DOT. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with the Paperwork Reduction Act of 1995, Public Law 104-13, (44 U.S.C. 3501 et seq.) this notice announces that the Information Collection Request, abstracted below, is being forwarded to the Office of Management and Budget for extension of currently approved reporting requirements. Earlier, a Federal Register Notice with a 60- day comment period was published on February 3, 2006 (71 FR 5904). The agency did not receive any comments to its previous notice. [[Page 25646]] DATES: Written comments should be submitted by May 31, 2006. FOR FURTHER INFORMATION CONTACT: Bernie Stankus, Office of Airline Information, RTS-42, Room 4125, RITA, BTS, 400 Seventh Street, SW., Washington, DC 20590-0001, Telephone Number (202) 366-4387, Fax Number (202) 366-3383 or E-MAIL [email protected]. Comments: Comments should be sent to OMB at the address that appears below and should identify the associated OMB Number 2139-0001 and Docket Number RITA-2005-23755. SUPPLEMENTARY INFORMATION: OMB Approval No.: 2139-0001. Title: Passenger Origin-Destination Survey Report. Form No.: None. Type Of Review: Extension of a currently approved reporting requirement. Respondents: Large certificated air carriers. Number of Respondents: 32. Total Annual Burden: 30,720 hours. Needs and Uses: Survey data are used in monitoring the airline industry, negotiating international air agreements, selecting new international routes, selecting U.S. carriers to operate limited entry international routes, forecasting future traffic demands, and modeling the spread of contagious diseases from foreign countries. The Confidential Information Protection and Statistical Efficiency Act of 2002 (44 U.S.C. 3501 note), requires a statistical agency to clearly identify information it collects for non-statistical purposes. BTS hereby notifies the respondents and the public that BTS uses the information it collects under this OMB approval for non-statistical purposes including, but not limited to, publication of both Respondent's identity and its data, submission of the information to agencies outside BTS for review, analysis and possible use in regulatory and other administrative matters. ADDRESSES: Send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 715-17th Street, NW., Washington, DC 20503, Attention RITA Desk Officer. Comments are invited on whether the proposed retention of records is necessary for the proper performance of the functions of the Department of Transportation. Issued in Washington, DC, on April 25, 2006. Donald W. Bright, Assistant Director, Airline Information, Bureau of Transportation Statistics. [FR Doc. E6-6533 Filed 4-28-06; 8:45 am] BILLING CODE 4910-HY-P
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2024-10-08T14:08:35.795997
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6533.htm" }
FR
FR-2006-05-01/E6-6475
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25646] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6475] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF THE TREASURY Internal Revenue Service Proposed Collection; Comment Request for Form 944-SS and Form 944-PR AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice and request for comments. ----------------------------------------------------------------------- SUMMARY: The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 944-SS, Employer's ANNUAL Federal Tax Return (American Samoa, Guam, the Northern Mariana Islands, and the U.S. Virgin Islands, and Form 944-PR, Planilla para la Declaracion ANNUAL de la Cotribucion Federal del Patrono. DATES: Written comments should be received on or before June 30, 2006 to be assured of consideration. ADDRESSES: Direct all written comments to Glenn P. Kirkland, Internal Revenue Service, room 6516, 1111 Constitution Avenue, NW., Washington, DC 20224. FOR FURTHER INFORMATION CONTACT: Requests for additional information or copies of the form and instructions should be directed to R. Joseph Durbala, (202) 622-3634, at Internal Revenue Service, room 6516, 1111 Constitution Avenue, NW., Washington, DC 20224, or through the internet at [email protected]. SUPPLEMENTARY INFORMATION: Title: Employer's ANNUAL Federal Tax Return (American Samoa, Guam, the Northern Mariana Islands, and the U.S. Virgin Islands and Form 944- PR, Planilla para la Declaracion ANNUAL de la Cotribucion Federal del Patrono. OMB Number: 1545-2010. Form Number: Form 944-SS and Form 944-PR. Abstract: Form 944-SS and Form 944-PR are designed so the smallest employers (those whose annual liability for social security and Medicare taxes is $1,000 or less) will have to file and pay these taxes only once a year instead of every quarter. Current Actions: There is no change in the paperwork burden previously approved by OMB. This form is being submitted for renewal purposes only. Type of Review: Extension of a currently approved collection. Affected Public: Businesses and other for-profit organizations, Farms. Estimated Number of Respondents: 20,000. Estimated Time Per Respondent: 9 hours 34 minutes. Estimated Total Annual Burden Hours: 191,200. The following paragraph applies to all of the collections of information covered by this notice: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103. Request for Comments: Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on: (a) Whether the 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 collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (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; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Approved: April 24, 2006. Glenn P. Kirkland, IRS Reports Clearance Officer. [FR Doc. E6-6475 Filed 4-28-06; 8:45 am] BILLING CODE 4830-01-P
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2024-10-08T14:08:35.811203
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6475.htm" }
FR
FR-2006-05-01/E6-6479
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Page 25647] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6479] [[Page 25647]] ----------------------------------------------------------------------- DEPARTMENT OF THE TREASURY Internal Revenue Service Proposed Collection; Comment Request for Form 637 Questionnaires AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice and request for comments. ----------------------------------------------------------------------- SUMMARY: The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Questionnaires A, B, C, D, E, F, H, I, J, K, M, Q, R, S, T, UP, UV, V, W, X, and Y, Form 637 Questionnaires. DATES: Written comments should be received on or before June 30, 2006 to be assured of consideration. ADDRESSES: Direct all written comments to Glenn P. Kirkland, Internal Revenue Service, room 6516, 1111 Constitution Avenue, NW., Washington, DC 20224. FOR FURTHER INFORMATION CONTACT: Requests for additional information or copies of Form 637 Questionnaires should be directed to R. Joseph Durbala, (202) 622-3634, at Internal Revenue Service, room 6516, 1111 Constitution Avenue, NW., Washington, DC 20224, or through the internet at [email protected]. SUPPLEMENTARY INFORMATION: Title: Form 637 Questionnaires. OMB Number: 1545-1835. Form Number: Questionnaires A, B, C, D, E, F, H, I, J, K, M, Q, R, S, T, UP, UV, V, W, X, and Y. Abstract: Form 637 Questionnaires will be used to collect information about persons who are registered with the Internal Revenue Service (IRS) in accordance with Internal Revenue Code (IRC) section 4104 or 4222. The information will be used to make an informed decision on whether the applicant/registrant qualifies for registration. Current Actions: There are no changes being made to the schedules at this time. Type of Review: Extension of a currently approved collection. Affected Public: Business or other for-profit organizations. Estimated Number of Respondents: 2,840. Estimated Average Time Per Respondent: 1 hour, 14 minutes. Estimated Total Annual Burden Hours: 3,479. The following paragraph applies to all of the collections of information covered by this notice: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103. Request for Comments: Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on: (a) Whether the 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 collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (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; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Approved: April 25, 2006. R. Joseph Durbala, IRS Reports Clearance Officer. [FR Doc. E6-6479 Filed 4-28-06; 8:45 am] BILLING CODE 4830-01-P
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2024-10-08T14:08:35.840046
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6479.htm" }
FR
FR-2006-05-01/E6-6480
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25647-25648] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6480] ----------------------------------------------------------------------- DEPARTMENT OF THE TREASURY Internal Revenue Service Information Reporting Program Advisory Committee (IRPAC); Nominations AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Request for nominations. ----------------------------------------------------------------------- SUMMARY: The Internal Revenue Service (IRS) requests nominations of individuals to be considered for selection as Information Reporting Program Advisory Committee (IRPAC) members. Individuals or interested organizations may nominate themselves and/or a qualified person for membership. Nominations will be accepted for current vacancies and should describe and document the applicants qualifications for membership. IRPAC can be comprised of no more than twenty-three (23) members. There are six (6) positions open for calendar year 2007. It is important that the IRPAC continue to represent a diverse taxpayer and stakeholder base. Accordingly, to maintain membership diversity, selection is based on applicant's qualifications as well as the segment or group he/she represents. The IRPAC advises the IRS on information reporting issues of mutual concern to the private sector and the federal government. The committee works with the Commissioner and other IRS executives to provide recommendations on a wide range of information reporting administration issues. Membership is balanced to include representation from the tax professional community, small and large businesses, state tax administration, colleges and universities, insurance, securities, payroll and other industries. DATES: Written nominations must be received on or before July 14, 2006. ADDRESSES: Nominations should be sent to Ms. Caryl Grant, National Public Liaison, CL:NPL:SRM, Room 7559 IR, 1111 Constitution Avenue, NW., Washington, DC 20224, Attn: IRPAC Nominations. Applications may be submitted by mail to the address above or faxed to 202-622-8345. Application packages are available on the Tax Professional's Page, which is located on the IRS Internet Web site at http://www.irs.gov/taxpros/index.html. Application packages may also be requested by telephone from National Public Liaison, 202-927-3641 (not a toll-free number). FOR FURTHER INFORMATION CONTACT: Ms. Caryl Grant, at 202-927-3641 (not a toll-free number) or *[email protected]. SUPPLEMENTARY INFORMATION: IRPAC was established in 1991 in response to an administrative recommendation in the final Conference Report of the Omnibus Budget Reconciliation Act of 1989. Since its inception, IRPAC has worked closely with the Internal Revenue Service (``IRS'') to provide recommendations on a wide range of issues intended to improve the information reporting program and achieve fairness to taxpayers. IRPAC members are drawn from and represent a broad sample of industries including the payroll community, major [[Page 25648]] professional and trade associations, colleges and universities, insurance, banking, securities, state taxing agencies and other industries. Conveying the public's perception of IRS activities to the Commissioner, the IRPAC is comprised of individuals who bring substantial, disparate experience and diverse backgrounds on the Committee's activities. IRPAC members are appointed by the Commissioner and serve a term of three years with approximately one third of the member's terms expiring each year. Working groups address policies and administration issues specific to information reporting. Members are not paid for their services. However, travel expenses for working sessions, public meetings and orientation sessions, such as airfare, per diem, and transportation to and from airports, train stations, etc., are reimbursed within prescribed federal travel limitations. Receipt of applications will be acknowledged, and all individuals will be notified when selections have been made. In accordance with Department of Treasury Directive 21-03, a clearance process including, pre-appointment and annual tax checks, and a Federal Bureau of Investigation criminal and subversive name check through fingerprinting will be conducted on the final applicants. Equal opportunity practices will be followed for all appointments to the IRPAC in accordance with the Department of Treasury and IRS policies. To ensure that the recommendations of the IRPAC have taken into account the needs of the diverse groups served by the IRS, membership shall include, to the extent practicable, individuals who demonstrate the ability to represent minorities, women, and persons with disabilities. The Secretary of Treasury will review the recommended candidates and make final selections. Dated: April 24, 2006. Cynthia Vanderpool, Designated Federal Official, National Public Liaison. [FR Doc. E6-6480 Filed 4-28-06; 8:45 am] BILLING CODE 4830-01-P
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2024-10-08T14:08:35.878626
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6480.htm" }
FR
FR-2006-05-01/E6-6478
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25648-25649] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6478] ----------------------------------------------------------------------- DEPARTMENT OF THE TREASURY Internal Revenue Service Quarterly Publication of Individuals, Who Have Chosen To Expatriate, as Required by Section 6039G AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice is provided in accordance with IRC section 6039G, as amended, by the Health Insurance Portability and Accountability Act (HIPPA) of 1996. This listing contains the name of each individual losing United States citizenship (within the meaning of section 877(a)) with respect to whom the Secretary received information during the quarter ending March 31, 2006. ---------------------------------------------------------------------------------------------------------------- Last name First name Middle name/initials ---------------------------------------------------------------------------------------------------------------- GARDINER............................. LINDA........................ HAUSER............................... BERNHARD..................... D. NAYLOR............................... BRENT........................ G. NAYLOR............................... K............................ GAYLE FURBERT.............................. HELEN........................ MARIE CALACE............................... BARBARA...................... CLARA BOULLE............................... NATHALIE..................... A. KATARIA.............................. TARUN........................ COMBS................................ MARIELUISE................... HORBER DICKERSON............................ WILLIAM...................... J. DICKERSON............................ JANISE....................... ESER................................. FLORIDA...................... O. BALDWIN.............................. WONG......................... KWOK LEARN NICHOLIS............................. HUMPHREY..................... .......................................... PETTERSSON........................... JAN.......................... B. EICHLER.............................. KRISTA....................... WITT................................. ALEXANDRA.................... KADOORIE............................. NATALIE...................... LOUISE ESCOUFLAIRE.......................... ANNETTE...................... GILLIAM.............................. TERENCE...................... VANCE PARK................................. KANG......................... OP WATKINS.............................. FE........................... ALAAN BERGERIOUX........................... ANTHONY...................... G. SAM.................................. CHOON........................ HAN MCKECHNIE............................ MICHAEL...................... M. HERMANSON............................ MINA......................... KRISTINE GREENBERG............................ MARYANA...................... HAMILTON............................. JANET........................ SILVER............................... ROBERT....................... SPENCER VERWER............................... DANIEL....................... FEDERICO BIRCHFIELD........................... STEVEN....................... ELLIS METWALLY............................. MOHAMED...................... ELSAS................................ OSKAR........................ LEO FERNANDEZ............................ MANUEL....................... URIA DENG................................. SUK-YEE...................... F. KIM.................................. ANNE......................... MCDONALD............................. ELEANOR...................... ANN JEUN................................. WOOYONG...................... JUDY NILSSON.............................. KIRSTEN...................... COUILLARD............................ FELICIA...................... DAWN PARK................................. YONG KON..................... RAPHAEL MASSETT.............................. ELLEN........................ STRUBEN.............................. RICHARD...................... L. [[Page 25649]] HAINAULT............................. TALBOT....................... RICHWELL............................. RHETT........................ TERRENCE QUINTANA............................. JYTTE........................ NOWAK................................ ELAINE....................... URSULA BLANK................................ WALTER....................... GERHARD BSEISU............................... AMJAD........................ FISHER............................... JOHN......................... WOUTERS.............................. JOHAN........................ LI................................... KENNETH...................... BENJAMIN CHOW................................. SAVIO........................ S. GARDINER............................. ELIZABETH.................... SUSANNE...................... RUDGE................................ PENELOPE..................... JANE UTZSCHNEIDER......................... SUSANNE...................... KIM.................................. SUNG......................... SOO LORENCEAU............................ CHARLES...................... ANTOINE WETTERLIN............................ ALLISON...................... LOUISE PRESTGARD............................ LOUANN....................... SUMMITT.............................. HEINRICH..................... JOSEF SCHOENFELD........................... JOSEPHINE.................... A. FOSTER............................... STEPHEN...................... M. SCHOENFELD........................... ARTHUR....................... D. PAIZ DE ESCOBAR...................... CLAUDIA...................... LUCIA WU................................... CINDY........................ S. CHASE................................ ROBERT....................... ROBERTS RICHARDSON........................... ALMA......................... CATHERINE CLEVELAND............................ STEVEN....................... WILLIAM PELHAM............................... CLARE........................ JOHANNA BAMFORD.............................. JOSEPH....................... HEIKENFELD........................... MARK......................... IAN MARCIL............................... ADRIANA...................... GERALDINE LUNDSDAL............................. OLOF......................... NICKOLAUS GOODER............................... RICHARD...................... DENNIS LOPEZ III............................ JOSE......................... JOAQUIN PHILLIPS............................. ANDREW....................... CORENTON PRZYBYLSKI........................... AE........................... MARTIN DRAKE................................ SEAN......................... PATRICK PRICE................................ MALIYA....................... ANN LABRIE............................... PETER........................ CHARDON BOND................................. PETER........................ J. DORRELL.............................. DAVID........................ R. DORRELL.............................. ANGELA....................... M. STRYKER.............................. DEANNA....................... VASWANI.............................. KIRAN........................ HANEET SVENSSON............................. INGRID....................... AUGESTAD............................. LIV.......................... BERIT HIRSCH COHEN................................ DAN.......................... ALAN ROLLO................................ TERRENCE..................... RD KIMMERLE............................. HORST........................ OBERAI............................... ANJUL........................ THIBAUT.............................. DIANE........................ M. PETERS-BAXSTEVENS.................... KAREN........................ IDA HILL................................. TRISTRAM..................... W. HILL................................. SUSAN........................ E. BEER................................. SUSAN........................ GENE HARRIS............................... JUDITH....................... M. BARRUS............................... JOHN......................... P. KIM.................................. SEONGMOON.................... ---------------------------------------------------------------------------------------------------------------- Dated: April 17, 2006. Angie Kaminski, Examinations Operations, Philadelphia Compliance Services. [FR Doc. E6-6478 Filed 4-28-06; 8:45 am] BILLING CODE 4830-01-P
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{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6478.htm" }
FR
FR-2006-05-01/E6-6476
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Notices] [Pages 25649-25650] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: E6-6476] ----------------------------------------------------------------------- DEPARTMENT OF THE TREASURY Internal Revenue Service Open meeting of the Area 7 Taxpayer Advocacy Panel (including the states of Alaska, California, Hawaii, and Nevada) AGENCY: Internal Revenue Service (IRS) Treasury. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: An open meeting of the Area 7 committee of the Taxpayer Advocacy Panel will be conducted (via teleconference). The Taxpayer Advocacy Panel (TAP) is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service. The TAP will use citizen input to make [[Page 25650]] recommendations to the Internal Revenue Service. DATES: The meeting will be held Wednesday, May 24, 2006. FOR FURTHER INFORMATION CONTACT: Dave Coffman at 1-888-912-1227, or 206-220-6096. SUPPLEMENTARY INFORMATION: Notice is hereby given pursuant to Section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that an open meeting of the Area 7 Taxpayer Advocacy Panel will be held Wednesday, May 24, 2006 from 2 p.m. Pacific Time to 3 p.m. Pacific Time via a telephone conference call. The public is invited to make oral comments. Individual comments will be limited to 5 minutes. If you would like to have the TAP consider a written statement, please call 1- 888-912-1227 or 206-220-6096, or write to Dave Coffman, TAP Office, 915 2nd Avenue, MS W-406, Seattle, WA 98174 or you can contact us at http://www.improveirs.org. Due to limited conference lines, notification of intent to participate in the telephone conference call meeting must be made with Dave Coffman. Mr. Coffman can be reached at 1-888-912-1227 or 206-220-6096. The agenda will include the following: Various IRS issues. Dated: April 20, 2006. Bernard Coston, Director, Taxpayer Advocacy Panel. [FR Doc. E6-6476 Filed 4-28-06; 8:45 am] BILLING CODE 4830-01-P
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{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/E6-6476.htm" }
FR
FR-2006-05-01/C6-3833
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Corrections] [Pages 25651-25652] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: C6-3833] Federal Register / Vol. 71, No. 83 / Monday, May 1, 2006 / Corrections [[Page 25651]] DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-2235-NC] RIN 0938-AO38 State Children's Health Insurance Program (SCHIP); Redistribution of Unexpended SCHIP Funds From the Appropriation for Fiscal Year 2003; Additional Allotments to Eliminate SCHIP Fiscal Year 2006 Funding Shortfalls; and Provisions for Continued Authority for Qualifying States to Use a Portion of Certain SCHIP Funds for Medicaid Expenditures Correction In notice document 06-3833 beginning on page 20697 in the issue of Friday, April 21, 2006 make the following correction: On page 20705 the graphic should appear as follows: [[Page 25652]] [GRAPHIC] [TIFF OMITTED] TN01MY06.000 [FR Doc. C6-3833 Filed 4-28-06; 8:45 am] BILLING CODE 1505-01-D
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{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/C6-3833.htm" }
FR
FR-2006-05-01/06-3982
Federal Register Volume 71 Issue 83 (May 1, 2006)
2006-05-01T00:00:00
United States National Archives and Records Administration Office of the Federal Register
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)] [Proposed Rules] [Pages 25654-25704] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 06-3982] [[Page 25653]] ----------------------------------------------------------------------- Part II Department of Health and Human Services ----------------------------------------------------------------------- Centers for Medicare & Medicaid Services ----------------------------------------------------------------------- 42 CFR Parts 411, 414, and 424 Medicare Program; Competitive Acquisition for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) and Other Issues; Proposed Rule Federal Register / Vol. 71, No. 83 / Monday, May 1, 2006 / Proposed Rules [[Page 25654]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 411, 414, and 424 [CMS-1270-P] RIN 0938-AN14 Medicare Program; Competitive Acquisition for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) and Other Issues AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: This proposed rule would implement competitive bidding programs for certain covered items of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) throughout the United States in accordance with sections 1847(a) and (b) of the Social Security Act (the Act). These programs would change the way that Medicare pays for these items under Part B of the Medicare program by utilizing bids submitted by DMEPOS suppliers to establish applicable payment amounts. We would phase in these programs over several years. This proposed rule would also detail requirements for CMS approved accreditation organizations that will be applying quality standards for all DMEPOS suppliers, including DMEPOS suppliers that participate in the DMEPOS competitive bidding program. In addition, this rule proposes a new fee schedule for home dialysis supplies and equipment still paid on a reasonable charge basis. This proposed rule would also clarify our policy on the scope of the statutory eyeglass coverage exclusion. We are proposing to specify in regulations that the eyeglass exclusion encompasses all devices that use lenses to aid vision or provide magnification of images for impaired vision. Further, this proposed rule would implement a revised methodology for calculating fee schedule amounts for new DMEPOS items. DATES: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on June 30, 2006. ADDRESSES: In commenting, please refer to file code CMS-1270-P. 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. (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-1270-P, P.O. Box 8013, Baltimore, MD 21244-8013. 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-1270-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. 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) 786-7195 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 21244-1850. (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. Submission of comments on paperwork requirements. You may submit comments on this document's paperwork requirements by mailing your comments to the addresses provided at the end of the ``Collection of Information Requirements'' section in this document. For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Lorrie Ballantine, (410) 786-7543--Overall implementation. Joel Kaiser, (410) 786-4499--Overall implementation. Michael Keane, (410) 786-4495--Overall implementation. Walter Rutemueller, (410) 786-5395--Overall implementation. Linda Smith, (410) 786-5650--Quality Standards and Accreditation. SUPPLEMENTARY INFORMATION: Submitting Comments: We welcome comments from the public on all issues set forth in this rule to assist us in fully considering issues and developing policies. You can assist us by referencing the file code CMS-1270-P 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. CMS posts all electronic comments received before the close of the comment period on its public Web site as soon as possible after they have been received. Hard copy comments received timely will 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. Table of Contents I. Background A. Payment Under Reasonable Charges B. Payment Under Fee Schedules C. Healthcare Common Procedural Coding System (HCPCS) D. Medicare Competitive Bidding Demonstrations E. Medicare Prescription Drug, Improvement, and Modernization Act of 2003 F. Deficit Reduction Act (DRA) G. Program Advisory and Oversight Committee H. Quality Standards for Suppliers of (DMEPOS) I. Accreditation for Suppliers of DMEPOS and Other Items J. Low Vision Aid Exclusion K. Establishing Fee Schedule Amounts for New DMEPOS Items L. New Fee Schedules for Home Dialysis Supplies and Equipment [[Page 25655]] M. Covered Item Updates for Class III DME for CYs 2007 and 2008 II. Provisions of the Proposed Regulations A. Purpose and Definitions (Proposed Sec. 414.400 and Sec. 414.402) B. Implementation Contractor (Proposed Sec. 414.406) C. Payment Basis (Proposed Sec. 414.408) 1. Payment Basis (Proposed Sec. 414.408(a)) 2. General Payment Rules (Proposed Sec. 414.408(c)-(j)) 3. Special Rules for Certain Rented Items of DME and Oxygen (Grandfathering of Suppliers) (Proposed Sec. 414.408(k)) a. Process for Grandfathering Suppliers b. Payment Amounts to Grandfathered Suppliers (1) Grandfathering of Suppliers Furnishing Items Prior to the First Competitive Bidding Program in an Area (Proposed Sec. 414.408(k)) (2) Suppliers That Lose Their Contract Status in a Subsequent Competitive Bidding Program c. Payment for Accessories for Items Subject to Grandfathering 4. Payment Adjustment to Account for Inflation (Proposed Sec. 414.408(b)) 5. Authority to Adjust Payments in Other Areas (Proposed Sec. 414.408(e)) 6. Requirement to Obtain Competitively Bid Items From a Contract Supplier (Proposed Sec. 414.408(f)) 7. Limitation on Beneficiary Liability for Items Furnished by Non Contract Suppliers (Proposed Sec. 414.408(f)) D. Competitive Bidding Areas 1. Proposed Methodology for MSA Selection for 2007 and 2009 Competitive Bidding Programs (Proposed Sec. 414.410) a. MSAs for 2007 b. MSAs for 2009 2. Establishing Competitive Bidding Areas (Proposed Sec. 414.410) a. Authority to Exempt Rural Areas and Areas With Low Population Density Within Urban Areas (Proposed Sec. 414.410(c)) b. Establishing the Competitive Bidding Areas for 2007 and 2009 (Proposed Sec. 414.410(b)) c. Nationwide or Regional Mail Order Competitive Bidding Program (Proposed Sec. 414.410(d)(2)) d. Additional Competitive Bidding Areas After 2009 (Proposed Sec. 414.410(d)) E. Criteria for Item Selection F. Submission of Bids Under the Competitive Bidding Program (Proposed Sec. 414.412) 1. Providers (Proposed Sec. 414.404 and 414.422) 2. Physicians (Proposed Sec. 414.422) 3. Product Categories for Bidding Purposes (Proposed Sec. 414.412) 4. Bidding Requirements (Proposed Sec. 414.408) a. Inexpensive or Other Routinely Purchased DME Items b. DME Items Requiring Frequent and Substantial Servicing c. Oxygen and Oxygen Equipment d. Capped Rental Items e. Enteral Equipment and Supplies f. Maintenance and Servicing of Enteral Infusion Pumps g. Supplies Used in Conjunction With DME h. OTS Orthotics G. Conditions for Awarding Contracts (Proposed Sec. 414.414) 1. Quality Standards and Accreditation (Proposed Sec. 414.414(c)) 2. Eligibility (Proposed Sec. 414.414(b)) 3. Financial Standards (Proposed Sec. 414.414(d)) 4. Evaluation of Bids (Proposed Sec. 414.414(e)) a. Market Demand and Supplier Capacity (Proposed Sec. 414.414(e)) b. Composite Bids (Proposed Sec. 414.414(e)) c. Determine the Pivotal Bid (Proposed Sec. 414.414(e)) d. Assurance of Savings (Proposed Sec. 414.414(f)) e. Assurance of Multiple Contractors (Proposed Sec. 414.414(g)) f. Selection of New Suppliers After Bidding (Proposed Sec. 414.414(h)) H. Determining Single Payment Amounts for Individual Items (Proposed Sec. 414.416) 1. Setting Single Payment Amounts for Individual Items (Proposed Sec. 414.416(b)) 2. Rebate Program (Proposed Sec. 414.416(c)) I. Terms of Contracts (Proposed Sec. 414.422) 1. Terms and Conditions of Contracts 2. Furnishing of Items (Proposed Sec. 414.422(c)) 3. Repairs and Replacements of Patient Owned Items Subject to Competitive Bidding (Proposed Sec. 414.422(c)) 4. Furnishing Items to Beneficiaries Whose Permanent Residence Is Within a CBA 5. Furnishing Items to Beneficiaries Whose Permanent Residence Is Outside a CBA 6. Information Collection from the Supplier 7. Change in Ownership (Proposed Sec. 414.422(d)) 8. Suspension or Termination of a Contract (Proposed Sec. 414.422(f)) J. Administrative or Judicial Review (Proposed Sec. 414.424) K. Opportunity for Participation by Small Suppliers L. Opportunity for Networks (Proposed Sec. 414.418) M. Education and Outreach 1. Supplier Education 2. Beneficiary Education N. Monitoring and Complaint Services for the Competitive Bidding Program O. Physician Authorization/Treating Practitioner and Consideration of Clinical Efficiency and Value of Items in Determining Categories for Bids (Proposed Sec. 414.420) P. Quality Standards and Accreditation for Suppliers of DMEPOS 1. Special Payment Rules for Items Furnished by DMEPOS Suppliers and Issuance of DMEPOS Supplier Billing Privileges (Proposed Sec. 424.57) 2. Accreditation (Proposed Sec. 424.58) 3. Ongoing Responsibilities of CMS Approved Accreditation Organizations 4. Continuing Federal Oversight of Approved Accreditation Organizations a. Equivalency Review b. Validation Review c. Notice of Intent To Withdraw Approval for Deeming Authority d. Withdrawal of Approval for Deeming Authority e. Reconsideration Q. Low Vision Aid Exclusion (Proposed Sec. 414.15) R. Establishing Payment Amounts for New DMEPOS (Gap-filling) (Proposed Sec. 414.210(g)) S. Fee Schedules for Home DialysIs Supplies and Equipment (Proposed Sec. 414.107) T. Fee Schedules for Therapeutic Shoes (Proposed Sec. 414.228(c)) III. Collection of Information Requirements IV. Response to Comments V. Regulatory Impact AnalysIs A. Overall Impact B. Anticipated Affects C. Implementation Costs D. Program Savings E. Effect on Beneficiaries F. Effect on Suppliers 1. Affected Suppliers 2. Small Suppliers G. Accounting Statement Regulation Text I. Background A. Payment Under Reasonable Charges Payment for most DMEPOS items, including supplies and equipment, furnished under Part B of the Medicare program (Supplementary Medical Insurance) is made through contractors known as Medicare carriers. Before January 1, 1989, payment for most of these services was made on a reasonable charge basis by these carriers. The methodology for determining reasonable charges is set forth in section 1842(b) of the Social Security Act (Act) and 42 CFR part 405, subpart E of the regulations. Reasonable charge determinations are generally based on customary and prevailing charges derived from historic charge data, with the ``reasonable charge'' for an item being the lowest of the following factors: The supplier's actual charge for the item. The supplier's customary charge for the item. The prevailing charge in the locality for the item. The prevailing charge may not exceed the 75th percentile of the customary charges of suppliers in the locality. The inflation indexed charge (IIC). The IIC is defined in Sec. 405.509(a) as the lowest of the fee screens used to determine reasonable charges for services, including supplies, and equipment paid on a reasonable charge basis (excluding physicians' services) that is in effect on December 31 of the previous fee screen year, updated by the inflation adjustment factor. The inflation adjustment factor is based on the current change in the consumer price index for all urban consumers (CPI-U), as compiled by the Bureau of Labor Statistics, for the 12-month period ending June 30 each year. [[Page 25656]] B. Payment Under Fee Schedules Section 4062 of the Omnibus Budget Reconciliation Act of 1987 (Pub. L. 100-203) (OBRA ``87) added section 1834 to the Act and implemented a fee schedule payment methodology for most durable medical equipment (DME), prosthetic devices, and orthotic devices furnished after January 1, 1989. Specifically, sections 1834(a)(1)(A) and (B) and 1834(h)(1)(A) of the Act provide that Medicare payment for these items is equal to 80 percent of the lesser of the actual charge for the item or the fee schedule amount for the item. We implemented this new payment methodology at 42 CFR part 414, subpart D of our regulations. Sections 1834(a)(2) through (a)(5) and section 1834(a)(7) of the Act, as well as Sec. 414.200 through Sec. 414.232 (with the exception of Sec. 414.228) of the regulations, set forth separate payment categories of DME and describe how the fee schedule for each of the following categories is established: Inexpensive or other routinely purchased items (section 1834(a)(2) of the Act and Sec. 414.220 of the regulations); Items requiring frequent and substantial servicing (section 1834(a)(3) of the Act and Sec. 414.222); Customized items (section 1834(a)(4) of the Act and Sec. 414.224); Oxygen and oxygen equipment (section 1834(a)(5) of the Act and Sec. 414.226); Other items of DME (section 1834(a)(7) of the Act and Sec. 414.229). Each category has its own unique payment rules. With the exception of customized items, a fee schedule amount is calculated for each item or category of DME that is identified by a code in the Healthcare Common Procedure Coding System (HCPCS). The Medicare payment amount for a customized item of DME is based on the Medicare carrier's individual consideration of that item. The fee schedule amounts for oxygen and oxygen equipment are monthly payment amounts. Payment under the DME benefit is made for supplies necessary for the effective use of DME (for example, lancets and test strips used with blood glucose monitors). These supplies are paid for using the same methodology that we use to pay for inexpensive or routinely purchased items. The fee schedule amounts for DME are generally adjusted annually by the change in the CPI-U for the 12-month period ending June 30 of the preceding year. The fee schedule amounts are also generally limited by a ceiling (upper limit) and floor (lower limit) equal to 100 percent and 85 percent, respectively, of the median of the statewide fee schedule amounts. Since 1994, Medicare has paid for most surgical dressings in accordance with section 1834(i) of the Act and Sec. 414.220(g) of the regulations, using the same methodology as is used for payment of inexpensive or routinely purchased DME. Under section 1834(h) of the Act and Sec. 414.228 of the regulations, payment for prosthetic and orthotic devices is made on a lump sum basis and is equal to the lower of the fee schedule amount calculated for the item or the actual charge for the item, less any unmet deductible. The fee schedule amounts are calculated using a weighted average of Medicare payments made in the States in each of 10 CMS regions from July 1, 1986 through June 30, 1987, adjusted annually by the change in the CPI-U for the 12-month period ending June 30 of the preceding year. The regional fee schedule amounts are limited by a ceiling (upper limit) and floor (lower limit) equal to 120 percent and 90 percent, respectively, of the average of the regional fee schedule amounts for each State. As authorized under section 1842(s) of the Act and 42 CFR, part 414, subpart C of our regulations, Medicare pays for parenteral and enteral nutrition (PEN) nutrients, equipment and supplies on the basis of 80 percent of the lesser of the actual charge for the item, or the fee schedule amount for the item (Sec. 414.102(a)). The fee schedule amounts for PEN items are calculated on a nationwide basis and are the lesser of the reasonable charges for 1995, or the reasonable charges that would have been used in determining payment for these items in 2002 under the former reasonable charge payment methodology (Sec. 414.104(b)). The fee schedule amounts are generally adjusted annually by the percentage increase in the CPI-U for the 12-month period ending with June 30 of the preceding year (Sec. 414.102(c)). Under Sec. 414.104(a), payment for PEN nutrients and supplies is made on a purchase basis, and payment for PEN equipment that is rented is made on a monthly basis. We are proposing to revise Sec. 414.1 of our regulations to specify that fee schedules were established for PEN items in accordance with our authority under section 1842(s) of Act. Section 627 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) amended section 1833(o)(2) of the Act to require implementation of fee schedule amounts, effective January 1, 2005, for the purpose of determining payment for custom molded shoes, extra-depth shoes, and inserts (collectively, ``therapeutic shoes''). We believe that this section of the MMA is largely self-implementing because it mandates use of the methodology set forth in section 1834(h) of the Act for prosthetic and orthotic devices in determining the fee schedule amounts for therapeutic shoes. We implemented that methodology through regulations at part 414, subpart D, and section 627 of the MMA provides that the same methodology shall apply to therapeutic shoes. Section 627 of the MMA was implemented through program instructions, and on January 1, 2005, Medicare began paying for therapeutic shoes based on fee schedule amounts determined in accordance with section 1834(h) of the Act and part 414, subpart D of our regulations. C. Healthcare Common Procedure Coding System (HCPCS) The Healthcare Common Procedure Coding System (HCPCS) is a standardized coding system used to process claims submitted to Medicare, Medicaid, and other health insurance programs by providers, physicians, and other suppliers. The HCPCS code set is divided into the following 2 principal subsystems, referred to as level I and level II of the HCPCS: Level I of the HCPCS codes is comprised of Current Procedural Terminology (CPT) codes. CPT codes are a uniform coding system consisting of descriptive terms and identifying codes that are used primarily to identify medical services and procedures furnished by physicians and other health care professionals which are billed to public or private health insurance programs. CPT codes are developed, published, and maintained by the American Medical Association. CPT codes do not include codes needed to separately report medical items that are regularly billed by suppliers other than physicians. Level II of the HCPCS codes is a standardized coding system used primarily to identify products and supplies that are not included in the CPT codes, such as DME, orthotics, prosthetics, and supplies when used outside a physician's office. HCPCS Level II Codes classify like items by category for the purpose of efficient claims processing. Assignment of a HCPCS code is not a coverage determination, and does not imply that any payer will cover the items in the code category. For some DMEPOS items, such as wheelchairs and wheelchair cushions, minimum performance [[Page 25657]] standards must be met before an item can be classified under a HCPCS code. In October of 2003, the Secretary delegated authority under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to CMS to maintain and distribute the HCPCS Level II Codes. The HCPCS Level II Codes will be used to describe the DME, orthotic, and enteral nutrition items furnished under the competitive bidding programs being proposed in this proposed rule, both for the purpose of requesting bids and for establishing payment amounts. D. Medicare Competitive Bidding Demonstrations Section 4319 of the Balanced Budget Act of 1997 (BBA) authorized implementation of up to five demonstration projects of competitive bidding for Medicare Part B items, except physician services. In accordance with section 4319 of the BBA, we planned and implemented the DMEPOS Competitive Bidding Demonstration to test the feasibility and program impacts of using competitive bidding to set prices for DME and prosthetics, orthotics, and supplies. The demonstration was implemented at two sites: Polk County, Florida, and in the San Antonio, Texas, Metropolitan Statistical Area (MSA). The competitive bidding demonstrations, authorized under the BBA, were implemented successfully in both demonstration sites from 1999 to 2002, resulted in a substantial savings to the program and offered beneficiaries sufficient access and a quality product. At the first site, Polk County, Florida, we conducted the first of two rounds of bidding in 1999. Five categories of DMEPOS were put up for bidding: Oxygen equipment and supplies (required by statute), hospital beds and accessories, enteral nutrition formulas and equipment, urological supplies, and surgical dressings. A total of 16 contract suppliers began providing demonstration products in Polk County on October 1, 1999, and continued for 2 years. The second and final round of bidding in Polk County was conducted in 2001 for the same product categories minus enteral nutrition. (Enteral nutrition was dropped to retain only product categories that are overwhelmingly used in private homes.) The second set of competitively bid payment amounts took effect in October 2001. As in round one, 16 suppliers were selected, of whom half had participated as winners previously. The new fee schedules developed from the bids in each round replaced the statewide Medicare DMEPOS fees. The second round of the demonstration in Polk County ended in September 2002. Texas was the second site for the demonstration. In the San Antonio MSA's Bexar, Comal, and Guadalupe counties we conducted bidding in 2000 for five kinds of DMEPOS: Oxygen equipment and supplies, hospital beds and accessories, wheelchairs and accessories, general orthotics, and nebulizer drugs. Fifty-one suppliers were selected and began serving Medicare beneficiaries under the new fees in February 2001. The San Antonio site ended operations in December 2002, the statutorily required termination date in the BBA. In each area of evaluation, the data indicated mostly favorable results for the Medicare program. The demonstration led to lower Medicare fees for almost every item in almost every product category in each round of bidding. Fee reductions varied by product category and item, resulting in a nearly 20 percent overall savings at each site. Statistical and qualitative data indicate that beneficiary access and quality of services were essentially unchanged. The DMEPOS Competitive Bidding Demonstration offers valuable lessons for understanding the impacts of competitive bidding for Medicare services. These lessons are especially important now because the MMA mandates a larger role for competitive bidding within the Medicare program. Specifically, section 302(b) of the MMA requires the Secretary to establish and implement competitive bidding programs for the furnishing of certain DME and associated supplies, enteral nutrition and associated supplies, and off-the-shelf orthotics. In addition, section 303(d) of the MMA requires the Secretary to implement a competitive bidding program for certain Medicare Part B drugs not paid on a cost or prospective payment system basis, and section 302(b) of the MMA mandates competitive bidding demonstration projects for clinical laboratory services and managed care. E. Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173) Section 302(b)(1) of the MMA amended section 1847 of the Act to require the Secretary to establish and implement programs under which competitive bidding areas are established throughout the United States for contract award purposes for the furnishing of certain competitively priced items for which payment is made under Part B (the ``Medicare DMEPOS Competitive Bidding Program''). Competitive bidding provides a way to harness marketplace dynamics to create incentives for suppliers to provide quality items in an efficient manner and at a reasonable cost. In our view, the Medicare DMEPOS Competitive Bidding Program has five objectives, as follows: To implement competitive bidding programs for certain DMEPOS items. To assure beneficiary access to quality DMEPOS as a result of the program. To reduce the amount Medicare pays for DMEPOS and create a payment structure under competitive bidding that is more reflective of a competitive market. To limit the financial burden on beneficiaries by reducing their out-of-pocket expenses for DMEPOS they obtain through the program. To contract with suppliers who conduct business in a manner that is beneficial for the program and for Medicare beneficiaries. F. Deficit Reduction Act of 2005 (Pub. L. 109-171) Section 5101(a) of the Deficit Reduction Act of 2005 (DRA) amended section 1834(a)(7)(A) of the Act to change the way Medicare pays for capped rental items. This section revised the period of payment for capped rental from 15 to 13 months. After rental payments are made for a 13 month period of continuous use, title to the capped rental items transfers from the supplier to the beneficiary. Once the title has transferred, amended section 1834(a)(7)(A)(iv) provides that reasonable and necessary maintenance and servicing payments (for parts and labor not covered by the supplier's or manufacturer's warranty, as determined by the Secretary to be appropriate for the particular item) will be made. These statutory changes apply only to capped rental items whose first rental month occurs on or after January 1, 2006. Section 5101(b) of the DRA also amended section 1834(a)(5) of the Act to limit monthly payments for oxygen equipment to a 36 month period of continuous use. Then ownership of the oxygen equipment will be transferred from the supplier to the beneficiary. Medicare will continue making monthly payments for oxygen contents when appropriate for beneficiary owned stationary and portable systems in the amounts recognized under section 1834(a)(9) after title to the equipment transfers to the beneficiary. However, under new section 1834(a)(5)(F)(II)(bb), maintenance and servicing payments for beneficiary owned oxygen equipment (for parts and labor not covered by the supplier's or manufacturer's warranty) [[Page 25658]] will be made only if they are reasonable and necessary. These statutory changes went into effect on January 1, 2006. For beneficiaries receiving Medicare covered oxygen equipment as of December 31, 2005, the 36-month rental period begins January 1, 2006. In a future rulemaking, we will propose to revise regulations found in part 414, subpart D to incorporate these DRA provisions. G. Program Advisory and Oversight Committee Section 1847(c) of the Act requires the Secretary to establish a Program Advisory and Oversight Committee (PAOC) that will provide advice to the Secretary with respect to the following functions, including-- The implementation of the Medicare DMEPOS Competitive Bidding Program; The establishment of financial standards for entities seeking contracts under the Medicare DMEPOS Competitive Bidding Program, taking into account the needs of small providers; The establishment of requirements for collection of data for the efficient management of the Medicare DMEPOS Competitive Bidding Program; The development of proposals for efficient interaction among manufacturers, providers of services, suppliers (as defined in section 1861(d) of the Act) and individuals; and The establishment of quality standards for DMEPOS suppliers under section 1834(a)(20) of the Act. In addition, section 1847(c)(3)(B) of the Act authorizes the PAOC to perform additional functions to assist the Secretary in carrying out the Medicare DMEPOS Competitive Bidding Program as the Secretary may specify. As authorized under section 1847(c)(2) of the Act, the PAOC members were appointed by the Secretary of Health and Human Services and represent a broad mix of relevant industry, consumer, and government parties. Specifically, the membership roster includes two beneficiary/ consumer representatives, four manufacturer representatives, five supplier representatives, three certification/standards representatives, six Federal and State program representatives, one physician and one pharmacist. The representatives have expertise in a variety of subject matter areas, including DMEPOS, competitive bidding methodologies and processes, and rural and urban marketplace dynamics. The first PAOC meeting was announced in a Federal Register notice (CMS- 1279-N2, 69 FR 31125) and was held at CMS on October 6, 2004. We have held two additional PAOC meetings where we, along with our contractor RTI, presented material to both the PAOC and the public relating to the provisions that are outlined in this proposed rule. The topics that we presented include-- Medicare's timeline for implementation of the Medicare DMEPOS Competitive Bidding Program; Results of the Medicare competitive bidding demonstration projects authorized by section 4319 of the BBA; Structure of the Medicare DMEPOS Competitive Bidding Program being proposed in this proposed rule; Existing non-Medicare competitive bidding programs for DMEPOS items; Program design options for the Medicare DMEPOS Competitive Bidding Program being proposed in this proposed rule; Criteria for selecting Metropolitan Statistical Areas (MSAs) in which competition under the Medicare DMEPOS Competitive Bidding Program will occur in both 2007 and 2009; Criteria for selecting items for competitive bidding; Bidding process overview; Methodology for setting single payment amounts for competitively bid items; Capacity of DMEPOS suppliers and beneficiary utilization of DMEPOS items; Financial capabilities of bidding suppliers; Exception authority under section 1847(a)(3) of the Act for rural areas and areas with low population density within urban areas that are not competitive; and Quality standards and accreditation procedures applicable to all DMEPOS suppliers. In addition to the PAOC meetings, we have designed and implemented a CMS Web site (http://cms.hhs.gov/suppliers/dmepos/compbid/paoc.asp) specifically for the public to have access to all PAOC presentations, minutes, and updates for the Medicare DMEPOS Competitive Bidding Program. In accordance with section 1847(c)(5) of the Act, the PAOC will continue to operate until December 31, 2009. Future PAOC meeting dates, as well as other information pertinent to the Medicare DMEPOS Competitive Bidding Program, can be found on our Web site. H. Quality Standards for Suppliers of (DMEPOS) Section 302(a)(1) of the MMA added section 1834(a)(20) to the Act, which requires the Secretary to establish and implement quality standards for suppliers of certain items, including consumer service standards, to be applied by recognized independent accreditation organizations. Suppliers of DMEPOS must comply with the quality standards in order to furnish any item for which payment is made under Part B, and to receive and retain a provider or supplier billing number used to submit claims for reimbursement for any such item for which payment may be made under Medicare. Section 1834(a)(20)(D) of the Act requires us to apply these quality standards to suppliers of the following items for which we deem the standards to be appropriate: Covered items, as that term is defined in section 1834(a)(13), for which payment may be made under section 1834(a); Prosthetic devices and orthotics and prosthetics described in section 1834(h)(4); and Items described in section 1842(s)(2) of the Act, which include medical supplies, home dialysis supplies and equipment, therapeutic shoes, parenteral and enteral nutrients, equipment, and supplies, electromyogram devices, salivation devices, blood products, and transfusion medicine. Section 1834(a)(20)(E) of the Act explicitly authorizes the Secretary to establish the quality standards by program instruction or otherwise after consultation with representatives of relevant parties. We consulted with the PAOC and determined that it is in the best interest of the industry and beneficiaries to publish the quality standards through program instructions and select the accreditation organizations in order to ensure that suppliers that wish to participate in competitive bidding will know what standards they must meet in order to be awarded a contract. The standards will be applied prospectively and will be published on our website. All suppliers of DMEPOS and other items to which section 1834(a)(20) of the Act applies will be required to meet the quality standards established under that section. Finally, section 1847(b)(2)(A)(i) of the Act requires an entity (a DMEPOS supplier) to meet the quality standards specified by the Secretary under section 1834(a)(20) of the Act before being awarded a contract under the Medicare DMEPOS Competitive Bidding Program. Since December 11, 2000, suppliers have been required to meet the Medicare enrollment standards at Sec. 424.57, satisfaction of which is required for these suppliers to participate in the Medicare program and [[Page 25659]] receive Medicare payments for DMEPOS and other items. Even with the implementation of the enrollment standards at Sec. 424.57, we believe there has not been sufficient oversight of suppliers of DMEPOS and other items related to the quality and provision of their products. The Department of Health and Human Services, Office of Inspector General (OIG), has conducted several investigations of suppliers of DMEPOS and other items to determine the legitimacy of their businesses and has uncovered many examples of fraud and abuse. Examples of the types of fraud and abuse that were discovered include-- Billing for services not performed; Billing for a more expensive service than was rendered; Billing separately for several services that should be combined into one billing; Billing twice for the same service; Billing for more expensive equipment or supplies than were used; Offering or receiving kickbacks (that is, offering or accepting something in return for services); Offering or accepting a bribe to use a particular service or company; Providing unnecessary services; and Submitting false cost reports. The OIG began publicizing fraud alerts as a vehicle to identify fraudulent and abusive practices being committed by DMEPOS suppliers within the health care industry. To enhance the quality of services provided by suppliers of DMEPOS and further reduce fraudulent practices, we are developing quality standards, as required by section 1834(a)(20) of the Act, to address suppliers' accountability, business integrity, provision of quality products to beneficiaries, and performance management. These standards will measure the effect of suppliers' services on beneficiaries. The supplier quality standards will include product specific requirements that will focus on a consumer-directed model of service delivery for suppliers to improve beneficiary access to information about DMEPOS. We believe these requirements will empower beneficiaries to make better- informed choices regarding equipment selection and the proper and safe use of DMEPOS, which we believe will lead to increased beneficiary satisfaction, safe and appropriate use of purchased equipment, and positive health outcomes. The supplier quality standards will provide more efficient processes and standardized materials for suppliers to increase consistency and continuity for supplier services to beneficiaries, beneficiary education, and responsiveness to beneficiary requests for equipment options. We are using contractor support and input from industry suppliers and national associations to develop the quality standards. Additionally, the contractors will meet with beneficiaries who use the specific products to solicit their input and assurance that their needs are being addressed by the quality standards requirements. The quality standards will include performance management requirements to ensure the development, implementation, monitoring, and evaluation of policies, procedures, and products so that suppliers can maintain compliance with regulatory requirements and our policy instructions. The quality standards will include language from current CMS standards and industry best practice standards for the following areas: Administration; financial management; human resource management; beneficiary services; performance management; environment and safety; beneficiary rights/ethics; and information management. Additionally, the supplier quality standards will include requirements for monitoring beneficiary satisfaction with products and suppliers' responses to beneficiary complaints. As is authorized under section 1834(a)(20)(E), we will be establishing the supplier quality standards through program instructions and will publish them on our Web site. Additionally, in a future rule, we will propose to address DMEPOS supplier requirements for enrollment and enforcement procedures. I. Accreditation for Suppliers of DMEPOS and Other Items Section 1834(a)(20)(B) of the Act requires the Secretary, notwithstanding section 1865(b) of the Act, to designate and approve one or more independent accreditation organizations to apply the quality standards to suppliers of DMEPOS and other items. The Medicare program currently contracts with State Agencies to perform survey and review functions for providers and suppliers to approve their participation in or coverage under the Medicare program. Additionally, section 1865(b) of the Act sets forth the general procedures for CMS to designate national accreditation organizations to deem providers or suppliers to meet Medicare conditions of participation or coverage if they are accredited by a national accreditation organization approved by CMS. Many types of providers and suppliers have a choice between having the State Agency or the CMS approved accreditation organization survey them. If the provider or supplier selects the CMS-approved accreditation organization and is in compliance with the accreditation organization standards, it is generally deemed to meet the Medicare conditions of participation or coverage. CMS is responsible for the oversight and monitoring of the State Agencies and the approved accreditation organizations. The procedures, implemented by the Secretary, for designating private and national accreditation organizations and the Federal review process for accreditation organizations are located at 42 CFR parts 422 (for Medicare Advantage organizations) and 488 (for most providers and suppliers). Although, the statute itself does not require us to issue a rulemaking or provide notice in the Federal Register in order to designate and approve DMEPOS accreditation organizations, we believe that the Administrative Procedure Act does require us to give notice and an opportunity for comment before we institute our procedures for designating and supervising these organizations. To accommodate suppliers that wish to participate in the Medicare DMEPOS Competitive Bidding Program, we will phase-in the accreditation process and require accreditation organizations to prioritize their surveys to accredit suppliers in the selected MSAs and competitive bidding areas. We will provide further guidance in a Federal Register notice on the grandfathering-in of suppliers that have already been accredited, and the submission procedures for accreditation after this rule is finalized. J. Low Vision Aid Exclusion Section 1862(a)(7) of the Act excludes payment where ``expenses are for * * * eyeglasses (other than eyewear described in section 1861(s)(8)) or eye examinations for the purpose of prescribing, fitting, or changing eyeglasses, procedures performed (during the course of any eye examination) to determine the refractive state of the eyes * * *.'' The Medicare regulations at Sec. 411.15(b) exclude from coverage eyeglasses and contact lenses, except for-- Post-surgical prosthetic lenses customarily used during convalescence for eye surgery in which the lens of the eye was removed (for example, cataract surgery); Prosthetic lenses for patients who lack the lens of the eye because of congenital absence or surgical removal; and One pair of conventional eyeglasses or conventional contact lenses furnished [[Page 25660]] after each cataract surgery during which an intraocular lens is inserted. From as early as 1980, we have clarified that we viewed closed circuit visual aid systems and other low vision devices to be subject to the eyeglass coverage exclusion at section 1862(a)(7) of the Act. We have also concurred with carrier policies that have excluded payment for low vision aids because of the eyeglass exclusion. Moreover, the Medicare Appeals Council has recognized that video magnifiers, or closed circuit televisions (CCTVs), are excluded from coverage by section 1862(a)(7) of the Act. However, we have never issued a regulation or national coverage decision that specifically states that the eyeglass exclusion at section 1862(a)(7) of the Act applies to low vision aids. We are proposing to revise Sec. 411.15(b), with certain specific exceptions, to expressly state that the eyeglass exclusion applies to all devices that use one or more lens for the primary purpose of aiding vision. In proposing this revision, we are mindful that three United States district courts have found that section 1862(a)(7) of the Act does not prohibit payment for video magnifiers. (Collins v. Thompson, No 2:03-cv-265-FtM-29SPC (M.D. Fla. June 4, 2004); Davidson v. Thompson, No. Civ. 04-32 LFG (D.N.M. 2004); Currier v. Thompson, 369 F. Supp. 2d 65 (D. Me. 2005).) The Currier court, however, recognized that the statute was ambiguous. Moreover, the Supreme Court has recently recognized that a prior judicial construction of an ambiguous statute does not categorically control an agency's contrary construction. (National Cable & Telecommunications Association v. Brand X Internet Services, 125 S. Ct. 2688, 2701 (2005).) In section II.O. of this proposed rule, we explain the reasons for our interpretation of the statute that the eyeglass exclusion does apply to low vision aids. K. Establishing Fee Schedule Amounts for New DMEPOS Items Since 1989, CMS and its contractors have used an administrative process known as gap-filling to establish fee schedule amounts for DMEPOS items when fee schedule base data is not available, such as when a new code is added to Level II of the HCPCS to describe a new category of items. For example, section 1834(a)(2)(B) of the Act requires that the fee schedules for inexpensive or routinely purchased DME (for example, canes) be based on average reasonable charges for the item from July 1, 1986 through June 30, 1987. When a new code for an item (for example, a new category of canes) falling under this category is added to the HCPCS, reasonable charge data from 1986/87 is not available and the gap-filling process is used to estimate 1986/87 reasonable charges. Since 1989, fee schedule amounts have been gap- filled using either-- Fee schedule amounts for comparable items; Supplier or retail prices; or Wholesale or manufacturer prices plus a reasonable mark- up. There is currently no methodology set forth in regulations for establishing fee schedule amounts for DMEPOS items in these situations. Therefore, in Sec. 414.210, we are proposing a modified version of our existing gap-filling process to be used in establishing fee schedule amounts for DMEPOS items to which are assigned new HCPCS Level II Codes. This process will be used to set payment amounts for all new DMEPOS items, even if those items fall within a product category that is subject to competitive bidding, until bids for those items are available for establishing payments in accordance with section 1847(b)(5) of the Act. L. New Fee Schedules for Home Dialysis Supplies and Equipment Section 1842(s)(1) of the Act gives the Secretary the authority to implement fee schedules to be used for payment under Medicare of specific items (listed in section 1842(s)(2) of the Act) still paid using the reasonable charge payment methodology described in section I.A. of this proposed rule. In Sec. 414.107, we are proposing to use this authority to implement a fee schedule payment methodology for home dialysis supplies and equipment, one of these specified items. M. Covered Item Updates for Class III DME for CYs 2007 and 2008 Sections 1834(a)(14)(H) and (I) of the Act give the Secretary discretion in determining the appropriate fee schedule update percentages for CYs 2007 and 2008, respectively, for DME which are ``class III medical devices described in section 513(a)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(c)(1)(C)).'' In making these determinations, the Secretary must take into account recommendations contained in a report from the Government Accountability Office (GAO) regarding the appropriate update percentages for these devices. The GAO report is mandated by section 302(c)(1)(B) of the MMA and must be submitted to the Congress and transmitted to the Secretary by no later than March 1, 2006. Class III devices paid in accordance with the DME fee schedule payment methodology include osteogenesis or bone growth stimulators, implantable infusion pumps, external defibrillators, and ultraviolet light therapy systems. We are soliciting comments on how to determine the appropriate fee schedule percentage change for these devices for 2007 and 2008 and will consider these comments in conjunction with the recommendations in the GAO report in determining the appropriate update percentage for these devices for 2007 and 2008. II. Provisions of the Proposed Regulation We are proposing to add a new subpart F to part 414 to specify the requirements for the Medicare DMEPOS Competitive Bidding Program. Subpart F would set forth policies and procedures relating to the program in Sec. Sec. 414.400 through 414.446. A. Purpose and Definitions (Proposed Sec. 414.400 and Sec. 414.402) [If you choose to comment on issues in this section, please include the caption ``Use of terms'' at the beginning of your comments.] We propose in Sec. 414.400 to state that the purpose of proposed new subpart F would be to implement the Medicare DMEPOS Competitive Bidding Program for certain DMEPOS items as required by sections 1847(a) and (b) of the Act. As set forth in proposed Sec. 414.402, we are proposing to define certain frequently occurring terms that will be used in competitive bidding. Specifically, we are proposing to define the following terms: Bid means an offer to furnish an item for a particular price and time period that includes, where appropriate, any services that are directly related to the furnishing of the item. Competitive bidding area (CBA) means an area established by the Secretary under this proposed rule. Composite bid means the sum of a bidding supplier's weighted bids for all items within a product category for purposes of allowing a comparison across bidding suppliers. Competitive bidding program means a program established under this proposed rule. Contract supplier means an entity that is awarded a contract by CMS to furnish items under a competitive bidding program. DMEPOS stands for durable medical equipment, prosthetics, orthotics and supplies. Grandfathered item means any one of the following items for which payment is made on a rental basis prior to the [[Page 25661]] implementation of a competitive bidding program. (1) An inexpensive or routinely purchased item described in Sec. 414.220; (2) An item requiring frequent and substantial servicing as described in Sec. 414.222; (3) Oxygen and oxygen equipment described in Sec. 414.226; and (4) A capped rental item described in Sec. 414.229. Grandfathered supplier means a noncontract supplier that furnishes a grandfathered item. Item means one of the following products identified by a HCPCS code, other than class III devices under the Federal Food, Drug and Cosmetic Act and inhalation drugs, and includes the services directly related to the furnishing of that product to the beneficiary: (1) Durable medical equipment (DME), as defined in Sec. 414.202 and further classified into the following categories: (a) Inexpensive or routinely purchased items, as specified in Sec. 414.220(a); (b) Items requiring frequent and substantial servicing, as specified in Sec. 414.222(a); (c) Oxygen and oxygen equipment, as specified in Sec. 414.226(b); and (d) Other DME (capped rental items), as specified in Sec. 414.229. (2) Supplies necessary for the effective use of DME. (3) Enteral nutrients, equipment, and supplies. (4) Off-the-shelf orthotics, which are orthotics described in section 1861(s)(9) of the Act that require minimal self-adjustment for appropriate use and do not require expertise in trimming, bending, molding, assembling, or customizing to fit a beneficiary. Item weight is a number assigned to an item based on its beneficiary utilization rate in a competitive bidding area when compared to other items in the same product category. Metropolitan Statistical Area (MSA) has the same meaning as that given by the Office of Management and Budget. Nationwide competitive bidding area means a competitive bidding area that includes the United States and its territories. Noncontract supplier means a supplier that is located in a competitive bidding area or that furnishes items through the mail to beneficiaries in a competitive bidding area but that is not awarded a contract by CMS to furnish items included in the competitive bidding program for that area. Physician has the same meaning as in section 1861(r)(1) of the Act. Pivotal bid means the highest composite bid based on bids submitted by suppliers for a product category that will include a sufficient number of suppliers to meet beneficiary demand for the items in that product category. Product category means a grouping of related items that are included in a competitive bidding program. Single payment amount means the allowed payment for an item furnished under a competitive bidding program. Supplier means an entity with a valid Medicare supplier number, including an entity that furnishes items through the mail. Treating practitioner means a physician assistant, nurse practitioner, or clinical nurse specialist, as those terms are defined in section 1861(aa)(5) of the Act. Weighted bid means the item weight multiplied by the bid price submitted for that item. B. Implementation Contractor (Proposed Sec. 414.406) [If you choose to comment on issues in this section, please include the caption ``Implementation Contractor'' at the beginning of your comments.] Section 1847(b)(9) of the Act provides that the Secretary may contract with appropriate entities to implement the Medicare DMEPOS Competitive Bidding Program. Therefore, in proposed Sec. 414.406(a), we would designate one or more competitive bidding implementation contractors (CBICs) for the purpose of implementing the Medicare Competitive Bidding Program. Section 1847(a)(1)(C) of the Act also authorizes the Secretary to waive such provisions of the Federal Acquisition Regulation (FAR) as are necessary for the efficient implementation of this section, other than provisions relating to confidentiality of information and such other provisions as the Secretary determines appropriate. The Secretary is exercising this authority to waive all requirements of the FAR, other than provisions dealing with confidentiality, because of the need for expeditious implementation of a program of this significance and magnitude. However, this does not preclude us from voluntarily using or adapting certain provisions of the FAR for purposes of the competitive bidding contracts. We envision that the Medicare DMEPOS Competitive Bidding Program will have six primary functions, including overall oversight and decision making, operation design functions (including the design of both bidding and outreach material templates, as well as program processes), bidding and evaluation, access and quality monitoring, outreach and education, and claims processing. We considered the organizational structure and requirements necessary to conduct these functions, and have chosen to exercise our contracting authority under section 1847(b)(9) of the Act and contract with one or more CBICs to assist us with many of these functions. We considered several options in designing the most appropriate framework for implementing the Medicare DMEPOS Competitive Bidding Program. Since the implementation of competitive bidding involves many functions that are time limited and require specialized skills, for example, setting up bidding areas, reviewing bids, and setting single payment amounts, we believe that it would be prudent to initially implement most aspects of the Medicare Competitive Bidding Program through one or more CBICs. Processing of Medicare claims for most DMEPOS is currently done by four DME regional carriers (DMERCs). These DMERCs would continue to process claims for DMEPOS items subject to competitive bidding and would continue to perform other existing DMERC functions. We have evaluated the anticipated feasibility and cost of using one or more implementation contractor(s) to assist us with implementing the Medicare DMEPOS Competitive Bidding Program, concentrating on the potential for capturing economies of scale and scope, program consistency, existing resources and infrastructure, and the viability of implementation under the timeframe mandated by section 1847(a)(1)(B) of the Act. We would contract with one or more CBICs to conduct some program functions at a national level and interact with the DMERC contractors. Specifically, we envision that the CBIC(s) would conduct certain functions related to competitive bidding, such as preparing the request for bids (RFB), performing bid evaluations, selecting qualified suppliers, and setting single payment amounts for all competitive bidding areas. Additionally, the CBIC(s) would be charged with educating the DMERCs on the bidding process and procedures. The CBIC(s) would also assist CMS and the DMERCs in monitoring program effectiveness, access, and quality. The DMERCs would continue to provide outreach and education to beneficiaries and suppliers in their regions, process claims, apply the single payment amounts set by the CBIC(s) for each competitive bidding area, and continue to be responsible for complaints related to claims processing. We would continue to be responsible for overall [[Page 25662]] oversight and decision making, as well as policy related outreach and education to the CBIC(s), DMERCs, suppliers, and beneficiaries. In our view, this approach would achieve economies of scale since the responsibility for producing program materials and evaluating bids would rest with the CBIC(s). As a result, we believe that this approach would both lower costs and ensure regional consistency in that the responsibility would not be divided between various entities. We considered two other alternatives for implementation of the Medicare DMEPOS Competitive Bidding Program. The first was to have each DMERC conduct competitive bidding in its respective area and be responsible for all activities related to competitive bidding. The second alternative was to have the CMS Consortium Contractor Management Officer (CCMO)/ Regional Offices (RO) and the DMERCs implement the program. However, we believe that by using one or more specialized CBICs, we can successfully implement and effectively manage this program. C. Payment Basis (Proposed Sec. 414.408) [If you choose to comment on issues in this section, please include the caption ``Payment Basis'' at the beginning of your comments.] 1. Payment Basis (Sec. 414.408(a)) Section 1847(b)(5) of the Act mandates that a single payment amount be established for each item in each competitive bidding area based on the bids submitted and accepted for that item. Medicare payment for the item is then made on an assignment-related basis equal to 80 percent of the applicable single payment amount, less any unmet Part B deductible described in section 1833(b) of the Act. Section 1847(a)(6) of the Act requires that this payment basis be substituted for the payment basis otherwise applied under section 1834(a) of the Act for DME, section 1834(h) of the Act for Off-The-Shelf (OTS) orthotics, or section 1842(s) of the Act for enteral nutrition, as appropriate. We are proposing in Sec. 414.408 that payment to the contract supplier would be based on the single payment amount for the item in the competitive bidding area where the beneficiary maintains a permanent residence. If an item that is included in a competitive bidding program is furnished to a beneficiary who does not maintain a permanent residence in a competitive bidding area, the payment basis for the item would be 80 percent of the lesser of the actual charge for the item, or the applicable fee schedule amount for the item. We are also proposing that implementation of a competitive bidding program would not preclude the use of an Advanced Beneficiary Notice (ABN) to allow beneficiaries to make informed consumer choices regarding whether to obtain items for which Medicare might not make payment. 2. General Payment Rules (Proposed Sec. 414.408 (c-j)) Section 1834(a) of the Act and Sec. 414.200 through Sec. 414.232 (with the exception of Sec. 414.228) set forth the Medicare Part B payment methodology we use to pay for the rental or purchase of new and used DME. Each item of DME that is paid for under these sections is classified into a payment category, and each category has its own unique payment rules. Section 1842(s) of the Act provides authority for establishing a statewide or area wide fee schedule to be used for the payment of items described in section 1842(s)(2) of the Act. Under this authority, we implemented fee schedules for the payment of purchased and rented enteral nutrients, equipment, and supplies (see Sec. 414.100 through Sec. 414.104). Section 1834(h) of the Act and Sec. 414.228 of our regulations set forth the Medicare Part B payment methodology we use to pay for orthotics and prosthetics. Other than the rules governing calculation of the single payment amount and other proposed modifications to existing policies that are addressed in this regulation, we propose that the current requirements regarding the rental or purchase of DMEPOS items would continue to apply under the Medicare DMEPOS Competitive Bidding Program. While we believe that we have discretion under section 1847(a)(6) of the Act to adopt new rules that would govern these requirements, at this time we are proposing only to change the payment basis for these items. 3. Special Rules for Certain Rented Items of DME and Oxygen (Grandfathering of Suppliers) (Proposed Sec. 414.408(k)) a. Process for Grandfathering Suppliers Section 1847(a)(4) of the Act requires that in the case of covered DME items for which payment is made on a rental basis under section 1834(a) of the Act, and in the case of oxygen for which payment is made under section 1834(a)(5) of the Act, the Secretary shall establish a ``grandfathering'' process by which rental agreements for those covered items and supply arrangements with oxygen suppliers entered into before the start of a competitive bidding program may be continued. DME paid on a rental basis under section 1834(a) of the Act includes inexpensive or routinely purchased items furnished on a rental basis, items requiring frequent and substantial servicing, and capped rental items. Section 1834(a)(5) of the Act mandates that payment be made for oxygen and oxygen equipment on the basis of monthly payment amounts for oxygen and oxygen equipment (other than portable oxygen equipment) with separate add-on payments for portable oxygen equipment. We are proposing the grandfathering process described below for rented DME and oxygen and oxygen equipment when these items are included under a competitive bidding program. This process would apply only to suppliers that began furnishing the items described above to beneficiaries who maintain a permanent residence in an area prior to the implementation of a competitive bidding program in that area that includes the same items. In the case of the specific items identified in this section, we are proposing in Sec. 414.408 to give beneficiaries the choice of deciding whether they would like to continue renting the item from the grandfathered supplier or a contract supplier, unless the grandfathered supplier is not willing to continue furnishing the item under the terms we have specified below. If the grandfathered supplier is not willing to continue furnishing the item under these terms, then a contract supplier would assume responsibility for continuing to furnish the item and be paid based on the single payment amount determined for that item under the competitive bidding program. In addition, the beneficiary could elect, at any time, to transition to a contract supplier and the contract supplier would be required to accept the beneficiary as a customer. Suppliers who agree to be grandfathered suppliers for a specific item must agree to be a grandfathered supplier for all beneficiaries who request to continue to use their service for that item. b. Payment Amounts to Grandfathered Suppliers (Sec. 414.408(k)) (1) Grandfathering of Suppliers Furnishing Items Prior to the First Competitive Bidding Program in an Area For items requiring frequent and substantial servicing, as well as oxygen and oxygen equipment, we are proposing that a grandfathered supplier may continue furnishing these items to beneficiaries in accordance with [[Page 25663]] existing rental agreements or supply arrangements. However, we are also proposing that the grandfathered supplier be paid the single payment amounts determined for those items under the competitive bidding program since beneficiaries rent these items for extended time periods as long as the items remain medically necessary. We believe that this payment proposal is consistent with section 1847(a)(4), which requires us to establish a ``process'' under which rental agreements and supply arrangements ``may be continued,'' but is silent regarding the terms of that process. Since the rental payments are not calculated based on or limited to the purchase fee for that item as is the case for other rented DME items, we do not believe that it is not reasonable to continue paying the fee schedule amounts for these items and that payment at the competitively determined rates will comport with an overarching goal of competitive bidding to achieve savings for the Medicare program. Unlike items requiring frequent and substantial servicing, the duration of the rental payments for capped rental items and inexpensive or routinely purchased items are limited. In addition, unlike oxygen equipment, the payment amounts made for capped rental items and inexpensive or routinely purchased items are limited to the approximate purchase fee for the item. For items that are furnished on a rental basis under Sec. 414.220 or Sec. 414.229, we are proposing in Sec. 414.408 that the grandfathered supplier could continue furnishing the items in accordance with existing rental agreements and continue to be paid in accordance with section 1834(a) of the Act. We believe that continuing to pay for these grandfathered items at the fee schedule rates is authorized under section 1862(a)(17) of the Act, which allows the Secretary to specify ``other circumstances'' in which Medicare will make payment where the expenses for a competitively bid item furnished in a competitive bidding area were incurred by a supplier other than a contract supplier. In our view, the limited duration of the rental agreements for capped rental items and inexpensive or routinely purchased items furnished on a rental basis, in addition to the fact that payments for these items are based on or limited to the purchase fees for the items, constitute appropriate circumstances under which we would allow these rental agreements, including their payment terms, to continue until their conclusion. The rental fee schedule amounts that we would pay for grandfathered items in the capped rental or inexpensive or routinely purchased categories would be those fee schedule amounts established for the State in which the beneficiary maintains a permanent residence. (2) Suppliers That Lose Their Contract Status in a Subsequent Competitive Bidding Program There may be instances when a supplier that was awarded a contract to furnish rental items or oxygen and oxygen equipment under a competitive bidding program is not awarded a contract to furnish the same rental items under a subsequent competitive bidding program in the same area. We are concerned that if this occurs, beneficiaries will need to switch suppliers in the middle of the rental period and could experience a disruption of service as a result. In order to minimize this possibility, we are proposing to apply section 1847(a)(4) not only in an area where we implement a competitive bidding program for the first time, but also in the same area when we implement a subsequent competitive bidding program. We believe this proposal is consistent with section 1847(a)(4), which we interpret as applying to each competitive bidding ``program'' that we implement in an area, since each program will be unique in terms of bidders, contract suppliers, items included in the program, and prices. Our proposed policy would allow beneficiaries to continue renting medically necessary items from their existing supplier, even if that supplier has lost its contract status under a subsequent competitive bidding program. However, where a supplier that is no longer a contract supplier continues to furnish a rental item or oxygen and oxygen equipment on a grandfathered basis, we are proposing that Medicare make payment for the item in the amount established for that item under the new competitive bidding program for that area. We believe that section 1847(a)(4) gives us this discretion, since that section only requires us to establish a ``process'' under which these rental agreements or supply arrangements ``may continue'' but does not specify a payment methodology that must be used under that process. In addition, we do not believe that the alternative, which would be to make payment for the item under the fee schedule, is reasonable since the rental agreement or supply arrangement began under a competitive bidding program. c. Payment for Accessories for Items Subject to Grandfathering We propose that accessories and supplies used in conjunction with an item which is furnished under a grandfathering process described above may also be furnished by the grandfathered supplier. Payment would be based on the single payment amount established for the accessories and supplies if the item is oxygen or oxygen equipment or one that requires frequent and substantial servicing. For accessories and supplies used in conjunction with capped rental and inexpensive or routinely purchased items, the payment amounts would be based on the fee schedule amounts for the accessories and supplies furnished prior to the implementation of the first competitive bidding program in an area, or on the newly established competitively bid single payment amounts if the items are furnished by a grandfathered supplier that was a contract supplier for a competitive bidding program, but is no longer a contract supplier for a subsequent competitive bidding program in the same area. Our proposal is similar to the grandfathering approach that was used in the DME competitive bidding demonstrations in that we paid grandfathered suppliers the competitively bid amount for certain items and the fee schedule amounts for other items. We specifically solicit comments on our grandfathering proposals. 4. Payment Adjustment to Account for Inflation (proposed Sec. 414.408(b)) The fee schedule payment amounts for DMEPOS items are updated by annual update factors described in part 414, subparts C and D. In general, the update factors are established based on the percentage change in the CPI-U for the 12-month period ending June of each year and preceding the calendar year to which the update applies. In accordance with section 1847(b)(3)(B) of the Act, the term of a competitive bidding contract may not exceed three years. We propose applying an annual inflation update to the single payment amounts established for a competitive bidding program. Specifically, beginning with the second year of a contract entered into under a competitive bidding program, we would update the single payment amounts by the percentage increase in the CPI-U for the 12-month period ending with June of the preceding calendar year. Using the CPI-U index is consistent with Medicare using this index to update the [[Page 25664]] DME fee schedule. This will obviate the need for the supplier to consider inflation in the cost of business when submitting its bids for furnishing competitively bid items under a multi-year contract. 5. Authority To Adjust Payments in Other Areas (Sec. 414.408(e)) Section 1834(a)(1)(F)(ii) of the Act provides authority, effective for covered items furnished on or after January 1, 2009 that are included in a competitive bidding program, for us to use the payment information determined under that competitive bidding program to adjust the payment amounts otherwise recognized under section 1834(a)(1)(B)(ii) of the Act for the same DMEPOS in areas not included in a competitive bidding program. Sections 1834(h)(1)(H)(ii) and 1842(s)(3)(B) of the Act provide the same authority for orthotic and prosthetic devices, and enteral nutrition, respectively. We are proposing to use this authority but have not yet developed a detailed methodology for doing so. Therefore, we specifically invite comments and recommendations on this issue. We believe that our methodology will be informed by our experience and information gained from the competitive bidding programs in 2007 and 2009. When submitting recommendations on a methodology for using this authority, commenters should keep in mind the following factors that are likely to be incorporated in the methodology: The threshold or amount or level of savings that the Medicare program must realize for an item or group of items before we would use payment information from a competitive bidding program to adjust payment amounts for those items in other areas. Whether adjustments of payment amounts in other areas would be on a local, regional, or national basis, depending on the extent to which the single payment amounts and price indexes (for example, local prices used in calculating the CPI-U) for an item or group of items varied across different areas of the country. Whether adjustments of payment amounts in other areas would be based on a certain percentage of the single payment amount(s) from the competitive bidding area(s). We will fully consider all comments and recommendations we receive on this subject. 6. Requirement To Obtain Competitively Bid Items From a Contract Supplier (Sec. 414.408(f)) Beneficiaries often travel to visit family members or to reside in a State with a warmer climate during the winter months. So that these beneficiaries do not have to return home to obtain needed DMPEOS items, in Sec. 414.408(f)(2)(ii), we are proposing that beneficiaries on travel status be allowed to obtain items that they would ordinarily be required to obtain from a contract supplier for their competitive bidding area from a supplier that has not been awarded a contract to furnish items for that area. If the area that the beneficiary is visiting is also a competitive bidding area and the item is subject to the competitive bidding program in that area, he or she would be required to obtain the item from a contract supplier for that area. If the area that the beneficiary is visiting is not a competitive bidding area, or if the area is a competitive bidding area but the item needed by the beneficiary is not included in the competitive bidding program for that area, he or she would be required to obtain the item from a supplier that has a valid Medicare supplier number. In either case, payment to the supplier would be paid based on the single payment amount for the item in the competitive bidding area where the beneficiary maintains a permanent residence. We propose that if a beneficiary is not visiting another area, but is merely receiving competitively bid items from a supplier located outside but near the boundary of the competitive bidding area, the proposed travel status exemption would not apply. We plan to closely monitor the programs to ensure that this type of abuse or circumvention of the competitive bidding process and requirements to obtain items from a contract supplier does not occur. We are also proposing to base claims jurisdiction and the payment amount on the beneficiary's permanent residence as we have done since the early 1990s with the current DMEPOS program under Sec. 421.210(e). Under this proposal, the DMERC responsible for the area where the beneficiary maintains a permanent residence would process all claims submitted for items furnished to that beneficiary, whether or not the beneficiary obtained the item in that area. If the beneficiary maintained a permanent residence in a competitive bidding area and obtained an item included in the competitive bidding program for that area, Medicare would pay the supplier the single payment amount for the item determined under the competitive bidding program for that area. If the beneficiary did not maintain a permanent residence in a competitive bidding area, Medicare would pay the supplier the fee schedule amount for the area in which the beneficiary maintains a permanent residence. We believe that this proposal is consistent with our current policy, under which suppliers across the country are paid the same amount for similar products obtained by beneficiaries who maintain their permanent residence within the same geographic area. We are proposing that Medicare beneficiaries who maintain their permanent residence in a competitive bidding area be required to obtain competitively bid items from a contract supplier for that area with the following two exceptions: A beneficiary may obtain an item from a supplier or a noncontract supplier in accordance with the competitive bidding program grandfathering provisions described in section II.C.3. above. A beneficiary who is outside of the competitive bidding area where he or she maintains a permanent residence may obtain an item from a contract supplier, if he or she is in another competitive bidding area and the same item is included under a competitive bidding program for that area, or from a supplier with a valid Medicare supplier number, if he or she is either in another competitive bidding area that does not include the item in its program or is in an area that is not a competitive bidding area. Unless one of the exceptions discussed above applies, Medicare would not pay for the item. 7. Limitation on Beneficiary Liability for Items Furnished by Noncontract Suppliers (Sec. 414.408(f)) We are proposing that if a noncontract supplier located in a competitive bidding area furnishes an item included in the competitive bidding program for that area to a beneficiary who maintains a permanent residence in that area, the beneficiary would have no financial liability to the noncontract supplier unless the grandfathering exception discussed in section II.C.3. of this preamble applies. This rule would not apply if the noncontract supplier furnished items that are not included in the competitive bidding program for the area. We are proposing to specially designate the supplier numbers of all noncontract suppliers so that we will be able to easily identify whether a noncontract supplier has furnished a competitively bid item to a beneficiary who maintains a permanent residence in a CBA. [[Page 25665]] D. Competitive Bidding Areas [If you choose to comment on issues in this section, please include the caption ``Competitive Bidding Areas'' at the beginning of your comments.] Section 1847(a)(1)(A) of the Act requires that competitive bidding programs be established and implemented in areas throughout the United States. We are interpreting the term ``United States'' to include all states, territories, and the District of Columbia. Section 1847(a)(1)(B) of the Act provides us with the authority to phase-in competitive bidding programs so that the competition under the programs occurs in-- 10 of the largest MSAs in 2007; 80 of the largest MSAs in 2009; and Additional areas after 2009. Section 1847(a)(1)(B) of the Act also authorizes us to phase-in competitive bidding programs first among the highest cost and volume items or those items that we determine have the largest savings potential. Our proposed methodologies for selecting the MSAs for 2007 and 2009 are described in section II.D.1. of this preamble. Once the MSAs are selected for 2007 and 2009, we would define the competitive bidding areas for 2007 and 2009. The process we propose to use in establishing competitive bidding areas in future years is provided in section II.D.2. of this preamble. 1. Proposed Methodology for MSA Selection for 2007 and 2009 Competitive Bidding Programs (Sec. 414.410) Based on sections 1847(a)(1)(B)(i)(I) and (II) of the Act, we have the authority to select from among the largest MSAs during the first two implementation phases in order to phase-in the programs in the most successful way, thereby achieving the greatest savings while maintaining quality and beneficiary access to care. In phasing in the competitive bidding programs, we would adopt a definition of the term ``metropolitan statistical area'' consistent with that issued by the Office of Management and Budget (OMB) and applicable for the years 2007 and 2009. OMB is the Federal agency responsible for establishing the standards for defining MSAs for the purpose of providing nationally consistent definitions for collecting, tabulating, and publishing Federal statistics for a set of geographic areas. OMB most recently revised its standards for defining MSAs in 2000 (65 FR 82228-82238). Under these standards, an MSA is defined as a core based statistical area (a statistical geographic area consisting of the county or counties associated with at least one core (urbanized area or urban cluster) of at least 10,000 population, plus adjacent counties having a high degree of social and economic integration as measured through commuting ties with the counties containing the core) associated with at least one urbanized area that has a population of at least 50,000, and is comprised of the central county or counties containing the core, plus adjacent outlying counties having a high degree of social and economic integration with the central county as measured through commuting. The OMB issues periodic updates of the MSAs between decennial censuses based on United States Census Bureau estimates, but other than identifying certain MSAs having a population core of at least 2.5 million, does not rank MSAs based on population size. The U.S. Census Bureau, however, periodically publishes a Statistical Abstract of the United States, which contains a table listing large MSAs, or MSAs having a population of 250,000 and over. For the purpose of this rule, we are proposing to use this data to identify the largest MSAs. In this section, we propose formula driven methodology for selecting the MSAs for competitive bidding in 2007 and 2009. After we select the MSAs, we would define the competitive bidding areas. For the purpose of this section, DMEPOS allowed charges are the Medicare fee- for-service (FFS) allowed charge data for DMEPOS items that we have authority to include in a competitive bidding program. This data does not include Medicare expenditures for DMEPOS items under the Medicare Advantage Program. a. MSAs for 2007 We propose to use a multiple step process in selecting the MSAs for 2007. First, we propose to identify the 50 largest MSAs in terms of total population in 2005 using population estimates published by the U.S. Census Bureau in its table of large MSAs from the Statistical Abstract of the United States. Second, the 25 MSAs out of the 50 MSAs identified in step one would be eliminated from consideration based on our determination that they have the lowest totals of DMEPOS allowed charges for items furnished in calendar year (CY) 2004. This step would allow us to focus on the 25 MSAs that have the highest totals of DMEPOS allowed charges which, we believe, would produce a greater chance of savings as a result of competitive bidding than MSAs with lower total DMEPOS allowed charges. For illustration purposes only, based on DMEPOS allowed charge data for items furnished in CY 2003 and Census Bureau population estimates as of July 1, 2003, the 25 MSAs that would be left for consideration after step two is completed are shown in Table 1. However, we would propose to select the actual MSAs for 2007 using U.S. Census Bureau population data published as of July 1, 2005, and DMEPOS allowed charge data for items furnished in CY 2004. We would propose using population data for 2005 and DMEPOS allowed charge data for 2004 since this data will be the most recently available data at the time that the MSAs are selected for 2007 implementation. Table 1.--Top 25 MSAs Based on Total DMEPOS Medicare Allowed Charges for 2003 ------------------------------------------------------------------------ MSA Allowed charges ------------------------------------------------------------------------ New York-Northern New Jersey-Long Island, NY-NJ-PA $312,124,291 (New York).......................................... Los Angeles-Long Beach-Santa Ana, CA (Los Angeles)... 253,382,483 Miami-Fort Lauderdale-Miami Beach, FL (Miami)........ 221,660,443 Chicago-Naperville-Joliet, IL-IN-WI (Chicago)........ 173,922,952 Houston-Baytown-Sugar Land, TX (Houston)............. 149,060,607 Dallas-Fort Worth-Arlington, TX (Dallas)............. 139,910,862 Detroit-Warren-Livonia, MI (Detroit)................. 121,444,298 San Juan, PR......................................... 108,478,208 Philadelphia-Camden-Wilmington, PA-NJ-DE-MD 97,487,063 (Philadelphia)...................................... Atlanta-Sandy Springs-Marietta, GA (Atlanta)......... 75,860,276 Tampa-St. Petersburg-Clearwater, FL (Tampa).......... 71,309,635 Boston-Cambridge-Quincy, MA-NH (Boston).............. 62,467,094 Washington-Arlington-Alexandria, DC-VA-MD-WV (DC).... 61,416,109 [[Page 25666]] Baltimore-Towson, MD (Baltimore)..................... 59,714,310 Pittsburgh, PA....................................... 56,612,095 St. Louis, MO-IL..................................... 55,931,373 Riverside-San Bernardino-Ontario, CA (Riverside)..... 52,910,209 Cleveland-Elyria-Mentor, OH (Cleveland).............. 52,237,312 Orlando, FL.......................................... 51,982,164 San Francisco-Oakland-Fremont, CA (San Francisco).... 45,565,320 San Antonio, TX...................................... 44,113,886 Cincinnati-Middletown, OH-KY-IN (Cincinnati)......... 41,582,961 Kansas City, MO-KS................................... 41,310,326 Virginia Beach-Norfolk-Newport News, VA-NC (Virginia 41,016,726 Beach).............................................. Charlotte-Gastonia-Concord, NC-SC (Charlotte)........ 37,874,144 ------------------------------------------------------------------------ Third, we propose to score the MSAs based on combined rankings of DMEPOS allowed charges per FFS beneficiary (charges per beneficiary) and the number of DMEPOS suppliers per number of beneficiaries receiving DMEPOS items (suppliers per beneficiary) in CY 2004, with equal weight (50 percent) being given to each factor. The MSAs would be ranked from 1 to 25 in terms of DMEPOS allowed charges per FFS beneficiary (for example, the MSA with the highest DMEPOS allowed charges per FFS beneficiary would be ranked number 1). Similarly, areas having more suppliers per beneficiary are more likely to be competitive and would be ranked higher than MSAs having fewer suppliers per beneficiary. Based on our experience from the DMEPOS competitive bidding demonstrations, the number of suppliers would be based on suppliers with at least $10,000 in allowed charges attributed to them for DMEPOS items furnished in the MSA in CY 2004. The number of beneficiaries would be based on the number of beneficiaries receiving DMEPOS items in the MSA in CY 2004. If more than one MSA receives the same score, we would propose to use total DMEPOS allowed charges for items that we have authority to include in a competitive bidding in each MSA as the tiebreaker since this would be an indicator of where more program funds would be spent on DMEPOS items subject to competitive bidding. Table 2 illustrates how the 25 MSAs from Table 1 above would be scored based on data for CY 2003. The MSA rankings for charges per beneficiary and suppliers per beneficiary are listed in parentheses. We propose that the final scoring be based on utilization data for CY 2004 and population data for CY 2005. Table 2.--Scoring of Top 25 MSAs Based on Data for 2003 [Scoring based on combined rank from columns 3 and 4] ---------------------------------------------------------------------------------------------------------------- Charges per Suppliers per MSA Score beneficiary beneficiary Allowed charges ---------------------------------------------------------------------------------------------------------------- Miami..................................... 3 $428.44 (1) 0.01121 (2) $221,660,443 Houston................................... 6 348.83 (2) 0.00864 (4) 149,060,607 Dallas.................................... 8 297.33 (3) 0.00749 (5) 139,910,862 Riverside................................. 9 220.93 (8) 0.01144 (1) 52,910,209 San Antonio............................... 9 243.03 (6) 0.00897 (3) 44,113,886 Los Angeles............................... 11 277.16 (5) 0.00692 (6) 253,382,483 Charlotte................................. 14 226.09 (7) 0.00661 (7) 37,874,144 Orlando................................... 18 212.57 (9) 0.00569 (9) 51,982,164 San Juan.................................. 25 291.97 (4) 0.00388 (21) 108,478,208 Atlanta................................... 25 185.80 (15) 0.00569 (10) 75,860,276 Tampa..................................... 25 190.30 (13) 0.00529 (12) 71,309,635 Kansas City............................... 25 186.39 (14) 0.00555 (11) 41,310,326 Pittsburgh................................ 26 197.95 (11) 0.00484 (15) 56,612,095 Virginia Beach............................ 26 207.28 (10) 0.00477 (16) 41,016,726 St. Louis................................. 32 169.81 (18) 0.00488 (14) 55,931,373 San Francisco............................. 32 127.56 (24) 0.00632 (8) 45,565,320 Cincinnati................................ 32 167.06 (19) 0.00528 (13) 41,582,961 Cleveland................................. 33 182.01 (16) 0.00470 (17) 52,237,312 Detroit................................... 37 195.99 (12) 0.00290 (25) 121,444,298 Baltimore................................. 37 174.38 (17) 0.00396 (20) 59,714,310 Philadelphia.............................. 40 152.38 (21) 0.00443 (19) 97,487,063 DC........................................ 41 128.97 (23) 0.00449 (18) 61,416,109 Chicago................................... 44 160.26 (20) 0.00327 (24) 173,922,952 New York.................................. 45 139.81 (22) 0.00342 (23) 312,124,291 Boston.................................... 47 113.99 (25) 0.00371 (22) 62,467,094 ---------------------------------------------------------------------------------------------------------------- For purposes of phasing-in the programs, we would propose to exclude from consideration for competitive bidding until 2009 the three largest MSAs in terms of population, as well as any MSA that is geographically located in an area served by two DMERCs. The three largest MSAs based on total population (based on 2003 data) are New York, Los Angeles, and Chicago. We believe that these MSAs should not be phased in until 2009 because of the [[Page 25667]] logistics associated with the start-up of this new and complex program. As of 2000, these three MSAs all had total populations of over 9 million. By comparison, the largest area in which the demonstrations were conducted was San Antonio (total population of 1.7 million in 2000). We want to gain experience with the competitive bidding process in MSAs larger than San Antonio before moving on to the three largest MSAs. After we have gained experience operating competitive bidding programs in CBAs that encompass smaller MSAs in 2007 and 2008, we would propose to implement programs that include New York, Los Angeles and Chicago in 2009. However, we are considering an alternative under which we would establish CBAs that include portions of one or more of these MSAs (for example, by county). We believe that this alternative is authorized by section 1847(a)(1)(B)(II), which states that competition under the programs shall occur in 80 of the largest MSAs in 2009 but does not require the competition to occur in the entire MSA. In addition, section 1847 does not prohibit us from implementing a competitive bidding program in an area that is larger than a MSA. We welcome comments on these alternatives. We are proposing not to include competitive bidding areas that cross DMERC regions because this could complicate implementation by having two DMERCs processing claims from one competitive bidding area. The next step we propose would entail ensuring that there is at least one competitive bidding area in each DMERC region by first selecting the highest scoring MSA in each DMERC region (other than New York, Los Angeles, Chicago, or MSAs that cross DMERC boundaries). This would ensure that each DMERC gains some experience with competitive bidding prior to 2009, when competitive bidding would be implemented in CBAs that include eighty MSAs. We would also propose to select no more than two MSAs per State among the initial competitive bidding areas selected for 2007 in order to learn how competitive bidding works in more states and regions of the country. In summary, we are proposing to select the ten MSAs in which competition under the programs would occur in 2007 using the following steps: Identify the top 50 MSAs in terms of general population. Focus on the 25 MSAs from step one with the greatest total of DMEPOS allowed charges. Score the MSAs from step two based on combined rankings of DMEPOS allowed charges per beneficiary and suppliers per beneficiary, with lower scores indicating a greater potential for savings if programs are implemented in those areas. Exclude the 3 largest MSAs in terms of population (New York, Los Angeles, Chicago) and any MSA that crosses DMERC boundaries. Select the lowest scoring MSA from each DMERC region. Select the next 6 lowest scoring MSAs regardless of DMERC region, but not more than 2 MSAs from 1 State. Break ties in scores using DMEPOS allowed charges, selecting MSAs with higher total DMEPOS allowed charges. There are a number of alternative methods for selecting the MSAs for 2007 that we considered. The MSAs could have been selected based on a combination of one or more variables or measures including, but not limited to-- General population; Medicare FFS beneficiary population; Number of beneficiaries receiving DMEPOS items that we have authority to include in a competitive bidding; Total Medicare allowed charges for DMEPOS items subject to competitive bidding; and Number of suppliers of DMEPOS items that we have authority to include in a competitive bidding program. In evaluating this alternative, we defined the general population as all individuals residing in an MSA, whether or not they were enrolled in Medicare. One advantage of this variable is that total population is a widely accepted measure of gauging MSA size and the data are readily accessible to the general public through the U.S. Census Bureau webpage. Another advantage of this option is that total population takes into account the demand for DMEPOS items and other supplies from population groups other than the Medicare population. DMEPOS demand from non-Medicare individuals might make it less likely that a supplier not selected for competitive bidding would exit the market. This could help increase the likelihood of competition in future rounds of competitive bidding within that MSA. However, we recognize that the MSAs with the largest total populations may not have the most Medicare beneficiaries or the greatest potential for savings. One reason is that the age distribution is not uniform across MSAs. MSAs located in states that have either large immigrant populations or have experienced rapid recent growth often have younger than average age profiles. Another reason is that DMEPOS utilization and potential profits are not uniform across MSAs. It is quite possible that some of the smaller population MSAs may have a greater potential for savings than MSAs with much larger populations. We believe that the disadvantages of selecting MSAs based on general population are greater than the advantages of using this method and, therefore, do not propose using general population as the sole variable in selecting the MSAs for 2007. An advantage of selecting MSAs based on the Medicare FFS population is that this population represents the number of individuals who could potentially be affected by competitive bidding. A disadvantage of selecting MSAs based solely on this variable is that it does not reflect actual DMEPOS utilization; therefore, we do not propose using FFS population as the sole variable in selecting the MSAs for 2007. Per capita DMEPOS utilization rates vary across MSAs. As a result, MSAs with fewer Medicare beneficiaries could have a greater potential for savings from competitive bidding. The advantage of using the number of Medicare beneficiaries receiving DMEPOS items to select the MSAs is that MSAs would be selected based on the number of individual beneficiaries that are most likely to be directly affected by competitive bidding because they already have a need for these items. A disadvantage of this option is that the number of specific beneficiaries receiving DMEPOS items is only a static measure. The number of beneficiaries who would be receiving DMEPOS products in the future could be substantially different from the current number. Treatment patterns within the MSA could change or the number of beneficiaries receiving DMEPOS items could fluctuate if beneficiaries switch from FFS to a Medicare Advantage plan. For these reasons, we do not propose using number of beneficiaries receiving DMEPOS items as the sole variable in selecting the MSAs for 2007. Selecting the MSAs using the steps we propose utilizes a variety of variables that we believe will help us predict which MSAs will offer the largest savings potential under a competitive bidding program. In step 2 above, we would focus on a subset of large MSAs with higher allowed charges for DMEPOS items, which is consistent with section 1847(a)(1)(B)(ii) of the Act, which would allow us to phase in the Medicare DMEPOS Competitive Bidding Program first for those items that have the highest cost and highest volume, or those items that have the largest savings potential. This step would directly address the question of which MSAs have the highest costs. In step 3 above, [[Page 25668]] we would use allowed DMEPOS charges per beneficiary and the number of suppliers per beneficiary to further measure the savings potential for each MSA. Allowed DMEPOS charges per beneficiary is a measure of per capita DMEPOS utilization in terms of the overall DMEPOS cost per beneficiary. We believe that areas with higher utilization rates and costs would have a greater potential for savings under the programs, which will rely on competition among suppliers to lower costs in the area. Competition among suppliers is necessary for competitive bidding to be successful. Without sufficient competition among suppliers, suppliers have little incentive to submit low bids in response to the request for bids for DMEPOS products. In addition, we believe that competition for market share among winning suppliers will act as a market force to maintain a high level of quality products. The number of suppliers per beneficiary is a direct measure of how many suppliers are competing for each beneficiary's business. We expect that the higher the number of suppliers per beneficiary, the higher the degree of competition will be. We welcome comments about the selection method for the original ten MSAs in 2007. We welcome recommendations of other options and criteria for consideration. After further consideration of comments, in the final rule, we may adopt other criteria regarding issues described above or other criteria and options brought to our attention through the comment process. b. MSAs for 2009 In selecting the 70 additional MSAs in which competition will occur in 2009, we propose using generally the same criteria used to select the MSAs for 2007. Since the number of MSAs in which competition must occur in 2009 is much higher than the number for 2007, the steps in the selection process would change as follows: We would score all of the MSAs included in the table of large MSAs in the most recent publication of the U.S. Census Bureau s Statistical Abstract of the United States. We would propose using the same criteria to score the MSAs as we would use in selecting the MSAs for 2007, but use data from CY 2006. One option we are considering and on which we are requesting comments is whether we should modify the ranking of MSAs based on allowed DMEPOS charges per beneficiary so that it focuses on charges in each MSA for the items that experienced the largest payment reductions or savings under the initial round of competitive bidding in 2007. In selecting the MSAs for 2009, we do not propose excluding the 3 largest MSAs in terms of population size or MSAs that cross DMERC boundaries from the 80 largest MSAs to be included in the CBAs. In addition, we do not propose limiting the number of MSAs that can be selected from any one state. 2. Establishing Competitive Bidding Areas (Sec. 414.410) Section 1847(a)(1) of the Act requires that we phase in competitive bidding programs and establish competitive bidding areas throughout the United States over several years beginning in 2007. Section 1847(a)(3) of the Act gives us the authority to ``exempt rural areas and areas with low population density within urban areas that are not competitive, unless there is a significant national market through mail order for a particular item.'' Our proposed methodology for establishing competitive bidding areas under the Medicare DMEPOS Competitive Bidding Program is presented below. a. Authority To Exempt Rural Areas and Areas With Low Population Density Within Urban Areas (Sec. 414.410(c)) Section 1847(a)(3) of the Act allows us to exempt from the Medicare DMEPOS Competitive Bidding Program rural areas and areas with low population density within urban areas that are not competitive, unless there is a significant national market through mail order for a particular item. We propose to use this authority to exempt areas from competitive bidding if data for the areas indicate that they are not competitive based on a combination of the following indicators: Low utilization of items in terms of number of items and/ or allowed charges for DMEPOS in the area relative to other similar geographic areas. Low number of suppliers of DMEPOS items subject to competitive bidding serving the area relative to other similar geographic areas; and/or Low number of Medicare FFS beneficiaries in the area relative to other similar geographic areas. We would propose to make decisions regarding what constitutes low (non-competitive) levels of utilization, suppliers, and beneficiaries on the basis of our analysis of the data for allowed charges, allowed services for items that may be subject to competitive bidding, and the number of Medicare FFS beneficiaries and DMEPOS suppliers in specific geographic areas. In defining urban and rural areas, we propose to use the definitions currently in Sec. 412.64(b)(1)(ii) of the regulations. We invite comments on the methodologies we have proposed for determining whether an area within an urban area that has a low population density is not competitive. We will be reviewing the total allowed charges, number of beneficiaries, and number of suppliers to determine whether a rural area should be exempted from competitive bidding. In addition, we also are inviting comments on standards for exempting particular rural areas from competitive bidding. b. Establishing the Competitive Bidding Areas for 2007 and 2009 (Sec. 414.410(b)) Section 1847(a)(1)(B) of the Act requires that the competition ``occurs in'' 10 of the largest MSAs in 2007, and in 80 of the largest MSAs in 2009, but does not require us to define the competition boundaries concurrently with the MSA boundaries, as long as 10 MSAs are involved in 2007 and 80 MSAs are involved in 2009. Therefore, we do not believe that section 1847(a)(1)(B) of the Act prohibits us from extending individual competition areas beyond the MSA boundaries in 2007 or 2009. We propose that an area (for example, a county, parish, zip code, etc.) outside the boundaries of an MSA be considered for inclusion in a competitive bidding area for 2007 and/or 2009 if all of the following apply: The area adjoins an MSA in which a competitive bidding program will be operating in 2007 or 2009. The area is not part of an MSA in which a competitive bidding program will be operating in 2007 or 2009. The area is competitive, as explained below. The area is part of the normal service area or market for suppliers who also serve the MSA market or areas within the boundaries of an MSA in which a competitive bidding program will be operating in 2007 or 2009. As explained in section D.1. above, we are defining an MSA as a core based statistical area associated with at least one urbanized area that has a population of at least 50,000, and comprised of the central county or counties containing the core, plus adjacent outlying counties having a high degree of social and economic integration with the central county as measured through commuting. However, when using this definition to establish the boundaries of an MSA, the OMB would not consider whether an area or areas adjoining an MSA are served by the same DMEPOS suppliers that furnish items to beneficiaries residing in the MSA. If an area has a high level of utilization, significant expenditures, and/or a large number of [[Page 25669]] suppliers of DMEPOS items included in the competitive bidding program for the adjoining MSA, we believe that it would be practical and beneficial to include this area in the competitive bidding area. The savings to the program associated with adding the area to the competitive bidding area would likely offset any incremental administrative costs incurred by the implementation contractor associated with including the area in the competitive bidding program for the MSA. Finally, we are not proposing to consider counties that do not adjoin an MSA for inclusion in a competitive bidding area for 2007 or 2009 because we believe that these outlying counties are too far removed from the areas that OMB has determined to be economically integrated. We are proposing that we have the discretion to define a CBA to be either concurrent with an MSA, larger than an MSA, or smaller than an MSA. We will detail in the request for bids the exact boundaries of each CBA. We invite comments on the criteria to be used in considering whether to include counties outside MSAs in a competitive bidding area in 2007 or 2009. c. Nationwide or Regional Mail Order Competitive Bidding Program (Sec. 414.410(d)(2)) Our data shows that a significant percentage of certain items such as diabetic testing supplies (blood glucose test strips and lancets) are furnished to beneficiaries by national mail order suppliers. Therefore, we propose to establish a nationwide or regional competitive bidding program, effective for items furnished on or after January 1, 2010, for the purpose of awarding contracts to suppliers to furnish these items across the nation or region to beneficiaries who elect to obtain them through the mail order outlet. The national or regional competitive bidding areas under this program would be phased in after 2009, and payment would be based on the bids submitted and accepted for the furnishing of items through mail order throughout the nation or region. Suppliers that furnish these items through mail order on either a national or regional basis would be required to submit bids to participate in any competitive bidding program implemented for the furnishing of mail order items. We propose that prior to the establishment of a nationwide or regional competitive bidding program in 2010, mail order suppliers would be eligible to submit bids for furnishing items in one or more of the CBAs we establish for purposes of the 2007 and 2009 implementation phases. In addition, beginning with programs implemented in 2010, mail order suppliers would be eligible to submit bids in one or more CBAs to furnish items that are not included in a nationwide or regional competitive bidding program. National or regional mail order suppliers would be required to submit bids and be selected as contract suppliers for each CBA in which they seek to furnish these items. They would, however, have the choice of either submitting the same bid amounts for each CBA or submitting separate bids. For items that are subject to a nationwide or regional mail order competitive bidding program, we propose that suppliers who furnish these same items in the local market and do not furnish them via mail order would not be required to participate in the national or regional mail order competitive bidding program. However, we would only allow these suppliers to continue furnishing the items in areas if they were selected as a contract supplier. We propose to allow these non-mail order suppliers to continue furnishing these items in areas subject to a competitive bidding program if the supplier has been selected as a contract supplier. When furnishing items to beneficiaries that do not maintain a permanent residence in a competitive bidding area, non-mail order suppliers would be paid based on the payment amount applicable to the area where the beneficiary maintains his or her permanent residence. In its September 2004 report (GAO-04-765), the GAO recommended that we consider using mail delivery for items that can be provided directly to beneficiaries in the home as a way to implement a DMEPOS competitive bidding strategy. We are asking for comments on our proposal to implement this recommendation, as well as for comments on the types of items that would be suitable for a mail order competitive bidding program. In addition, we are requesting public comment on an alternative that would require replacement of all supplies such as test strips and lancets for Medicare beneficiaries to be furnished by mail order suppliers under a nationwide or regional mail order program. For example, there are services paid under the physician fee schedule that are associated with the furnishing of blood glucose testing equipment (for example, home blood glucose monitors) such as training, education, assistance with product selection, maintenance and servicing, that do not relate to the furnishing of replacement supplies used with the equipment. Once the brand of monitor has been selected by the patient, the services associated with furnishing the supplies must be provided on a timely basis and the patient must receive the brand of test strips needed for his or her monitor. We invite public comment on whether the service of furnishing replacement test strips, lancets or other supplies can easily, effectively, and conveniently be performed by national mail order suppliers. d. Additional Competitive Bidding Areas After 2009 (Sec. 414.410(d)) Section 1847(a)(1)(B)(III) of the Act requires that competition under the Medicare DMEPOS Competitive Bidding Program occur in additional areas after 2009. Beginning in 2010, we would designate through program instructions additional competitive bidding areas based on our determination that the implementation of a competitive bidding program in a particular area would be likely to result in significant savings to the Medicare program. E. Criteria for Item Selection If you choose to comment on issues in this section, please include the caption ``Criteria for Item Selection'' at the beginning of your comments.> Section 1847(a)(2) of the Act describes the items subject to competitive bidding as follows: Durable Medical Equipment and Medical Supplies--Covered items (as defined in section 1834(a)(13) of the Act) for which payment would otherwise be made under section 1834(a) of the Act, including items used in infusion and drugs (other than inhalation drugs) and supplies used in conjunction with DME, but excluding class III devices under the Federal Food, Drug, and Cosmetic Act. ?> Other Equipment and Supplies (enteral nutrition, equipment and supplies)--items described in section 1842(s)(2)(D) of the Act, other than parenteral nutrients, equipment, and supplies. Off-The-Shelf (OTS) Orthotics--orthotics described in section 1861(s)(9) of the Act for which payment would otherwise be made under section 1834(h) of the Act, which require minimal self-adjustment for appropriate use and do not require expertise in trimming, bending, molding, assembling, or customizing to fit the individual. We are proposing that minimal self-adjustment would mean adjustments that the beneficiary, caretaker for the beneficiary, or supplier of the device can perform without the assistance of a [[Page 25670]] certified orthotist (that is, an individual certified by either the American Board for Certification in Orthotics and Prosthetics, Inc. or the Board for Orthotist/Prosthetist Certification). By contrast, we would consider any adjustments that can only be made by a certified orthotist to be adjustments that require an expertise in trimming, bending, molding, assembling, or customizing to fit the individual. We are proposing to consult with a variety of individuals including experts in orthotics to determine which items and/or HCPCS codes would be classified as OTS orthotics. We welcome comments on a process for identifying OTS orthotics subject to competitive bidding. Section 1847(a)(1)(B)(ii) of the Act gives us the authority to phase in competitive bidding ``first among the highest cost and highest volume items or those items that the Secretary determines have the largest savings potential.'' In addition, section 1847(a)(3)(B) of the Act grants us the authority to exempt items for which the application of competitive bidding is not likely to result in significant savings. In exercising this authority, we propose to exempt items outright or on an area by area basis using area-specific utilization data. For example, if we found that utilization (that is, allowed services or allowed charges) for commode chairs was low (or the number of commode chair suppliers was low) in a given area compared to other areas, we might choose to exempt commode chairs from the competitive bidding program in the CBA where significant savings would not be likely while including commode chairs in the competitive bidding programs for other CBAs. This decision would be based on area-specific utilization data. We are proposing to use the authority provided by section 1847(a)(1)(B)(ii) of the Act to phase in only those items that we determine are among the highest cost and highest volume items during each phase of the Medicare DMEPOS Competitive Bidding Program. In section II.F. of this preamble, we propose to conduct competitive bidding for product categories that would be described in each RFB. Suppliers will submit a separate bid for each item under a defined product category, unless specifically excluded in the RFB. We propose to include a ``core'' set of product categories in each competitive bidding area. We may elect to phase in some individual product categories in a limited number of competitive bidding areas in order to test and learn about their suitability for competitive bidding. Because we have not yet identified the product categories for competitive bidding, we are using policy groups developed by the statistical analysis durable medical equipment regional carrier (SADMERC) for purposes of illustration. The SADMERC has defined a set of 64 DMERC policy groups for analytical purposes in its role as the statistical analysis contractor for DMEPOS. A policy group is a set of HCPCS codes that describe related items that are addressed in a DMERC medical review policy. For example, the policy group, oxygen and supplies, consists of approximately 20 HCPCS codes. Although the product categories subject to competitive bidding will not necessarily correspond to these policy groups, we present data for these policy groups and items contained in these policy groups for the purpose of identifying the highest cost and highest volume DMEPOS items that may be subject to competitive bidding. In other words, we propose using SADMERC data for ``policy groups'' to identify groups of items we will consider phasing in first under the competitive bidding programs, but the actual ``product categories'' for which we would request bids could be a subset of items from a ``policy group'' or a combination of items from different ``policy groups.'' The highest volume items (HCPCS codes) fall into a relatively small number of policy groups as illustrated in Table 3. Table 3.--2003 High Volume Items [HCPCS Codes] ---------------------------------------------------------------------------------------------------------------- HCPCS Allowed charges Product description Product group ---------------------------------------------------------------------------------------------------------------- E1390.................................. $2,033,123,147 Oxygen concentrator...... Oxygen. K0011*................................. 1,176,277,899 Power wheelchair with Wheelchairs. programmable features. A4253.................................. 779,756,243 Blood glucose/reagent Diabetic Supplies & strips, box of 50. Equipment. E0260.................................. 331,457,962 Semi-electric hospital Hospital Beds/ bed. Accessories. E0431.................................. 228,066,037 Portable gaseous oxygen Oxygen. equipment. B4150*................................. 206,396,813 Enteral formula, category Enteral Nutrition. I. B4035.................................. 197,057,150 Enteral feeding supply Enteral Nutrition. kit, pump fed, per day. E0277.................................. 156,762,241 Powered air mattress..... Support Surfaces. E0439.................................. 141,268,474 Stationary liquid oxygen. Oxygen. E0601.................................. 123,865,463 Continuous positive CPAP Devices. airway pressure device (CPAP). K0001.................................. 103,217,209 Standard manual Wheelchairs. wheelchair. K0004.................................. 87,208,486 High strength lightweight Wheelchairs. manual wheelchair. A4259.................................. 79,575,166 Lancets, box of 100...... Diabetic Supplies & Equipment. E0570.................................. 76,588,088 Nebulizer with compressor Nebulizers. B4154*................................. 76,326,903 Enteral formula, category Enteral Nutrition. IV. E0143.................................. 75,950,410 Folding wheeled walker w/ Walkers. o seat. K0533*................................. 75,136,517 Respiratory assist device Respiratory Assist with backup rate feature. Devices. K0538*................................. 65,603,531 Negative pressure wound Negative Pressure Wound therapy electrical pump. Therapy (NPWT) Devices. K0532*................................. 56,046,930 Respiratory assist device Respiratory Assist without backup rate Devices. feature. K0003.................................. 55,318,959 Lightweight manual Wheelchairs. wheelchair. K0108.................................. 52,139,979 Miscellaneous wheelchair Wheelchairs. accessory. E0192*................................. 48,413,938 Wheelchair cushion....... Support Surfaces. E0163.................................. 48,216,855 Stationary commode chair Commodes. with fixed arms. B4034.................................. 42,277,968 Enteral feeding supply Enteral Nutrition. kit syringe, per day. ---------------------------------------------------------------------------------------------------------------- * Due to HCPCS coding changes made since 1993, the descriptions or code numbers for several codes above have been modified. We expect that power wheelchairs (K0011) will be billed under several new HCPCS codes in the near future. [[Page 25671]] Because we propose that we will conduct competitive bidding for items grouped into product categories, we will consider DMEPOS allowed charges and volume at the product category level for the purpose of selecting which items to phase in first under the competitive bidding programs. The table below provides data for the top 20 policy groups based on Medicare allowed charges for the items within each policy group that we may choose to include in a competitive bidding program. Data from the SADMERC for claims received in 2003 is used for all policy groups except those for nebulizers and OTS orthotics. For the nebulizer and OTS orthotics groups, data is included from the CMS BESS (Part B Extract and Summary System) database for items furnished in 2003. The percentage of total allowed Medicare charges for DMEPOS that each policy group makes up is included in Table 4. Table 4.--2003 DMEPOS Allowed Charges by Policy Group ---------------------------------------------------------------------------------------------------------------- Percent of Rank Policy group 2003 DMEPOS ---------------------------------------------------------------------------------------------------------------- 1........................................ Oxygen Supplies/Equipment...... $2,433,713,269 21.3 2........................................ Wheelchairs/POVs**............. 1,926,210,675 16.9 3........................................ Diabetic Supplies & Equipment.. 1,110,934,736 9.7 4........................................ Enteral Nutrition.............. 676,122,703 5.9 5........................................ Hospital Beds/Accessories...... 373,973,207 3.3 6........................................ CPAP Devices................... 204,774,837 1.8 7........................................ Support Surfaces............... 193,659,248 1.7 8........................................ Infusion Pumps & Related Drugs. 149,208,088 1.3 9........................................ Respiratory Assist Devices..... 133,645,918 1.2 10....................................... Lower Limb Orthoses*........... 122,813,555 1.1 11....................................... Nebulizers*.................... 98,951,212 0.9 12....................................... Walkers........................ 96,654,035 0.8 13....................................... NPWT Devices................... 88,530,828 0.8 14....................................... Commodes/Bed Pans/Urinals...... 51,372,352 0.5 15....................................... Ventilators.................... 42,890,761 0.4 16....................................... Spinal Orthoses*............... 40,731,646 0.4 17....................................... Upper Limb Orthoses*........... 29,069,027 0.3 18....................................... Patient Lifts.................. 26,551,310 0.2 19....................................... Seat Lift Mechanisms........... 15,318,552 0.1 20....................................... TENS Devices**................. 15,258,579 0.1 ------------------------------------- Total for 20 Groups........... 7,830,384,538 68.6 ------------------------------------- Total for DMEPOS.............. 11,410,019,351 ................. ---------------------------------------------------------------------------------------------------------------- * Data is from BESS (Date of Service). Data for orthoses policy groups excludes data for custom fabricated orthotics, but may include data for other items that will not be considered OTS orthotics. ** POVs are power operated vehicles (scooters) and TENS devices are transcutaneous electrical nerve stimulation devices. Section 1847(a)(1)(B)(ii) of the Act provides that the items we phase in first under competitive bidding may include products having the greatest potential for savings. We are proposing to use a combination of the following variables when making determinations about an item's potential savings as a result of the application of competitive bidding. Annual Medicare DMEPOS Allowed Charges Annual Growth in Expenditures Number of Suppliers Savings in the DMEPOS Demonstrations Reports and Studies Items with high allowed charges or rapidly increasing allowed charges would be our highest priority in selecting items for competitive bidding. The number of suppliers furnishing a particular item or group of items would also be an important variable in identifying items with high savings potential. We believe that a relatively large number of suppliers for a particular group of items would likely increase the degree of competition among suppliers and increase the probability that suppliers would compete on quality for business and market share. We saw evidence in the competitive bidding demonstrations that products furnished by a large number of suppliers had large savings rates and fewer problems with quality. We understand that having a large number of suppliers is not always a necessary condition for competition. A competitive bidding area could be more concentrated and less competitive than the number of suppliers would predict if the market is dominated by only a few suppliers and the remaining suppliers have only minimal charges. The DMEPOS demonstration took place from 1999 to 2002 in two MSAs: Polk County, Florida and San Antonio, Texas. Five product categories containing items we might include in the Medicare DMEPOS Competitive Bidding Program were included in at least one round of the DMEPOS demonstration: Oxygen equipment and supplies; hospital beds and accessories; enteral nutrition; wheelchairs and accessories; and general orthotics. The demonstration results provide useful information because they are based on actual Medicare competitive bidding and the amounts suppliers actually were willing to accept as payment from Medicare. However, we recognize that these results should be used with caution. The demonstration occurred more than three years ago and the fee schedule has changed as a result of certain provisions in the MMA, such as, section 302(c)(2) (codified at 1834(a)(21) of the Act), which requires that CMS adjust the fee schedules for certain items based on a comparison to other payers such as the Federal employee health plan (FEHP). The Office of Inspector General (OIG) and the GAO frequently conduct studies that analyze the extent to which Medicare overpays for specific items, and we believe that these studies could assist with determining the saving potential for an item(s) if it were included in competitive bidding. Examples of relevant studies from the OIG include the following: [[Page 25672]] Medicare Allowed Charges for Orthotic Body Jackets, March 2000 (OEI-04-97-00391); Medicare Payments for Enteral Nutrition, February 2004 (OEI-03-02-00700); and A Comparison of Prices for Power Wheelchairs in the Medicare Program, April 2004 (OEI-03-03-00460). In addition, CMS and the DMERCs obtain retail pricing information for items in the course of establishing fee schedule amounts and considering whether payment adjustments are warranted for items using the inherent reasonableness authority in section 1842(b)(8) of the Act. We could use these studies to identify products where CMS pays excessively and where we could potentially achieve savings. Excessive payments are only one factor to consider when evaluating whether savings will be realized by the application of competitive bidding to an item. However, these studies do offer us a guide regarding which items may have the greatest potential for savings. We also recognize that some studies are older than others and that recent MMA and FEHP reductions in fees may affect the results of these studies. F. Submission of Bids Under the Competitive Bidding Program (Proposed Sec. 414.412) [If you choose to comment on issues in this section, please include the caption ``Submission of Bids Under the Competitive Bidding Program'' at the beginning of your comments.] Sections 1847(b)(6)(A)(i) and (ii) of the Act state that payment will not be made for items furnished under a competitive bidding program unless the supplier has submitted a bid to furnish those items and has been selected as a contract supplier. Therefore, in order for a supplier that furnishes competitively bid items in a competitive bidding area to receive payment for those items, the supplier must have submitted a bid to furnish those particular items and must have been awarded a contract to do so by CMS. There are limited exceptions to this requirement for beneficiaries who reside in a competitive bidding area but are out of the area and need items. There is also an exception for suppliers that are grandfathered to continue to provide and service certain items, as discussed in section II.C.3. of this preamble. 1. Providers (Proposed Sec. 414.404, Sec. 414.422) We are proposing that providers that furnish Part B items and are located in a competitively bidding area and are also DMEPOS suppliers, must submit bids in order to furnish competitively bid items to Medicare beneficiaries. Providers that are not awarded contracts must use a contract supplier to furnish these items to the Medicare beneficiaries to whom they provide services. However, a skilled nursing facility (SNF) defined in section 1819(a) of the Act would not be required to furnish competitively bid items to beneficiaries outside of the SNF, if it elected not to function as a commercial supplier. This is consistent with the current practice of some SNFs to furnish Part B services only to their own residents. 2. Physicians (Proposed Sec. 414.404, Sec. 414.422) We are proposing that physicians that are also DMEPOS suppliers must submit bids and be awarded contracts in order to furnish items included in the competitive biding program for the area in which they provide medical services. Physicians that do not become contract suppliers must use a contract supplier to furnish competitively bid items to their Medicare patients. However, they will not be required to furnish these items to beneficiaries who are not their patients if they choose not to function as commercial suppliers. In proposing this policy for physicians who are also DMEPOS suppliers, we recognize that the physician self-referral law (section 1877 of the Act) generally prohibits physicians from furnishing to their office patients a variety of common DMEPOS items. Physicians who choose to participate in the competitive bidding process must ensure that their arrangements for referring for and furnishing DMEPOS items under a competitive bidding program comply with the physician self-referral law as well as any other Federal or State law or regulation governing billing or claims submission. We have established a Web site where requests for bids (RFBs) and other pertinent program information will be posted, and we plan to alert the supplier community by e-mail of all postings on this site. In addition, we will be providing education and outreach to suppliers on requirements for submitting RFBs. Suppliers must fully complete the RFB in order to be considered for participation in a competitive bidding program. The RFBs will require suppliers to complete at a minimum such documents as an application, bidding sheet, bank and financial information and referral source references. We will establish an administrative process to ensure that all information that the supplier submitted is accurately captured and considered in the bid evaluation process. This process will ensure that all the information submitted by the supplier is included as part of the bid evaluation process. We considered requiring all suppliers to be physically located within a competitive bidding area in order to submit a bid to furnish items in that area. However, we feel that this requirement would be too proscriptive. We believe that suppliers that are located outside of a competitive bidding area, but do business in the competitive bidding area and are able to service beneficiaries residing within the CBA should be permitted to submit bids and participate in the competitive bidding program for that area. 3. Product Categories for Bidding Purposes (Proposed Sec. 414.412) We propose to conduct bidding for items that are grouped into product categories. Suppliers would be required to submit a separate bid for all items that we specify in a product category. The submitted bid must include all costs related to the furnishing of each item such as delivery, set-up, training, and proper maintenance for rental items. However, suppliers would only be required to submit bids for the product categories that they are seeking to furnish under the program. All items that would be included in a product category for bidding purposes would be detailed in the RFB. We propose to define the term ``product category'' as a group of similar items used in the treatment of a related medical condition (for example, hospital beds and accessories). We believe that the use of product categories will allow Medicare beneficiaries to receive all of their related products (for example, hospital beds and accessories) from one supplier, which will minimize disruption to the beneficiary. There were other design options that we considered but did not propose. One option was to require suppliers to submit a bid for all items in every defined product category. Another option was for suppliers to bid at the HCPCS level and submit a bid only for the individual items that they were seeking to furnish under the program. There are currently approximately 55 separate policy groups already established by the DMERCs. However, these policy groups were not established for the purpose of competitive bidding. We are proposing to specifically develop product categories for the purpose of competitive bidding. We anticipate that the product categories will range from Breast Prosthesis, Dialysis Equipment and Supplies, to Oxygen and Power Wheelchairs. Each [[Page 25673]] group would be defined and comprised of individual HCPCS codes. Section 1847(a)(3)(B) of the Act gives us the authority to exempt items for which the application of competitive bidding is unlikely to result in significant savings. We would propose not to include items in a product category if they are rarely used or billed to the program. In addition, we would not include items within a product category if we believed that these were items for which we might not realize a savings. Therefore, under this approach, we propose to establish product categories to identify those items included in competitive bidding and may establish different product categories from one CBA to another, as well as in different rounds of competitive bidding in the same CBA. We chose to allow suppliers to submit bids only for the product categories they are seeking to furnish under a competitive bidding program because this option accommodates DMEPOS suppliers who want to specialize in one or a few product categories. For example, if a supplier wants to specialize in the treatment of respiratory conditions, the supplier can choose to bid on all items that fall within the Oxygen product category, the Continuous Positive Airway Pressure product category, or the Respiratory Assist Device product category. We believe that specialization at the product category level will make it easier for referral agents (entities that refer beneficiaries to health care practitioners or suppliers to obtain DMEPOS items) and other practitioners to order related products from the same supplier. Establishing a bidding process that promotes specialization would allow suppliers to realize economies of scope within a product category, which means that a supplier may be able to furnish a bundle of items at a lower cost than it can produce each individual item. This approach is also more favorable to small suppliers because they can choose to specialize in only one product category. It would be more difficult for a small supplier rather than a large supplier to furnish all product categories. This approach is also more convenient for Medicare beneficiaries, as they can choose to receive all their related supplies from one supplier and would not have to deal with multiple suppliers to obtain the proper items for their condition. We recognize the importance of the relationship between a DMEPOS supplier and the Medicare beneficiary. The supplier delivers the item to the beneficiary, sets up the equipment and also educates the beneficiary on the proper use of the equipment. The use of product categories will facilitate the transition for those beneficiaries who have to change suppliers. It is also our goal to establish a productive relationship between the supplier and the beneficiary, and we believe we can accomplish this goal by designing the competitive bidding program so the beneficiary has the option of selecting one supplier that would be responsible for the delivery of all medically necessary items that fall within a product category. 4. Bidding Requirements (Sec. 414.408) In preparing a bid in response to the request for bids, we would propose that suppliers look to our existing regulations at part 414, subparts C and D to determine whether a rental or purchase payment would be made for the item and whether other requirements would apply to the furnishing of that item, as further explained below. a. Inexpensive or Other Routinely Purchased DME Items The current fee schedule amounts for these items are based on average reasonable charges for the purchase of new items, purchase of used items, and rental of items from July 1, 1986 through June 30, 1987. In those cases where reasonable charge data from 1986/87 is not available, the fee schedule amounts for the purchase of new items are generally based on retail purchase prices deflated to the 1986/1987 base period by the percentage change in the CPI-U, the fee schedule amounts for the purchase of used items are generally based on 75 percent of the fee schedule amounts for the purchase of new items, and the fee schedule amounts for the monthly rental of items are generally based on 10 percent of the fee schedule amounts for purchase of new items. This method of establishing fee schedule amounts in the absence of reasonable charge data has been in use since 1989. Under the Medicare DMEPOS Competitive Bidding Program, we propose that bids be submitted only for the furnishing of new items in this category that are included in a competitive bidding program. Based on the bids submitted and accepted for these new items, we would propose to also calculate a single payment amount for used items based on 75 percent of the single payment amount for new items. In addition, we would propose to calculate a single payment amount for the rental of these items based on 10 percent of the single payment amount for new items. We believe that calculating single payment amounts for used items and items rented on a monthly basis based on bids submitted and accepted for new items will simplify the bidding process and will not create problems with access to used items or rented items in this category. b. DME Items Requiring Frequent and Substantial Servicing We propose that bids be submitted for the monthly rental of items in this payment category with the exception of continuous passive motion exercise devices. We propose that bids be submitted for the daily rental of continuous passive motion exercise devices. For items in this category other than continuous passive motion exercise devices, this is consistent with Sec. 414.222(b) our regulations. Coverage of continuous passive motion exercise devices is limited to 21 days of use in the home following knee replacement surgery; therefore, payment can only be made on a daily basis as opposed to a monthly basis for this item. Based on the bids submitted and accepted for these items, we would calculate single payment amounts for the furnishing of these items on a rental basis. c. Oxygen and Oxygen Equipment If included under a competitive bidding program, we would propose that the single payment amounts for oxygen and oxygen equipment be calculated based on separate bids submitted and accepted for furnishing on a monthly basis of each of the oxygen and oxygen equipment categories of services described in Sec. 414.226(b)(1)(i) through (b)(1)(iv). d. Capped Rental Items With the exception of power wheelchairs, payment for items that fall into this payment category is currently made on a rental basis only. The rental fee schedule payments for months 1 through 3 are based on 10 percent of the purchase price for the item as determined under Sec. 414.229(c). The rental fee schedule payments for months 4 through 15 are based on 7.5 percent of the purchase price for the item as determined under Sec. 414.229(c). Since the DRA change does not apply to beneficiaries using a capped rental item prior to January 1, 2006, these beneficiaries may still elect either to take ownership of the item after 13 months of continuous use or to continue renting the item beyond 13 months of continuous use. In addition, the DRA leaves in tact the rule under which a supplier must offer the beneficiary the option to purchase a power wheelchair [[Page 25674]] at the time the supplier initially furnishes the item (in which case payment would be made for the item on a lump-sum basis). However, with regard to all other capped rental items for which the rental period begins after January 1, 2006, the DRA requires suppliers to transfer title to the item to the beneficiary after 13 months of continuous use. Under the Medicare DMEPOS Competitive Bidding Program, we propose that separate payment for reasonable and necessary maintenance and servicing only be made for beneficiary-owned DME. Payment for maintenance and servicing of rented equipment would be included in the single payment amount for rental of the item. We propose that the lump sum purchase option in Sec. 414.229(d) for power wheelchairs be retained under the Medicare DMEPOS Competitive Bidding Program. Under the Medicare DMEPOS Competitive Bidding Program, we propose that ``purchase'' bids be submitted for the furnishing of new items in this category. Based on these bids, a single payment amount for purchase of a new item will be calculated for each item in this category for the purpose of determining both the single payment amount for the lump sum purchase of a new power wheelchair, and for calculating the single payment amounts for the rental of all items in this category. In cases where the beneficiary elects to purchase a used power wheelchair the single payment amount for the lump sum purchase of the used power wheelchair would be based on 75 percent of the single payment amount for a new power wheelchair. In the case of all items in this category that are furnished on a rental basis, the single payment amount for rental of the item for months 1 through 3 would be based on 10 percent of the single payment amount for purchase of the item, and the single payment amount for rental of the item for months 4 through 13 would be based on 7.5 percent of the single payment amount for purchase of the item. We believe that calculating single payment amounts for used items and items rented on a monthly basis based on bids submitted and accepted for new items will simplify the bidding process and will not result in problems with access to used items or rented items in this category. e. Enteral Nutrition Equipment and Supplies Enteral nutrition equipment is currently paid on a purchase or rental basis. Section 6112(b)(2)(A) of the Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239) (OBRA 89) limits the rental payments to 15 months. To be consistent with the bidding requirements proposed above for capped rental DME, we propose that bids be submitted for the purchase of new items in this category. Based on the bids submitted and accepted for new items, we would calculate a single payment amount for rented items for months 1 through 3 based on 10 percent of the single payment amount for new items. The single payment amount for rented items for months 4 through 15 would be based on 7.5 percent of the single payment amount for new items. In cases where the beneficiary elects to purchase enteral nutrition equipment, the single payment amount for new enteral nutrition equipment would be based on the bids submitted and accepted for new enteral nutrition equipment, and the single payment amount for used enteral nutrition equipment would be based on 75 percent of the single payment amount for the purchase of new enteral nutrition equipment. Based on the bids submitted and accepted for new items, we would calculate a single payment amount for purchase of enteral nutrients and supplies. f. Maintenance and Servicing of Enteral Nutrition Equipment Section 6112(b)(2)(B) of OBRA 89 requires payment for maintenance and servicing of enteral nutrition equipment after monthly rental payments have been made for 15 months. The maintenance and servicing payments are to be made in amounts that we determine are reasonable and necessary to ensure the proper operation of the equipment. Since October 1, 1990, program instructions have specified when and how these payments are made. These program instructions are currently found at section 40.3 of chapter 20 of the Medicare Claims Processing Manual (pub. 100-04). These instructions provide that maintenance and servicing payments may be made beginning 6 months after the last rental payment for the equipment and no more often than once every 6 months for actual incidents of maintenance where the equipment requires repairs and/or extensive maintenance. Extensive maintenance involves the breaking down of sealed components or performance of tests that require specialized testing equipment not available to the beneficiary or nursing facility. The program instructions also state that the maintenance and servicing payments cannot exceed one-half of the rental payment amounts for the equipment. Under the Medicare DMEPOS Competitive Bidding Program, we propose that the monthly rental payments for enteral nutrition equipment for months 1 through 3 be equal to 10 percent of the single payment amounts for the purchase of the new enteral nutrition equipment. We propose that for months 4 through 15, the monthly rental payment amounts would be equal to 7.5 percent of the single payment amounts for the purchase of new items. In addition, we propose to establish the maintenance and service payments for enteral nutrition equipment so that they are equal to 5 percent of the single payment amounts for the purchase of new enteral nutrition equipment. This would limit the payment rate for maintenance and service to one-half of the rental payment amount for the first month of rental, which is similar to the program instructions mentioned above. We are proposing that the contract supplier to which payment is made in month 15 for furnishing enteral nutrition equipment on a rental basis must continue to furnish, maintain and service the pump for as long as the equipment is medically necessary. This proposed policy is similar to current Medicare payment rules in Chapter 20 of the claims processing manual, section 40.3. g. Supplies Used in Conjunction With DME We propose that bids be submitted for the purchase of supplies necessary for the effective use of DME, including drugs (other than inhalation drugs). Based on the bids submitted and accepted for these items, we would calculate single payment amounts for the furnishing of these items on a purchase basis. h. OTS Orthotics We propose that bids be submitted for the purchase of OTS orthotics. Based on the bids submitted and accepted for these items, we would calculate single payment amounts for the furnishing of these items on a purchase basis. G. Conditions for Awarding Contracts (Proposed Sec. 414.414) [If you choose to comment on issues in this section, please include the caption ``Conditions for Awarding Contracts'' at the beginning of your comments.] 1. Quality Standards and Accreditation (Proposed Sec. 414.414(c)) Section 1847(b)(2)(A)(i) of the Act specifies that a contract may not be awarded to any entity unless the entity meets applicable quality standards specified by the Secretary under section [[Page 25675]] 1834(a)(20) of the Act. Section 1834(a)(20) instructs the Secretary to establish and implement quality standards for all DMEPOS suppliers in the Medicare program, not just for suppliers in the competitive bidding areas. All suppliers will have to meet these quality standards to be eligible to submit claims to the Medicare program, irrespective of the competitive bidding program. The quality standards are to be applied by recognized independent accreditation organizations designated by the Secretary under section 1834(a)(20)(B) of the Act. A grace period may be granted for suppliers that have not had sufficient time to obtain accreditation before submitting a bid. If a supplier does not then successfully attain accreditation, we will suspend or terminate the supplier contract. The length of time for the grace period will be determined by the accrediting organizations' ability to complete the accrediting process within each competitive bidding area. The length of time of the grace period will be specified in the RFB for each competitive bidding program. We solicit public comments on the length of time for the grace period. Suppliers that received a valid accreditation before CMS-approved accreditation organizations are designated will be considered to be grandfathered if the accreditation was granted by an organization that we designate through the process described in proposed Sec. 424.58. These suppliers will not need to be re-accredited until their next regularly scheduled accreditation. 2. Eligibility (Proposed Sec. 414.414(b)) We propose that all bidders must meet eligibility rules to be considered for selection under the Medicare DMEPOS Competitive Bidding Program. The eligibility rules are included in the supplier standards regulation at Sec. 424.57. Also, each bidder must be enrolled with Medicare and be a current supplier, in good standing with the Medicare program, and not under any current Medicare sanctions. Each bidding supplier must certify in its bid that it, its high level employees, chief corporate officers, members of board of directors, affiliated companies and subcontractors are not now and have not been sanctioned by any governmental agency or accreditation or licensing organization. In the alternative, the bidding supplier must disclose information about any prior or current legal actions, sanctions, or debarments by any Federal, State or local program, including actions against any members of the board of directors, chief corporate officers, high-level employees, affiliated companies, and subcontractors. Sanctions would include, but are not limited to, debarment from any Federal program, sanctions issued by the Office of Inspector General, or sanctions issued at the State or local level. In addition, the bidder must have all State and local licenses required to furnish the items that are being bid. Finally, the supplier must agree to all of the terms in the contract outlined in the RFBs. We would suspend or terminate a contract if a supplier loses its good standing with us or any other government agency. 3. Financial Standards (Proposed Sec. 414.414(d)) Section 1847(b)(2)(A)(ii) specifies that we may not award a contract to an entity unless the entity meets applicable financial standards specified by the Secretary. Evaluation of financial standards for suppliers assists us in assessing the expected quality of suppliers, estimating the total potential capacity of selected suppliers, and ensuring that selected suppliers are able to continue to serve market demand for the duration of their contracts. Ultimately, we believe that financial standards for suppliers will help maintain beneficiary access to quality services. Therefore, as part of the bid selection process, the RFBs will identify the specific information we will require to evaluate suppliers, which may include: a supplier's bank reference that reports general financial condition, credit history, insurance documentation, business capacity and line of credit to successfully fulfill the contract, net worth, and solvency. We welcome comments on the financial standards, in particular the most appropriate documents that will support these standards. We found that in the demonstration, general financial condition, adequate financial ratios, positive credit history, adequate insurance documentation, adequate business capacity and line of credit, net worth, and solvency, were important considerations for evaluating financial stability. As we develop our methodology for financial standards, we will further consider which individual measures should be required so that we can obtain as much information as possible while minimizing the burden on bidding suppliers and the bid evaluation process. 4. Evaluation of Bids (Proposed Sec. 414.414(e)) We are proposing to select the product categories that include individual items for which we will require competitive bidding. Individual products will be identified by the Healthcare Common Procedure Coding System (HCPCS Codes) and will be further described in the RFB. Suppliers will be required to submit bids for each individual item within each product category they are seeking to furnish under the program, but will not be required to bid for every product category. a. Market Demand and Supplier Capacity (Proposed Sec. 414.414(e)) Section 1847(b)(4)(A) of the Act requires that in awarding competitive bidding contracts, the Secretary must select the number of contract suppliers necessary to furnish items to meet the projected demand in the geographic area. Therefore, the first step is for us to determine the expected demand for an item in a competitive bidding area. We propose to calculate expected demand in each competitive bidding area in a relatively straightforward way using existing Medicare claims. We will examine claims data to determine the number of units of each item supplied to Medicare beneficiaries during the past 2 years, and then determine the number of new beneficiaries that have entered the market during the last 2 years. We feel that 2 years worth of data is sufficient to allow us to identify trend analyses and utilization measurements. We will also gather data on the number of new fee-for-service Medicare enrollees coming into a competitive bidding area and use this number to project the number of new enrollees. We propose to calculate two years worth of claims on a monthly basis to determine beneficiary demand. We will take into consideration the expected demand over the total duration of the contract and the seasonal effects (for example, an increase in beneficiary population in Florida during the winter), and propose to use 2 years of data to identify any time trends. If there are no seasonal effects or time trends, we propose to use the average monthly total and new patient figures as the market demand measures. If there are seasonal effects or changes identified only during certain months, the maximum monthly total and new patient figures would be used as the market demand measures. If trends show that there is noticeable growth or reduction in beneficiary demand for products in an area, we would take these factors into consideration when developing estimates of beneficiary demand for competitively bid items. We propose to adopt the following approach to estimate supplier capacity [[Page 25676]] to meet the projected demand in a CBA. First, we propose to analyze Medicare claims to determine how many items a supplier is currently providing in the competitive bidding area, as well as in total. Second, as part of the bid, we would ask suppliers to say how many units they are willing and capable of supplying at the bid price in the CBA. We would compare this information to what the supplier has dispensed to Medicare beneficiaries in the past and what it specified in its response to the RFB as its projected capacity. We would require evidence of financial resources to support market expansion, such as letters from investors or lending agents. We would use this information to evaluate the capacity of the bidder. Third, we would compare expected capacity and Medicare volume to determine how many suppliers we would need in an area. For new suppliers, we would ask them for their expected capacity, look at trend data for new suppliers in that area, and examine the capacity of other suppliers in that area. We would need to use this data to make estimates about capacity because suppliers may have more capacity potential than they are currently exhibiting. During the DMEPOS demonstration, demonstration suppliers were able to expand their output to meet market demand and replace market share previously provided by non-demonstration suppliers; indeed, some demonstration suppliers were disappointed that they did not gain more market share during the demonstration. We presented numerous issues to the PAOC where we requested advice on issues such as market capacity and demands. During the February 28, 2005 PAOC meeting, we asked the panel to discuss the issue of demand and capacity. Several members of the committee, based upon their expertise and knowledge of the industry, suggested that most DMEPOS suppliers would be able to easily increase their total capacity to furnish items by up to 20 percent and the increase could be even larger for products like diabetes supplies that require relatively little labor. We welcome comments on our proposed approach for calculating market demand and estimating supplier capacity. We are especially interested in any information that would help us compare current Medicare volume with potential capacity, including potential formulas we could apply to determine capacity. b. Composite Bids (Proposed Sec. 414.414(e)) When suppliers are bidding for multiple items in a product category, the lowest bid for each item will not always be submitted by the same supplier. In this case, looking at the bids for individual items would not tell us which supplier should be selected since different suppliers may submit the lowest bids for different items. Therefore, we propose to use a composite bid to compare all of the suppliers' bids submitted for an entire product category in a CBA. Using a composite bid is a way to aggregate a supplier's bids for individual items within a product category into a single bid for the whole product category. This will allow us to determine which suppliers can offer the lowest expected costs to Medicare for all items in a product category. To compute the composite bid for a product category, we would multiply a supplier's bid for each item in a product category by the item's weight and sum these numbers across items. The weight of an item would be based on the utilization of the individual item compared to other items within that product category based on historic Medicare claims. Item weights would be used to reflect the relative market importance of each item in the product category. We would select item weights that ensure that the composite bid is directly comparable to the costs that Medicare would pay if it bought the expected bundle of items in the product category from the supplier. The sum of each supplier's weighted bids for every item in a product category would become the supplier's composite bid for that product category. We seek comment on the best method of weighting individual items within a product category to determine the composite bid. One approach we are considering is to set the weight for each item based on the volume of the individual item's share compared to the total utilization of the product category. Under this weighting system, the composite bid would be exactly proportional to the expected cost of furnishing the entire bundle of items. Therefore, if supplier 1 had a lower composite bid than supplier 2, it would also have a lower expected cost of furnishing the entire product bundle that makes up the product category. Another approach we are considering is to set the weight based on the payment amounts attributable to each DMEPOS fee schedule item relative to the overall payment amount for the total product category. This approach may better reflect the relative value of each item because it is based on how much we actually pay for an item. This is the approach that we used in the round 1 bidding in Polk County under the competitive bidding demonstration program. However, we found that this approach could result in too much weight being placed on low volume and high-priced items. The first year evaluation report also found that using the allowed charges as the weights could result in a supplier who offered lower bids having a higher composite bid than a supplier who offered a higher bid for individual items. We use volume of items or units as the basis of the following examples but we are requesting comments on which weighting method should be used in calculating the composite. We also request comments on other methods of weighting that could be applied to individual items. Table 5.--Item Weights ---------------------------------------------------------------------------------------------------------------- Item A B C All ---------------------------------------------------------------------------------------------------------------- Units............................................................ 5 3 2 10 Item Weight...................................................... 0.5 0.3 0.2 1 ---------------------------------------------------------------------------------------------------------------- The example above shows how a proposed weight setting methodology would work. The expected volume for Items A, B, and C are 5, 3, and 2 units, respectively, for a total volume of 10 units. The item weight for Item A is 0.5 (5/10), the weight for Item B is 0.3 (3/10), etc. As explained above, the composite bid for a supplier would equal the item weight times the item bid summed across all items in the product category. The item weights would be the same for bidders for the same product categories. In our example, supplier 1 bid $1.00 for item A, $4.00 for item B and $1.00 for item C. The composite bid for Supplier 1 = (0.5 * $1.00) + (0.3 * $4.00) + (0.2 * $1.00) = 1.90. The table shows the expected cost of the bundle based on [[Page 25677]] each supplier's bids. The expected costs are directly proportional to the composite bids; the factor of proportionality is equal to the total number of units (10) in the product category. We used the composite bid to determine the expected costs for all of the items in the product category based upon expected volume. Table 6.--Composite Bids ---------------------------------------------------------------------------------------------------------------- Expected Item A B C Composite cost of bid bundle ---------------------------------------------------------------------------------------------------------------- Units............................................... 5 3 2 .......... .......... Item weight......................................... 0.5 0.3 0.2 .......... .......... Supplier 1 bid...................................... $1.00 $4.00 $1.00 $1.90 $19.00 Supplier 2 bid...................................... $3.00 $3.00 $2.00 2.80 28.00 Supplier 3 bid...................................... $2.00 $2.00 $2.00 2.00 20.00 Supplier 4 bid...................................... $1.00 $2.00 $2.00 1.50 15.00 ---------------------------------------------------------------------------------------------------------------- Under this proposed methodology, bid selection would proceed by ranking the composite bids from lowest to highest (Table 6). In order to ensure that we would pay less under competitive bidding than we would under the current fee schedule, as is required under section 1847(b)(2)(A)(iii), we would compute the expected cost of the bundle of goods for comparison purposes. This would require us to calculate the bid amount times the expected number of units that we expect suppliers will furnish based on the most current Medicare claims data and sum across each item by supplier. For example, if supplier 1 bid $1.00 for item A and we expected to purchase 5 units--$1.00 x 5 units = $5.00, item B--$4.00 x 3 units = $12.00, item C--$1.00 x 2 units = $2.00, the sum for these 3 items would be $19.00. As previously noted, prior to bid selection we would first ensure that suppliers meet quality and financial standards prior to arraying the bids and selecting suppliers. c. Determine the Pivotal Bid (Proposed Sec. 414.414(e)) We propose that the pivotal bid would be the point where expected combined capacity of the bidders is sufficient to meet expected demands of beneficiaries for items in a product category. In the example below, the projected demand would be for 1000 units, therefore supplier 10's composite bid would represent the pivotal bid, since the cumulative capacity of 1100 would exceed the projected demand of 1000. The statute requires multiple winners, so in all cases where we award bids, we would need to accept at least two winning bidders. All bidders who are eligible for selection and whose composite bid for the product category is less than or equal to the pivotal bid would be selected as winning bidders. In the table below, for example, $135.00 would be the pivotal bid. Suppliers 2, 3, 1, and 10 would then be selected as winning bidders with supplier 10's composite bid becoming the pivotal bid. We realize that this approach may leave out other suppliers with very close, but slightly higher bids. Table 7.--Determine the Pivotal Bid [Point where beneficiary demand is met by supplier capacity--for this example, beneficiary expected demand is 1000 units--supplier 10's bid is the pivotal bid] ---------------------------------------------------------------------------------------------------------------- Composite Supplier Cumulative Supplier number Eligible for selection bid capacity capacity ---------------------------------------------------------------------------------------------------------------- 2......................................... Yes.......................... $100 100 100 3......................................... Yes.......................... 115 300 400 1......................................... Yes.......................... 120 400 800 10........................................ Yes.......................... 135 300 1100 4......................................... Yes.......................... 140 500 1600 7......................................... Yes.......................... 150 100 1700 No longer being considered: 5......................................... No........................... 120 n.c. n.c. 6......................................... No........................... 130 n.c. n.c. 8......................................... No........................... 175 n.c. n.c. 9......................................... No........................... 200 n.c. n.c. ---------------------------------------------------------------------------------------------------------------- n.c. = not calculated. We also considered the use of a competitive range to determine the contract suppliers. In this approach we would determine a competitive range for the composite bid. We would array all suppliers by their bids and eliminate all suppliers whose composite bid is greater than the competitive range. We would then evaluate the quality and financial standards only for those remaining suppliers. During the demonstration, evaluating quality and financial standards was time-consuming for the bid evaluation panel and required bidders to provide extensive information on quality and finances. The last two rounds of the demonstration used a competitive range to reduce the burden on the bid evaluation panel and bidders. After evaluating basic eligibility requirements, the composite bids were calculated and arrayed, and a competitive range was selected with more than enough suppliers to serve the market. Suppliers whose composite bids were clearly outside of this range were not required to provide detailed financial information, and the bid panel was not required to evaluate the eligibility of these suppliers to participate. Suppliers within the competitive range provided detailed financial information and had their quality rigorously evaluated. The [[Page 25678]] remaining suppliers were only selected as contract suppliers if they met the quality and financial standards and their composite bids were at or below the pivotal bid. There are other options that we have considered to determine the pivotal bid. One of these options would be to make the pivotal bid depend on one of the summary statistics (for example, mean, median, 45th percentile) associated with the distribution of bids from eligible suppliers. For example, the pivotal bid could be set equal to the median bid from eligible suppliers. This option has the advantage that the pivotal bid could be set near the central distribution of bids. We considered including additional suppliers who are close to the central distribution as being eligible to become a contract supplier. Both options would likely affect the number of contract suppliers. Finally, the exact summary statistic or percentile can be increased or decreased to reflect our trade-off between the number of winners and program costs. One negative aspect of this approach would be that winners may have insufficient capacity. In addition, with a given percentile cutoff, the pivotal bid might include an excessive number of winning bidders. As the number of eligible bidders increases, so does the number of winners. If additional bidders have higher costs, and their bids fall into the upper half of the distribution, the pivotal bid will increase, resulting in greater payments by the Medicare program and a loss of savings. Another option would be to base the pivotal bid on a target number of winners. For example, we may decide to select 5 winners in each product category. Suppliers may respond to this approach by bidding aggressively, knowing that only a fixed number of winners are guaranteed to be selected. A negative aspect of this approach is that there is no assurance that a predetermined target number of winners would have sufficient capacity to meet projected market demand. In addition, the target number of winners must somehow be selected and this could result in selecting an arbitrary number. If too high, suppliers may have little incentive to bid aggressively. We also considered an option to base the pivotal bid on a target composite bid, for example, we would choose a target that was 20 percent below the DMEPOS fee schedule amount for that product category. A possible advantage of this approach is that the target composite bid can be set to ensure savings for the program. On the other hand, we believed that suppliers might perceive this approach to be anticompetitive. Rather than letting bidding and the market forces determine the pivotal bid and fee schedule we might have been viewed as pre-ordaining the outcome. In addition, suppliers that bid below the target composite bid might have had insufficient capacity to meet projected market demand. We are proposing that the pivotal bid be at the point where we have a sufficient number of suppliers to ensure we have enough capacity to meet projected demand and that beneficiaries have adequate access to quality items. d. Assurance of Savings (Proposed Sec. 414.414(f)) Section 1847(b)(2)(A)(iii) of the Act prohibits awarding contracts to any entity for furnishing items unless the total amounts to be paid to contractors in a competitive bidding area are expected to be less than the total amounts that would otherwise be paid. We are proposing to interpret this requirement to mean that contracts will not be awarded to any entity unless the amounts to be paid to contract suppliers in a competitive bidding area are expected to be less for a competitively bid item than would have otherwise been paid. Therefore, we would not accept any bid for an item that is higher than the current fee schedule amount for that item. This approach would require that single payment amounts for each item in a product category be equal to or less than our current fee schedule amount for that item. An alternative interpretation of ``less than the total amounts that would otherwise be paid'' could mean contracts will not be awarded to an entity unless the amounts paid to contract suppliers in a CBA for the product category are expected to be less than that would have otherwise been paid. During the demonstration, several product categories received overall savings, whereas payment amounts increased for a few individual items within those product categories. This approach may not result in adequate savings, and we believe a reasonable interpretation of the Act would be one in which ``the total amounts'' mean payment at the item level. One concern with this approach is that there may be a greater potential for shifting of utilizations from one item to another higher priced item. We specifically request comments on the various methods for assuring savings under the Medicare DMEPOS Competitive Bidding Program. e. Assurance of Multiple Contractors (Proposed Sec. 414.414(g)) Section 1847(b)(4)(B) of the Act specifies that the Secretary will award contracts to multiple entities submitting bids in each area for an item. In addition, section 1847(b)(2)(A)(iv) of the Act specifies that contracts may not be awarded unless access of individuals to a choice of multiple suppliers is maintained. As a result, we will have multiple contract suppliers in each competitive bidding area for each product category if at least two suppliers meet all requirements for participation, and the single payment amounts to be paid to those suppliers do not exceed the fee schedule amounts for the items that were bid. We know that offering choices to beneficiaries, referral agents, and treating practitioners that order DMEPOS for Medicare beneficiaries is important to maintain competition among suppliers based on quality of items. We have to weigh that advantage against the disincentive for a supplier to submit its best bid if we select too many suppliers to service a competitive bidding area. Therefore, we believe that having multiple suppliers servicing one product category in a competitive bidding area will allow us to accomplish these goals. f. Selection of New Suppliers After Bidding (Proposed Sec. 414.414(h)) We are proposing to select only as many suppliers as necessary to ensure we have enough capacity to meet projected demand. However, we may have to suspend or terminate a contract supplier's contract if that supplier falls out of compliance with any of the requirements identified in the regulation and in the bidding contract. Alternatively, we could determine that the number of contract suppliers we selected to furnish a product category under a competitive bidding program was insufficient to meet beneficiary demand for those items. In situations where CMS determines that there is an unmet demand for items, for example, if CMS terminates a contract supplier's contract, we would propose to contact the remaining contract suppliers for that product category to determine if they could absorb the unmet demand. If the remaining contract suppliers could not absorb the unmet demand in a timely manner, we would propose to then refer to the list of suppliers that submitted bids for that product category in that round of competitive bidding in that competitive bidding area, use the list of composite bids that we arrayed from lowest to highest, and proceed to the next supplier on the list. We would [[Page 25679]] contact that supplier to determine if it would be interested in becoming a contract supplier. If the supplier was interested, we would require the supplier to provide updated information to ensure its continued eligibility for participation. A condition for acceptance of a contract would be that the supplier must agree to accept the already determined single payment amounts for the individual items within the product category in the competitive bidding area. We would continue to go down the list until we were satisfied that the expected demand would be met and beneficiary access to the items in the product category would not be a problem. After consultation with the DMEPOS industry and PAOC, CMS was told that additional capacity should not be a problem as suppliers would be willing and able to handle the expected demand. Another option that we considered, but are not proposing, was to conduct a new round of bidding to select additional suppliers. However, we did not choose this option because it would delay the resolution of an access problem and place an additional administrative burden on the program. H. Determining Single Payment Amounts for Individual Items (Proposed Sec. 414.416) [If you choose to comment on issues in this section, please include the caption ``Determining Single Payment Amounts for Individual Items'' at the beginning of your comments.] 1. Setting Single Payment Amounts for Individual Items (Proposed Sec. 414.416(b)) Section 1847(b)(5)(A) of the Act requires that the Secretary determine a single payment amount for each item in each competitive bidding area based on the bids submitted and accepted for that item. Once contract suppliers are selected for a product category based on their composite bid and the pivotal bid, single payment amounts for individual items in the product category must be determined. We are considering several different methodologies for determining the single payment amounts. Each of the options under consideration are discussed in detail in this section. After careful consideration of these options, we are proposing to adopt the following principles to determine the single payment amounts for individual items in a product category: Principle 1 Bid amounts from all winning bids for an item in a CBA will be used to set the single payment amount for that item in the CBA. Principle 2 We must expect to pay less for each individual item than we would have otherwise paid for that item under the current fee schedule. Single payment amounts cannot be higher than our current fee schedule amounts for individual items within a product category. To satisfy these principles, we evaluated several different approaches to setting payment amounts. As a result of our review, we have decided on a preferred approach that would determine the single payment amounts for individual items by using the median of the supplier bids that are at or below the pivotal bid for each individual item within each product category. The individual items would be identified by the appropriate HCPCS codes. The median of the bids submitted by the contract suppliers for a particular item would be the single payment amount that we would establish under the competitive bidding program for the HCPCS code that describes that item. In cases where there is an even number of winning bidders for an item, we would employ the average (mean) of the two bid prices in the middle of the array to set the single payment amount. We believe that setting the single payment amount based on the median of the contract suppliers' bids satisfies the statutory requirement that single payment amounts are to be based on bids submitted and accepted. This will result in a single payment for an item under a competitive bidding program that is representative of the winning bids for that item. This methodology also has the advantage of being easily understood by suppliers and implemented by our contractors. It also results in what we consider to be a reasonable payment amount based on prices available in the marketplace. As illustrated in Table 8, this methodology would reduce the effect of excessively high or excessively low bids and would also help to ensure savings for the Medicare program. We believe it is also consistent with the intent of competitive bidding. Table 8.--Median of the Winning Bids ---------------------------------------------------------------------------------------------------------------- Actual Item A B C composite bid ---------------------------------------------------------------------------------------------------------------- Supplier 4 bid.............................................. $1.00 $2.00 $2.00 $1.50 Supplier 1 bid.............................................. 1.00 4.00 1.00 1.90 Supplier 3 bid.............................................. 2.00 2.00 2.00 2.00 Median of winning bids--Single payment amount............... 1.00 2.00 2.00 ........... ---------------------------------------------------------------------------------------------------------------- While this is our proposed approach, we are soliciting comments on other methodologies for setting the single payment amount, including using an adjustment factor as part of the methodology for setting the single payment amount. This was the methodology we used for the competitive bidding demonstrations, and it would require the following steps. The first step of this methodology would be to calculate the average of the winning bids per individual item. The second step would be to calculate the average of the composite bids by taking the sum of the composite bids for all contract suppliers in the applicable CBA and dividing that number by the number of contract suppliers. The third step would be to determine an adjustment factor, the purpose of which would be to bring every winner's overall bids for a product category up to the pivotal bidder's composite bid. Once we determined the adjustment factor, we would take the average of the winning bids per item and multiply that by the adjustment factor to adjust all bids up to the point of the pivotal bid, so that all winners would be paid by Medicare as much for the total product category as the pivotal bidder. This amount would become the single payment amount for the individual item. This is the price that all contract suppliers within a competitive bidding area would be paid for that product as illustrated in Table 9. [[Page 25680]] Table 9.--Adjusting the Average Winning Bids ---------------------------------------------------------------------------------------------------------------- Average Actual Item A B C composite composite bid bid ---------------------------------------------------------------------------------------------------------------- Supplier 4 bid................................. $1.00 $2.00 $2.00 ........... $1.50 Supplier 1 bid................................. 1.00 4.00 1.00 ........... 1.90 Supplier 3 bid................................. 2.00 2.00 2.00 ........... 2.00 Supplier 2 bid................................. N/A N/A N/A ........... N/A Average of winning bids........................ 1.33 2.67 1.67 1.80 ........... Adjustment factor = (Pivotal Composite Bid) / 1.11 1.11 1.11 ........... ........... (Average Composite Bid)....................... Adjusted average bids--single payment amount 1.48 2.96 1.85 ........... ........... per item...................................... ---------------------------------------------------------------------------------------------------------------- This approach would ensure that the overall payment amounts that contract suppliers received was at least as much as their bids. As a result, this may have guarded against suppliers leaving the Medicare program because the payment amounts are not sufficient. However, we do not favor this alternative because, in general, most payment amounts would be higher than the actual bids as a result of the adjustment factor being greater than zero. This is true because the purpose of the adjustment factor would have been to make the composite bid of all winning suppliers equivalent to the composite bid of the pivotal supplier. While this approach is still under consideration, we are considering whether this approach is reflective of the actual winning bids accepted. Also, we are concerned that this methodology may be confusing and overly complicated. We also considered taking the minimum winning bid for each item in a CBA and not applying an adjustment factor. We do not favor this alternative because we also do not consider it as being reflective of the actual bids accepted because it is only reflective of the lowest bid. The lowest bid would not be reflective of what suppliers would sell the item for since most of them bid higher. Finally, we considered taking the maximum winning bid for each item. However, this approach would have led to program payment amounts that were higher than necessary because some suppliers were willing to provide these items to beneficiaries at a lower cost. We are still in the process of determining the appropriate approach for setting payment amounts, as well as the alternatives considered and outlined above and invite comments on our proposed methodology. We will consider all comments in the final regulation. 2. Rebate Program (Proposed Sec. 414.416(c)) We are proposing to allow contract suppliers that submitted bids for an individual item below the single payment amount to provide the beneficiary with a rebate. The rebate would be equal to the difference between their actual bid amount and the single payment amount. The following example illustrates how the rebates would be applied: If, based on the bids received and accepted for an item, we determined that the single payment amount for the item was $100, Medicare payment for the item would be 80 percent of that amount, or $80, and the co-insurance amount for the item would be 20 percent, or $20. However, if a contract supplier submitted a bid of $90 for this item and chose to offer a rebate, the rebate amount would be equal to the difference between the single payment amount ($100) and the contract supplier's actual bid ($90), or $10. Therefore, after the contract supplier received the Medicare payment of $80 and the $20 co- insurance, the contract supplier would be responsible for providing the beneficiary with a $10 rebate. We are soliciting comments on how to handle those cases in which the rebates would exceed the co-payment amount. Before deciding to propose this methodology, we considered whether to make the rebates mandatory or optional. We are proposing that the rebates be voluntary but that contract suppliers cannot implement them on a case by case basis. If a contract supplier submits a bid below the single payment amount and chooses to offer a rebate, it must offer the rebate to all Medicare beneficiaries receiving the competitively bid item to which the rebate applies. This commitment would be incorporated into the contract supplier's contract. Stated another way, while the decision to offer rebates may be voluntary, once a contract supplier decides to provide rebates, the rebates become a binding contractual condition for payment during the term of the contract with CMS. Moreover, the contract supplier may not amend or otherwise alter the provision of rebates during the term of the contract. Contract suppliers would also be prohibited from directly or indirectly advertising these rebates to beneficiaries, referral sources, or prescribing health care professionals. However, this would not preclude CMS from providing to beneficiaries comparative information about contract suppliers that offer rebates. Only contract suppliers that submitted bids below the single payment amount for a competitively bid item would have the choice to offer rebates. Contract suppliers that submitted bids above the single payment amount would not be allowed to issue rebates because their actual bids for an individual item would be above this amount. Our reasons for allowing these contract suppliers to offer rebates is to allow beneficiaries the ability to realize additional savings and the full benefits of the Medicare DMEPOS Competitive Bidding Program. We are asking for comments concerning the rebate process outlined in this proposed rule. CMS will continue to evaluate the fraud and abuse risks of the proposed rebate program, and we are specifically soliciting comments on such risks. I. Terms of Contracts (Proposed Sec. 414.422) [If you choose to comment on issues in this section, please include the caption ``Terms of Contract'' at the beginning of your comments.] Section 1847(b)(3)(A) of the Act gives the Secretary the authority to specify the terms and conditions of the contracts used for competitive bidding. Section 1847(b)(3)(B) requires the Secretary to recompete contracts under the Medicare DMEPOS Competitive Bidding Program at least every 3 years. The length of the contracts may be different for different product categories, and we propose to specify the length of each contract in the Request for Bids. 1. Terms and Conditions of Contracts We propose that the competitive bidding contracts will contain, at a [[Page 25681]] minimum, provisions relating to the following: Covered product categories and covered beneficiaries, operating policies. Subcontracting rules. Cooperation with us and our agents. Potential onsite inspections. Minimum length of participation. Terms of contract suspension or termination. Our discretion not to proceed if we find that the Medicare program will not realize significant savings as a result of the program. Compliance with changes in Federal laws and regulations during the course of the agreement. Non-discrimination against beneficiaries in a competitive bidding area (so that all beneficiaries inside and outside of a competitive bidding area receive the same products that the contract supplier would provide to other customers). Supplier enrollment and quality standards. The single payment amounts for covered items. Other terms as we may specify. 2. Furnishing of Items (Proposed Sec. 414.422(c)) A contract supplier must agree to furnish the items included in its contract to all beneficiaries who maintain a permanent residence or who visit the competitive bidding area and request those items from the contract supplier. However, as explained in sections II.F.1 and II.F.2 above, a skilled nursing facility defined in section 1819(a) of the Act that is also a contract supplier must only agree to furnish the items included in its contract to patients to whom it would otherwise furnish Part B services. In addition, a physician that is also a contract supplier must only agree to furnish the items included in its contract to his or her patients. 3. Repairs and Replacements of Patient Owned Items Subject to Competitive Bidding. (Proposed Sec. 414.422(c)) Repair or replacement of patient-owned DME, enteral nutrition equipment or off-the-shelf orthotics, that are subject to the competitive bidding program, must be furnished by a contract supplier because only winning suppliers can provide these items in a competitive bidding area. The contract supplier cannot refuse to repair or replace patient-owned items subject to competitive bidding. This proposed policy will help ensure that the beneficiaries will get the items from qualified suppliers, and it is consistent with the competitive bidding program in that it directs business to contract suppliers. Therefore, we propose that repair or replacement of patient-owned items subject to a competitive bidding program must be furnished by a contract supplier. This requirement does not apply to beneficiaries who are outside of a competitive bidding area. 4. Furnishing Items to Beneficiaries Whose Permanent Residence Is Within a CBA We propose that a contract supplier cannot refuse to furnish items and services to a beneficiary residing in a CBA based on the beneficiary's geographic location within the CBA. This policy will prohibit contract suppliers from refusing to furnish items to beneficiaries because they are not in close proximity to that supplier. In order to ensure beneficiary access to competitively bid items that are rented, we are proposing that the contract supplier must agree to accept as a customer a beneficiary who began renting the item from a different supplier regardless of how many months the item has already been rented. This is particularly important in those cases where a supplier or noncontract supplier does not elect to continue furnishing the item in accordance with the grandfathering provisions discussed in section II.C.3. above. Suppliers must factor the cost of furnishing items in these situations into their bid submissions. Also, in order to ensure beneficiary access to the competitively bid items in the inexpensive or routinely purchased DME payment category or to a competitively bid power wheelchair, the contract supplier must agree to give the beneficiary or his or her caregiver the choice of either renting or purchasing the item and must furnish the item on a rental or purchase basis as directed by the beneficiary or the beneficiary's caregiver. Suppliers must factor the cost of furnishing these items on both a rental and purchase basis into their bid submissions. 5. Furnishing Items to Beneficiaries Whose Permanent Residence Is Outside a CBA In order to obtain medically necessary DMEPOS or other equipment, a beneficiary whose permanent residence is located outside of a CBA must use a contract supplier to obtain all items subject to competitive bidding in the competitive bidding area that he or she visits. We considered allowing beneficiaries whose residence is outside of a competitive bidding area to obtain these items from noncontract suppliers when coming into a competitive bidding area. However, consistent with section 1847(b)(6), we are proposing that they be required to use a contract supplier because we believe that new business for competitively bid items should be directed only to contract suppliers. Noncontract suppliers would be allowed to continue servicing current beneficiaries who maintain a permanent residence in a competitive bidding area if they qualified for the grandfathering program discussed in section II.C.3 above. 6. Information Collection From the Supplier The following is a list of some of the terms, conditions and information that we propose a supplier must agree to provide to CMS for purposes of assessment prior to becoming a contract supplier: Information on product integrity. Information on business integrity. Organizational conflicts of interest. Name. Physical address. Billing address. Phone number. NSC number. Names of all owners. NSC number of any affiliated company. Address and phone number of any affiliated company. Employee information. Number of employees. Training and qualifications. Customer service protocol. Information on any bankruptcy proceedings involving the bidding company or any affiliated company. We invite comments on what terms and conditions should be included in a contract for the competitive bidding program. We are interested both in terms and conditions that should be omitted as well as terms and conditions that should be added. 7. Change in Ownership (Proposed Sec. 414.422(d)) We propose to evaluate a company's ownership information, its compliance with appropriate quality standards, its financial status, and its compliance status with government programs before we determine that a supplier can qualify as a contract supplier if there is a change of ownership. For this reason, we are proposing that suppliers would not be granted winning status by merely merging with or acquiring a contract supplier's business. We do not want to allow suppliers to adopt a strategy of circumventing the regular bidding process by gaining winning status through acquisitions of or mergers with [[Page 25682]] contract suppliers or to violate any anti-competition prohibitions. Therefore, contract suppliers must notify CMS in writing 60 days prior to any changes of ownership, mergers or acquisitions being finalized. We have the discretion to allow a successor entity after a merger with or acquisition of a contract supplier to function as contract supplier when-- There is a need for the successor entity as a contractor to ensure Medicare s capacity to meet expected beneficiary demand for a competitively bid item; and We determine that the successor entity meets all the requirements applicable to contract suppliers. The successor entity must agree to assume the contract supplier s contract, including all contract obligations and liabilities that may have occurred after the awarding of the contract to the previous supplier. The successor entity is legally liable for the non- fulfillment of obligations of the original contract supplier. In addition, we would only allow the successor entity to function as a contract supplier if it executed a novation agreement. 8. Suspension or Termination of a Contract (Proposed Sec. 414.422(f)) Contract suppliers are held to all the terms of their contracts for the full length of the contract period. Any deviation from contract requirements, including a failure to comply with governmental agency or licensing organization requirements, would constitute a breach of contract. If we conclude that the contract supplier has breached its contract, the actions we might take include, but are not limited to, asking the contract supplier to correct the breach condition, suspending the contract, terminating the contract for default (that may include reprocurement costs), precluding the supplier from participating in the competitive bidding program, or availing ourselves of other remedies permitted by law. We would also have the right to terminate the contract for convenience. J. Administrative or Judicial Review (Sec. 414.424) [If you choose to comment on issues in this section, please include the caption ``Administrative or Judicial Review'' at the beginning of your comments.] Section 1847(b)(10) of the Act provides that there will be no administrative or judicial review under section 1869, section 1878, or any other section of the Act, for the: Establishment of payment amounts under a competitive bidding program; Awarding of contracts under a competitive bidding program; Designation of competitive bidding areas for the Medicare DMEPOS Competitive Bidding Program; Phased-in implementation of the Medicare DMEPOS Competitive Bidding Program; Selection of items for a competitive bidding program. Bidding structure and number of contract suppliers selected under a competitive bidding program. This proposed regulation has no impact on the current beneficiary or supplier right to appeal denied claims. However, neither the beneficiary nor the supplier would be able to bring such an appeal if a competitively bid item was furnished in a competitive bidding area in a manner not authorized by this rule. K. Opportunity for Participation by Small Suppliers [If you choose to comment on issues in this section, please include the caption ``Opportunity for Participation by Small Suppliers'' at the beginning of your comments.] In developing bidding and contract award procedures, section 1847(b)(6)(D) of the Act requires us to take appropriate steps to ensure that small suppliers of items have an opportunity to be considered for participation in the Medicare DMEPOS Competitive Bidding Program. Section 1847(b)(2)(A)(ii)) of the Act also states that the needs of small suppliers must be taken into account when evaluating whether an entity meets applicable financial standards. Size definitions for small businesses are, for some purposes, developed by the Small Business Administration (SBA) based on annual receipts or employees, using the North American Industry Classification System (NAICS). Based on the advice from the SBA, we expect that most DME suppliers will fall into either NAICS Code 532291, Home Health Equipment Rental, or NAICS Code 446110, Pharmacies, since the SBA defines these small businesses as businesses having less than $6 million in annual receipts. We propose using the SBA small business definition when evaluating whether a DMEPOS supplier is a small supplier. We are relying on the expertise of the SBA to determine what constitutes the appropriate definition of a small supplier. All contract suppliers are expected to service the whole competitive bidding area. However, we considered allowing a small supplier that has fewer than 10 full-time equivalent employees to designate a geographic service area that is smaller than the entire competitive bidding area. However, we are not proposing this approach because we want to ensure that beneficiaries have the choice of going to any contract supplier in their respective CBA. Carve out areas could lead to confusion for the beneficiary faced with multiple competitive bidding sub-areas. Further, we believe such an approach would allow selection of more favorable market areas by smaller businesses potentially leading to an unfair market advantage. We seek comments on this issue. Information available to us on the size distribution of businesses that provide DMEPOS indicates that the majority of suppliers in the DMEPOS industry qualify as small businesses according to the SBA definitions. Our analysis of DMEPOS claims data suggests that at least 90 percent of DMEPOS suppliers had Medicare allowed charges of less than $1 million in 2003. The figure of $1 million could be an underestimate of total receipts, since it does not include non-Medicare receipts and non-DMEPOS receipts, but it does suggest that most DMEPOS suppliers are small. Although section 1847(b)(6)(D) of the Act focuses on ensuring participation in the bidding, and not on bidding outcomes, we believe that it is worth noting how small suppliers fared in the bidding in the demonstration. Both small and large suppliers were selected as demonstration suppliers. Some small suppliers that were selected as demonstration suppliers were able to increase their market share substantially during the demonstration. Others experienced little change in market share. We recognize the importance, benefits and convenience offered by the local presence of small suppliers. We propose to take the following steps to ensure that small suppliers have the opportunity to be considered for participation in the program. First, as required by section 1847(b)(4)(B) of the Act, we will select multiple winners in each CBA. If a single winner was selected in an area, a small supplier would have difficulty participating in the competition because the supplier would have to somehow demonstrate that it could rapidly expand to serve the entire projected demand in the area. Selecting multiple suppliers should make it easier for small suppliers to participate in the program. Second, we propose to conduct separate bidding competitions for product categories, allowing suppliers to decide how many product categories [[Page 25683]] for which they want to submit bids, rather than conduct a single bidding competition for all DMEPOS items and other equipment. We believe that separate competitions for product categories will encourage participation by small suppliers that specialize in one or a few product categories. If a single competition was held for all DMEPOS items and other equipment, small, specialized suppliers would have to either significantly expand their product and service offerings or submit bids for items they currently do not provide. We recognize the importance of small suppliers in the DMEPOS industry, and we welcome comments on any the options identified above. We are also interested in other ways to ensure that small suppliers have opportunities to be considered for participation in the program. To collect additional information on this issue, we contracted with RTI International to conduct focus groups with small suppliers. The purpose of the focus groups was to gather input on ways to facilitate participation by small suppliers in the program. The focus groups also discussed the impact of the requirement for the quality standards and accreditation, which will affect all small suppliers, regardless of whether they seek to participate in a competitive bidding program. We will review our efforts to ensure participation by small suppliers in the Medicare DMEPOS Competitive Bidding Program after we review comments to this proposed rule and the results of the focus groups. We will consider the findings of the focus groups along with additional options and comments presented on this proposed rule. L. Opportunity for Networks (Proposed Sec. 414.418) [If you choose to comment on issues in this section, please include the caption ``Opportunity for Networks'' at the beginning of your comments.] We propose allowing suppliers the option to form networks for bidding purposes. Networks are several companies joining together via some type of legal contractual relationship to submit bids for a product category under competitive bidding. This option will allow suppliers to band together to lower bidding costs, expand service options, or attain more favorable purchasing terms. We recognize that forming a network may be challenging for suppliers, and it also poses challenges for bid evaluation and program monitoring. Networking was included as an option in the demonstration project, but no networks submitted bids. Still, we believe that networking may be a useful option for suppliers in some cases, so we propose to offer it as an option. If suppliers do decide to form networks, we propose that the following rules must be met: A legal entity must be formed for the purpose of competitive bidding, such as a joint venture, limited partnership, or contractor/subcontractor relationship which would act as the applicant and submit the bid. We are specifically requesting comments regarding other types of suitable arrangements that would not require suppliers to form a new legal entity but would allow them to form a network for purposes of submitting bids. For example, one supplier could be designated as a primary contractor and the other suppliers in the group would function as subcontractors. In this example, if the contract with the primary contractor was terminated, the contracts with the subcontractors would also be terminated, thus nullifying the entire contract. All legal contracts must be in place and signed before the network entity can submit a bid for the Medicare DMEPOS Competitive Bidding Program. Each member of the network must be independently eligible to bid. If a member of the network is determined to be ineligible to bid, the network will be notified and given 10 business days to resubmit its application. Each member must meet any accreditation and quality standards that are required. Each member is equally responsible for the quality of care, service and items that it delivers to Medicare beneficiaries. If any member of the network falls out of compliance with this requirement, we would have the option of terminating the network contract. The network cannot be anti-competitive. We propose that the network members' market shares for competitive bid item(s) when added together, cannot exceed 20 percent of the Medicare market within a competitive bidding area. We believe that by setting the maximum size of the network's market shares at 20 percent of the marketplace, firms will be able to gain the potential efficiencies of networking while at the same time ensure that there would continue to be competition in the area. If the 20 percent rule were adopted and suppliers joined networks, there would still be at least 5 networks competing in a DMEPOS competitive bidding program, which we believe would allow for sufficient competition among suppliers. In particular, we are requesting comment about what percentage of the marketplace would be appropriate for networks for suppliers. A supplier may only join one network and cannot submit individual bids if part of a network. The network must identify itself as a network and identify all members in the network. The legal entity would be responsible for billing Medicare and receiving payment on behalf of the network suppliers. The legal entity would also be responsible for appropriately distributing reimbursements to the other network members. M. Education and Outreach [If you choose to comment on issues in this section, please include the caption ``Education and Outreach'' at the beginning of your comments.] 1. Supplier Education We would also propose to undertake a proactive education campaign to provide all suppliers with information about the Medicare DMEPOS Competitive Bidding Program, bidding timelines, and bidding and program requirements. The goal of this campaign would be to make it as easy as possible for suppliers to submit bids. To ensure that suppliers have timely access to accurate information on competitive bidding, we are proposing to instruct the CBIC and the DMERCs to provide early education and resources to all suppliers, referral agents, beneficiaries and other providers who service a competitive bidding area. Customer service support, ombudsmen networks, and the claims processing system would all be used to notify and educate all parties regarding competitive bidding. The CBIC(s) would be instructed to utilize data analysis in tailoring outreach to those that will be directly affected by competitive bidding. After the release of bidding instructions, we would also propose to hold bidders conferences that would provide an open forum for suppliers and allow us to disseminate additional information. More information on the bidders conferences and other competitive bidding activities will be available on our Web site at http://cms.hhs.gov/suppliers/dmepos/compbid/paoc.asp. We are also proposing that each DMERC include discussions and updates on competitive bidding as part of its existing outreach mechanisms. The fundamental goal of our supplier educational outreach is to ensure that those who supply DMEPOS products to Medicare beneficiaries receive information they need in a timely [[Page 25684]] manner so they have an understanding of the program and our expectations. 2. Beneficiary Education The competitive bidding program will have an impact on the beneficiaries who receive DMEPOS items in a competitive bidding area. Competitive bidding represents a new way for Medicare beneficiaries to receive their DMEPOS products, so we believe that education is important to the success of the program. We propose to educate beneficiaries utilizing numerous approaches. For example, our press office may consider creating press releases and fact sheets for each CBA. Notices would provide summaries of competitive bidding, background information, and objectives of the competitive bidding program. Publications may also be available on CMS Web sites, and from local contractors and the DMERCS. We believe that it is important for beneficiaries to learn about the benefits of the Medicare DMEPOS Competitive Bidding Program, such as lower out-of-pocket expenses and increased quality of products, from suppliers that have completed the detailed selection process that CMS will require under the program. Enforcement of supplier standards and the threat of exclusion from the Medicare program will encourage suppliers to maintain a high level of service. These factors make an extensive outreach approach critical to the program's success. Although we are not proposing at this time any additional education requirements, we are interested in seeking comments on other mechanisms that might be utilized to inform beneficiaries and suppliers about the competitive bidding program. N. Monitoring and Complaint Services for the Competitive Bidding Program [If you choose to comment on issues in this section, please include the caption ``Monitoring and Complaint Services for the Competitive Bidding Program'' at the beginning of your comments.] Moving to a competitive bidding environment will not adversely affect CMS'' program integrity efforts in reviewing claims and rooting out fraud, waste, or abuse. Claims will still be reviewed for medical necessity, coordination of benefits status, and benefits integrity. Any suspected instances of DMEPOS competitive bidding market manipulation and collusion will be referred to the appropriate federal agencies that are responsible for addressing these issues. We are proposing to establish a formal complaint monitoring system to address complaints in each competitive bidding area. Beneficiaries, referral agents, providers, and suppliers, including physicians, hospitals, nurses, and home health agencies, will be able to report problems or difficulties that they encounter regarding the ordering and furnishing of DMEPOS in a competitive bidding area. Some examples of problems that we would consider to be serious include: Contract suppliers refusing to furnish items to beneficiaries in the competitive bidding area for which they were awarded a contract; contract suppliers furnishing items of inferior quality than those that they bid to furnish; or contract suppliers violating assignment and billing requirements. We also propose to monitor Medicare claims data to ensure that competitive bidding does not negatively impact beneficiary access to medically necessary items. Claims data will be monitored to identify trends, spikes or decreases in utilization and changes in utilization patterns within a product category. O. Physician Authorization/Treating Practitioner and Consideration of Clinical Efficiency and Value of Items in Determining Categories for Bids (Proposed Sec. 414.420) [If you choose to comment on issues in this section, please include the caption ``Physician Authorization/Treating Practitioner'' at the beginning of your comments.] Section 1847(a)(5)(A) of the Act provides authorization to the Secretary to establish a process for certain items under which a physician may prescribe a particular brand or mode of delivery of an item within a particular HCPCS code if the physician determines that use of the particular item would avoid an adverse medical outcome on the individual. We are proposing to implement this section in proposed Sec. 414.440, and to also apply it to certain treating practitioners, including physician assistants, nurse practitioners, and clinical nurse specialists, since these practitioners also order DMEPOS for which Medicare makes payment. Since a HCPCS code may contain many brand products made by a wide range of manufacturers, we expect that suppliers will choose to only offer certain brands of products within a HCPCS code. This is a common practice used by suppliers to reduce the amount of inventory they maintain. However, we are proposing that the physician or treating practitioner would be able to determine that a particular item would avoid an adverse medical outcome, and that the physician or treating practitioner would have discretion to specify a particular product brand or mode of delivery. When a physician or other treating practitioner requests a specific item, brand, or mode of delivery, contract suppliers would be required to furnish that item or mode of delivery, assist the beneficiary in finding another contract supplier in the CBA that can provide that item, or consult with the physician or treating practitioner to find a suitable alternative product or mode of delivery for the beneficiary. If, after consulting with the contract supplier, the physician or treating practitioner is willing to revise his or her order, that decision must be reflected in a revised written prescription. However, if the contract supplier decides to provide an item that does not match the written prescription from the physician or treating practitioner, the contract supplier should not bill Medicare as this would be considered a non-covered item. For the Medicare DMEPOS Competitive Bidding Program, we would not require a contract supplier to provide every brand of products included in a HCPCS code. However, regardless of what brands the contract supplier furnishes, the single payment amount for the HCPCS code would apply. This issue will be studied in more detail by the Office of the Inspector General in 2009. At that time, we will evaluate the need for a specific process for certain brand names or modes of delivery. In addition, section 1847(b)(7) of the Act provides authority to establish separate categories for items within HCPCS codes if the clinical efficiency and value of items within a given code warrants a separate category for bidding purposes. Currently, HCPCS codes are developed for items that are similar in function and purpose. For this reason, items within the same code are paid at the same rate. We believe that the HCPCS process has worked well in the past, and we believe that it adequately separates items based on their function. We welcome public comment on this issue. P. Quality Standards and Accreditation for Suppliers of DMEPOS [If you choose to comment on issues in this section, please include the caption ``Quality Standards and Accreditation for Supplies of DMEPOS'' at the beginning of your comments.] Section 1847(b)(2)(A)(i) of the Act specifies that a contract may not be awarded to any entity unless the entity meets applicable quality standards specified by the Secretary under section [[Page 25685]] 1834(a)(20) of the Act. Any supplier seeking to participate in the Medicare DMEPOS Competitive Bidding Program will need to satisfy the quality standards issued under section 1834(a)(20) of the Act. Additionally, section 1834(a)(20) of the Act gives us the authority to establish through program instructions or otherwise quality standards for all suppliers of DMEPOS and other items, including those who do not participate in competitive bidding, and to designate one or more independent accreditation organizations to implement the quality standards. Therefore, to ensure the integrity of suppliers' businesses, products, we are proposing to revise Sec. 424.57 and add a new Sec. 424.58. 1. Special Payment Rules for Items Furnished by DMEPOS Suppliers and Issuance of DMEPOS Supplier Billing Privileges (Sec. 424.57) In accordance with sections 1834(a)(20) and 1834(j)(1)(B)(ii)(IV) of the Act, we propose to amend Sec. 424.57 as discussed in this section of the proposed rule. In paragraph (a), Definitions, we would propose to define the following terms: CMS-approved accreditation organization is an independent accreditation organization selected by CMS to apply the supplier quality standards established by CMS; Accredited DMEPOS supplier means a supplier that has been accredited by an independent accreditation organization meeting the requirements of and approved by CMS in accordance with Sec. 424.58; and Independent accreditation organization means an accreditation organization that accredits a supplier of DMEPOS and other items and services for a specific DMEPOS product category or a full line of DMEPOS product categories. Proposed new paragraph (c)(22) would specify that all suppliers of DMEPOS and other items be accredited by a CMS approved accreditation organization before receiving a supplier billing number. 2. Accreditation (Sec. 424.58) Under section 1834(a)(20) of the Act, we would add a new section Sec. 424.58 to address the requirements for CMS approved accreditation organizations in the application of the quality standards to suppliers of DMEPOS and other items. To promote consistency in accrediting providers and suppliers throughout the Medicare program, we would use existing procedures for the application, reapplication, selection, and oversight of accreditation organizations detailed at Part 488 and apply them to organizations accrediting suppliers of DMEPOS and other items. We would make modifications to the existing requirements for accreditation organizations to meet the specialized needs of the DMEPOS industry. These modifications may require an independent accreditation organization applying for approval or re-approval of deeming authority to-- Identify the product-specific types of DMEPOS suppliers for which the organization is requesting approval or re-approval; Provide CMS with a detailed comparison of the organization's accreditation requirements and standards with the applicable Medicare quality standards (for example, a crosswalk); Provide a detailed description of the organization's survey processes including procedures for performing unannounced surveys, frequency of the surveys performed, copies of the organization's survey forms, guidelines and instructions to surveyors, quality review processes for deficiencies identified with accreditation requirements; Describe the decision-making processes; describe procedures used to notify suppliers of compliance or noncompliance with the accreditation requirements; Describe procedures used to monitor the correction of deficiencies found during the survey; and Describe procedures for coordinating surveys with another accrediting organization if the organization does not accredit all products the supplier provides. We also propose to use the application procedure currently specified in Sec. 488.4(c) through (i) as the application process for DMEPOS accreditation organizations. We may request detailed information about the professional background of the individuals who perform surveys for the accreditation organization including: The size and composition of accreditation survey teams for each type of supplier accredited; the education and experience requirements surveyors must meet; the content and frequency of the continuing education training provided to survey personnel; the evaluation systems used to monitor the performance of individual surveyors and survey teams; and policies and procedures for a surveyor or institutional affiliate of an accrediting organization that participates in a survey or accreditation decision regarding a DMEPOS supplier with which this individual or institution is professionally or financially affiliated. We may request a description of the organization's data management, analysis, and reporting system for its surveys and accreditation decisions, including the kinds of reports, tables, and other displays generated by that system. We may require a description of the organization's procedures for responding to and investigating complaints against accredited facilities including policies and procedures regarding coordination of these activities with appropriate licensing bodies, ombudsmen programs, National Supplier Clearinghouse, and with CMS; a description of the organization's policies and procedures for notifying CMS of facilities that fail to meet the requirements of the accrediting organization; a description of all types, categories, and duration of accreditation decisions offered by the organization; a list of all currently accredited DMEPOS suppliers; a list of the types and categories of accreditation currently held by each supplier; a list of the expiration date of each supplier's current accreditation; and a list of the next survey cycles for all DMEPOS suppliers accreditation surveys scheduled to be performed by the organization. We may require the accreditation organization to submit the following supporting documentation: A written presentation that would demonstrate the organization's ability to furnish CMS with electronic data in ASCII- comparable code; A resource analysis that would demonstrate that the organization's staffing, funding and other resources are sufficient to perform the required surveys and related activities; and An acknowledgement that the organization would permit its surveyors to serve as witnesses if CMS took an adverse action against the DMEPOS supplier based on the accreditation organization's findings. We propose to survey accredited suppliers from time to time to validate the survey process of a DMEPOS accreditation organization (validation survey). These surveys would be conducted on a representative sample basis, or in response to allegations of supplier noncompliance with quality standards. When conducted on a representative sample basis, the survey would be comprehensive and address all Medicare supplier quality standards or would focus on a specific standard. When conducted in response to an allegation, the CMS survey team would survey for any standard that CMS determined was related to the [[Page 25686]] allegations. If the CMS survey team substantiated a deficiency and determined that the supplier was out of compliance with Medicare supplier quality standards, we would revoke the supplier's billing number and re-evaluate the accreditation organization's approved status. A supplier selected for a validation survey would be required to authorize the validation survey to occur and authorize the CMS survey team to monitor the correction of any deficiencies found through the validation survey. If a supplier selected for a validation survey failed to comply with the requirements at Sec. 424.58, it would no longer meet the Medicare supplier quality standards and its supplier billing number would be revoked. 3. Ongoing Responsibilities of CMS Approved Accreditation Organizations A DMEPOS independent accreditation organization approved by CMS would be required to undertake the following activities on an ongoing basis: Provide to CMS in written form and on a monthly basis all of the following: ++ Copies of all accreditation surveys along with any survey- related information that CMS may require (including corrective action plans and summaries of CMS requirements that were not met). ++ Notice of all accreditation decisions. ++ Notice of all complaints related to suppliers of DMEPOS and other items. ++ Information about any suppliers of DMEPOS and other items for which the accrediting organization has denied the supplier's accreditation status. ++ Notice of any proposed changes in its accreditation standards or requirements or survey process. If the organization implemented the changes before or without CMS approval, CMS could withdraw its approval of the accreditation organization. Submit to CMS (within 30 days of a change in CMS requirements): ++ An acknowledgment of CMS's notification of the change; ++ A revised cross-walk reflecting the new requirements; and ++ An explanation of how the accreditation organization would alter its standards to conform to CMS' new requirements, within the time frames specified by CMS in the notification of change it received. Permit its surveyors to serve as witnesses if CMS takes an adverse action based on accreditation findings. Provide CMS with written notice of any deficiencies and adverse actions implemented by the independent accreditation organization against an accredited DMEPOS supplier within 2 days of identifying such deficiencies, if such deficiencies pose immediate jeopardy to a beneficiary or to the general public. Provide written notice of the withdrawal to all accredited suppliers within 10 days of CMS's notice to withdraw approval of the accreditation organization. Provide, on an annual basis, summary data specified by CMS that related to the past year's accreditation activities and trends. 4. Continuing Federal Oversight of Approved Accreditation Organizations This paragraph would establish specific criteria and procedures for continuing oversight and for withdrawing approval of an accreditation organization. a. Equivalency Review We would compare the accreditation organization's standards and its application and enforcement of those standards to the comparable CMS requirements and processes when: CMS imposed new requirements or changed its survey process; an accreditation organization proposed to adopt new standards or changes in its survey process; or the term of an accreditation organization's approval expired. b. Validation Review A CMS survey team would conduct a survey of an accredited organization, examine the results of the accreditation organization's own survey procedure onsite, or observe the accreditation organization's survey, in order to validate the organization's accreditation process. At the conclusion of the review, we would identify any accreditation programs for which validation survey results indicated: A 10 percent rate of disparity between findings by the accreditation organization and findings by CMS on standards that did not constitute immediate jeopardy to patient health and safety if not met; Any disparity between findings by the accreditation organization and findings by CMS on standards that constituted immediate jeopardy to patient health and safety if not met; or There were widespread or systemic problems in the organization's accreditation process such that the accreditation no longer provided assurance that suppliers met or exceeded the Medicare requirements, irrespective of the rate of disparity. c. Notice of Intent To Withdraw Approval for Deeming Authority If an equivalency review, validation review, onsite observation, or our concerns with the ethical conduct of the accreditation organization suggest that the accreditation organization is not meeting the requirements of proposed Sec. 424.58, we would provide the organization written notice of its intent to withdraw approval of the accreditation organization's deeming authority. d. Withdrawal of Approval for Deeming Authority We could withdraw approval of an accreditation organization at any time if we determine that: Accreditation by the organization no longer guaranteed that the suppliers of DMEPOS and other items met the supplier quality standards and the failure to meet those requirements could pose an immediate jeopardy to the health or safety of Medicare beneficiaries or constitute a significant hazard to the public health; or the accreditation organization failed to meet its obligations for application and reapplication procedures. e. Reconsideration An accreditation organization dissatisfied with a determination that its accreditation requirements did not provide or do not continue to provide reasonable assurance that the entities accredited by the accreditation organization met the applicable supplier quality standards would be entitled to a reconsideration. We would reconsider any determination to deny, remove, or not renew the approval of deeming authority to accreditation organizations if the accreditation organization filed a written request for a reconsideration through its authorized officials or through its legal representative. The request would have to be filed within 30 days of the receipt of CMS notice of an adverse determination or nonrenewal. The request for reconsideration would be required to specify the findings or issues with which the accreditation organization disagreed and the reasons for the disagreement. A requestor could withdraw its request for reconsideration at any time before the issuance of a reconsideration determination. In response to a request for reconsideration, we would provide the accrediting organization the opportunity for an informal hearing that would be conducted by a hearing officer appointed by the Administrator of CMS and provide the accrediting organization the opportunity to present, in writing [[Page 25687]] and in person, evidence or documentation to refute the determination to deny approval, or to withdraw or not renew deeming authority. We would provide written notice of the time and place of the informal hearing at least 10 days before the scheduled date. The informal reconsideration hearing would be open to CMS and the organization requesting the reconsideration, including authorized representatives, technical advisors (individuals with knowledge of the facts of the case or presenting interpretation of the facts), and legal counsel. The hearing would be conducted by the hearing officer who would receive testimony and documents related to the proposed action. Testimony and other evidence could be accepted by the hearing officer. However, it would be inadmissible under the usual rules of court procedures. The hearing officer would not have the authority to compel by subpoena the production of witnesses, papers, or other evidence. Within 45 days of the close of the hearing, the hearing officer would present the findings and recommendations to the accrediting organization that requested the reconsideration. The written report of the hearing officer would include separate numbered findings of fact and the legal conclusions of the hearing officer. The hearing officer's decision would be final. Q. Low Vision Aid Exclusion (Proposed Sec. 414.15) [If you choose to comment on issues in this section, please include the caption ``Low vision aid exclusion'' at the beginning of your comments.] We are proposing to clarify that the scope of the eyeglass coverage exclusion encompasses all devices irrespective of their size, form, or technological features that use one or more lens to aid vision or provide magnification of images for impaired vision. This proposed regulatory provision clarifies that the statute does not support the interpretation that the term eyeglasses only applies to lenses supported by frames that pass around the nose and ears. The underlying technology and the function of eyeglasses are to use lenses to assist persons with impaired vision. Dorland's Illustrated Medical Dictionary (28th Ed. 1994) defines ``eyeglass'' simply as a ``lens for aiding sight.'' We interpret the eyeglass exclusion at section 1862(a)(7) of the Act as encompassing all of the various types of devices that use lenses for the correction of vision unless there is a statutory provision that provides for coverage. For example, section 1861(s)(8) of the Act provides for intraocular lenses, conventional eyeglasses and contact lenses after each cataract surgery with insertion of an intraocular lens. We specifically invite public comment on this issue. We note that if the term ``eyeglasses'' as used at section 1862(a)(7) of the Act only refers to the exclusion of payment for lenses supported by frames that pass around the nose and ears, then the eyeglass exclusion would not apply to contact lenses and there would have been no reason for the Congress to make an exception to section 1862(a)(7) of the Act for contact lenses. However, the Congress did make such an exception to section 1862(a)(7) of the Act for conventional contact lenses after cataract surgery. A comparison of sections 1862(a) and 1861(s) of the Act indicate that the eyeglass exclusion also applies to contact lenses except for one pair after cataract surgery. By applying the eyeglass exclusion to contact lenses, the statute reinforces the interpretation that the use of lenses to aid impaired vision is the scope of what is excluded by the eyeglass exclusion and not just lenses supported by frames that pass around the nose and ears. Also, when referring to ``conventional eyeglasses,'' section 1861(s)(8) of the Act is affirming that the term ``eyeglasses'' has a wider application than ``conventional eyeglasses'' and the terms ``conventional eyeglasses'' and ``eyeglasses'' are not synonymous in the statute. This interpretation of the term eyeglasses is consistent with the regulatory language used for the optional benefit in the Medicaid program under Sec. 440.120(d) for eyeglasses, which is ``lenses, including frames, and other aids to vision * * *'' This language gives States that cover eyeglasses the flexibility to adopt a reasonable definition that includes low vision aids that are determined medically necessary. The definition used by the Medicaid program demonstrates that the term eyeglasses can appropriately be defined to include low vision aids. Consistent with this framework, we consider the eyeglass exclusion for the Medicare program to apply to eyepieces, hand-held magnifying glasses, contact lenses and other instruments, such as closed-circuit televisions and video magnifiers that use lenses to aid vision. Although the technology of using lenses to aid low vision may be improved with new innovations, such as contact lenses, progressive lenses and low vision aids, this does not exempt the new technology from the eyeglass exclusion. The adaptation of the vision aid technology does not change the essential nature of the device: A video magnifier is still a device that utilizes a lens to enhance vision. We believe this interpretation is consistent with the decision in Warder v. Shalala, 149 F 3d73 (1st Cir. 1998), in which the United States Court of Appeals for the First Circuit held, in part, that the Secretary's classification of a technologically advanced seating system as DME, and not as an orthotic, was supported by the Medicare statute and regulations. In reaching this conclusion, the court stated that the Secretary could conclude that the seating system met the definition of DME, which ``unequivocally includes `wheelchairs', '' since the system served the same (as well as additional) functions as a wheelchair. We believe this case affirms the principle that the Secretary has the discretion to interpret the statute and to assign a product to a particular Medicare category even when this will result in non-coverage determinations by Medicare. R. Establishing Payment Amounts for New DMEPOS Items (Gap-Filling) (Proposed Sec. 414.210(g)) [If you choose to comment on issues in this section, please include the caption ``Gap-filling'' at the beginning of your comments.] There is no process set forth in the statute or regulations for calculating fee schedule amounts for new DMEPOS items (that is, new HCPCS codes representing categories of items for which there is no historic Medicare pricing information). Since 1989, CMS and its contractors have used a process referred to as ``gap filling'' to establish fee schedule amounts for items for which fee schedule base data is not available. In the past, the gap-filling process was described in the Medicare Carriers Manual. The process is now contained in the Medicare Claims Processing Manual and provides that fee schedule amounts are to be gap-filled using fee schedule amounts already established for comparable items; properly calculated fee schedule amounts from a neighboring carrier; or supplier price lists with prices in effect during the database year. If the only available price information is from a period other than the fee schedule base period (for example, 1992 for surgical dressings), a deflation factor is applied to the price in order to approximate the base year price for gap-filling purposes. The deflation factors are based on the percentage change in [[Page 25688]] the CPI-U from the mid-point of the fee schedule base period (for example, June 1992 for surgical dressings) to the mid-point (that is, June) of the calendar year that the gap-filling source price is in effect. When gap-filling base fees for capped rental items, it is necessary to first gap-fill the purchase fee and then compute the rental fee based on 10 percent of the gap-filled purchase fee. For used equipment, base fees are gap-filled using 75 percent of the gap-filled fee for new equipment. The process of gap-filling essentially estimates what the average reasonable charges would be for an item if it was paid for under Medicare during the fee schedule base period. The gap-filled base fees are updated by the covered item updates and are subject to regional fees, and ceiling and floor limitations, if applicable. We have consistently used the gap-filling process as the method for replicating historical charge data. However, this method can lead to very high or very low fee schedule amounts without validation that these amounts are realistic and equitable relative to the cost of furnishing the item. Since the gap-filling process began in 1989, most base fees have been gap-filled using either supplier price lists or manufacturers' suggested retail prices. Many manufacturers are aware of the process and realize that if a unique HCPCS code is added for their device, they can establish inflated suggested retail prices that would be used to establish the Medicare fee schedule payment amounts. We also view the continued use of deflation factors to replicate historic prices or charges to be an imperfect method of establishing base fee schedule amounts. Under the Medicare DMEPOS benefits, there is an inherent responsibility to pay enough for beneficial new technologies to ensure beneficiary access to care, while also being a prudent payer. To increase the Medicare program's ability to ensure fair treatment across technologies, we have focused on developing strategies that recognize those technologies that provide a demonstrated clinical benefit and clearly identify the additional benefits over existing technologies. This initiative has been endorsed by the Council on Technology and Innovation (CTI), which was established under section 942 of the MMA to coordinate the activities of coverage, coding, and payment processes affecting new technologies and procedures and to coordinate the exchange of information on new technologies between CMS and other entities that make similar decisions. We procured two contractors to conduct a pilot study on the benefits, effectiveness, and costs of several products. These projects were very successful in compiling the technical information that is necessary to evaluate technologies for the purpose of making payment and HCPCS coding decisions for new items. The products studied were assessed in terms of three main areas as follows: Functional Assessment--This step involved evaluating the device's operations, safety, and user documentation relative to the Medicare population. Interviews were conducted with health care providers to determine how and under what circumstances they would prescribe the product for a Medicare beneficiary. Price Comparison Analysis--A comparative cost analysis determined how the cost of this product compared to similar products on the market or alternative treatment modalities. Medical Benefit Assessment--This step focused on the effectiveness of the product in doing what it claims to do. Scientific literature reviews and interviews with health care providers were conducted to determine if the product significantly improved clinical outcomes compared to other products and treatment modalities. Competitive bidding will allow market forces to determine the price Medicare pays for certain DMEPOS items. In order to ensure that only quality products are provided to our beneficiaries, we are proposing to use the three types of assessments described above to assist us in ensuring that the HCPCS codes for DMEPOS items reflect current technology and functional differences in items and that new products are included within the appropriate HCPCS code. The functional technology assessment will allow us to compare older, similar products already on the market and newer more expensive products. The functional assessment and medical benefit assessment of devices will greatly aid our decision-making process regarding the need to create unique HCPCS code categories. The price comparison analysis of devices will help us determine if manufacturers' suggested retail prices are overly inflated, will provide a basis for establishing adequate payment amounts for new items, and will assist in establishing payment amounts for new items that are introduced after a bidding cycle has begun. Sections 1834(a), (h), (i) and 1833(o) of the Act require the establishment of fee schedule amounts to pay for DME, prosthetic devices, orthotics, prosthetics, surgical dressings, and therapeutic shoes. In addition, payment for PEN is also based on fee schedule amounts authorized by section 1842(s) of the Act. The fee schedule amounts are based on average payments made under the previous reasonable charge payment methodology as mandated by the statute. When a new HCPCS code is created for a category of items, the gap-filling process outlined in this section is used to establish the fee schedule amounts for the new code. We are proposing that this gap-filling process be revised as follows: We would continue to make every effort to utilize existing fee schedule amounts or historic Medicare payment amounts, if applicable, in establishing payment amounts for new HCPCS codes. In addition, the method of using payment amounts for comparable items would be retained under the revised process for establishing payment amounts for new HCPCS codes. We would discontinue the practice of deflating supplier prices and manufacturers suggested retail prices to the fee schedule base period. When fee schedule amounts are established based on pricing information, prices in effect at the time that the fee schedule amounts are established would be used. For subsequent years, the fee schedule amounts established using supplier or manufacturer pricing information would be updated as required by the statute as it is applicable to each category of items. In the past, when retail pricing information is not available, wholesale prices plus an appropriate mark-up are used to establish the fee schedule amounts. We would use the functional technology assessment process, in part or in whole, as another method for establishing payment amounts for new items. Based on the results of the technology assessment, the fee schedule amounts would be established using fee schedule amounts for items determined to be comparable to the new item or an amount determined to be appropriate for the new item based on the cost comparison analysis. We can use the technology assessment process at any time to adjust prices on or after January 1, 2007 that were previously established using the gap-filling methodology if it is determined that those pricing methods resulted in payment amounts that do not reflect the cost of furnishing the item. Fee schedule amounts established using this process would be updated as required by the statute as it is applicable to each category of items. In those cases where the addition of the HCPCS code for a new item occurs in the middle of a bidding cycle and a Medicare pricing history or profile does not exist for the item or is not applicable [[Page 25689]] for the new code category, we propose that the revised gap-filling process for establishing fee schedule payment amounts for new DMEPOS items would also be used in establishing payment amounts for new items until they are added to a product category subject to competitive bidding. Any qualified Medicare supplier will be allowed to supply one of these items until the next bidding cycle. The next bidding cycle will set a new single payment amounts for this item. We propose that other revisions to HCPCS codes for items under a competitive bidding program that occur in the middle of a bidding cycle will be handled as follows: If a single HCPCS code for an item is divided into multiple codes for the components of that item, the sum of payments for these new codes will not be higher than the payment for the original item. Suppliers selected through competitive bidding to provide the item will also provide the components of the item. During the subsequent competitive bidding cycle, suppliers will bid on each new code for the components of the item, and we will determine new single payment amounts for these components. If a single HCPCS code for two or more similar items is divided into two or more separate codes, the payment amount applied to these codes will continue to be the same payment amount applied to the single code until the next competitive bidding cycle. During the next cycle, suppliers will bid on the new separate and distinct codes. If the HCPCS codes for several components of one item are merged into one new code for the single item, the payment amount of the new code will be equal to the total of the separate payment amounts for the components. Suppliers that were selected through competitive bidding to supply the various components of the item will continue to supply the item using the new code. During the subsequent bidding cycle, suppliers will bid on the new code for the single item to determine a new single payment amount for this new code. If multiple codes for different, but related or similar items are placed into a single code, the payment amount for the new single code will be the average (arithmetic mean) weighted by frequency of payments for the formerly separate codes. Suppliers providing the items originally will also provide the item under the new single code. During the subsequent bidding cycle, suppliers will bid on the new single code and determine a new single payment amounts for this code. S. Fee Schedules for Home Dialysis Supplies and Equipment (Proposed Sec. 414.107) [If you choose to comment on issues in this section, please include the caption ``Fee Schedules for Home Dialysis Supplies and Equipment'' at the beginning of your comments.] Section 1842(s) of the Act provides authority for implementing statewide or other area wide fee schedules to be used for payment of home dialysis supplies and equipment. Section 1842(s)(1) of the Act provides that the fee schedules are to be updated on an annual basis by the percentage increase in the CPI-U (United States city average) for the 12-month period ending with June of the preceding year. Section 4315(d) of the BBA requires that the fee schedules that are established using this authority are set initially so that total payments under the fee schedules are approximately equal to the estimated total payments that would be made under the reasonable charge payment methodology. On July 27, 1999, we published a proposed rule, Replacement of Reasonable Charge Methodology by Fee Schedules (64 FR 40534), to establish fee schedules for these items. Fee schedules were established for PEN items and services in 2002 following the publication of the final rule, Replacement of Reasonable Charge Methodology by Fee Schedules for Parenteral and Enteral Nutrients, Equipment, and Supplies, on August 28, 2001 (66 FR 45173). However, fee schedule amounts were not established for home dialysis supplies and equipment because the data needed to establish budget neutral fee schedule amounts was not available at the time that final rule was published. We are now proposing to establish fee schedule amounts for home dialysis supplies and equipment because the data needed to establish budget neutral fee schedule amounts are now available. Sections 1832(a)(1) and 1861(s)(2)(F) of the Act establish that home dialysis supplies and equipment are a covered benefit under Part B of the Medicare program. Home dialysis supplies and equipment are defined under section 1881(b)(8) of the Act as ``medically necessary supplies and equipment (including supportive equipment) required by an individual suffering from end stage renal disease in connection with renal dialysis carried out in his home (as defined in regulations), including obtaining, installing, and maintaining such equipment.'' We implemented these provisions in title 42, part 414 subpart E of the regulations. Total monthly payments to a supplier for home dialysis supplies and equipment may not exceed the limit for equipment and supplies established in Sec. 414.330(c)(2). We have determined that total monthly payments for these items per supplier were equal to the monthly limit 79 percent of the time for items furnished from January 1, 2004 through November 30, 2004. This means that suppliers billed up to or in excess of the monthly payment limit in 79 percent of the claims submitted during this 11-month period. We are proposing that nationwide fee schedule amounts be implemented for these items effective January 1, 2007. These amounts would be based on the average allowed charges calculated using data for allowed services furnished from January 1, 2005 through December 31, 2005, increased by the percentage change in the CPI-U for the 24-month period ending June of 2006. We expect that the total payments made under the fee schedule will be approximately equal to the total payments that would be made under the reasonable charge payment methodology because the overall payment limit for equipment and supplies established in Sec. 414.330(c)(2) is not affected by implementation of the fee schedules for these items. By using the average, we do not anticipate a significant impact on utilization of home dialysis, supplies and equipment. Beginning with 2008, the fee schedule amounts for home dialysis supplies and equipment will be updated on an annual basis by the percentage increase in the CPI-U for the 12-month period ending with June of the preceding year under section 1842(s)(1) of the Act. T. Fee Schedules for Therapeutic Shoes (Proposed Sec. 414.228(c)) [If you choose to comment on issues in this section, please include the caption ``Fee Schedules for Therapeutic Shoes'' at the beginning of your comments.] We are proposing to add Sec. 414.228(c) to part 414, subpart D of the regulations to specify that the Medicare fee schedule amounts for therapeutic shoes, inserts, and shoe modifications are established in accordance with the methodology specified in sections 1833(o) and 1834(h) of the Act. III. Collection of Information Requirements Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. In order to fairly evaluate [[Page 25690]] whether an information collection should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues: The need for the information collection and its usefulness in carrying out the proper functions of our agency. The accuracy of our estimate of the information collection burden. The quality, utility, and clarity of the information to be collected. Recommendations to minimize the information collection burden on the affected public, including automated collection techniques. We are soliciting public comment on each of these issues for the following sections of this document that contain information collection requirements. Section 414.412 Submission of Bids Under the Competitive Bidding Program Section 414.412 establishes the requirements for the submission of bids under the competitive bidding process. The burden associated with these requirements is the time and effort necessary to prepare and submit a bid. The burden is estimated to be 70 hours per bid. In the competitive bidding demonstration, suppliers estimated that they spent between 40 and 100 hours to complete the bids. We therefore use the median of 70 hours per bid. In connection with the competitive bidding programs that we are proposing to begin implementing in 2006, we assume that 90 percent of suppliers of potentially eligible products in the designated competitive bidding areas will submit bids resulting in 16,545 bids. Therefore, we estimate it would take 1,158,150 total annual hours to complete the bids in 2006. In later years, as additional CBAs are added, the number of bids will increase as will the estimated total annual number of hours to complete the bids. By 2008, if 90 percent of suppliers of eligible products in the bidding CBAs submit bids there will be 72,865 bids. We estimate that the annual hours to complete the bids will rise to 5,100,550 total annual hours in connection with the competitive bidding round that we expect to occur in 2008, which will involve 70 of the largest MSAs. However, the number of hours necessary to complete the bids may fall over time as suppliers become more familiar with the forms and the competitive bidding process. The number of hours may also be lower if additional suppliers do not submit bids. As a result, it is possible that the above figures overestimate the number of hours required to fill out the bidding forms. The cost associated with the requirements pertaining to the accreditation program are not included as part of the cost or burden for the competitive bidding program. If you comment on these information collection and recordkeeping requirements, please mail copies directly to the following: Centers for Medicare & Medicaid Services, Office of Strategic Operations and Regulatory Affairs, Regulations Development and Issuances Group, Attn: William Parham, Room C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850; and Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503, Attn: Carolyn Lovett, CMS Desk Officer, [email protected]. Fax (202) 395-6974. IV. Response to Comments Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document. V. Regulatory Impact Analysis [If you choose to comment on issues in this section, please include the caption ``Regulatory Impact Analysis'' at the beginning of your comments.] A. Overall Impact We have examined the impacts of this rule as required by Executive Order 12866 (September 1993, Regulatory Planning and Review), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132. Executive Order 12866 (as amended by Executive Order 13258, which merely reassigns responsibility of duties) directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects (that is, a final rule that would have an annual effect on the economy of $100 million or more in any 1 year, or would adversely affect in a material way the economy, a sector or the economy, productivity, competition, jobs, the environment, public health or safety, or communities). Since this rule is considered to be a major rule because it is economically significant, we have prepared a regulatory impact analysis. We expect that this rule will have a significant impact on a substantial number of small suppliers. The RFA requires that we analyze regulatory options for small businesses and other entities. The analysis must include a justification concerning the reason action is being taken, the kinds and numbers of small entities the rule affects, and an explanation of any meaningful options that achieve the objectives with less significant adverse economic impact on the small entities. B. Anticipated Affects We can anticipate the probable effects of the regulation, but the actual effects will vary depending on which competitive bidding areas and product categories are ultimately selected for competitive bidding. The analysis which follows, taken together with the rest of this preamble, constitutes both a regulatory impact analysis (RIA) and an initial regulation flexibility analysis (IRFA). Therefore, for the purpose of this impact analysis, because of the uncertainty concerning the actual number of suppliers who will participate, the bid amounts and the specific items and areas for which competitive bidding will be conducted, it is necessary to make several assumptions. First, we assume that the first round of bidding will occur in 2006 with prices taking effect in October, 2007, and the second round of bidding will occur in 2008 with prices taking effect in January, 2009. We also assume rebidding will only occur every three years. Second, we assume that competitive bidding will occur in 10 of the largest MSAs in 2006, excluding New York, Chicago, and Los Angeles. We exclude the three largest MSAs in 2006 because we are proposing not to include them in the initial phase implementation. We are excluding the three largest MSAs because they are significantly larger than any of the areas in which we implemented the competitive bidding demonstrations and we would like to gain more experience in smaller markets before we enter into the largest markets. [[Page 25691]] Competitive bidding will take place in 70 of the largest MSAs in 2008 and an additional 10 competitive bidding areas (CBAs) will be added in both 2009 and 2010 for a total of 100 CBAs. For the initial competition, we assume that bidding will take place in fall 2006, bids will be evaluated in 2007, and prices will go into effect in October 2007. We also assume that the same timeframes will apply when bidding takes place in the initial 10 MSAs in fall 2009. In all other cases, we assume that competitive bidding will take place in the fall and prices will go into effect on January 1 of the following year in the relevant CBAs. Third, we make some assumptions about which product categories would be selected for competitive bidding. We recognize that potential savings, implementation costs, the number of affected suppliers, and supplier bid costs all depend on which product groups are ultimately selected. The product categories have yet to be decided. We estimate that approximately 10 product categories will be selected for competitive bidding for 2006 and as many as 7 or 8 of the selected product categories will be among the 10 largest in terms of allowed charges. The remaining 2 or 3 product categories will come from the top 20 product groups ranked by allowed charges. Table 10 shows the top 20 eligible DMEPOS policy groups and their 2003 allowed charges. Table 10.--2003 Allowed Charges: Top 20 Eligible DME Policy Groups ---------------------------------------------------------------------------------------------------------------- Percent of Rank Policy group 2003 eligible DMEPOS charges ---------------------------------------------------------------------------------------------------------------- 1........................................ Oxygen Supplies/Equipment...... $2,433,713,269 29 2........................................ Wheelchairs/POVs............... 1,926,210,675 23 3........................................ Diabetic Supplies & Equipment.. 1,110,934,736 13 4........................................ Enteral Nutrition.............. 676,122,703 8 5........................................ Hospital Beds/Accessories...... 373,973,207 4 6........................................ CPAP........................... 204,774,837 2 7........................................ Support Surfaces............... 193,659,248 2 8........................................ Infusion Pumps & Related Drugs. 149,208,088 2 9........................................ Respiratory Assist Device...... 133,645,918 2 10....................................... Lower Limb Orthoses*........... 122,813,555 1 11....................................... Nebulizers..................... 98,951,212 1 12....................................... Walkers........................ 96,654,035 1 13....................................... Negative Pressure Wound Therapy 88,530,828 1 14....................................... Commodes/Bed Pans/Urinals...... 51,372,352 1 15....................................... Ventilators.................... 42,890,761 0 16....................................... Spinal Orthoses*............... 40,731,646 0 17....................................... Upper Limb Orthoses*........... 29,069,027 0 18....................................... Patient Lift................... 26,551,310 0 19....................................... Seat Lift Mechanism............ 15,318,552 0 20....................................... TENS........................... 15,258,579 0 Total for 20 Groups........... 7,830,384,538 92 ---------------------------------------------------------------------------------------------------------------- *Excludes Custom Fabricated Items; but does not exclude all items that might require more than minimal self- adjustment or expertise in trimming, bending, molding, assembling, or customizing to fit the individual. However, we reiterate that our selection for the impact analysis should in no way be interpreted as signifying which product categories will be selected for the actual competitive bidding program. Our product category selection for this impact analysis is only to assist us in estimating the potential savings, costs of implementation, and supplier impact. Fourth, we assume that the Medicare DMEPOS fee schedule will increase at the rate of inflation for those years in which a statutory freeze has not been put in place by the MMA, and that total charges will increase at the same rate as Part A and Part B Medicare expenditures. We exclude Part D expenditure growth because this data is not currently available. We base our estimates on the expected growth in Part A and Part B expenditures from the Trustees Reports. (Tables IV.F.2 and IV.F.3 of the 2004 Medicare Trustees Report). This proposed rule is expected to affect Medicare and its beneficiaries, certain CMS contractors including the four current DMERCs, the SADMERC, the NSC, one or more proposed CBICs, and DMEPOS suppliers. Although the work-load of referral agents, including hospital discharge planners and some healthcare providers, appeared to increase during implementation of the demonstration, we do not anticipate that competitive bidding will result in an appreciable, ongoing burden on referral agents. In addition, rural healthcare facilities should not be significantly impacted as the program is expected to operate primarily within relatively large MSAs. The DMEPOS supplier industry is expected to be significantly impacted by this rule when finalized. However, not all suppliers will be affected directly by the competitive bidding program. Only suppliers who furnish products in at least one product category eligible for competitive bidding and in areas selected for competitive bidding could potentially be affected. A customized orthotics supplier in Manhattan that does not supply off-the-shelf orthotics will not be affected. We estimate that approximately 30,000 suppliers offer at least one product eligible for competitive bidding and are located in one of the largest 100 MSAs and could therefore be impacted by the program. Some of these suppliers will be affected in multiple CBAs if they offer products in more than one CBA. Based on our analysis of 2003 claims data, we also estimate that approximately 90 percent of registered DMEPOS suppliers are considered small according to the SBA definition. According to the SBA, ``A small business is a concern that is organized for profit, with a place of business in the United States, and which operates primarily within the United States or makes a significant contribution to the U.S. economy through payment of taxes or use of American products, materials or labor. Further, the concern cannot be dominant in its field, on a national basis. Finally, the concern must meet the numerical small business size [[Page 25692]] standard for its industry. SBA has established a size standard for most industries in the U.S. economy.'' The size standard for NAICS code, 532291, Home Health Equipment Rental is $6 million. (see http://www.sba.gov/size/sizetable2002.html, read May 9, 2005.) Many of these suppliers provide minimal amounts of DMEPOS, and thus the remaining larger suppliers control significant market share. We anticipate that the bidding process will be designed to neither reward nor penalize small suppliers, however the fixed costs required to undergo the bidding process may be a larger deterrent to small businesses than larger firms. We do not expect that the regulation will result in direct costs that exceed $120 million per year, and thus the Unfunded Mandates Reform Act (UMRA) would not apply. Since suppliers can choose whether to submit a bid for the competitive bid program, the regulation imposes no direct costs and therefore does not reach the $120 million direct cost threshold under UMRA. While not included in this regulation, it is expected that the separate MMA requirement for accreditation will result in added supplier costs beyond those included in this regulation. The proposed rule will also impact CMS and its contractors. There are four DMERCs currently contracted by CMS to process claims for the DMEPOS benefit. The Statistical Analysis DME Regional Carrier, (SADMERC), the existing contractor assigned to perform statistical support and the National Supplier Clearinghouse, (NSC), which maintains a registry of approved suppliers, will need to adapt to the competitive bidding environment. Finally, we will need to devote resources necessary for overseeing program operations. C. Implementation Costs We will incur administrative costs in connection with the implementation and operation of competitive bidding, which can affect the net savings that can be expected under the proposed rule. However, many of the variable costs associated with bid solicitation and evaluation will ultimately depend on how many suppliers choose to participate in competitive bidding. Because of this uncertainty, we do not estimate bid solicitation and evaluation costs at this time. We will incur initial start up costs. We estimate the costs to CMS and its contractors will include approximately $1 million in immediate fixed costs for contractor startup and system changes for the initial competitive bidding phase in 2006. In addition to the initial start up costs, we will also incur maintenance costs and bid solicitation and evaluation costs. We will need to pay maintenance costs every year for the running of the program; however, we will only need to pay bid costs in the years in which competitive bidding is conducted. Yearly maintenance costs will depend on the number of CBAs where the program has been implemented, while bid solicitation and evaluation costs will depend on the number of sites which have bidding that year. Our maintenance costs will include a small staff to oversee the program, office costs for the staff, as well as staff travel costs, and overhead. In addition, we propose that the CBIC(s) will be responsible for much of the program maintenance. The maintenance costs could also include the costs for an Ombudsman(s) per DMERC region to assist suppliers, beneficiaries, and referral agents with the competitive bidding process and questions. We also expect to incur costs for education and outreach expenses such as staff resources and material costs for producing education materials and supplier directories. We will incur bid costs in the years in which we conduct competitive bidding and when we evaluate bids. These costs will be a direct result of the bid solicitation and evaluation process. Bid solicitation costs include costs associated with mailing necessary information to beneficiaries, printing, and duplicating. The actual costs will vary by CBA and will depend on the number of potential suppliers. We will incur bid evaluation costs whenever bidding occurs in a CBA. We are proposing that the bid evaluation will be done by the CBIC(s). According to the DMEPOS evaluation report, it took about 9.4 hours to evaluate each bid during the demonstration. However, since the Medicare DMEPOS Competitive Bidding Program entails Quality Standards/ Accreditation as a separate process, we expect that the time required to evaluate bids will be lower than in the demonstration. The total bid evaluation costs will ultimately depend on the number of suppliers that choose to submit bids. D. Program Savings We estimate large savings from the competitive bidding program. Our estimates of gross savings utilize as a starting point the savings results in the demonstration. Excluding surgical dressings that are not eligible for competitive bidding, the average product group savings rate in the demonstration ranged from 9 to 30 percent in a CBA round with most product groups around a 20 percent savings. Table 11 shows the savings rate for selected product groups and CBAs by round during the DMEPOS demonstration. Table 11.--DMEPOS Competitive Bidding Demonstration Savings Rates ---------------------------------------------------------------------------------------------------------------- Polk County Polk County Product group round 1 round 2 San Antonio ---------------------------------------------------------------------------------------------------------------- Oxygen Equipment and Supplies................................... $2,364,811 $1,525,490 $2,096,707 (17%) (20%) (19%) Hospital Beds and Accessories................................... $290,715 $195,140 $644,514 (23%) (31%) (19%) Urological Supplies............................................. $36,169 $12,585 (\1\) (18%) (9%) Surgical Dressings.............................................. -$30,321 -$637 (\1\) (-12%) (-1%) Enteral Nutrition............................................... $342,251 (\1\) (\1\) (17%) Wheelchairs and Accessories..................................... (\1\) (\1\) $796,617 (19%) General Orthotics............................................... (\1\) (\1\) $89,462 (23%) [[Page 25693]] Nebulizer Drugs................................................. (\1\) (\1\) $1,020,072 (26%) ---------------------------------------------------------------------------------------------------------------- Source: Evaluation of Medicare's Competitive Bidding Demonstration for DMEPOS, Final Evaluation Report (November 2003), pages 90 and 92. \1\ Not included. In our estimates, we have taken into account that some DMEPOS prices have been adjusted downward since 2000. We assume that if prices for an individual item have already been reduced by 10 percent after the demonstrations were completed, then prices would most likely fall 10 percent rather than 20 percent. We, therefore, netted out any statutory reductions in prices that had already occurred such as the 2005 reductions in oxygen supplies. Table 12 shows the fee-for-service program impact for the 10 policy groups. In the table, savings are reported as negative values. The savings are attributable to the lower prices anticipated from competitive bidding. The table shows the reduction in Medicare allowed charges, without any impact on Medicare Advantage, associated with the program for the calendar year. The impact includes reductions in Medicare payments (80 percent) and reductions in beneficiary co- insurance (20 percent). Table 12.--Program Impact for 10 Policy Groups in Millions* ---------------------------------------------------------------------------------------------------------------- Year ----------------------------------------------------------------------- 2006 2007 2008 2009 2010 2011 ---------------------------------------------------------------------------------------------------------------- Allowed Charges......................... -$0 -$38 -$120 -$844 -$1000 -$1,199 Medicare share of allowed charges (80% -0 -30 -96 -675 -800 -959 of allowed charges).................... Beneficiary Costs (20% of allowed 0 -8 -24 -169 -200 -240 charges)............................... ---------------------------------------------------------------------------------------------------------------- * Numbers may not add up due to rounding. Table 13 presents the impact differently than Table 12. In contrast to Table 12, which is on a Medicare-allowed-charge-incurred basis and is without considering the Medicare Advantage impact, Table 13 considers fiscal year cash impact on the entire Medicare Program including Medicare Advantage for the fiscal year rather than calendar year. The fiscal year--calendar year distinction is an important one when comparing savings. For example, the prices for the Medicare DMEPOS Competitive Bidding program will be in effect for 0 months of fiscal year 2007, but for 3 months of calendar year 2007.\1\ Table 13 considers the impact on program expenditures, and does not include beneficiary coinsurance. Finally, the estimates in Table 13 incorporate spillover effects from the competitive acquisition program onto the MA program. The expectation is that lower prices for DME products in FFS will lead to lower prices in the MA market.\2\ --------------------------------------------------------------------------- \1\ Fiscal year 2007 will end September 30, 2007, and the Medicare DMEPOS Competitive Bidding Program will begin on October 1, 2007. \2\ In addition, most managed care plan rates are linked to FFS expenditures, so a decrease in FFS expenditures should translate into a decrease in Medicare Advantage plan payment rates. Table 13.--Fiscal Year Cost on the Medicare Program [In millions] ------------------------------------------------------------------------ Year 10 products ------------------------------------------------------------------------ 2006.................................................... $0 2007.................................................... 0 2008.................................................... -110 2009.................................................... -620 2010.................................................... -990 2011.................................................... -1,230 ------------------------------------------------------------------------ E. Effect on Beneficiaries Possible impacts on beneficiaries are a primary concern during the design and implementation of the program. While there may be some decrease in choice of suppliers, there will be a sufficient number of suppliers to ensure adequate access. We also expect there will be an improvement in quality because we will more closely scrutinize the suppliers before, during, and after implementation of the program. The analysis of the impact of the DMEPOS competitive bidding demonstration on patient access to care and quality showed minimal adverse results. Therefore, we assume that there will be no negative impacts on beneficiary access as a sufficient number of quality suppliers will be selected to serve the entire market. We acknowledge that implementation of competitive bidding may result in some beneficiaries needing to switch from their current supplier if their current supplier is not selected for competitive bidding. However, we anticipate that the necessity of switching suppliers will be minimal in many product categories because of the existence of grandfather policies for products such as capped rentals. We assume that beneficiary out of pocket expenses will decrease by 20 percent of program gross savings for those products for which we do competitive bidding. Table 14.--Beneficiary Co-Insurance Savings Estimates for 10 Products [In millions] ------------------------------------------------------------------------ Year 10 products ------------------------------------------------------------------------ 2007.................................................... $8 2008.................................................... 24 2009.................................................... 169 2010.................................................... 200 2011.................................................... 240 ------------------------------------------------------------------------ F. Effect on Suppliers We expect DME suppliers to be significantly impacted by the implementation of the proposed rule. We assume that suppliers may be affected in one of 3 ways as follows: [[Page 25694]] Suppliers that wish to participate in competitive bidding will have to incur the cost of submitting a bid. Noncontract suppliers (including suppliers who do not submit bids) will see a decrease in revenues because they will no longer receive payment from Medicare for competitively bid items. Contract suppliers will see a decrease in expected revenue per item as a result of lower allowed charges from lower bid prices. However, because there will be fewer suppliers, a supplier's volume could increase. As a result, because we do not know which effect will dominate, the net effect on an individual contract supplier's revenue is uncertain prior to bidding. The increase in the supplier's volume could offset the decrease in revenue per item. 1. Affected Suppliers Based on 2003 claims data, the average MSA in the top 25 MSAs, excluding New York, Los Angeles, and Chicago, has 2754 DMEPOS suppliers that furnish any DMEPOS product and 1838 suppliers that furnish products subject to competitive bidding and could potentially be affected by competitive bidding. We estimate that 27,540 suppliers will provide DMEPOS items in the CBAs that we initially designate. If suppliers furnish products in more than one MSA, we counted them more than once because they are affected in more than one MSA. Not all products are subject to competitive bidding; we estimate that only 18,383 suppliers will furnish products subject to competitive bidding and will be affected by competitive bidding. This means in 2006, the remaining 9157 suppliers in the 10 selected MSAs will not be affected by competitive bidding because they do not furnish products subject to competitive bidding. However, the actual number of affected suppliers may be smaller if we do not select all eligible product categories for competitive bidding. Deciding whether or not to submit a bid is a business decision that will be made by each DMEPOS supplier. We expect that most suppliers providing covered services will choose to participate in order to maintain and expand their businesses. For the calculations below, we assume that 90 percent of suppliers will submit a bid. We assume the remaining 10 percent of suppliers will not have received the necessary accreditation to submit a bid. Based on this assumption, 16,545 suppliers will submit a bid because they will want the opportunity to continue to provide these products to Medicare beneficiaries and to expand their business base. We also assume, based on the results of the demonstration, that 50 percent of bidding suppliers will be selected as winners because approximately 50 percent of those who submitted bids during the demonstration were selected as contract suppliers. As a result, we expect that there will be 8272 contract suppliers and 10,111 non contract suppliers in the competitive bidding areas that we initially designate. The 10,111 suppliers that are not awarded a contract, either because they chose not to submit a bid or did not submit a winning bid would represent about 37 percent of the total DMEPOS suppliers in these CBAs. We expect that losing bidders will be distributed roughly proportionately across the selected CBAs, but the exact distribution will depend on the distribution of bids received and the number of winners selected in each CBA. It is important to note that there will be a revenue shift from the non contract suppliers to the contract suppliers, and that although some suppliers may be worse off, it is because they did not offer competitive prices or quality. We also note that if a supplier submitted a bid in multiple product categories, its probability of winning would increase, so that the total number of wining suppliers would be higher, and the number of non contract suppliers would be lower. It is difficult to estimate how much revenue a losing supplier will lose because of the DMEPOS competitive acquisition program. The amount will depend on how much revenue the supplier previously received from Medicare and whether the supplier continues to provide services to existing patients under transition policies. Estimates can be made by making assumptions about these factors. For example, if bidding occurred in 10 product categories, losing suppliers previously provided 50 percent of allowed charges in these product categories, and losing suppliers did not continue to serve any existing patients, then the average lost Medicare allowed charges per losing supplier per CBA would be between $35,000 and $40,000. Under these assumptions, the total allowed charges lost by losing suppliers would be $275 million in 2008, the first full year after the prices take effect, and increase to almost $2 billion in 2011. These estimates reflect our best assumptions. As noted, because of the nature of competitive bidding, winning bidders will absorb much of the allowed charges lost by losing suppliers. Suppliers who submit bids will incur a cost of bidding. In the demonstration, bidders in Polk County, Florida reported spending 40 to 100 hours submitting bids. We therefore assume that suppliers will use the midpoint number of hours, 70 hours, to complete their bids. According to 2003 Bureau of Labor Statistics (BLS) data, the average hourly wage for an accountant and auditor was $24.35. Accounting for inflation and overhead, we assume suppliers will incur $31.25 per hour in wage and overhead costs. Based on this information, we assume that a supplier that bids will spend $2,187.50 ($31.25*70) to prepare its bid. We calculate the total cost for all supplier bids, including those of both future winning and future losing suppliers. Therefore, we expect that 2006 total supplier bidding costs for 16,545 bids will be $36,192,187 ($2187.50*16545). This estimate is clearly dependent on our assumption that all eligible suppliers will bid. In 2008, we will conduct competitive bidding in 80 MSAs, which may include New York, Los Angeles, and Chicago; and in 2009 and 2010 we will add additional areas. This will increase the number of affected suppliers, contract suppliers, and non contract suppliers. For the purposes of the impact analysis, we assume that there will be at least 10 additional large CBAs added in both 2009 and 2010. We also assume bid cycles will be three years in length. Under our assumptions, we will conduct bidding for programs that involve the initial 10 MSAs in 2006 and 2009, for programs that involve 70 additional MSAs in 2008 and 2011, and for programs that involve additional areas in 2009 and 2010. It is interesting to note that the average number of suppliers per CBA decreases over time. This is because smaller CBAs with fewer beneficiaries and lower allowed charges have fewer suppliers. Table 15 summarizes the effect on suppliers for 2006 through 2011. [[Page 25695]] Table 15.--Suppliers Bidding Years: 2006-2011 [10 product categories] -------------------------------------------------------------------------------------------------------------------------------------------------------- Bidding year ----------------------------------------------------------------------------------------------- 2006 2007 2008 2009 2010 2011 -------------------------------------------------------------------------------------------------------------------------------------------------------- Average number of suppliers per CBA..................... 2754 2754 1863 1776 1687 1863 Average number of affected suppliers per CBA............ 1838 1838 1242 1183 1125 1242 Total number of suppliers............................... 27540 27540 149035 159864 168702 149035 Total number of affected suppliers...................... 18383 18383 99344 106439 112471 99344 Number of bidding suppliers............................. 16545 0 72865 22930 5429 72865 Cost of bidding......................................... $36,192,188 $0 $159,392,188 $50,159,375 $11,875,938 $159,392,188 Number of contract suppliers............................ 8272 8272 44705 47898 50612 44705 Number of non contract suppliers........................ 10111 10111 54639 58541 61859 54639 Non contract suppliers as a percent of total suppliers.. 37% 37% 37% 37% 37% 37% -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ Actual numbers will depend on CBAs selected, product groups selected, number of suppliers that choose to submit a bid, the prices bid, and the number of contract suppliers selected. \2\ Some suppliers furnish products in more than one selected CBA. Consequently, some suppliers may be counted more than once. \3\ Numbers in the table are rounded. 2. Small Suppliers We use the Small Business Administration definition of a small supplier. The SBA defines a small supplier in Home Health Equipment (NAICS Code 532291) as having less than $6 million in revenues. We do not have information on each supplier's total revenue. We only have information on suppliers' Medicare revenues. As a result, we had to make an assumption about what percent of a supplier's revenues come from Medicare. We looked at filings by public DMEPOS companies and based on that information, we assume one-half of the average supplier's revenues come from Medicare DEMPOS. We therefore classified a small supplier as any supplier with fewer than $3 million in Medicare allowed charges for all DMEPOS products whether or not they are eligible for competitive bidding. For example, an orthotics supplier's allowed charges could include charges for both customized and off-the-shelf orthotics, but customized orthotics are not subject to competitive bidding. By this definition, the majority of DMEPOS suppliers are small. Table 16 shows our estimate of the number of affected small suppliers and total affected suppliers. Some suppliers are counted more than once if they are affected in more than one CBA. Table 16.--Number of Small Suppliers \1\ [$3 million or less in Medicare allowed charges] ---------------------------------------------------------------------------------------------------------------- Number of Total number Bidding year affected small of affected Percent suppliers suppliers ---------------------------------------------------------------------------------------------------------------- 2006............................................................ 16,741 18,383 91 2007............................................................ 16,741 18,383 91 2008............................................................ 88,912 99,344 90 2009............................................................ 94,969 106,439 89 2010............................................................ 100,083 112,471 89 2011............................................................ 100,083 112,471 89 ---------------------------------------------------------------------------------------------------------------- \1\ Some suppliers furnish products in more than one selected CBA. Consequently, some suppliers may be counted more than once. Small suppliers are likely to have similar costs for submitting bids as large suppliers. As discussed in the previous section, the average cost of submitting a bid in one CBA is $2187.50. The cost of bidding as a share of Medicare revenue will depend on the size of the small supplier's Medicare revenue. The share for a supplier with $50,000 in Medicare revenue would be 4.4 percent; the totals for suppliers with $100,000, $1,000,000, and $3,000,000 would be 2.2 percent, 0.2 percent, and less than 0.01 percent, respectively. We considered the following options for minimizing the burden of competitive bidding on small businesses: Networking: As stated in section L of the preamble we discuss our proposal for allowing suppliers the option to form networks for bidding purposes. Networks are several companies joining together to submit bids for a product category under competitive bidding. This option will allow small suppliers to band together to lower bidding costs, expand service options, or attain more favorable purchasing terms. We recognize that forming a network may be challenging for suppliers, and it also poses challenges for bid evaluation and program monitoring. Not requiring bids for every product category: As discussed previously in the preamble, we are proposing to conduct separate bidding for items grouped together in product categories rather than conduct a single bidding program for all items. Therefore, small suppliers will have the option of deciding how many product categories for which they want to submit bids. We believe this will help minimize the burden on small suppliers. Another option we considered but did not accept would have allowed small suppliers to be exempted from the requirement that a contract supplier must service an entire CBA. This option [[Page 25696]] is also discussed in further detail in the preamble. We also considered the option to allow a small supplier to not submit a bid and then decide after the bidding whether or not they would accept the new competitive bidding single payment amounts. We are not accepting this option because the statue is clear about the requirement that suppliers must have submitted a bid in order to be a contract supplier. We believe that to allow this option would be an inappropriate interpretation of the statute. G. Accounting Statement As required by OMB Circular A-4 (available at http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf), in the following table below, we have prepared an accounting statement showing the classification of the expenditures associated with the provisions of this proposed rule. This table provides our best estimate of the decreased expenditures in Medicare payments under the Medicare DMEPOS Competitive Bidding Program as a result of the changes presented in this proposed rule. All expenditures are classified as transfers to the Federal Government from DMEPOS suppliers. Table 17.--Accounting Statement--Classification of Estimated Expenditures, From FY 2007 to FY 2011 ------------------------------------------------------------------------ Category Transfers ------------------------------------------------------------------------ Annualized Monetized Transfers......... $570.3 (in Millions). From Whom To Whom?..................... To Federal Government From Medicare DMEPOS Suppliers. ------------------------------------------------------------------------ In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget. List of Subjects 42 CFR Part 411 Kidney diseases, Medicare, Reporting and recordkeeping requirements. 42 CFR Part 414 Administrative practice and procedure, Health facilities, Health professions, Kidney diseases, Medicare, Reporting and recordkeeping requirements. 42 CFR Part 424 Emergency medical services, Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements. For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR chapter IV as set forth below: PART 411--EXCLUSIONS FOR MEDICARE AND LIMITATIONS ON MEDICARE PAYMENT 1. The authority for part 411 continues to read as follows: Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh). Subpart A--General Exclusions and Exclusions of Particular Services 2. Section 411.15 is amended by-- A. Revising paragraph (b). B. Adding new paragraph (s). The revision and addition read as follows: Sec. 411.15 Particular services excluded from coverage. * * * * * (b) Low vision aid exclusion. (1) Scope. The scope of the eyeglass exclusion encompasses all devices irrespective of their size, form, or technological features that use one or more lens to aid vision or provide magnification of images for impaired vision. (2) Exceptions. (i) Post-surgical prosthetic lenses customarily used during convalescence for eye surgery in which the lens of the eye was removed (for example, cataract surgery). (ii) Prosthetic intraocular lenses and one pair of conventional eyeglasses or contact lenses furnished subsequent to each cataract surgery with insertion of an intraocular lens. (iii) Prosthetic lenses used by Medicare beneficiaries who are lacking the natural lens of the eye and who were not furnished with an intraocular lens. * * * * * (s) Unless Sec. 414.408(f)(2) of this chapter applies, Medicare does not make payment if an item or service that is included in a competitive bidding program (as described in part 414, subpart F of this chapter) is furnished by a supplier other than a contract supplier (as defined in Sec. 414.402). PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES 3. The authority citation for part 414 continues to read as follows: Authority: Secs. 1102, 1871, and 1881(b)(1) of the Social Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(1)). Subpart A--General Provisions 4. Section 414.1 is amended by adding in numerical order the statutory sections to read as follows: Sec. 414.1 Basis and scope. * * * * * 1842(s)--Fee schedules for parenteral and enteral nutrition (PEN) nutrients, equipment, and supplies and home dialysis supplies and equipment. 1847(a) and (b)--Competitive bidding for certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). * * * * * 4a. The heading for subpart C is revised to read as follows: Subpart C--Fee Schedules for Parenteral and Enteral Nutrition (PEN) Nutrients, Equipment, and Supplies, and Home Dialysis Supplies and Equipment 5. Section 414.100 is revised to read as follows: Sec. 414.100 Purpose. This subpart implements fee schedules for parenteral and enteral nutrition (PEN) items and services and home dialysis supplies and equipment as authorized by section 1842(s) of the Act. 6. Section 414.102 is revised to read as follows: Sec. 414.102 General payment rules. (a) General rule. For PEN items and services specified under paragraph (b) of this section and furnished on or after January 1, 2002, and for home dialysis supplies and equipment specified under paragraph (b) of this section and furnished on or after January 1, 2007, Medicare pays for the items and services on the basis of 80 percent of the lesser of-- (1) The actual charge for the item or service; or (2) The fee schedule amount for the item or service, as determined in accordance with Sec. 414.104 or Sec. 414.107. (b) Payment classification. (1) CMS or the carrier determines fee schedules for PEN nutrients, equipment, and supplies [[Page 25697]] in accordance with Sec. 414.104, and the fee schedules for home dialysis supplies and equipment in accordance with Sec. 414.107. (2) CMS designates the specific items and services in each category through program instructions. (c) Updating the fee schedule amounts. (1) For each calendar year subsequent to CY 2002, the fee schedule amounts of the preceding year for PEN items and services are updated by the percentage increase in the CPI-U for the 12-month period ending with June of the preceding calendar year. (2) For each calendar year subsequent to CY 2007, the fee schedule amounts of the preceding year for home dialysis supplies and equipment are updated by the percentage increase in the CPI-U for the 12-month period ending with June of the preceding calendar year. (d) Establishing payment amounts for new items. (1) The DMERC or local carrier uses the process described in paragraph (d)(3) of this section to establish the fee schedule amounts for the items and services included in a new HCPCS code created for a category of items and services payable under this subpart, but only if reasonable charge data are not available to calculate a fee schedule amount. (2) The fee schedule amounts are updated in accordance with this subpart. (3) CMS calculates the Medicare fee schedule amounts for the items and services described in paragraph (d)(1) of this section taking into account one or more of the following: (i) The median retail price for items and services classified under the new HCPCS code. CMS determines the retail price for an individual item and service based on supplier price lists, manufacturer suggested retail prices, or wholesale prices plus an appropriate mark-up; (ii) Fee schedule amounts for comparable items; or (iii) A functional technology assessment of the items or services classified under the new HCPCS code that takes into account one or more of the following factors: (A) Functional assessment. (B) Price comparison analysis. (C) Medical benefit assessment. (4) A functional technology assessment described in paragraph (d)(2)(iii) of this section is also used to adjust fee schedule amounts calculated under paragraph (d)(2) of this section if CMS determines that these amounts do no reflect the costs of furnishing the item or service. 7. A new Sec. 414.107 is added to read as follows: Sec. 414.107 Home dialysis supplies and equipment. (a) Payment rules. Payment for home dialysis supplies and equipment defined in Sec. 410.52(a)(1) and (a)(2) of this chapter is made in a lump sum for supplies and equipment that are purchased, and on a monthly basis for supplies and equipment that are rented. Total payments per month for supplies and equipment may not exceed the payment limits described in Sec. 414.330(c)(2) of this part. (b) Fee schedule amount. The fee schedule amount for payment of home dialysis supplies and equipment defined in Sec. 410.52(a)(1) and (a)(2) of this chapter and furnished in CY 2007 is the average reasonable charge for the supplies and equipment furnished from January 1, 2005 through December 31, 2005, increased by the percentage change in the CPI-U for the 24-month period ending June 2006. Subpart D--Payment for Durable Medical Equipment and Prosthetic and Orthotic Devices 8. Section 414.210 is amended by adding a new paragraph (g) to read as follows: Sec. 414.210 General payment rules. * * * * * (g) Establishing fee schedule amounts for new items and services. (1) The DMERC or local carrier uses the process described in paragraph (g)(2) of this section to establish the fee schedule amounts for the items and services included in a new HCPCS code created for a category of items and services payable under this subpart, but only if reasonable charge data are not available to calculate a fee schedule amount. (i) The fee schedule amounts are updated in accordance with this subpart. (ii) Items described in Sec. 414.224 are not subject to paragraph (g)(1) of this section. (2) CMS calculates the Medicare fee schedule amounts for the items and services described in paragraph (g)(1) of this section taking into account one or more of the following: (i) The median retail price for items and services classified under the new HCPCS code (CMS determines the retail price for an individual item and service based on supplier price lists, manufacturer suggested retail prices, or wholesale prices plus an appropriate mark-up); (ii) Existing fee schedule amounts for comparable items; or (iii) A functional technology assessment of the items or services classified under the new HCPCS code that takes into account one or more of the following factors: (A) Functional assessment. (B) Price comparison analysis. (C) Medical benefit assessment. (3) A functional technology assessment described in paragraph (g)(2)(iii) of this section is also used to adjust fee schedule amounts calculated under paragraph (g)(2) of this section if CMS determines that these amounts do not reflect the costs of furnishing the item or service. 9. Section 414.228 is amended by adding paragraph (c) to read as follows: Sec. 414.228 Prosthetic and orthotic devices. * * * * * (c) Payment for therapeutic shoes. The payment rules specified in paragraphs (a) and (b) of this section are applicable to custom molded and extra depth shoes, modifications, and inserts (therapeutic shoes) furnished after December 31, 2004. Subpart E--Determination of Reasonable Charges Under the ESRD Program 10. Section 414.330 is amended by revising paragraph (a)(2) introductory text to read as follows: Sec. 414.330 Payment for home dialysis equipment, supplies, and support services. (a) * * * (2) Exception. If the conditions in paragraphs (a)(2)(i) through (a)(2)(iv) of this section are met, Medicare pays for home dialysis equipment and supplies on a fee schedule basis in accordance with Sec. 414.102, but the amount of payment may not exceed the limit for equipment and supplies described in paragraph (c)(2) of this section. * * * * * 11. A new subpart F is added to read as follows: Subpart F--Competitive Bidding for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Sec. 414.400 Purpose. 414.402 Definitions. 414.404 Basis, scope, and applicability. 414.406 Implementation of programs. 414.408 Payment rules. 414.410 Phased-in implementation of competitive bidding programs. 414.412 Submission of bids under a competitive bidding program. 414.414 Conditions for awarding contracts. 414.416 Determination of competitive bidding payment amounts. 414.418 Opportunity for networks. 414.420 Physician or treating practitioner authorization and consideration of clinical efficiency and value of items. 414.422 Terms of contracts. [[Page 25698]] 414.424 Administrative or judicial review. 414.426 Adjustments to competitive bidding payment amounts to reflect changes in the HCPCS. Subpart F--Competitive Bidding for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Sec. 414.400 Purpose. This subpart implements competitive bidding programs for certain DMEPOS items as required by sections 1847(a) and (b) of the Act. Sec. 414.402 Definitions. For purposes of this subpart, the following definitions apply: Bid means an offer to furnish an item for a particular price and time period that includes, where appropriate, any services that are directly related to the furnishing of the item. Competitive bidding area (CBA) means an area established by the Secretary under this subpart. Composite bid means the sum of a supplier's weighted bids for all items within a product category for purposes of allowing a comparison across bidding suppliers. Competitive bidding program means a program established under this subpart. Contract supplier means an entity that is awarded a contract by CMS to furnish items under a competitive bidding program. DMEPOS stands for durable medical equipment, prosthetics, orthotics and supplies. Grandfathered item means any one of the following items for which payment is made on a rental basis prior to the implementation of a competitive bidding program under this subpart: (1) An inexpensive or routinely purchased item described in Sec. 414.220. (2) An item requiring frequent and substantial servicing, as described in Sec. 414.222. (3) Oxygen and oxygen equipment described in Sec. 414.226. (4) A capped rental item described in Sec. 414.229. Grandfathered supplier means a noncontract supplier that furnishes a grandfathered item. Item means one of the following products identified by a HCPCS code, other than class III devices under the Federal Food, Drug and Cosmetic Act and inhalation drugs, and includes the services directly related to the furnishing of that product to the beneficiary: (1) Durable medical equipment (DME), as defined in Sec. 414.202 of this part and further classified into the following categories: (i) Inexpensive or routinely purchased items, as specified in Sec. 414.220(a). (ii) Items requiring frequent and substantial servicing, as specified in Sec. 414.222(a). (iii) Oxygen and oxygen equipment, as specified in Sec. 414.226(b). (iv) Other durable medical equipment (capped rental items), as specified in Sec. 414.229. (2) Supplies necessary for the effective use of DME. (3) Enteral nutrients, equipment, and supplies. (4) Off-the-shelf orthotics, which are orthotics described in section 1861(s)(9) of the Act that require minimal self-adjustment for appropriate use and do not require expertise in trimming, bending, molding, assembling, or customizing to fit a beneficiary. Item weight is a number assigned to an item based on its beneficiary utilization rate in a competitive bidding area when compared to other items in the same product category. Metropolitan Statistical Area (MSA) has the same meaning as that given by the Office of Management and Budget. Nationwide competitive bidding area means a competitive bidding area that includes the United States and its territories. Noncontract supplier means a supplier that is located in a competitive bidding area or that furnishes items through the mail to beneficiaries in a competitive bidding area but that is not awarded a contract by CMS to furnish items included in a competitive bidding program for that area. Physician has the same meaning as in section 1861(r)(1) of the Act. Pivotal bid means the highest composite bid based on bids submitted by a suppliers for a product category that will include a sufficient number of suppliers to meet beneficiary demand for the items in that product category. Product category means a grouping of related items that are included in a competitive bidding program. Single payment amount means the allowed payment for an item furnished under a competitive bidding program. Supplier means an entity with a valid Medicare supplier number, including an entity that furnishes an item through the mail. Treating practitioner means a physician assistant, nurse practitioner, or clinical nurse specialist, as those terms are defined in section 1861(aa)(5) of the Act. Weighted bid means the item weight multiplied by the bid price submitted for that item. Sec. 414.404 Basis, scope, and applicability. This subpart applies to the following entities that furnish the items described in Sec. 414.402 to beneficiaries under a competitive bidding program: (a) Suppliers. (b) Providers that furnish items under Medicare Part B as suppliers. (c) Physicians that furnish items under Medicare Part B as suppliers. Sec. 414.406 Implementation of programs. (a) Implementation contractor. CMS designates one or more implementation contractors for the purpose of implementing this subpart. (b) Competitive bidding areas. CMS designates through program instructions each competitive bidding area in which a competitive bidding program may be implemented under this subpart. (c) Revisions to competitive bid. CMS may revise the competitive bidding areas designated under paragraph (b) of this section. (d) Competitively bid items. CMS designates the items that are included in a competitive bidding program through program instructions. (e) Claims processing. The regional carrier designated under Sec. 421.210 of this chapter to process DMEPOS claims for a particular geographic region also processes claims for items furnished under a competitive bidding program in the same geographic region. Sec. 414.408 Payment rules. (a) Payment basis. (1) The payment basis for an item furnished under a competitive bidding program is 80 percent of the single payment amount calculated for the item under Sec. 414.416 for the competitive bidding area in which the beneficiary maintains a permanent residence. (2) If an item that is included in a competitive bidding program is furnished to a beneficiary who does not maintain a permanent residence in a competitive bidding area, the payment basis for the item is 80 percent of the lesser of the actual charge for the item, or the applicable fee schedule amount for the item, as determined under subparts C or D of this part. (b) Updating the single payment amounts. Beginning with the second year of a contract entered into under this subpart, the single payment amounts are updated by the percentage increase in the CPI-U for the 12- month period ending with June of the preceding calendar year. (c) Payment on an assignment-related basis. Payment for an item furnished under this subpart is made on an assignment-related basis. (d) Applicability of advanced beneficiary notice. Implementation of a [[Page 25699]] program in accordance with this subpart does not preclude the use of an advanced beneficiary notice. (e) Adjustment of payment amounts in other areas. For items furnished to Medicare beneficiaries on or after January 1, 2009 for which payment is made under this subpart, CMS may use the single payment amounts determined under Sec. 414.416 of this subpart to adjust the amounts Medicare pays for the same items in areas that are not designated as competitive bidding areas. (f) Requirement to obtain competitively bid items from a contract supplier. (1) General rule. All items that are included in a competitive bidding program must be furnished by a contract supplier for that program. (2) Exceptions. (i) A grandfathered supplier may furnish a grandfathered item to a beneficiary in accordance with paragraph (k) of this section. (ii) If a beneficiary is outside of the competitive bidding area in which he or she maintains a permanent residence, he or she may obtain an item included in the competitive bidding program for that area from a-- (A) Contract supplier, if the beneficiary is in another competitive bidding area and the item is included in the competitive bidding program for that area; or (B) Supplier, if the beneficiary is not in another competitive bidding area. (iii) Unless paragraph (f)(2) of this section applies, a beneficiary who maintains a permanent residence in a competitive bidding area has no financial liability to a supplier that furnishes an item included in the competitive bidding program for that area in violation of paragraph (f)(1) of this section. (3) CMS separately designates the supplier numbers of all noncontract suppliers to monitor compliance with paragraph (f)(1) of this section. (g) Purchased equipment. (1) The single payment amounts for new purchased durable medical equipment, including power wheelchairs that are purchased when the equipment is initially furnished, and enteral nutrition equipment, if included under a competitive bidding program, are calculated based on the bids submitted and accepted for these items. (2) Payment for used purchased durable medical equipment and enteral nutrition equipment, if included under a competitive bidding program, is made in an amount equal to 75 percent of the single payment amounts calculated for new purchased equipment under paragraph (g)(1) of this section. (h) Purchased supplies and orthotics. The single payment amounts for the following purchased items, if included under a competitive bidding program, are calculated based on the bids submitted and accepted for the following items: (1) Supplies used in conjunction with durable medical equipment. (2) Enteral nutrients. (3) Enteral nutrition supplies. (4) Orthotics. (i) Rented equipment. (1) Payment for capped rental durable medical equipment, if included under a competitive bidding program, is made in an amount equal to 10 percent of the single payment amounts calculated for new durable medical equipment under paragraph (g)(1) of this section for each of the first 3 months, and 7.5 percent of the single payment amounts calculated for these items for each of the remaining months 4 through 13. (2) Separate maintenance and servicing payments will not be made for any rented equipment. Payment for maintenance and servicing of rented equipment is included in the single payment amount for rental of the item. (3) Payment for enteral nutrition equipment, if included under a competitive bidding program, is made in an amount equal to 10 percent of the single payment amounts calculated for new enteral nutrition equipment under paragraph (g)(1) of this section for each of the first 3 months, and 7.5 percent of the single payment amount calculated for these items under paragraph (g)(1) of this section for each of the remaining months 4 through 15. The contract supplier to which payment is made in month 15 for furnishing enteral nutrition equipment on a rental basis must continue to furnish, maintain and service the equipment until a determination is made by the beneficiary's physician or treating practitioner that the equipment is no longer medically necessary. (4) Payment for the maintenance and servicing of rented enteral nutrition equipment, if included under a competitive bidding program, is made in an amount equal to 5 percent of the single payment amounts calculated for these items under paragraph (g)(1) of this section. (5) Payment for inexpensive or routinely purchased durable medical equipment furnished on a rental basis, if included under a competitive bidding program, is made in an amount equal to 10 percent of the single payment amount calculated for new purchased equipment. (6) The single payment amounts for rented durable medical equipment requiring frequent and substantial servicing, if included under a competitive bidding program, are calculated based on the bids submitted and accepted for these items. (j) Monthly payment amounts for oxygen and oxygen equipment. The single payment amounts for oxygen and oxygen equipment, if included under a competitive bidding program, are calculated based on the separate bids submitted and accepted for the furnishing on a monthly basis of each of the four categories of oxygen and oxygen equipment described in Sec. 414.226(b)(1)(i) through (b)(1)(iv). (k) Special rules for certain rented durable medical equipment and oxygen and oxygen equipment. (1) Supplier election. (i) A supplier that is furnishing DME on a rental basis or is furnishing oxygen and oxygen equipment on a monthly basis to a beneficiary prior to the implementation of a competitive bidding program in the area where the beneficiary maintains a permanent residence may elect to continue furnishing the item as a grandfathered supplier. (ii) A supplier that elects to be a grandfathered supplier must continue to furnish a grandfathered item to all beneficiaries who elect to continue receiving the grandfathered item from that supplier. (2) Payment for grandfathered items furnished during the first competitive bidding program implemented in an area. Medicare pays for grandfathered items furnished during the first competitive bidding program implemented in an area as follows: (i) For items described in Sec. 414.220, payment is made in the amount determined under Sec. 414.220(b). (ii) For items that meet the definition of a capped rental item in Sec. 414.229, payment is made in the amount determined under Sec. 414.229(b). (iii) For items described in Sec. 414.222, payment is made in the amount determined under Sec. 414.416. (iv) For items described in Sec. 414.226, payment is made in the amount determined under Sec. 414.416. (3) Payment for grandfathered items furnished during all subsequent competitive bidding programs in an area. Beginning with the second competitive bidding program implemented in an area, payment is made for grandfathered items in the amounts determined under Sec. 414.416. (4) Choice of suppliers. (i) Beneficiaries described in paragraph (k)(1) of this section may elect to obtain a grandfathered item from a grandfathered supplier. (ii) A beneficiary who is otherwise entitled to obtain an item from a grandfathered supplier under paragraph [[Page 25700]] (k) of this section may elect to obtain the same item from a contract supplier at any time after a competitive bidding program is implemented. (iii) If a beneficiary elects to obtain the item from a contract supplier, payment is made for the item in the amount determined under Sec. 414.416. Sec. 414.410 Phased-in implementation of competitive bidding programs. (a) Phase-in of MSA for CY 2007, CY 2009, and subsequent calendar years. CMS phases in competitive bidding programs so that competition under the programs occurs in-- (1) Ten of the largest MSAs in CY 2007; (2) Eighty of the largest MSAs in CY 2009; (3) Additional areas after CY 2009. (b) Selection of MSAs for CY 2007 and CY 2009. CMS selects the MSAs for purposes of designating competitive bidding areas in CY 2007 and CY 2009 by considering the following variables: (1) The total population of an MSA. (2) The Medicare allowed charges for DMEPOS items per fee-for- service (FFS) beneficiary in an MSA. (3) The total number of DMEPOS suppliers per FFS beneficiary that received DMEPOS items in an MSA. (4) An MSA's geographic location. (c) Exclusions from a competitive bidding area. CMS may exclude from a competitive bidding area a rural area (as defined in Sec. 412.64(b)(1)(ii)(C) of this chapter), or an area with low population density based on the following factors-- (1) Low utilization of DMEPOS items by Medicare FFS beneficiaries relative to similar geographic areas; (2) Low number of DMEPOS suppliers relative to similar geographic areas; or (3) Low number of Medicare FFS beneficiaries relative to similar geographic areas. (d) Selection of additional areas after CY 2009. (1) Beginning in CY 2010, CMS designates additional competitive bidding areas based on CMS' determination that the implementation of a competitive bidding program in an area is likely to result in significant savings to the Medicare program. (2) CMS may designate one or more regional or nationwide competitive bidding areas for purposes of implementing competitive bidding programs for items that are furnished through the mail. Sec. 414.412 Submission of bids under a competitive bidding program. (a) In order for a supplier to receive payment for items furnished to beneficiaries under a competitive bidding program, the supplier must submit a bid to furnish those items and be awarded a contract under this subpart. (b) Bids are submitted for items grouped into product categories. (c) Product categories include items that are used to treat a related medical condition. The list of product categories, and the items included in each product category that is included in a particular competitive bidding program, are identified in the request for bids for that competitive bidding program. (d) Suppliers must submit a separate bid for every item included in each product category that they are seeking to furnish under a competitive bidding program. (e) A bid must include all costs related to furnishing an item, including all services directly related to the furnishing of the item. (f) Mail order suppliers. (1) Suppliers that furnish items through the mail must submit a bid to furnish these items in any area in which a competitive bidding program is implemented which includes the items. (2) Suppliers that submit one or more bids under paragraph (f)(1) of this section may submit the same bid amount for each item under each competitive bidding program for which it submits a bid. (g) Applicability of the mail order program. Suppliers that do not furnish items through the mail are not required to participate in a national or regional mail order competitive bidding program that includes the same items. Suppliers may continue to furnish these items in-- (1) A competitive bidding area, if the supplier is awarded a contract under this subpart; or (2) An area not designated as a competitive bidding area. Sec. 414.414 Conditions for awarding contracts. (a) General rule. The rules set forth in this section govern the evaluation and selection of suppliers for contract award purposes under a competitive bidding program. (b) Basic supplier eligibility. (1) Each bidding supplier must meet the enrollment standards specified in Sec. 424.57 of this chapter. (2) Each bidding supplier must-- (i) Certify in its bid that it, its high level employees, chief corporate officers, members of its board of directors, its affiliated companies, and its subcontractors are not now and was not sanctioned by any governmental agency or accreditation or licensing organization, or (ii) Disclose information about any prior or current legal actions, sanctions, or debarments by any Federal, State or local program, including actions against any members of the board of directors, chief corporate officers, high-level employees, affiliated companies, and subcontractors. (3) Each bidding supplier must submit with its bid evidence of all State and local licenses required to perform the services identified in its response to the request for bids. (4) Each bidding supplier must agree to all the terms contained in the request for bids and the supplier contract. (c) Quality standards and accreditation. (1) Quality standards. All bidding suppliers must meet applicable quality standards developed by CMS in accordance with section 1834(a)(20) of the Act. (2) Accreditation. (i) All bidding suppliers must be accredited by a CMS approved accreditation organization, as defined under Sec. 424.57(a) of this chapter. (ii) A supplier satisfies paragraph (c)(2)(i) of this section if it was accredited by an organization that CMS designates as a CMS-approved accreditation organization under Sec. 424.58 of this chapter. (d) Financial standards. All suppliers must meet the applicable financial standards specified in the request for bids. (e) Evaluation of bids. CMS evaluates bids submitted for a product category by-- (1) Calculating the expected beneficiary demand in a competitive bidding area for items in a product category; (2) Establishing a composite bid for each supplier that submitted a bid for the product category; (3) Arraying the composite bids from the lowest to the highest; (4) Calculating the pivotal bid for the product category; and (5) Selecting all bidding suppliers whose composite bids are less than or equal to the pivotal bid for that product category, and that meet the requirements in paragraphs (b) through (d) of this section. (f) Expected savings. CMS does not award a contract under this subpart unless CMS determines that the amounts to be paid to a contract supplier for an item under a competitive bidding program are expected to be less than the amounts that would otherwise be paid for the same item under subparts C or D of this part. (g) Sufficient number of suppliers. If the requirements in paragraphs (e)(5) and (f) of this section are satisfied by two or more suppliers for a product category under a competitive bidding [[Page 25701]] program, then CMS awards at least two contracts for the furnishing of that product category under a competitive bidding program. (h) Selection of new suppliers after bidding. (1) Subsequent to the awarding of contracts under this subpart, CMS may award additional contracts if it determines that additional contract suppliers are needed to meet beneficiary demand for items under a competitive bidding program. CMS selects additional contract suppliers by-- (i) Referring to the arrayed list of suppliers that submitted bids for the product category included in the competitive bidding program for which beneficiary demand is not being met; and (ii) Beginning with the supplier whose composite bid is the first composite bid above the pivotal bid for that product category, determining if that supplier is willing to become a contract supplier under the same terms and conditions that apply to other contract suppliers in the competitive bidding area. (2) Before CMS awards additional contracts under paragraph (h)(1) of this section, a supplier must submit updated eligibility information, and CMS must determine that the supplier continues to meet the requirements under paragraphs (b) through (d) of this section. Sec. 414.416 Determination of competitive bidding payment amounts. (a) General rule. CMS establishes a single payment amount for each item furnished under a competitive bidding program. (b) Methodology for setting payment amount. (1) The single payment amount for an item furnished under a competitive bidding program is equal to the median of the accepted bids for that item that are at or below the pivotal bid for the product category that includes the item. (2) The single payment amount for an item must be less than the amount that would otherwise be paid for the same item under subparts C or D of this part. (c) Rebate. (1) A contract supplier that submitted a bid for an item in an amount that is below the single payment amount calculated by CMS for that item may elect to issue a rebate. (2) A contract supplier that elects to offer a rebate under paragraph (c)(1) of this section must agree to issue the same rebate to all beneficiaries to whom it furnishes an item to which a rebate applies. (3) A contract supplier's election to offer a rebate will be included as an express term in the contract supplier's contract to furnish items under this subpart. (4) The rebate election cannot be amended or otherwise modified during the term of the contract. (5) A contract supplier may not advertise that it issues a rebate for any item furnished under this subpart. Sec. 414.418 Opportunity for networks. (a) For purposes of this section, a network is comprised of at least two suppliers that collectively submit a single bid to furnish the items included in a product category under a competitive bidding program. (b) The following rules apply to networks that seek contracts under this subpart: (1) Each network must form a single legal entity that acts as the bidder and submits the bid. Any agreement entered into for purposes of forming a network must be submitted to CMS. (2) Each member of the network must be independently eligible to bid. If CMS determines that a member of the network is ineligible to bid, CMS notifies the network, and the network has 10 business days to resubmit its bid. (3) Each network member must meet all accreditation and quality standards that are required. Each member is responsible for the quality of care, service, and items that it furnishes to Medicare beneficiaries. If any network member does not comply with this requirement, CMS may terminate its contract with the network. (4) The network cannot be anticompetitive. The network members' market shares for a product category, when added together, cannot exceed 20 percent of the Medicare market within a competitive bidding area. (5) A supplier may only join one network and cannot submit individual bids if part of a network. The network must identify itself as a network and identify all of its members. (6) The network must designate a primary contract supplier among its members. The primary contract supplier bills and receives payment on behalf of the network members. The primary contract supplier is responsible for appropriately distributing reimbursement to other network members. Sec. 414.420 Physician or treating practitioner authorization and consideration of clinical efficiency and value of items. (a) A physician or treating practitioner may prescribe in writing a particular brand of an item for which payment is made under a competitive bidding program, or a particular mode of delivery for an item, if he or she determines that the particular brand or mode of delivery would avoid an adverse medical outcome for the beneficiary. (b)(1) The contract supplier must make a reasonable effort to furnish the particular brand or mode of delivery of an item as prescribed by the physician or treating practitioner. (2) A contract supplier that, despite making a reasonable effort under paragraph (b)(1) of this section, cannot furnish an item as prescribed under paragraph (a) of this section, must consult with the physician or treating practitioner to find an appropriate item, or mode of delivery, for the beneficiary. (3) Any change to a prescription made in accordance with paragraph (b)(2) of this section must be memorialized in a revised written prescription. (c) Medicare does not make an additional payment to a contract supplier that furnishes a particular item or provides a particular mode of delivery for an item, as directed by a prescription written by the beneficiary's physician or treating practitioner. (d) A contract supplier is prohibited from billing Medicare if it furnishes an item different from that specified in the written prescription received from the beneficiary's physician or treating practitioner. Sec. 414.422 Terms of contracts. (a) A contract supplier must comply with all terms of its contract, including any option exercised by CMS, for the full duration of the contract period. (b) Recompeting competitive bidding contracts. CMS recompetes competitive bidding contracts at least once every 3 years. (c) Repair and replacement of patient owned equipment. (1) Beneficiary owned items furnished under a competitive bidding program must be serviced by a contract supplier for that competitive bidding program, and a contract supplier must agree to service all items included in its contract and furnished to any beneficiary who maintains a permanent residence in that contract supplier's competitive bidding area. (2) Paragraph (c)(1) of this section does not apply if the beneficiary is outside the competitive bidding area. (d) Change of ownership. (1) A contract supplier must notify CMS in writing 60 days prior to any change of ownership, mergers or acquisitions. (2) CMS may award a contract to an entity that merges with, or acquires, a contract supplier if-- (i) CMS determines that awarding a contract to the successor entity is necessary to ensure that beneficiary [[Page 25702]] demand for the items furnished by the contract supplier continues to be met; (ii) The successor entity meets all requirements applicable to contract suppliers for the applicable competitive bidding program; (iii) The successor entity agrees to assume all obligations and liabilities borne by the prior contract supplier under the contract; (iv) The successor entity executes a novation agreement. (e) Furnishing of items. (1) A contract supplier must agree to furnish items under a competitive bidding program to any beneficiary who maintains a permanent residence in, or who visits, the competitive bidding area and who requests those items from that contract supplier. (2) Exceptions. (i) A skilled nursing facility defined under section 1819(a) of the Act that is also a contract supplier must agree to furnish items under a competitive bidding program to patients to whom it would otherwise furnish Part B services. (ii) A physician that is also a contract supplier must agree to furnish items under the competitive bidding program to his or her patients. (f) Breach of contract. (1) Any deviation from contract requirements, including a failure to comply with governmental agency or licensing organization requirements, constitutes a breach of contract. (2) In the event a contract supplier breaches the contract, CMS may take one or more of the following actions: (i) Require the contract supplier to correct the breach condition; (ii) Suspend performance under the contract; (iii) Terminate the contract for default (which may include requiring the contract supplier to reimburse CMS' reprocurement costs); (iv) Preclude the contract supplier from participating in the competitive bidding program; (v) Revoke the supplier number of the contract supplier; or (vi) Avail itself of other remedies allowed by law. (g) CMS has the right to terminate performance under the contract in whole or in part when termination would be in CMS' interest. Sec. 414.424 Administrative or judicial review. (a) There is no administrative or judicial review under this subpart of the following: (1) Establishment of payment amounts. (2) Awarding of contracts. (3) Designation of competitive bidding areas. (4) Phase-in of the competitive bidding programs. (5) Selection of items for competitive bidding. (6) Bidding structure and number of contract suppliers selected for a competitive bidding program. (b) A denied claim is not appealable if CMS determines that a competitively bid item was furnished in a competitive bidding area in a manner not authorized by this subpart. Sec. 414.426 Adjustments to competitively bid payment amounts to reflect changes in the HCPCS. If a HCPCS code for a competitively bid item is revised during a competitive bidding program, CMS adjusts the single payment amount for that item as follows: (a) If a single HCPCS code for an item is divided into multiple codes for the components of that item, the sum of single payment amounts for the new codes equals the single payment amount for the original item, and contract suppliers must furnish the components of the item in accordance with the new codes. (b) If a single HCPCS code for two or more similar items is divided into two or more separate codes, the single payment amount applied to these codes is the same single payment amount applied to the single code, and contract suppliers must furnish the items in accordance with the new codes. (c) If the HCPCS codes for components of an item are merged into a single code for the item, the single payment amount for the new code is equal to the total of the separate single payment amounts for the components, and contract suppliers must furnish the item in accordance with the new code. (d) If multiple codes for similar items are merged into a single code, the single payment amount for the new single code is the average (arithmetic mean) weighted by the frequency of payments for the formerly separate codes, and contract suppliers must furnish the item under the new single code. PART 424--CONDITIONS FOR MEDICARE PAYMENT 12. The authority citation for part 424 continues to read as follows: Authority: Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh). Subpart A--General Provisions 13. Section 424.1 is amended by adding in numerical order the statutory sections to read as follows: Sec. 424.1 Basis and scope. * * * * * 1834(a)--Payment for durable medical equipment. 1834(j)--Requirements for suppliers of medical equipment and supplies. * * * * * Subpart D--To Whom Payment is Ordinarily Made 14. Section 424.57 is amended by-- A. Adding the definitions ``Accredited DMEPOS supplier,'' ``CMS approved accreditation organization'' and ``Independent accreditation organization'' in alphabetical order in paragraph (a). B. Adding a new paragraph (c)(22). The additions read as follows: Sec. 424.57 Special payment rules for items furnished by DMEPOS suppliers and issuance of DMEPOS supplier billing privileges. (a) Definitions. * * * * * * * * Accredited DMEPOS supplier means a supplier that has been accredited by a recognized independent accreditation organization meeting the requirements of and approved by CMS in accordance with Sec. 424.58. CMS approved accreditation organization means a recognized independent accreditation organization approved by CMS under Sec. 424.58. * * * * * Independent accreditation organization means an accreditation organization that accredits a supplier of DMEPOS and other items and services for a specific DMEPOS product category or a full line of DMEPOS product categories. * * * * * (c) Application certification standards. * * * (22) All suppliers of DMEPOS and other items and services must be accredited by a CMS approved accreditation organization before receiving a supplier billing number. * * * * * 15. A new Sec. 424.58 is added to read as follows: Sec. 424.58 Accreditation. (a) Scope and purpose. This part implements section 1834(a)(20)(B) of the Act, which requires the Secretary to designate and approve one or more independent accreditation organizations for purposes of enforcing the quality standards for suppliers of DMEPOS and other items of service. Section 1847(b)(2)(A)(i) of the Act requires a DMEPOS supplier to meet the quality standards under section 1834(a)(20) of [[Page 25703]] the Act before being awarded a contract under part 414, subpart F of this chapter. (b) Application and reapplication procedures for accreditation organizations. (1) An independent accreditation organization applying for approval or reapproval of authority to survey suppliers for compliance with Medicare DMEPOS supplier quality standards is required to furnish the following to CMS: (i) A list of the product-specific types of DMEPOS suppliers for which the organization is requesting approval. (ii) A detailed comparison of the organization's accreditation requirements and standards with the applicable Medicare quality standards, such as a crosswalk. (iii) A detailed description of the organization's survey process, including procedures for performing unannounced surveys, frequency of the surveys performed, copies of the organization's survey forms, guidelines and instructions to surveyors, accreditation survey review process and the accreditation status decision-making process. (iv) Procedures used to notify suppliers of compliance or noncompliance with the accreditation requirements. (v) Procedures used to monitor the correction of deficiencies found during an accreditation survey. (vi) Procedures for coordinating surveys with another accrediting organization if the organization does not accredit all products the supplier provides. (vii) Detailed professional information about the individuals who perform surveys for the accreditation organization, including the size and composition of accreditation survey teams for each type of supplier accredited, and the education and experience requirements surveyors must meet. The information must include the following: (A) The content and frequency of the continuing education training provided to survey personnel. (B) The evaluation systems used to monitor the performance of individual surveyors and survey teams. (C) Policies and procedures for a surveyor or institutional affiliate of the independent accrediting organization that participates in a survey or accreditation decision regarding a DMEPOS supplier with which that individual or institution is professionally or financially affiliated. (viii) A description of the organization's data management, analysis and reporting system for its surveys and accreditation decisions, including the kinds of reports, tables, and other displays generated by that system. (ix) Procedures for responding to, and investigating complaints against, accredited facilities, including policies and procedures regarding coordination of these activities with appropriate licensing bodies, ombudsmen programs, the National Supplier Clearinghouse, and CMS. (x) The organization's policies and procedures for notifying CMS of facilities that fail to meet the accreditation organization's requirements. (xi) A description of all types, categories, and durations of accreditations offered by the organization. (xii) A list of the following: (A) All currently accredited DMEPOS suppliers. (B) The types and categories of accreditation currently held by each supplier. (C) The expiration date of each supplier's current accreditation. (D) The upcoming survey cycles for all DMEPOS suppliers' accreditation surveys scheduled to be performed by the organization. (xiii) A written presentation that demonstrates the organization's ability to furnish CMS with electronic data in ASCII comparable code. (xiv) A resource analysis that demonstrates that the organization's staffing, funding and other resources are adequate to perform fully the required surveys and related activities. (xv) An agreement that makes surveyors available as witnesses if CMS takes an adverse action based on accreditation findings. (2) Validation survey. CMS surveys suppliers of DMEPOS and other items and services accredited under this section on a representative sample basis, or in response to substantial allegations of noncompliance, in order to validate the accreditation organization's survey process. When conducted-- (i) On a representative sample basis, the CMS survey may be comprehensive or focus on a specific standard; (ii) In response to a substantial allegation, CMS surveys for any standard that CMS determines is related to the allegations. (3) Discovery of a deficiency. If CMS discovers a deficiency and determines that the DMEPOS supplier is out of compliance with Medicare supplier quality standards, CMS may revoke the suppliers' billing number or require the accreditation organization to perform a subsequent full accreditation survey at the accreditation organization's expense. (4) A supplier selected for a validation survey. A supplier selected for a validation survey must authorize the-- (i) Validation survey to take place; and (ii) CMS survey team to monitor the correction of any deficiencies found through the validation survey. (5) Refusal to cooperate with survey. If a supplier selected for a validation survey fails to comply with the requirements specified at paragraph (b)(4) of this section, it is deemed to no longer meet the Medicare supplier quality standards and may have its supplier billing number revoked. (6) Validation survey findings. If a validation survey results in a finding that the supplier is out of compliance with one or more Medicare supplier quality standards, the supplier no longer meets the Medicare standards and may have its supplier billing number revoked. (c) Ongoing responsibilities of a CMS approved accreditation organization. An accreditation organization approved by CMS must undertake the following activities on an ongoing basis: (1) Provide to CMS all of the following in written format and on a monthly basis all of the following: (i) Copies of all accreditation surveys, together with any survey- related information that CMS may require (including corrective action plans and summaries of unmet CMS requirements). (ii) Notice of all accreditation decisions. (iii) Notice of all complaints related to suppliers of DMEPOS and other items and services. (iv) Information about any suppliers of DMEPOS and other items and services against which the CMS approved accreditation organization has taken remedial or adverse action, including revocation, withdrawal, or revision of the supplier's accreditation. (v) Notice of any proposed changes in its accreditation standards or requirements or survey process. If the organization implements the changes before or without CMS' approval, CMS may withdraw its approval of the accreditation organization. (2) Within 30 days of a change in CMS requirements, submit to CMS: (i) An acknowledgment of CMS' notification of the change. (ii) A revised cross-walk reflecting the new requirements. (iii) An explanation of how the accreditation organization plans to alter its standards to conform to CMS's new requirements, within the timeframes [[Page 25704]] specified in the notification of change it receives from CMS. (3) Permit its surveyors to serve as witnesses if CMS takes an adverse action based on accreditation findings. (4) Within 2 calendar days of identifying a deficiency of an accredited DMEPOS supplier that poses immediate jeopardy to a beneficiary or to the general public, provide CMS with written notice of the deficiency and any adverse action implemented by the accreditation organization. (5) Within 10 days after CMS's notice to a CMS approved accreditation organization that CMS intends to withdraw approval of the accreditation organization, provide written notice of the withdrawal to all the CMS approved accreditation organization's accredited suppliers. (6) Provide, on an annual basis, summary data specified by CMS that relate to the past year's accreditation activities and trends. (d) Continuing Federal oversight of approved accreditation organizations. This paragraph establishes specific criteria and procedures for continuing oversight and for withdrawing approval of a CMS approved accreditation organization. (1) Equivalency review. CMS compares the accreditation organization's standards and its application and enforcement of those standards to the comparable CMS requirements and processes when-- (i) CMS imposes new requirements or changes its survey process; (ii) An accreditation organization proposes to adopt new standards or changes in its survey process; or (iii) The term of an accreditation organization's approval expires. (2) Validation survey. CMS or its designated survey team may conduct a survey of an accredited DMEPOS supplier, examine the results of a CMS approved accreditation organization's survey of a supplier, or observe a CMS approved accreditation organization's onsite survey of a DMEPOS supplier, in order to validate the CMS approved accreditation organization's accreditation process. At the conclusion of the review, CMS identifies any accreditation programs for which validation survey results indicate-- (i) A 10 percent rate of disparity between findings by the accreditation organization and findings by CMS or its designated survey team on standards that do not constitute immediate jeopardy to patient health and safety if unmet; (ii) Any disparity between findings by the accreditation organization and findings by CMS on standards that constitute immediate jeopardy to patient health and safety if unmet; or (iii) That, irrespective of the rate of disparity, there are widespread or systemic problems in an organization's accreditation process such that accreditation by that accreditation organization no longer provides CMS with adequate assurance that suppliers meet or exceed the Medicare requirements. (3) Notice of intent to withdraw approval. CMS provides the organization written notice of its intent to withdraw approval if an equivalency review, validation review, onsite observation, or CMS's daily experience with the accreditation organization suggests that the accreditation organization is not meeting the requirements of this section. (4) Withdrawal of approval. CMS may withdraw its approval of an accreditation organization at any time if CMS determines that-- (i) Accreditation by the organization no longer guarantees that the suppliers of DMEPOS and other items and services are meeting the supplier quality standards, and that failure to meet those requirements could jeopardize the health or safety of Medicare beneficiaries and could constitute a significant hazard to the public health; or (ii) The accreditation organization has failed to meet its obligations with respect to application or reapplication procedures. (e) Reconsideration. (1) An accreditation organization dissatisfied with a determination that its accreditation requirements do not provide or do not continue to provide reasonable assurance that the entities accredited by the accreditation organization meet the applicable supplier quality standards is entitled to a reconsideration. CMS reconsiders any determination to deny, remove, or not renew the approval of deeming authority to accreditation organizations if the accreditation organization files a written request for reconsideration by its authorized officials or through its legal representative. (2) The request must be filed within 30 days of the receipt of CMS notice of an adverse determination or non renewal. (3) The request for reconsideration must specify the findings or issues with which the accreditation organization disagrees and the reasons for the disagreement. (4) A requestor may withdraw its request for reconsideration at any time before the issuance of a reconsideration determination. (5) In response to a request for reconsideration, CMS provides the accreditation organization the opportunity for an informal hearing to be conducted by a hearing officer appointed by the Administrator of CMS and provide the accreditation organization the opportunity to present, in writing and in person, evidence or documentation to refute the determination to deny approval, or to withdraw or not renew deeming authority. (6) CMS provides written notice of the time and place of the informal hearing at least 10 days before the scheduled date. (7) The informal reconsideration hearing is open to CMS and the organization requesting the reconsideration, including authorized representatives; technical advisors (individuals with knowledge of the facts of the case or presenting interpretation of the facts); and legal counsel. (i) The hearing is conducted by the hearing officer who receives testimony and documents related to the proposed action. (ii) Testimony and other evidence may be accepted by the hearing officer even though it is inadmissible under the rules of court procedures. (iii) The hearing officer does not have the authority to compel by subpoena the production of witnesses, papers, or other evidence. (8) Within 45 days of the close of the hearing, the hearing officer presents the findings and recommendations to the accreditation organization that requested the reconsideration. (9) The written report of the hearing officer includes separate numbered findings of fact and the legal conclusions of the hearing officer. The hearing officer's decision is final. (Catalog of Federal Domestic Assistance Program No. 93.778, Medical Assistance Program; Catalog of Federal Domestic Assistance Program No. 93.773, Medicare--Hospital Insurance; and Program No. 93.774, Medicare--Supplementary Medical Insurance Program) Dated: August 15, 2005. Mark B. McClellan, Administrator, Centers for Medicare & Medicaid Services. Approved: April 3, 2006. Michael O. Leavitt, Secretary. [FR Doc. 06-3982 Filed 4-24-06; 4:00 pm] BILLING CODE 4120-01-P
usgpo
2024-10-08T14:08:36.030274
{ "license": "Public Domain", "url": "https://www.govinfo.gov/content/pkg/FR-2006-05-01/html/06-3982.htm" }