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Code · REGISTER · 2007-02-08 · Environmental Protection Agency (EPA) · Notices

Notices. Notice

12,741 words·~58 min read·/register/2007/02/08/07-567·

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

BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY [FRL-8277-1] Science Advisory Board Staff Office; Notification of Two Public Teleconferences of the Science Advisory Board Committee on Valuing the Protection of Ecological Systems and Services AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The EPA Science Advisory Board
(SAB)Staff Office announces two public teleconferences of the SAB Committee on Valuing the Protection of Ecological Systems and Services (C-VPESS) to discuss components of a draft report related to valuing the protection of ecological systems and services. DATES: The SAB will conduct two public teleconferences on April 3, 2007 and April 10, 2007. Each teleconference will begin at 12:30 p.m. and end at 2:30 p.m. (eastern standard time). *Location:* Telephone conference call only. FOR FURTHER INFORMATION CONTACT: Any member of the public wishing to obtain general information concerning this public teleconference may contact Dr. Angela Nugent, Designated Federal Officer (DFO), *via telephone at:*
(202)343-9981 *or e-mail at: nugent.angela@epa.gov.* General information concerning the EPA Science Advisory Board can be found on the EPA Web Site at: *http://www.epa.gov/sab.* SUPPLEMENTARY INFORMATION: The SAB was established by 42 U.S.C. 4365 to provide independent scientific and technical advice, consultation, and recommendations to the EPA Administrator on the technical basis for Agency positions and regulations. The SAB is a Federal advisory committee chartered under the Federal Advisory Committee Act (FACA), as amended, 5 U.S.C., App. The SAB will comply with the provisions of FACA and all appropriate SAB Staff Office procedural policies. *Background:* Background on the SAB C-VPESS and its charge was provided in 68 FR 11082 (March 7, 2003). The two new teleconferences replace teleconferences previously announced in 71 FR 78202-78203 (December 28, 2006) for February 5, 2007 and February 13, 2007. The purpose of the teleconferences is for the SAB C-VPESS to discuss components of a draft advisory report calling for expanded and integrated approach for valuing the protection of ecological systems and services. The Committee will discuss draft assessments of methods for ecological valuation and application of those methods for valuing the protection of ecological systems and services. These activities are related to the Committee's overall charge: to assess Agency needs and the state of the art and science of valuing protection of ecological systems and services and to identify key areas for improving knowledge, methodologies, practice, and research. *Availability of Meeting Materials:* Agendas and materials in support of the teleconferences will be placed on the SAB Web Site at: *http://www.epa.gov/sab/* in advance of each teleconference. *Procedures for Providing Public Input:* Interested members of the public may submit relevant written or oral information for the SAB to consider during the public teleconference and/or meeting. *Oral Statements:* In general, individuals or groups requesting an oral presentation at a public SAB teleconference will be limited to three minutes per speaker, with no more than a total of one-half hour for all speakers. To be placed on the public speaker list, interested parties should contact Dr. Angela Nugent, DFO, in writing (preferably via e-mail) 5 business days in advance of each teleconference. *Written Statements:* Written statements should be received in the SAB Staff Office 5 business days in advance of each teleconference above so that the information may be made available to the SAB for their consideration prior to each teleconference. Written statements should be supplied to the DFO in the following formats: One hard copy with original signature, and one electronic copy via e-mail (acceptable file format: Adobe Acrobat PDF, WordPerfect, MS Word, MS PowerPoint, or Rich Text files in IBM-PC/Windows 98/2000/XP format). *Accessibility:* For information on access or services for individuals with disabilities, please contact Dr. Angela Nugent at
(202)343-9981 or *nugent.angela@epa.gov.* To request accommodation of a disability, please contact Dr. Nugent preferably at least ten days prior to the teleconference, to give EPA as much time as possible to process your request. Dated: February 1, 2007. Anthony Maciorowski, Deputy Director, EPA Science Advisory Board Staff Office. [FR Doc. E7-2113 Filed 2-7-07; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY [FRL-8276-9] Science Advisory Board Staff Office; Notification of a Public Meeting of the Science Advisory Board Hypoxia Advisory Panel AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The EPA's Science Advisory Board
(SAB)Staff Office is announcing a public meeting of the SAB Hypoxia Advisory Panel to discuss the science concerning the hypoxic zone in the Gulf of Mexico. DATES: The meeting will be held from February 28-March 2, 2007. ADDRESSES: The meeting will be held at the SAB Conference Center located at 1025 F Street, NW., Washington, DC 20004. FOR FURTHER INFORMATION CONTACT: Any member of the public wishing further information regarding the public meeting may contact Dr. Holly Stallworth, Designated Federal Officer (DFO), U.S. EPA Science Advisory Board Staff Office by telephone/voice mail at
(202)343-9867, or via e-mail at *stallworth.holly@epa.gov.* The SAB mailing address is: U.S. EPA, Science Advisory Board (1400F), 1200 Pennsylvania Avenue, NW., Washington, DC 20460. General information about the SAB, as well as any updates concerning the meeting announced in this notice, may be found in the SAB Web site at: *http://www.epa.gov/sab.* SUPPLEMENTARY INFORMATION: Pursuant to the Federal Advisory Committee Act, Public Law 92-463, notice is hereby given that the SAB Hypoxia Advisory Panel will hold a public meeting to develop a report that details advances in the state-of-the science regarding hypoxia in the Northern Gulf of Mexico. The SAB was established by 42 U.S.C. 4365 to provide independent scientific and technical advice to the Administrator on the technical basis for Agency positions and regulations. The SAB is a Federal Advisory Committee chartered under the Federal Advisory Committee Act (FACA), as amended, 5 U.S.C., App. The SAB will comply with the provisions of FACA and all appropriate SAB Staff Office procedural policies. *Background:* EPA participates with other Federal agencies, states and tribes in the Mississippi River/Gulf of Mexico Watershed Nutrient Task Force. In 2001, the Task Force released the Action Plan for Reducing, Mitigating and Controlling Hypoxia in the Northern Gulf of Mexico (or Action Plan available at *http://www.epa.gov/msbasin/taskforce/actionplan.htm* ). The Action Plan was informed by the science described in An Integrated Assessment of Hypoxia in the Northern Gulf of Mexico (or Integrated Assessment available at *http://www.noaa.gov/products/hypox_finalfront.pdf* ) developed by the National Science and Technology Council, Committee on Environment and Natural Resources. Six technical reports provided the scientific foundation for the Integrated Assessment and are available at *http://www.nos.noaa.gov/products/pub_hypox.html* . The aforementioned documents provide a comprehensive summary of the state-of-the-science for the Gulf of Mexico hypoxic zone through about the year 2000. EPA's Office of Water has requested that the SAB develop a report that evaluates the state-of-the-science regarding the causes and extent of hypoxia in the Gulf of Mexico, as well as the scientific basis of possible management options in the Mississippi River Basin. In response to EPA's request, the SAB Staff Office formed the SAB Hypoxia Advisory Panel. Background on the Panel formation process was provided in a **Federal Register** notice published on February 17, 2006 (71 FR 8578-8580). The SAB Hypoxia Advisory Panel met on September 6-7, 2006 (noticed in 71 FR 45543-45544) and again on December 6-8, 2006 (noticed in 71 FR 66329-66330). Teleconferences of the full Hypoxia Advisory Panel and its three subgroups have also been published in **Federal Register** notices (71 FR 55786-55787, 71 FR 59107 and 71 FR 77743-77744). Information about the SAB Hypoxia Advisory Panel is available on the SAB Web site at: *http://www.epa.gov/sab.* *Availability of Meeting Materials:* Materials in support of this meeting will be placed on the SAB Web site *http://www.epa.gov/sab/* in advance of the meeting. *Procedures for Providing Public Input:* Interested members of the public may submit relevant written or oral information for the SAB to consider during the advisory process. *Oral Statements:* In general, individuals or groups requesting an oral presentation at a public meeting will be limited to five minutes per speaker, with no more than a total of one hour for all speakers. Interested parties should contact Dr. Stallworth, DFO, at the contact information noted above, no later than February 20, 2007, to be placed on the public speaker list for the February 28-March 2, 2007 meeting. *Written Statements:* Written statements should be received in the SAB Staff Office no later than February 20, 2007 so that the information may be made available to the SAB for their consideration prior to this meeting. Written statements should be supplied to the DFO in the following formats: One hard copy with original signature, and one electronic copy via e-mail to *stallworth.holly@epa.gov* (acceptable file format: Adobe Acrobat PDF, WordPerfect, MS Word, MS PowerPoint, or Rich Text files in IBM-PC/Windows 98/2000/XP format). *Meeting Access:* For information on access or services for individuals with disabilities, please contact Dr. Stallworth at
(202)343-9867 or *stallworth.holly@epa.gov.* To request accommodation of a disability, please contact Dr. Stallworth, preferably at least 10 days prior to the meeting to give EPA as much time as possible to process your request. Dated: February 1, 2007. Anthony F. Maciorowski, Deputy Director, EPA Science Advisory Board Staff Office. [FR Doc. E7-2116 Filed 2-7-07; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY [Docket ID Number EPA-HQ-OECA-2007-0026; FRL-8277-2] Clean Water Act Class II: Proposed Administrative Settlement, Penalty Assessment and Opportunity To Comment Regarding VersaCold Corporation AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: EPA has entered into a consent agreement with VersaCold Corporation (“VersaCold” or “Respondent”) to resolve violations of the Clean Water Act (“CWA”) and its implementing regulations. The Administrator is hereby providing public notice of this Consent Agreement and proposed Final Order, and providing an opportunity for interested persons to comment on this Consent Agreement, in accordance with CWA section 311(b)(6)(C). DATES: Comments are due on or before March 12, 2007. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/courier. Follow the detailed instructions as provided in Section I.B of the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Beth Cavalier, Special Litigation and Projects Division (2248-A), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone
(202)564-3271; fax:
(202)564-0010; e-mail: *cavalier.beth@epa.gov.* SUPPLEMENTARY INFORMATION: I. General Information A. How Can I Get Copies of This Document and Other Related Information? 1. *Docket.* EPA has established an official public docket for this action under Docket ID No. EPA-HQ-OECA-2007-0026. The official public docket consists of the Consent Agreement, proposed Final Order, and any public comments received. Although a part of the official docket, the public docket does not include Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Enforcement and Compliance Docket Information Center (ECDIC) in the EPA Docket Center, (EPA/DC) EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is
(202)566-1744, and the telephone number for the ECDIC is
(202)566-1752. A reasonable fee may be charged by EPA for copying docket materials. 2. *Electronic Access.* You may access this **Federal Register** document electronically through the EPA Internet under the **“Federal Register”** listings at *http://www.epa.gov/fedrgstr/.* An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at *http://www.epa.gov/edocket/* to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the appropriate docket identification number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Section I.A.1. For public commentors, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the Docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the Docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff. B. How and To Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket identification number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments. 1. *Electronically.* If you submit an electronic comment as prescribed below, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD-ROM you submit, and in any cover letter accompanying the disk or CD-ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. *EPA Dockets.* Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at *http://www.epa.gov/edocket* , and follow the online instructions for submitting comments. Once in the system, select “search,” and then key in Docket ID No. EPA-HQ-OECA-2007-0026. The system is an “anonymous access” system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your comment. ii. *E-mail.* Comments may be sent by electronic mail (e-mail) to *docket.oeca@epa.gov* , Attention Docket ID No. EPA-HQ-OECA-2007-0026. In contrast to EPA's electronic public docket, EPA's e-mail system is not an “anonymous access” system. If you send an e-mail comment directly to the Docket without going through EPA's electronic public docket, EPA's e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA's e-mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. *Disk or CD-ROM.* You may submit comments on a disk or CD-ROM that you mail to the mailing address identified in Section I.A.1. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. *By Mail.* Send your comments to: Enforcement and Compliance Docket Information Center, Environmental Protection Agency, Mailcode: 2201T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, Attention Docket ID No. EPA-HQ-OECA-2007-0026. 3. *By Hand Delivery or Courier.* Deliver your comments to the address provided in Section I.A.1., Attention Docket ID No. EPA-HQ-OECA-2007-0026. Such deliveries are only accepted during the Docket's normal hours of operation as identified in Section I.A.1. C. How Should I Submit CBI To the Agency? Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e-mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI (if you submit CBI on disk or CD-ROM, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD-ROM, mark the outside of the disk or CD-ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified in the FOR FURTHER INFORMATION CONTACT section. II. Background VersaCold Corporation (“Respondent”) is a refrigerated warehouse company, located at 2115 Commissioner Street, Vancouver, British Columbia, V5L 1AG, and is incorporated in Vancouver, British Columbia, Canada. Respondent owns and/or operates facilities in the United States. VersaCold disclosed, pursuant to the EPA “Incentives for Self-Policing: Discovery, Disclosure, Correction and Prevention of Violations” (“Audit Policy”), 65 FR 19618 (April 11, 2000), violations of the Clean Water Act (“CWA”) and its implementing regulations. Specifically, VersaCold (“Respondent”) disclosed that it failed to prepare and implement a Spill Prevention, Control and Countermeasure
(SPCC)plan for its two facilities located in Darien, Wisconsin and Lynden, Washington and, in addition, failed to install adequate secondary containment at its Lynden, Washington facility in violation of CWA section 311(j), 33 U.S.C. 1321, and 40 CFR Part 112. EPA, as authorized by CWA section 311(b)(6), 33 U.S.C. 1321(b)(6), has assessed a civil penalty for these violations. Respondent further disclosed that it had failed to comply with:
(1)CWA section 301(a), 33 U.S.C. 1311(a), and the implementing regulations found at 40 CFR 122.26 when it failed to prepare and implement a stormwater pollution prevention plan at its Darien, Wisconsin facility;
(2)CWA section 301(a), 33 U.S.C. 1311(a), and the implementing regulations found at 40 CFR 122.26 when it failed to obtain a permit for discharging non-contact cooling water to a surface water, or submit a Notice of Intent to discharge, at its Darien, Wisconsin facility; and
(3)CWA section 301(a), 33 U.S.C. 1311(a), and the implementing regulations found at 40 CFR 122.26(g)(1)(ii) when it failed to submit a No Exposure Certification at its Lynden, Washington facility. EPA, as authorized by CWA section 309(b), 33 U.S.C. 1319, has assessed a civil penalty for these violations. EPA determined that Respondent met the criteria set out in the Audit Policy for a 100% waiver of the gravity component of the penalty for the CWA. EPA waived the gravity based penalty of $139,000 and proposed a settlement penalty amount of $6,431. This is the amount of the economic benefit gained by Respondent, attributable to its delayed compliance with the CWA, all of which is attributable to the CWA-SPCC violations. The total civil penalty assessed for settlement purposes is six thousand four hundred and thirty-one dollars ($6,431). Respondent has agreed to pay this amount. EPA and Respondent negotiated and reached an administrative consent agreement, following the Consolidated Rules of Practice, 40 CFR 22.13(b), on January 12, 2007 ( *In Re: VersaCold Corporation* , Docket No. CWA-HQ-2005-8002). This consent agreement is subject to public notice and comment under CWA section 311(b)(6), 33 U.S.C. 1321(b)(6). Under CWA section 311(b)(6)(A), 33 U.S.C. 1321(b)(6)(A), any owner, operator, or person in charge of a vessel, onshore facility, or offshore facility from which oil is discharged in violation of CWA section 311(b)(3), 33 U.S.C. 1321(b)(3), or who fails or refuses to comply with any regulations that have been issued under CWA section 311(j), 33 U.S.C. 1321(j), may be assessed an administrative civil penalty of up to $157,500 by EPA. Class II proceedings under CWA section 311(b)(6) are conducted in accordance with 40 CFR part 22. The procedures by which the public may comment on a proposed Class II penalty order, or participate in a CWA Class II penalty proceeding, are set forth in 40 CFR 22.45. The deadline for submitting public comment on this proposed final order is March 12, 2007. All comments will be transferred to the Environmental Appeals Board (“EAB”) of EPA for consideration. The powers and duties of the EAB are outlined in 40 CFR 22.4(a). Pursuant to CWA section 311(b)(6)(C), EPA will not issue an order in this proceeding prior to the close of the public comment period. List of Subjects Environmental protection. Dated: February 1, 2007. Robert A. Kaplan, Director, Special Litigation and Projects Division, Office of Enforcement and Compliance Assurance. 1 [FR Doc. E7-2115 Filed 2-7-07; 8:45 am] BILLING CODE 6560-50-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary [Document Identifier: OS-0990-New; 60-day notice] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Office of the Secretary, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:
(1)The necessity and utility of the proposed information collection for the proper performance of the agency's functions;
(2)the accuracy of the estimated burden;
(3)ways to enhance the quality, utility, and clarity of the information to be collected; and
(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. *Type of Information Collection Request:* New Collection. *Title of Information Collection:* Evaluation of Approaches to Preventing Adolescent Sexual Risk Behaviors. *Form/OMB No.:* 0990-NEW. *Use:* The Evaluation of Approaches to Preventing Adolescent Sexual Risk Behaviors incorporates parallel evaluations of two different approaches to preventing adolescent sexual risk behavior with the overall goal of estimating the effects of abstinence education and comprehensive sex education delivered as part of middle school curricula. The proposed study will be longitudinal; annual surveys will be administered to a cohort of sixth grade students from sixth grade through high school (or age eighteen for those who drop out of school or fail to graduate). These surveys will focus on measuring behavioral changes—non-sexual risk or precursor behaviors for younger teens and sexual behaviors for older teens, including premarital sexual activity, incidence of sexually transmitted diseases; and incidence of pregnancies and births. The surveys will also include age-appropriate questions about attitudes and intentions. Interviews will also be conducted with school health directors concerning health initiatives and issues in the sampled schools. This request is for the baseline and first follow-up instruments. *Frequency:* Annual. *Affected Public:* Individual. *Annual Number of Respondents:* 3,027. *Total Annual Responses:* 8,257. *Average Burden per Response:* 46.93 minutes. *Total Annual Hours:* 6,459. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, e-mail your request, including your address, phone number, OMB number, and OS document identifier, to *Sherette.funncoleman@hhs.gov* , or call the Reports Clearance Office on
(202)690-6162. Written comments and recommendations for the proposed information collections must be received with 60-days, and directed to the OS Paperwork Clearance Officer at the following address: Department of Health and Human Services, Office of the Secretary, Assistant Secretary for Research and Technology, Office of Resource Management, Attention: Sherrette Funn-Coleman (0990-NEW), Room 537-H, 200 Independence Avenue, SW., Washington, DC 20201. Dated: January 31, 2007. Alice Bettencourt, Office of the Secretary, Paperwork Reduction Act Reports Clearance Officer. [FR Doc. E7-2120 Filed 2-7-07; 8:45 am] BILLING CODE 4151-05-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-07-05BU] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention
(CDC)publishes a list of information collection requests under review by the Office of Management and Budget
(OMB)in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at
(404)639-5960 or send an email to *omb@cdc.gov* . Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to
(202)395-6974. Written comments should be received within 30 days of this notice. Proposed Project Assessment and Monitoring of Breastfeeding-Related Maternity Care Practices in Intra-partum Care Facilities in the United States and Territories—New—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description There is substantial evidence on the social, economic and health benefits of breastfeeding for both the mother and infant and the importance of the health care system in promoting the initiation and maintenance of breastfeeding. Yet breastfeeding initiation rates and duration in the United States did not achieve Healthy People 2000 goals, and significant disparities continue to exist between African American and white women in breastfeeding rates. The Healthy People 2010 goals are to increase the proportion of mothers who breastfeed in the early postpartum period from 64% (1998 estimate) to 75%, the proportion who breastfeed their babies through 6 months of age from 29% to 50%, and to increase from 16% to 25% the proportion of mothers who breastfeed to 1 year of age and to decrease the disparities in breastfeeding initiation, exclusivity, and duration between African American and white women. In addition to ethnic and racial disparities, there is evidence of significant variation in state breastfeeding rates. For example, the breastfeeding initiation rate in Louisiana was 46.4% in 2003 and in Oregon was 88.8%. One important and effective means to promote and support the initiation and maintenance of breastfeeding is through the health care system. While the few studies on breastfeeding practices at intra-partum care facilities in individual states and facilities show significant variation in practices, it is not currently possible to assess and monitor breastfeeding-related practices and policies in hospitals and free-standing childbirth centers across the United States with data currently available. CDC plans to conduct an assessment of breastfeeding-related maternity care practices in intra-partum care facilities in the United States and Territories to provide information to individual facilities, state health departments, and CDC on the extent to which facilities are providing effective breastfeeding-related maternity care. The assessment will provide detailed information on general facility characteristics related to maternity care such as facility policies related to breastfeeding-related maternity care practices, practices related to the training of health care staff on breastfeeding instruction, management and support, rooming-in, infant supplementation, and discharge from facility. CDC will provide facility-specific information based on the assessment to the individual facilities and state-specific information to state health departments. The information from the survey can be used by facilities to evaluate and modify breastfeeding-related maternity care practices, and by states and CDC to inform and target programs and policies to improve breastfeeding-related maternity care practices at intra-partum care facilities. Approximately 4,375 facilities providing maternity care in the United States and Territories will be mailed a survey every other year in this study. The survey will be administered for the first time in 2007 and for the second time in 2009. Survey content will be similar in each of the administrations to examine changes in practices and policies over time. It is expected that approximately 3,700 facilities will complete the thirty-minute questionnaire in each administration. The facilities will be identified from the American Hospital Association's Annual Survey of Hospitals
(AHA)and the National Association of Childbearing Centers (NACC). A five-minute screening telephone call will be made prior to survey administrations to all facilities identified as providing maternity care in AHA and NACC to ensure they are currently providing maternity care, to identify possible satellite clinics providing maternity care, and to identify survey respondent in each of the facilities. The respondents will have the option of either responding by mail or through a Web-based system. The survey will provide detailed information about breastfeeding-related maternity care practices and policies at hospitals and free-standing birth centers. There are no costs to respondents other than their time. The approximate annualized burden hours are 1,484 hours. Estimated Annualized Burden Hours Questionnaire/respondents Number of respondents Number of responses/ respondent Average burden per response (in hours) Screening call to facilities that have at least one registered maternity bed
(2006)1458 1 5/60 Mail survey/ facilities providing maternity care in the past calendar year
(2006)1240 1 30/60 Screening call to facilities that have at least one registered maternity bed
(2008)1458 1 5/60 Mail survey/ facilities providing maternity care in the past calendar year
(2008)1240 1 30/60 Dated: January 31, 2007. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-2070 Filed 2-7-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30 Day-07-06BI] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention
(CDC)publishes a list of information collection requests under review by the Office of Management and Budget
(OMB)in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at
(404)639-4766 or send an e-mail to *omb@cdc.gov.* Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to
(202)395-6974. Written comments should be received within 30 days of this notice. Proposed Project Determining Stakeholder Awareness and the Use and Impact of Products Developed by the Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Model Project—New—National Center for Chronic Disease Prevention and Health Promotion/National Office of Public Health Genomics (NOPHG), Centers for Disease Control and Prevention (CDC). Background and Brief Description More than 1,000 genetic tests are currently available in clinical practice. Most are used for diagnosis of rare genetic diseases, but a growing number have population-based applications, and the potential for broad public health impact. A number of issues have been raised about the current status of genetic testing implementation, including the need to develop evidence to establish validity and utility of genetic tests before tests are commercialized. Advisory panels, professional organizations, and clinical experts have produced recommendations on the development and clinical implementation of safe and effective genetic tests. In response to the need for a coordinated approach for effectively integrating genomic tests into clinical practice and health policy, CDC's National Office of Public Health Genomics (NOPHG) initiated the (Evaluation of Genomic Applications in Practice and Prevention) EGAPP model project in 2004 to establish a systematic, evidence-based process for assessing genetic tests in transition from research to practice. To support this goal, an independent, non-federal, multidisciplinary EGAPP Working Group was established to identify, prioritize, and select genetic tests to be reviewed; establish review methods and processes; monitor progress of the reviews; and develop conclusions and recommendations based on the evidence. The plan for surveying key stakeholders described here represents a large component of the overall project evaluation plan. The study will be conducted in collaboration with a consultant, Judith L. Johnson, PhD, under a CDC task order with the McKing Consulting Corporation. Dr. Johnson and McKing Consulting Corporation worked with CDC on study design, and will collect data for the study, conduct data analyses, and develop written reports of results. The purpose of this study is to collect information on the value and impact of the EGAPP products developed and disseminated ( *e.g.* , evidence reports, recommendations) by surveying members of key stakeholder groups considered by project advisors to have the most immediate need and interest in EGAPP products. The four key stakeholder groups are *healthcare providers, healthcare payers and purchasers, policy makers* ( *e.g.* , medical professional organizations, healthcare policy organizations), as well as *targeted consumer groups* and *Web site visitors.* Healthcare providers/payers have expressed interest in evidence-based information on emerging genetic tests, and will receive the first surveys about six months after the release of the first evidence reports and EGAPP Working Group recommendations; these groups will be surveyed again one year later. Policy makers, consumers, and healthcare purchasers are likely to identify and be impacted by information developed by EGAPP over a somewhat longer timeline. Therefore, these groups will be surveyed twelve months after the first products are released, and surveyed again one year later. During two specified periods of time one year apart, individuals accessing the EGAPP website will be given the option to participate in an EGAPP survey. There are no costs to the respondents other than their time. The total estimated annualized burden hours are 448.52. Estimated Annualized Burden Hours Type of respondent Survey name Number of respondents Number of responses per respondent Average response per respondent Healthcare Providers: Healthcare Provider Survey. Primary Care Providers 385 1 10/60 Specialists 385 1 10/60 Genetic Counselors 200 1 10/60 Mid-level Practitioners 385 1 10/60 Nurses 385 1 10/60 Healthcare Payers and Purchasers: Healthcare Payers Policy/Payer Survey 100 1 10/60 Healthcare Purchasers Purchaser Survey 19 31 1 10/60 Healthcare Policy Makers Policy Survey 50 1 10/60 Consumers: Group members General Survey 385 1 10/60 Website visitors 385 1 10/60 Dated: January 31, 2007. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-2071 Filed 2-7-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30 Day-07-0479] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention
(CDC)publishes a list of information collection requests under review by the Office of Management and Budget
(OMB)in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at
(404)639-5960 or send an email to *omb@cdc.gov.* Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to
(202)395-6974. Written comments should be received within 30 days of this notice. Proposed Project Automated Management Information System
(MIS)for Diabetes Control Programs (OMB No. 0920-0479)—Revision—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description The Division of Diabetes Translation
(DDT)within the National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention (CDC), has implemented a Management Information System
(MIS)and federally sponsored data collection requirement for all CDC funded Diabetes Prevention and Control Programs. Diabetes is the sixth leading cause of death in the United States, contributing to more than 224,000 deaths each year. An estimated 14.6 million people in the United States have been diagnosed with diabetes and an estimated 6.2 million people have undiagnosed diabetes. The Division of Diabetes Translation provides funding to health departments of States and territories to develop, implement, and evaluate systems-based Diabetes Prevention and Control Programs (DPCPs). DPCPs are population-based, public health programs that design, implement and evaluate public health prevention and control strategies that improve access to and quality of care for all, and reach communities most impacted by the burden of diabetes (e.g., racial/ethnic minority populations, the elderly, rural dwellers and the economically disadvantaged). Support for these programs is a cornerstone of the DDT's strategy for reducing the burden of diabetes throughout the nation. The Diabetes Control Program is authorized under sections 301 and 317(k) of the Public Health Service Act [42 U.S.C. 241 and 247b(k)]. In accordance with the original OMB approval (0920-0479) and the first extension (August 14, 2003) for this project, this requested revision will continue to expand and enhance the use of the technical reporting capacity of the MIS for 3 years. The MIS is a Web- based, password access protected repository/technical reporting system that replaces an archaic paper reporting system. The MIS allows the accurate, uniform, and complete collection of diabetes program progress information using the Internet. The number of hours that DPCPs users spend to maintain and use the MIS has increased compared to the initial baseline period. This increase in data collection burden does not directly translate into a greater reporting burden; however, it facilitates better monitoring and tracking of program activities in real-time and helps create an organizational memory. Consequently, diabetes control programs are using the MIS to a great extent as an integral part of their program compared to previous years. DPCPs add updates about their work plans and other activities into the System on an ongoing basis. The hour-burden estimates include the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Based on input provided by a representative sample for DPCPs, the total annualized response burden is expected to increase from 4 to 96 hours, changing the total burden hours from 236 to 5,664. Even though there has been an increase in the burden hours the number of responses remains at one (1), because the DPCPs are only required to report annually to CDC. The MIS has improved upon the old data collection system by: • Improving accountability. • Shortening the information cycle. • Eliminating non-standard reporting. • Minimizing unnecessary duplication of data collection and entry. • Reducing the reporting burden on small state organizations. • Using plain, coherent, and unambiguous terminology that is understandable to respondents. • Implementing a consistent system for progress reporting and record keeping processes. • Identifying the retention periods for record keeping requirements. • Utilizing modern information technology for data collection and transfer. • Significantly reducing the amount of paper reports that diabetes prevention and control programs are required to submit. The MIS also allows CDC to more rapidly respond to outside inquiries concerning a specific diabetes control activity occurring in the state diabetes prevention and control programs. The data collection requirement has formalized the format and the content of diabetes data reported from the DPCPs and provides an electronic means for efficient collection and transmission to the CDC headquarters. The MIS has facilitated the staff's ability at CDC to fulfill its obligations under the cooperative agreements; to monitor, evaluate, and compare individual programs; and to assess and report aggregate information regarding the overall effectiveness of the DCP program. It has also supported DDT's broader mission of reducing the burden of diabetes by enabling DDT staff to more effectively identify the strengths and weaknesses of individual DPCPs and to disseminate information related to successful public health interventions implemented by these organizations to prevent and control diabetes. Implementation of the MIS has provided for efficient collection of state-level diabetes program data. There are no costs to the respondents other than their time. The total estimated annualized burden hours are 5,664. Estimated Annualized Burden Hours Type of respondents Form name No. of respondents No. of responses per respondent Average burden per response (in hours) State Diabetes Control and Prevention Program Officers Long-Term Objectives Updates 59 1 15 Process Objectives Updates 59 1 13 Resource Updates 59 1 10 Advisory Group Updates 59 1 10 Surveillance Sources Updates 59 1 10 Budget Updates 59 1 20 Staff Position Updates 59 1 10 Additional Accomplishments Updates 59 1 8 Dated: February 2, 2007. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-2072 Filed 2-7-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Healthcare Infection Control Practices Advisory Committee: Notice of Charter Renewal This gives notice under the Federal Advisory Committee Act (Pub. L. 92-463) of October 6, 1972, that the Healthcare Infection Control Practices Advisory Committee, Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through January 19, 2009. For information, contact Michael Bell, M.D., Executive Secretary, Healthcare Infection Control Practices Advisory Committee, Centers for Disease Control and Prevention, Department of Health and Human Services, 1600 Clifton Road, NE., Mailstop A-07, Atlanta, Georgia 30333, telephone 404/639-6490 or fax 404/639-4044. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-2080 Filed 2-7-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Board of Scientific Counselors, National Center for Health Statistics: Notice of Charter Renewal This gives notice under the Federal Advisory Committee Act (Pub. L. 92-463) of October 6, 1972, that the Board of Scientific Counselors, National Center for Health Statistics, Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through January 19, 2009. For information, contact Virginia Cain, Ph.D., Executive Secretary, Board of Scientific Counselors, National Center for Health Statistics, Centers for Disease Control and Prevention, Department of Health and Human Services, Metro IV Building, 3311 Toledo Road, Hyattsville, Maryland 20782, telephone 301-458-4395 or fax 301-458-4020. The Director, Management Analysis and Services Office, has been delegated the authority to sign **Federal Register** notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Dated: February 2, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. E7-2076 Filed 2-7-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Task Force on Community Preventive Services In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention
(CDC)announces the following meeting: *Name:* Task Force on Community Preventive Services. *Times and Dates:* 8 a.m.-5:15 p.m. EST, February 14, 2007. 8 a.m.-12:30 p.m. EST, February 15, 2007. *Place:* Centers for Disease Control and Prevention, 2500 Century Parkway, Atlanta, GA 30329. *Status:* Open to the public, limited only by the space available. *Purpose:* The mission of the Task Force is to develop and publish the *Guide to Community Preventive Services (Community Guide),* which is based on the best available scientific evidence and current expertise regarding essential public health and what works in the delivery of those services. *Matters to be discussed: Agenda items include:* controlling obesity; worksite health promotion and the assessment of health risks with feedback; alcohol outlet density; asthma; updating existing *Community Guide* reviews; and dissemination activities and projects in which the *Community Guide* is used. Agenda items are subject to change as priorities dictate. Persons interested in reserving a space for this meeting should call Tony Pearson-Clarke at 404-498-0972 by close of business on February 9, 2007. *Contact person or additional information:* Tony Pearson-Clarke, Community Guide Branch, Coordinating Center for Health Information and Service, National Center for Health Marking, Division of Health Communication and Marketing, 1600 Clifton Road, M/S E-69, Atlanta, GA 30333, phone: 404-498-0972. Dated: January 31, 2007. James D. Seligman, Chief Information Officer, Centers for Disease Control and Prevention. [FR Doc. E7-2078 Filed 2-7-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Prospective Grant of Co-Exclusive License AGENCY: Technology Transfer Office, Centers for Disease Control and Prevention (CDC), Department of Health and Human Services. ACTION: Notice. SUMMARY: This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Centers for Disease Control and Prevention (CDC), Technology Transfer Office, Department of Health and Human Services (DHHS), is contemplating the grant of a limited field of use, exclusive license in China, and a co-exclusive worldwide (excluding China) license to practice the invention embodied in the patent application referred to below to Ringpu (Baoding) Biologics and Pharmaceuticals Co. LTD., having a place of business in Baoding City, Hebel Province, PR China. CDC intends to grant rights to practice this invention (in territories other than China) to no more than two other co-licensees. The patent rights in these inventions have been assigned to the government of the United States of America. The patent application to be licensed is: Provisional Patent Application *Title:* Method of Sequencing Whole Viral Genomes, Related Compositions, and Genome Sequences. *Serial No.* 60/727,038. *Filing date:* 10/14/2005. PCT Patent Application *Title:* Rabies Virus Compositions and Methods. *Serial No.:* N/A. *Filing Date:* 10/13/2006. *Domestic Status:* N/A. *Issue Date:* patent pending. The prospective exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The critical feature of this technology is the ERA rabies virus whole genome DNA sequence. With the availability of the entire rabies genome, a recombinant vaccine can be developed using reverse genetics. The vaccines that can be developed using this genome are fundamentally different from classic ones that are being produced. The technology is being applied to other negative stranded RNA viruses. ADDRESSES: Requests for a copy of these patent applications, inquiries, comments, and other materials relating to the contemplated license should be directed to Andrew Watkins, Director, Technology Transfer Office, Centers for Disease Control and Prevention (CDC), 4770 Buford Highway, Mailstop K-79, Atlanta, GA 30341, *telephone:*
(770)488-8610; *facsimile:*
(770)488-8615. Applications for an exclusive license to the territory of China filed in response to this notice will be treated as objections to the grant of the contemplated exclusive license. Only written comments and/or applications for a license which are received by CDC within thirty days of this notice will be considered. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552. A signed Confidential Disclosure Agreement will be required to receive a copy of any pending patent application. Dated: January 31, 2007. James D. Seligman, Chief Information Officer, Centers for Disease Control and Prevention. [FR Doc. E7-2077 Filed 2-7-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices 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 Committee* : Circulatory System Devices Panel of the Medical Devices 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 March 1, 2007, from 8 a.m. to 5:30 p.m., and March 2, 2007, from 8 a.m. to 6 p.m. *Location* : Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD. *Contact Person* : James Swink, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4179, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512625. Please call the Information Line for up-to-date information on this meeting. *Agenda* : On March 1, 2007, the committee will discuss and make recommendations regarding the premarket approval application, sponsored by Medtronic Inc., for the Chronicle Implantable Hemodynamic Monitoring System. This implantable device is intended to reduce hospitalization events or equivalent events for worsening heart failure in patients with moderate to advanced heart failure. On March 2, 2007, the committee will discuss and make recommendations regarding clinical trial designs for Patent Foreman Ovale closure devices intended to prevent recurrent stroke. FDA intends to make background material available to the public no later than 1 business day before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* , click on the year 2007 and scroll down to the appropriate advisory committee link. *Procedure* : On March 1, 2007, from 8 a.m. to 5:30 p.m., and March 2, 2007, from 8 a.m. to 10 a.m. and 12 p.m. to 6 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 on or before February 23, 2007. Oral presentations from the public will be scheduled for approximately 30 minutes at the beginning of committee deliberations on each day and for approximately 30 minutes near the end of the committee deliberations on each day. Those desiring to make formal oral presentations should notify the contact person 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 on or before February 15, 2007. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by February 16, 2007. *Closed Presentation of Data* : On March 2, 2007, from 10 a.m. to 12 p.m., the meeting will be closed to permit the discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)) presented by sponsors. 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 AnnMarie Williams, Conference Management Staff, at 301-827-7291, 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: February 1, 2007. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E7-2122 Filed 2-7-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005D-0091] Guidance for Industry on User Fee Waivers for Fixed Dose Combination and Co-Packaged Human Immunodeficiency Virus Drugs for the President's Emergency Plan for Acquired Immunodeficiency Syndrome Relief; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of a guidance for industry entitled “User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR.” This guidance describes the circumstances under which user fees will not be assessed for certain applications for fixed dose combination
(FDC)and co-packaged versions of previously approved antiretroviral therapies for the treatment of human immunodeficiency virus
(HIV)under the President's Emergency Plan for Acquired Immunodeficiency Syndrome Relief (PEPFAR). The guidance also describes some circumstances under which most of the applications that will be assessed fees may be eligible for a public health or a barrier-to-innovation waiver. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of the guidance to the Division of Drug Information (HFD- 240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the 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* . See the SUPPLEMENTARY INFORMATION section for electronic access to this guidance document. FOR FURTHER INFORMATION CONTACT: Michael Jones, Center for Drug Evaluation and Research (HFD-5), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled “User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR.” The guidance describes the circumstances under which user fees will not be assessed for certain applications for FDC and co-packaged versions of previously approved antiretroviral therapies for the treatment of HIV under PEPFAR. The guidance also describes some circumstances under which some of the applications that will be assessed fees may be eligible for a public health or a barrier-to-innovation waiver. In May 2004, as part of PEPFAR, FDA issued a draft guidance entitled “Fixed Dose Combination and Co-Packaged Drug Products for the Treatment of HIV” (Fixed Dose Guidance) (69 FR 28931, May 19, 2004). The draft Fixed Dose Guidance described some scenarios for approval of FDC or co-packaged products for the treatment of HIV and provided examples of drug combinations considered acceptable for FDC/co-packaging and examples of those not considered acceptable for FDC/co-packaging. The guidance also explained that the Federal Food, Drug, and Cosmetic Act provides for certain circumstances in which FDA can grant sponsors a waiver or reduction in fees. The guidance also stated that the agency was evaluating the circumstances under which it may grant user fee waivers or reductions for sponsors developing FDC and co-packaged versions of previously approved antiretroviral therapies for the treatment of HIV. Since issuance of the draft Fixed Dose Guidance, several potential applicants have asked that we clarify whether sponsors submitting drug applications covered by the draft Fixed Dose Guidance and proposed for use in the PEPFAR program will be required to pay user fees under the Prescription Drug User Fee Act (PDUFA) and, if so, whether they would be eligible for a waiver of those fees. In the **Federal Register** of April 18, 2005 (70 FR 20145), FDA announced the availability of a draft version of this guidance. FDA did not receive any comments in response to that draft guidance, and the agency has made only minor editorial changes to the guidance. This guidance describes some of the scenarios under which a sponsor could qualify for fee exemptions or would only be assessed a half fee, either because the sponsor is using an active ingredient that has already been approved or the application does not require clinical data for approval. A sponsor of an application that would be assessed either a full or a half fee may also qualify for a waiver of the application fee under several provisions of PDUFA. We expect that most of the applications, products, and establishments for FDC and co-packaged HIV therapies proposed for use in the PEPFAR program will either not be assessed fees in the first instance or will qualify for a waiver under the “other circumstances” part of the barrier-to-innovation user fee waiver. 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 waivers for FDC and co-packaged HIV PEPFAR products. 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 statutes and regulations. II. 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 copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The draft guidance and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. III. Electronic Access Persons with access to the Internet may obtain the guidance document at either *http://www.fda.gov/cder/guidance/index.htm* or *http://www.fda.gov/ohrms/dockets/default.htm* . Dated: February 1, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-2124 Filed 2-7-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Committee on Rural Health and Human Services; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given that the following committee will convene its fifty-fifth meeting. *Name:* National Advisory Committee on Rural Health and Human Services. *Dates and Times:* February 28, 2007, 9 a.m.-4:15 p.m., March 1, 2007, 9 a.m.-4:15 p.m., March 2, 2007, 9 a.m.-10:30 a.m. *Place:* The Sofitel Lafayette Square, 806 15th Street NW., Washington, DC 20005, *Phone:* 202-730-8800. *Status:* The meeting will be open to the public. *Purpose:* The National Advisory Committee on Rural Health and Human Services provides advice and recommendations to the Secretary with respect to the delivery, research, development and administration of health and human services in rural areas. *Agenda:* Wednesday morning, February 28, at 9 a.m., the meeting will be called to order by the Chairperson of the Committee, the Honorable David Beasley. Elizabeth M. Duke, Administrator of the Health Resources and Services Administration, has been invited to give opening remarks. The first presentation is titled Rural America: Then, Now and in the Future. The speakers will be John Cromartie and Carol Jones, Economic Research Service, U.S. Department of Agriculture. Following this session will be three panels on rural health and human services issues. The first will be a rural health panel with Becky Slifkin of the North Carolina Rural Health Research and Policy Analysis Center at the University of North Carolina at Chapel Hill; Gary Hart of the WWAMI Rural Health Research Center at the University of Washington; and Andy Coburn of the Maine Rural Health Research Center at the University of Southern Maine. The second will be a rural health panel with the following speakers: Julie Schoenman of the National Opinion Research Center at the University of Chicago; Michelle Casey of the Upper Midwest Rural Health Research Center at the University of Minnesota; and Keith Mueller of the Rural Policy Research Institute. The final panel of the day will be a rural human services panel with Robert Gibbs of the Economic Research Service at the U.S. Department of Agriculture; Dennis Dudley with the U. S. Administration on Aging; and Brian Dabson of the Poverty Center at the Rural Policy Research Institute. The Wednesday meeting will close at 4:15 p.m. Thursday morning, March 1, at 9 a.m., the Committee will open with a discussion on Wednesday's sessions. Immediately following, the Committee Chair will lead a discussion of the topics for the 2008 Report to the Secretary and assign Subcommittees. The first presentation of the day will be on Rural Policy Moving Forward by Mike O' Grady, Senior Fellow with the National Opinion Research Center. This will be followed by a presentation on the Commonwealth Fund Activity by Mary Wakefield, Director of the Center for Rural Health at the University of North Dakota. After lunch the Committee will have discussion on the day's presentations. The formal Committee meeting for Thursday will close at 2:30 p.m. The Subcommittees will meet from 2:30 p.m. to 4 p.m. The final session will be convened Friday morning, March 2, at 9 a.m. The Committee will receive reports from the Subcommittee discussions on Thursday, draft the letter to the Secretary, and discuss the June meeting. The meeting will be adjourned at 10:30 a.m. *For Further Information Contact:* Anyone requiring information regarding the Committee should contact Tom Morris, M.P.A., Executive Secretary, National Advisory Committee on Rural Health and Human Services, Health Resources and Services Administration, Parklawn Building, Room 9A-55, 5600 Fishers Lane, Rockville, MD 20857, Telephone
(301)443-0835, Fax
(301)443-2803. Persons interested in attending any portion of the meeting should contact Michele Pray-Gibson, Office of Rural Health Policy (ORHP), Telephone
(301)443-0835. The Committee meeting agenda will be posted on ORHP's Web site *http://www.ruralhealth.hrsa.gov.* Dated: February 2, 2007. Caroline Lewis, Acting Associate Administrator for Administration and Financial Management. [FR Doc. E7-2125 Filed 2-7-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of Inspector General Program Exclusions: Correction AGENCY: Office of Inspector General, HHS. ACTION: Notice of program exclusions; correction. SUMMARY: The HHS Office of Inspector General Published a document in the **Federal Register** of October 18, 2006, imposed exclusions. The document contained the incorrect monthly exclusions. FOR FURTHER INFORMATION CONTACT: Jacqueline Freeman,
(410)786-5197. Correction In the **Federal Register** of October 18, 2006, in FR Doc. 71 FR 61485, on page 61492, The list was for the September 2006 exclusions. The correct exclusions for September 2006 should read: Subject name, address Effective date PROGRAM-RELATED CONVICTION ABAD, NILDA 10/19/2006 ALPINE, CA ALLISON, KEITH 10/19/2006 LOS ANGELES, CA ANDERSON, THEODORE 10/19/2006 KINGSTON, WA BOUCHARD, JOHN 10/19/2006 PHILLIPSBURG, KS BOUGHTON, LLOYD 10/19/2006 LOS ANGELES, CA BRAZIL, MICHAEL 10/19/2006 ARLINGTON, VA CACAL, ROQUE 10/19/2006 LOS ANGELES, CA CACAL, ROSA 10/19/2006 LOS ANGELES, CA CARDILLO, JOHN 10/19/2006 BERKELEY HEIGHTS, NJ DELATOUR, GREGORY 10/19/2006 MIAMI, FL DELGADO, JOSUE 10/19/2006 BALDWIN PARK, CA DODDS, KYLE 10/19/2006 INDEPENDENCE, OR EASON, KIM 10/19/2006 FRESNO, CA EDWARDS, PHYLLIS 10/19/2006 HAMILTON, OH EVANS, AMY 10/19/2006 PATASKALA, OH FINLEY, SANDRA 10/19/2006 OKLAHOMA CITY, OK FLORES, VERGIL 10/19/2006 MESQUITE, TX FRANK, PAUL 10/19/2006 FORT DIX, NJ GALLEGOS, JODY 10/19/2006 THORNTON, CO GORDON, RICHARD 10/19/2006 SURPRISE, AZ GOTTSCHALL, ZAY 10/19/2006 BUTTE, MT HABEEB, GREGORY 10/19/2006 CLARK SUMMIT, PA HARRIS, KATRINA 10/19/2006 NILES, OH HARRIS, TAMMY 10/19/2006 AUSTIN, TX HARTSFIELD, ARCHIE 10/19/2006 EL PASO, TX HERIC, THOMAS 10/19/2006 HAWTHORNE, CA HERNANDEZ, JOSE 10/19/2006 MIAMI, FL HOLSAN, JASON 10/19/2006 GRAND JUNCTION, CO HOVATTER, KATHY 10/19/2006 PARMA, OH ISHAK, MAHER 10/19/2006 HARRIMAN, NY JOHNSON, SHELIA 10/19/2006 SARDINIA, OH JONES, WANDA 10/19/2006 YOUNGSTOWN, OH LAZARO, JUAN 10/19/2006 WESTBROOK, ME LUETTGEN, TAMMIE 10/19/2006 ALLENTOWN, PA MALAHIMOV, BORIS 10/19/2006 BRADFORD, PA MALCOLM-FORBES, SONIA 10/19/2006 COLUMBUS, OH MAYHUGH, JEFFREY 10/19/2006 THORNVILLE, OH MORTON, GEORGE 10/19/2006 PHENIX, VA PARKER, ROGER 10/19/2006 HAMPTON, VA PETERSON, RENE 10/19/2006 DES MOINES, IA REISBORD, DAVID 10/19/2006 LOS ANGELES, CA RUMMELT, HERMAN 10/19/2006 DULUTH, MN SERRANO, SUSAN 10/19/2006 DUBLIN, CA SHUMAKER, MARY 10/19/2006 SARDINIA, OH SISNEY, DEBRA 10/19/2006 BULL SHOALS, AR SOLIS, MARY 10/19/2006 WEST COVINA, CA SPEARS, RAMESHIA 10/19/2006 GRANDVIEW, MO SPEIGHT, DIANNA 10/19/2006 LAS VEGAS, NV STATLER, JOHN 10/19/2006 DAYTON, OH STIMPSON, RIETA 10/19/2006 HELENA, MT WALLED, RAFAEL 7/5/2006 MIAMI, FL WALLERICK, MELANIE 10/19/2006 YOUNGSTOWN, OH WILLIAMS, DRANETTA 10/19/2006 GATESVILLE, TX WILLIAMS, HENRY 10/19/2006 HUNTSVILLE, TX WOODBURY PHARMACY, INC 10/19/2006 HARRIMAN, NY FELONY CONVICTION FOR HEALTH CARE FRAUD BAILEY, LLEWELLYN 10/19/2006 ROSEDALE, NY BALL, HEIDI 10/19/2006 SPRINGFIELD, OR BATTERTON, CAROL 10/19/2006 CHEYENNE, OK BENTLEY, WILLIAM 10/19/2006 MONROE, WA BLEVINS, CHARLES 10/19/2006 MONTGOMERY, AL BOUGHTON, DARLA 10/19/2006 COEUR D'ALENE, ID CARTER, ANGEL 10/19/2006 BASTEVILLE, AR COULSON, ANDREA 10/19/2006 ORANGE, CA CRICHTON, SONJA 10/19/2006 LITCHFIELD PARK, AZ DECKER, CAROLINE 10/19/2006 BOULDER, CO FARR, CHARLENE 10/19/2006 SWANTON, VT FULKERSON, JANET 10/19/2006 TEMPLE, TX GONZALEZ, JOSEPH 10/19/2006 MIAMI BEACH, FL HARRIS, APRIL 10/19/2006 PHOENIX, AZ HARRIS, JOAN 10/19/2006 FONTANA, CA HENNEKES, ZACHARY 10/19/2006 CINCINNATI, OH KOWALSKI, KAREN 10/19/2006 DENVER, CO LANDIN, ALICIA 10/19/2006 WESTMINSTER, CO LIEN, JONATHAN 10/19/2006 SAN JOSE, CA MELTON, LINDA 10/19/2006 CENTRAL POINT, OR MOSS, MARGO 10/19/2006 NORWALK, IA NGUYEN, DENNIS 10/19/2006 ELK GROVE, CA ORZO, BILLIE 10/19/2006 ALLIANCE, OH POLZINE, ANTHONY 10/19/2006 SAN ANTONIO, TX SCHEMPP, JOANNE 10/19/2006 KENT, OH TAYLOR, MISTY 10/19/2006 STRATFORD, OK WILLIS, JACQUELYN 10/19/2006 FAIRFIELD, OH WOODRAL, JANNETTE 10/19/2006 HEAVENER, OK ZENTZ, NANCY 10/19/2006 CLARKSVILLE, IN ZOLOTAREVA, ELLA 10/19/2006 BROOKLYN, NY FELONY CONTROLLED SUBSTANCE CONVICTION BAIKAUSKAS, LAURIE 10/19/2006 PEARLAND, TX BARNWELL, TERRI 10/19/2006 BRIDGEPORT, TX BEAVER, CHERYL 10/19/2006 ELKHART, IN CAMPBELL, TINO 10/19/2006 BRIGHTON, CO CONLEY, JAMES 10/19/2006 FLATWOODS, KY COPLEY, TIFFANY 10/19/2006 LUBBOCK, TX DONCASTER-LAWSON, PATRICIA 10/19/2006 WILLIAMSBURG, KY FEE, CATHERINE 10/19/2006 EGG HARBOR CITY, NJ GINGLE, MICHELLE 10/19/2006 WESLEY CHAPEL, FL HUTTON, JOANNA 10/19/2006 HOCKESSIN, DE KELLEY-WALLER, SUSAN 10/19/2006 OVERTON, TX KNOX, ROBERT 10/19/2006 PRINCETON, WV NAGY, HEATHER 10/19/2006 PORT RICHEY, FL PORTINGA, DONNA 10/19/2006 WYLIE, TX RUPARD, LORA 10/19/2006 SHEPHERSVILLE, KY SANDLIN, JENNIFER 10/19/2006 ANCHORAGE, AK SZURGOT, LONDA 10/19/2006 JOSHUA, TX WAGMAN, PHILIP 10/19/2006 CAMP HILL, PA WHITE, TRACY 10/19/2006 IOWA CITY, IA YELTON, DEBRA 10/19/2006 NEVADA CITY, CA PATIENT ABUSE/NEGLECT CONVICTION AKTHAR, WAHEED 10/19/2006 HOUSTON, TX ALEXANDER, JASMINE 10/19/2006 LITTLETON, CO ALLDREDGE, JOYCE 10/19/2006 NEWBERG, OR BELTRAN, RICARDO 10/19/2006 WHITTIER, CA BOYCE, EMILY 10/19/2006 AMITYVILLE, NY CLARK, WILLIAM 10/19/2006 BALLWIN, MO CLOUGH, KRISTEN 10/19/2006 PORTSMOUTH, NH DUVALL, DONNA 10/19/2006 LOCO, OK ELMORE, ASHLEY 10/19/2006 BETHANY, OK EVANS, JOHN 10/19/2006 HARDWICK, GA GREENBERG, WILLIAM 10/19/2006 WEST BLOOMFIELD, MI GRIMES, BETTY 10/19/2006 GLENDORA, CA HAECK, MARGARET 10/19/2006 LANSING, MI HAMED, JILL 10/19/2006 COPPERAS COVE, TX HARTKOPF, PAMELA 10/19/2006 ROTHSCHILD, WI HENRY, JESSE 10/19/2006 ALBUQUERQUE, NM KATHPAL, GURBACHAN 10/19/2006 CANONSBURG, PA KNEELAND, ASHLEY 10/19/2006 JAY, OK KONADU, OFORI 10/19/2006 COLUMBUS, OH LARKIN, PATRICIA 10/19/2006 GUTHRIE, OK LOESER, PETER 10/19/2006 FRANKLIN, NH MAGANA, IGNACIO 10/19/2006 JUPITER, FL MASSEY, TRACI 10/19/2006 CANTON, OH MESSER, KIMBERLY 10/19/2006 CORINTH, MS PARKER, COURTNEY 10/19/2006 CHICKASHA, OK SANDERS, MICHAEL 10/19/2006 NEWTON, NJ SHOLES, MARK 10/19/2006 SAINT PETERSBURG, FL SINGLETON, EMILY 10/19/2006 MIAMI, FL SNIDER, CHARLES 10/19/2006 PORTLAND, OR SPEARS, VIRGINIA 10/19/2006 ROSEVILLE, CA STANG, ROBERT 10/19/2006 KINGSLEY, MI THOMPSON, COLLEEN 10/19/2006 ROCKVILLE, MD TROTTIER, PATRICIA 10/19/2006 LANCASTER, NH VILLAREAL, JULIUS 10/19/2006 CHULA VISTA, CA WILLIAMSEN, JEFFREY 10/19/2006 MT PLEASANT, IA WRIGHT, JOSEPH 10/19/2006 AUGUSTA, WV WUELLEH, JAMES 10/19/2006 COLUMBUS, OH YATES, GEORGE 10/19/2006 STERLING, CO CONVICTION FOR HEALTH CARE FRAUD ASHLEY, PEGGY 10/19/2006 MAYFLOWER, AR BASSETT, SARA 10/19/2006 LEON, IA GURUNIAN, TIFFANY 10/19/2006 BOSSIER CITY, LA PINKHAM, JENNIFER 10/19/2006 CANAAN, ME LICENSE REVOCATION/SUSPENSION/SURRENDER ABRAMS, BRUCE 10/19/2006 LEXINGTON, KY ALDRICH, JOYCE 10/19/2006 PARKER, CO ANDERSON, PEGGY 10/19/2006 STANWOOD, WA ANDERSON-STRATTON, JAIMEE 10/19/2006 OGDEN, UT BABINEAU, MARSHA 10/19/2006 SURPRISE, AZ BADER, RALPH 10/19/2006 TAFT, CA BALLENTINE, SALLY 10/19/2006 ARLINGTON, TX BATES, WILLIAM 10/19/2006 MONTICELLO, FL BEAUDOIN, PATRICIA 10/19/2006 HOUSTON, TX BELIN, MARY 10/19/2006 CORONA, CA BENASFRE, SANDERSON 10/19/2006 WILMINGTON, CA BEVINS, ELIZABETH 10/19/2006 WINCHESTER, KY BIRD, CHARLES 10/19/2006 ALTAMONTE SPRINGS, FL BOTEO, AURA 10/19/2006 S. SAN FRANCISCO, CA BOTKIN, JENNIFER 10/19/2006 FRENCHTOWN, MT BOUCHARD, ROXANNE 10/19/2006 ENFIELD, CT BOUTACOFF, MARIA 10/19/2006 FAIRFAX, CA BOYNTON, HOLLY 10/19/2006 EVANSTON, WY BRADBURN, JAMIE 10/19/2006 GOLDEN, CO BRECKEN, SIGRID 10/19/2006 OLD ORCHARD BEACH, ME BRISTOL, KENNETH 10/19/2006 FLAGSTAFF, AZ BROWN, KELLY 10/19/2006 FT OGLETHORPE, GA BROWNE, CLINTON 10/19/2006 GAINESVILLE, FL BROWNING, MICHELLE 10/19/2006 WESTMINSTER, CO BRUNELLE, ELIZABETH 10/19/2006 TUCSON, AZ BRUNNER, MARY 10/19/2006 DENVER, CO BUCKLAND, DEANNA 10/19/2006 ROCHESTER, NY BUSCHER, RICHARD 10/19/2006 YAKIMA, WA BUSEY, REBECCA 10/19/2006 SHREVEPORT, LA CACHUELA, DANILO 10/19/2006 CHULA VISTA, CA CARNEY, JOHN 10/19/2006 BLUEFIELD, VA CARPENTER, IZETTA 10/19/2006 LOS GATOS, CA CHAVEZ, YVETTE 10/19/2006 LOCKEFORD, CA CHIPMAN, BRENDA 10/19/2006 AMERICAN FORK, UT CHRAPA, EDEANE 10/19/2006 E AURORA, NY COHEN, STACIE 10/19/2006 FRAMINGHAM, MA COLEMAN, LYNDEE 10/19/2006 PHILO, CA COMBS, SANDRA 10/19/2006 WHITE RIVER JUNCTION, VT COMPTON, KATHRYN 10/19/2006 PIKEVILLE, KY CONLEY, TONY 10/19/2006 HOLDENVILLE, OK COON, JENNIFER 10/19/2006 BINGHAMTON, NY CROWLEY, CAITLIN 10/19/2006 MANCHESTER, NH CUDNEY, KATHI 10/19/2006 EUREKA, CA CYNEWSKI, KATELYN 10/19/2006 EXETER, NH CYPRESS, ROVET 10/19/2006 HAMPTON, VA DALLEY, MELISSA 10/19/2006 WEST JORDAN, UT DANIELS, STEPHANIE 10/19/2006 TEMECULA, CA DEVITO, DANIELLE 10/19/2006 MECHANICVILLE, NY DIAZ, CHRISTOPHER 10/19/2006 GRAND JUNCTION, CO DRAPER, SPENCER 10/19/2006 CANYON LAKE, TX DUFF, JONNA 10/19/2006 OXNARD, CA DUFFEY, DANNELL 10/19/2006 VISALIA, CA DUFFY, KATHY 10/19/2006 GREENVILLE, TX EARL, THEODORE 10/19/2006 PITTSBURGH, PA EASON, WALTER 10/19/2006 JACKSONVILLE, AL EDGE, NIKKI 10/19/2006 YERINGTON, NV EISENBERG, LAURA 10/19/2006 PORT HENRY, NY FALL, DONNA 10/19/2006 PITTSBURGH, PA FARMARTINO, ROCKY 10/19/2006 HERMITAGE, PA FIELDS, BRYAN 10/19/2006 MISSOURI CITY, TX FINCH, GHIA 10/19/2006 INDIANAPOLIS, IN FRANCOIS, IOLA 10/19/2006 GADSDEN, AL FRISBY, JODI 10/19/2006 PAYSON, UT GAINES, GINGER 10/19/2006 TAMPA, FL GARDNER, TODD 10/19/2006 KANAB, UT GERAGHTY, MARY 10/19/2006 RUNNING SPRINGS, CA GILLILAND, JAMES 10/19/2006 VANCOUVER, WA GISOLO, LINDA 10/19/2006 MIDLAND, TX GREEN, JUDITH 10/19/2006 ESSEX JUNCTION, VT GREER, JULIANA 10/19/2006 MESA, AZ HAHN, REBECCA 10/19/2006 PHOENIX, AZ HALL, LINDA 10/19/2006 ANDERSON, IN HALSTED, DAVID 10/19/2006 TRAVERSE CITY, MI HANGE, PAULEE 10/19/2006 LANSDALE, PA HANNA, DARWIN 10/19/2006 BOLINGBROOK, IL HANSEN, TAMMY 10/19/2006 HUTTO, TX HARRIS, JENNIFER 10/19/2006 TEMPE, AZ HARRIS, RICHARD 10/19/2006 HENDERSONVILLE, NV HARRIS, VISHUN 10/19/2006 REDLANDS, CA HERNANDEZ, SYLVIA 10/19/2006 GLENDALE, AZ HODGSON, MELISSA 10/19/2006 OKLAHOMA CITY, OK HOLLAND, ANGELICA 10/19/2006 TUCSON, AZ HOLZHAUSEN, KAREN 10/19/2006 NORTH EAST, PA HOPES, JAMES 10/19/2006 ALEXANDER, AR HOSKINS, VICKIE 10/19/2006 BAXTER, KY HUARD, KATHY 10/19/2006 BROOKFIELD, MA HUEBENER, CHRISTIANE 10/19/2006 DES MOINES, IA HUGHSON, KATHLEEN 10/19/2006 RICHMOND, VA HUNT, WAYNE 10/19/2006 BROOKLYN, NY HUTSON, TRACY 10/19/2006 ABILENE, TX JAMISON, LISA 10/19/2006 ARANSAS PASS, TX JEFFERSON, SHIRLEY 10/19/2006 WAXAHACHIE, TX JOHNSON, CHANIKA 10/19/2006 LONGVIEW, TX JOHNSON, ROBERT 10/19/2006 DELTONA, FL JOHNSTON, KELLIE 10/19/2006 BLUE BELL, PA JONES, LISA 10/19/2006 MONTGOMERY, IN JUAREZ, SANDRA 10/19/2006 BUTTE, MT KEEN, KIMBERLY 10/19/2006 WHITNEY, TX KING, PATRICIA 10/19/2006 HOUSTON, TX KLEIN, SHARON 10/19/2006 JACKSONVILLE, FL KOEN, SHAUN 10/19/2006 HANSFORD, CA KOLINSKY, BARBARA 10/19/2006 BERLIN, NH KRAEMER, LINDA 10/19/2006 BLANDON, PA KRIKSCIUN, DONNA 10/19/2006 OAKDALE, CT LA FAMILIA PHARMACY III, INC 10/19/2006 MIAMI, FL LA FAMILIA PHARMACY IV, INC 10/19/2006 DEERFIELD BEACH, FL LADD, ROBERT 10/19/2006 WESTMORELAND, TN LAFAYETTE, PATRICIA 10/19/2006 BRISTOL, VT LANCASTER, DAVID 10/19/2006 SAINT GEORGE, UT LANCASTER, MELISSA 10/19/2006 ARCHBALD, PA LANDERS, MARIBETH 10/19/2006 KELLER, TX LAPOINTE, DAVID 10/19/2006 PROVIDENCE, RI LAQUERRE, CHERI 10/19/2006 WEST BARNSTABLE, MA LATTERMAN, MICHAEL 10/19/2006 MIAMI BEACH, FL LAUBER, JANE 10/19/2006 TUCSON, AZ LEFAIVRE-KNUTSON, JULIE 10/19/2006 OCALA, FL LENTZ, BRIAN 10/19/2006 DENVER, CO LEWIS, FRANK 10/19/2006 DAVIS, CA LIMIDO, GLEN 10/19/2006 MAYWOOD, NJ LINEBARGER, NANCY 10/19/2006 GUILD, NH LO CASCIO, THOMAS 10/19/2006 FLORAL PARK, NY LOGAN, JOEL 10/19/2006 NORWELL, MA LOVATO, ANDREA 10/19/2006 MONROE, NH LOWMAN, BRIAN 10/19/2006 OOLTEWAH, TN LUCAS, KATINA 10/19/2006 STATEN ISLAND, NY LUCAS, KRISTI 10/19/2006 ROANOKE, VA LUCAS, LESLIE 10/19/2006 BARRE, VT MAGDELENA, EMILY 10/19/2006 MARICOPA, AZ MAGNON, CONSTANCE 10/19/2006 ELMENDORF, TX MANIG, MARK 10/19/2006 COLORADO SPRINGS, CO MARCH, LOIS 10/19/2006 CORDELE, GA MARRAZZO-TALLIA, CHRISTAL 10/19/2006 FAIRHAVEN, NJ MCGETTIGAN, MARY 10/19/2006 PHILADELPHIA, PA METIAM, FRANCROSENDO 10/19/2006 SPARKS, NV MILLER, CYNTHIA 10/19/2006 NASHVILLE, TN MILLER, TYLER 10/19/2006 MANTI, UT MITCHELL, JOSHUA 10/19/2006 AUGUSTA, ME MITCHELL, KENNETH 10/19/2006 SANFORD, ME MORALES, SUSAN 10/19/2006 FLORESVILLE, TX MORRIS, JANET 10/19/2006 JELLICO, TN MORRIS, THERESA 10/19/2006 ROCHESTER, NY MORRISON, HOLLY 10/19/2006 WESTERVILLE, OH NAZIR, KHALIL 10/19/2006 ALBANY, NY NELSON, J 10/19/2006 SALT LAKE CITY, UT NGUYEN, KHOA 10/19/2006 SEATTLE, WA NIELSEN, JAIMIE 10/19/2006 JOHNSON, VT NORRIS, DEBRA 10/19/2006 DALLAS, TX NORRIS, JO 10/19/2006 KRUM, TX NORWOOD, CAROLE 10/19/2006 BENTON, TN NURIAS LA FAMILIA PHARMACY 10/19/2006 DEERFIELD BEACH, FL OLIVER, BEVERLY 10/19/2006 DONALDSONVILLE, LA OLIVER, CRISTY 10/19/2006 ALVIN, TX OLMSTEAD, STEPHEN 10/19/2006 SEATTLE, WA ORNALES, JOEY 10/19/2006 YOAKUM, TX PARKER, ANDREA 10/19/2006 NEWARK, NY PARLANTE, DANIELLE 10/19/2006 WILLIAMSPORT, PA PASCO, MARITONE 10/19/2006 HOUSTON, TX PATURU, SUMATHI 10/19/2006 BIRMINGHAM, AL PETRIE, JENNIFER 10/19/2006 CLEARLAKE, CA PINA, DARLEEN 10/19/2006 TEATICKET, MA POOL-PARKER, MIKA 10/19/2006 NORMAN, OK PRIEM, LOREN 10/19/2006 DENVER, CO READ, BONNIE 10/19/2006 SPRING HILL, FL REDD, SHERRI 10/19/2006 SENATOBIA, MS REESE, CHRISTOPHER 10/19/2006 CLINTON, NY REHM, TODD 10/19/2006 LAKE GEORGE, NY ROCKE, DARCELLE 10/19/2006 DENVER, CO ROUSSEAU, JANET 10/19/2006 MIDDLETON, NH ROY, SUSAN 10/19/2006 SHREWSBURY, MA RUDOLPH, MELISSA 10/19/2006 CANAL WINCHESTER, OH SANDOVAL, MARIA 10/19/2006 WACO, TX SCHMITTLE, KARL 10/19/2006 YORK, PA SCOTT, SHARON 10/19/2006 BRIDGEWATER, MA SERTICH, PAMELA 10/19/2006 HELOTES, TX SHAPIRO, GARY 10/19/2006 SANTA MONICA, CA SHENKMAN, BERNARD 10/19/2006 ALLENTOWN, PA SILVA, MARLENE 10/19/2006 WILTON, CA SIMOLARIS, PAMELA 10/19/2006 LOWELL, MA SLAVIN, CARL 10/19/2006 ANNAPOLIS, MD SNOW, MICHAEL 10/19/2006 WEST CHESTER, PA SOMERVILLE, MICHAEL 10/19/2006 SALT LAKE CITY, UT SPILKER, BOBBI 10/19/2006 WESTON, OH STANLEY, TERESA 10/19/2006 CONROE, TX STECKEL, ELIZABETH 10/19/2006 HUDSON, OH STONE, MARY 10/19/2006 LAKEWOOD, NJ SUMMERSON, TAMMY 10/19/2006 FAIRHOPE, AL TERRIEN, MARGARET 10/19/2006 BURLINGTON, VT THOMAS, MARC 10/19/2006 ALBUQUERQUE, NM THOMPSON, VIOLET 10/19/2006 LAFAYETTE, IN TICE, FREDRICK 10/19/2006 SAN ANTONIO, TX TIPPETS, RANDY 10/19/2006 OGDEN, UT TOBAH, JAMES 10/19/2006 MESA, AZ TURNER, CLARENCE 10/19/2006 WORCESTER, MA UPCHURCH, YALINDA 10/19/2006 GARLAND, TX VALADEZ, STEPHEN 10/19/2006 SIGNAL MOUNTAIN, TN VAN DYKE, ALBERT 10/19/2006 MANTI, UT VINCENT, ERNIE 10/19/2006 CLAYTON, CA WALCZAK, CHRISTOPHER 10/19/2006 MONTPELIER, VT WALKER, PAMELA 10/19/2006 AUSTIN, TX WALTERS, BRENDA 10/19/2006 ABILENE, TX WATERS, MARK 10/19/2006 CEDAR CITY, UT WEISBACH, DAVID 10/19/2006 OCEANSIDE, CA WEISS, JUDITH 10/19/2006 APTOS, CA WELLS, MICHELLE 10/19/2006 WACO, TX WENZEL, STEPHEN 10/19/2006 FORT WORTH, TX WESLEY, MARILYN 10/19/2006 LITTLE ROCK, AR WHELAN, JOHN 10/19/2006 LINDENHURST, NY WHETSEL, SHARON 10/19/2006 ALVIN, TX WHITE, KENT 10/19/2006 CHATTANOOGA, TN WHITE, LINDA 10/19/2006 ENID, OK WILLIAMS, MATTHEW 10/19/2006 LAWTEY, FL WILLIAMS, ROBERT 10/19/2006 BALTIMORE, MD WRIGHT, CYNTHIA 10/19/2006 CHANTILLY, VA ZEIM, LISHA 10/19/2006 SALT LAKE CITY, UT ZINGARO, ROBERT 10/19/2006 EL PASO, TX FEDERAL/STATE EXCLUSION/SUSPENSION ASCONA AMBULETTE SERVICE, INC 10/19/2006 BROOKLYN, NY MARTINEZ, ROSA 10/19/2006 YAKIMA, WA FRAUD/KICKBACKS/PROHIBITED ACTS/SETTLEMENT AGREEMENT FERTAL, BRUCE 8/7/2006 CANAL FULTON, OH OWNED/CONTROLLED BY EXCLUDED/CONVICTED INDIVIDUAL ACTIVE PAIN CLINIC, PA 10/19/2006 NEW PORT RICHEY, FL BRANDON MOBILITY, INC 10/19/2006 W YARMOUTH, MA EMA EYEWEAR, INC 10/19/2006 HOLLYWOOD, FL HERNANDO ANESTHESIA ASSOCIATES PA 10/19/2006 WEEKI WACHEE, FL HIGHLAND HILLS MANAGEMENT CORP 10/19/2006 JESUP, GA NATIONALITIES UNITED, INCORPORATED 10/19/2006 LINCOLN, NE PRO-VENTION CHIROPRACTIC PC 10/19/2006 BETTENDORF, IA ST LUCIE PAIN CENTER, INC 10/19/2006 W PALM BEACH, FL ZAKY-SHERREL MEDICAL CORPORATION 10/19/2006 HUNTINGTON PARK, CA DEFAULT ON HEAL LOAN HERRING, CHARLES 10/19/2006 FREMONT, CA LANGSTON, MARTIN 10/19/2006 BATON ROUGE, LA PETRELL, ALICIA 10/19/2006 PLYMOUTH, MA PHIPPS, DONNA 10/19/2006 LONGVIEW, TX SATIR, SERVET 10/19/2006 ORANGE, TX CIVIL MONETARY PENAL LAW RICHARDS, CHRISTINE 4/25/2006 KNOXVILLE, IA Dated: February 2, 2007. Susan Earp, Acting Director, Exclusions Staff, Office of Inspector General. [FR Doc. E7-2081 Filed 2-7-07; 8:45 am] BILLING CODE 4152-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Office of the Director, National Institutes of Health; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the Advisory Committee to the Director, NIH. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. *Name of Committee:* Advisory Committee to the Director, NIH. *Date:* February 21, 2007. *Time:* 2:30 p.m. to 4 p.m. *Agenda:* To update members of the ACD on the NIH Reform Act of 2006 and other current issues affecting the NIH. *Place:* National Institutes of Health, Building 1, Conference Room 116, 9000 Rockville Pike, Bethesda, MD 20892. (Telephone Conference Call). *Contact Person:* Penny W. Burgoon, PhD, Senior Assistant to the Deputy Director, Office of the Director, National Institutes of Health, 1 Center Drive, Building 1, Room 114, Bethesda, MD 20892. 301-451-5870, *burgoonp@od.nih.gov.* This meeting is being published less than 15 days prior to the meeting due to timing limitations imposed by administrative matters. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Information is also available on the Institute's/Center's home page: *http://www.nih.gov/about/director/acd.htm,* where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals for Disadvantaged Backgrounds; 93.232, Loan Repayment Program for Research Generally; 93.39, Academic Research Enhancement Award; 93.936, NIH Acquired Immunodeficiency Syndrome Research Loan Repayment program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds, National Institutes of Health, HHS) Dated: February 1, 2007. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 07-567 Filed 2-7-07; 8:45 am]
Connectionstraces to 13
Traces to 13 documents
6 references not yet in our index
  • Pub. L. 92-463
  • 40 CFR 2
  • 40 CFR 112
  • 40 CFR 122.26
  • 40 CFR 122.26(g)(1)(ii)
  • 40 CFR 22
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U.S.C.§ 1311
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C.F.R.§ 22.45
C.F.R.§ 22.4
U.S.C.§ 241
U.S.C.§ 209
Pub. L.Pub. L. 92-463
Cite40 CFR 2
Cite40 CFR 112
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