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Code · REGISTER · 2006-12-12 · DEPARTMENT OF HEALTH AND HUMAN SERVICES · Notices

Notices. Notice

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BILLING CODE 4160-90-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-07-0008] 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 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 Emergency Epidemic Investigations (0920-0008)—Revision—Office of Workforce and Career Development (OWCD), Centers for Disease Control and Prevention (CDC). Background and Brief Description One of the objectives of CDC's epidemic services is to provide for the prevention and control of epidemics and protect the population from public health crises such as man made or natural biological disasters and chemical emergencies. This objective is carried out, in part, by training investigators, maintaining laboratory capabilities for identifying potential problems, collecting and analyzing data, and recommending appropriate actions to protect the public's health. When state, local, or foreign health authorities request help in controlling an epidemic or solving other health problems, CDC dispatches skilled epidemiologists from the Epidemiologist Intelligence Service
(EIS)to investigate and resolve the problem. The purpose of the Emergency Epidemic Investigation surveillance is to collect data on the conditions surrounding and preceding the onset of a problem. The data must be collected in a timely fashion so that information can be used to develop prevention and control techniques, to interrupt disease transmission and to help identify the cause of an outbreak. Since the events necessitating the collections of information are of an emergency nature, most data collection is done by direct interview or written questionnaire and are one-time efforts related to a specific outbreak or circumstance. If during the emergency investigation, the need for further study is recognized, a project is designed and separate OMB clearance is required. Interviews are conducted to be as unobtrusive as possible and only the minimal information necessary is collected. The Emergency Epidemic Investigations is the principal source of data on outbreaks of infectious and noninfectious diseases, injuries, nutrition, environmental health and occupational problems. Each investigation does contribute to the general knowledge about a particular type of problem or emergency, so that data collections are designed to take into account similar situations in the past. Some questionnaires are standardized, such as investigations of outbreaks aboard aircraft or cruise vessels. The Emergency Epidemic Investigations provides a range of data on the characteristics of outbreaks and those affected by them. Data collected include demographic characteristics, exposure to the causative agent(s), transmission patterns and severity of the outbreak on the affected population. These data, together with trend data, may be used to monitor the effects of change in the health care system, planning of health services, improving the availability of medical services and assessing the health status of the population. Users of the Emergency Epidemic Investigations data include, but are not limited to EIS Officers in investigating the patterns of disease or injury, investigating the level of risky behaviors, identifying the causative agent and identifying the transmission of the condition and the impact of interventions. Epi Trip Reports are delivered to the state health agency official requesting assistance shortly after completion of the Emergency Epidemic Investigation. The official can comment on both the timeliness and the practical utility of the recommendations from the investigation. CDC is requesting that a new form be added to the current clearance. Upon completion of the Emergency Epidemic Investigation, requesting officials at the state or local health department will be asked to complete a brief questionnaire to assess the promptness of the investigation and the usefulness of the recommendations. The total burden hours are 3,775. This slight increase over the last request for clearance is due to additional data that will be collected from the requesting state or local officials described above. *Estimated Annualized Burden Table:* Respondents Number of respondents Number of responses per respondent Average burden per response (in hours) General Public 15,000 1 15/60 State and Local Officials 100 1 15/60 Dated: December 6, 2006. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E6-21117 Filed 12-11-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-07-0603] 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 Information Network (REACH IN)-Extension-National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background and Brief Description Racial and Ethnic Approaches to Community Health 2010 (REACH 2010) currently funds forty local coalitions to establish community based programs and culturally appropriate interventions to eliminate racial and ethnic health disparities. Two previously funded grantees also retain access to the system. Communities served by REACH 2010 include: African American, American Indian, Hispanic American, Asian American, and Pacific Islander. These communities select among infant mortality, deficits in breast and cervical cancer screening and management, cardiovascular diseases, diabetes, HIV/AIDS, and deficits in childhood and adult immunizations to focus their interventions. Guided by logic models, each community articulates goals, objectives, and related activities; tracks whether goals and objectives are met, ongoing, or revised; and evaluates all program activities. This information is then entered into the REACH Information Network (REACH IN). REACH IN is a customized internet-based support system that allows REACH 2010 grantees to perform remote data entry and retrieval of data. This support system is designed to create on-demand graphs and reports of grantees' activities and accomplishments, monitor progress toward the achievement of goals and objectives, and share and synthesize information across grantees' activities. Both quantitative and qualitative analyses can be performed. These analyses relate primarily to three stages of the REACH 2010 logic model: capacity building, targeted actions (interventions), and community and systems change and change among change agents. Users are supported with technical assistance and training, covering the usage of the system from a content/project goals perspective, and technical operations. The annualized estimated burden is based on 42 respondents, including 40 currently funded grantees and two that were funded previously who retain access to the system. It is estimated that they each use the system four times a year to enter data, each data entry taking about 30 minutes. There are no costs to the respondents other than their time. The total estimated annualized burden hours are 84. *Estimated Annualized Burden Table:* Type of responses or kinds of respondents Nunber of respondents Number of responses per respondent Average burden per response (in hours) REACH 2010 grantees 42 4 30/60 Dated: December 6, 2006. Deborah Holtzman, Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E6-21118 Filed 12-11-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-07-07AC] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention
(CDC)will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 and send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to *omb@cdc.gov.* Comments are invited on:
(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;
(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;
(c)ways to enhance the quality, utility, and clarity of the information to be collected; and
(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project Formative Research to Inform the Routine HIV Testing for gynecologists providing primary care services and Prevention Is Care
(PIC)Social Marketing Campaigns—New—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)[Proposed], Coordinating Center for Infectious Diseases (CCID), Centers for Disease Control and Prevention (CDC). Background and Brief Description This project involves formative research to inform the development of two Centers for Disease Control and Prevention (CDC)-sponsored social marketing campaigns: Social Marketing Campaign to Make HIV Testing a Routine Part of Medical Care for Gynecologists Providing Primary Care Services (Routine HIV Testing), and Prevention Is Care (PIC). The goal of the Routine HIV Testing Campaign is to increase HIV testing rates among women seeking gynecological primary care services and the objective of the campaign is to make HIV testing a routine part of primary care provided by obstetrician/gynecologists (OB/GYN). PIC entails encouraging primary care physicians
(PCP)and Infectious Disease Specialists who deliver care to patients living with HIV and screen them for HIV transmission behaviors and deliver brief messages on the importance of protecting themselves and others by reducing their risky behaviors. The long-term objective of the campaign is to establish PIC as the standard of care for persons living with HIV. The study entails conducting focus groups and interviews to test creative materials with a sample of Obstetrician/Gynecologists (OB/GYN) for Routine HIV Testing and with PCP and Infectious Disease Specialists for PIC. Findings from this study will be used by CDC and its partners to inform current and future program activities. For Routine HIV Testing, we expect a total of 81 physicians to be screened for eligibility. Of the 81 physicians who are screened, we expect that 27 will participate in a focus group and 27 will participate in an interview. For PIC, we expect a total of 162 physicians to be screened for eligibility. Of the 162 physicians who are screened, we expect that 54 will participate in a focus group and 54 will participate in an interview. There are no costs to the respondents other than their time. *Estimate of Annualized Burden Hours* Respondents Number of respondents Responses per respondent Average burden per response (in hours) Total burden hours Routine HIV Testing Screener 81 1 10/60 14 Routine HIV Testing Focus Group 27 1 2 54 Routine HIV Testing Interview 27 1 1 27 PIC Screener 162 1 10/60 27 PIC Focus Group 54 1 2 108 PIC Interview 54 1 1 54 Total 284 Dated: December 6, 2006. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E6-21124 Filed 12-11-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-07-07AD] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention
(CDC)will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 and send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to * omb@cdc.gov* . *Comments are invited on:*
(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;
(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;
(c)ways to enhance the quality, utility, and clarity of the information to be collected; and
(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project Formative Research to Inform an HIV Testing Social Marketing Campaign for African American Heterosexual Men—New—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)[Proposed], Coordinating Center for Infectious Diseases (CCID), Centers for Disease Control and Prevention (CDC). Background and Brief Description This project involves formative research to inform the development of the HIV Testing Social Marketing Campaign for African American Heterosexual Men, a CDC-sponsored social marketing campaign aimed at increasing HIV testing rates among young, single, African American men. The study entails conducting focus groups and interviews with a sample of single African American heterosexual men, ages 18 to 45, with less than 4 years of college education to:
(1)Explore participants' knowledge, attitudes and beliefs about HIV and HIV testing to inform the development of campaign messages;
(2)identify the most motivating approach, supporting data, and key messages for materials development;
(3)test creative concepts, potential campaign themes, logos and names; and
(4)test creative materials developed based on the findings from the previous phases of the research. Findings from this study will be used by CDC and its partners to inform current and future program activities. We expect a total of 306 participants to be screened for eligibility. Of the 306 participants who are screened, we expect that 81 people will participate in a focus group and 72 people will participate in an interview. There are no costs to the respondents other than their time. *Estimated Annualized Burden Hours and Burden Table:* Respondents Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden hours Screener 306 1 10/60 51 Focus Group 81 1 2 162 Interview 72 1 1 72 Total 285 Dated: December 6, 2006. Joan F. Karr, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E6-21125 Filed 12-11-06; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration
(FDA)is announcing an amendment to the notice of meeting of the Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee. This meeting was originally announced in the **Federal Register** of November 24, 2006 (71 FR 67879). The amendment is being made to reflect a change in the *Date and Time* portion of the document, specifically, a change in the start time of the meeting. There are no other changes. FOR FURTHER INFORMATION CONTACT: Nancy Collazo-Braier, Office of the Center Director (HFZ-1), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-3959, *nancy.braier@fda.hhs.gov* , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014510232. Please call the Information Line for up-to-date information on this meeting. SUPPLEMENTARY INFORMATION: In the **Federal Register** of November 24, 2006, FDA announced that a meeting of the Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee would be held on December 15, 2006. On page 67879, in the second column, the *Date and Time* portion of the document is amended to read as follows: *Date and Time* : The meeting will be held on December 15, 2006, from 8 a.m. to 5 p.m. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees. Dated: December 5, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6-21020 Filed 12-11-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service [Funding Opportunity Number HHS-2006-IHS-SP-0001; CFDA Numbers: 93.971, 93.123, and 93.972] Health Professions Preparatory, Health Professions Pregraduate and Indian Health Professions Scholarship Programs; Announcement Type: Initial *Key Dates: Application Deadline:* February 28, 2007; *Application Review:* March 26-30, 2007; *Application Notification:* First week of July, 2007; *Award Start Date:* August 1, 2007. I. Funding Opportunity Description The Indian Health Service
(IHS)is committed to encouraging American Indians and Alaska Natives to enter the health professions and to assuring the availability of Indian health professionals to serve Indians. The IHS is committed to the recruitment of students for the following programs: • The Indian Health Professions Preparatory Scholarships authorized by section 103 of the Indian Health Care Improvement Act (IHCIA), as amended. • The Indian Health Professions Pregraduate Scholarships authorized by section 103 of the IHCIA, as amended. • The Indian Health Professions Scholarships authorized by section 104 of the IHCIA, as amended. Full-time and part-time scholarships will be funded for each of the three scholarship programs. II. Award Information Awards under this initiative will be administered using the grant mechanism of the IHS. *Estimated Funds Available:* An estimated $14.3 million will be available for FY 2007 awards. *Anticipated Number of Awards:* Approximately 194 awards will be made under the Health Professions Preparatory and Pregraduate Scholarship Programs for Indians. The awards are for 10 months in duration and the average award to a full-time student is approximately $24,366. An estimated 338 awards will be made under the Indian Health Scholarship (Professions) Program. The awards are for 12 months in duration and the average award to a full-time student is for approximately $38,236. In FY 2007, an estimated $5,130,000 is available for continuation awards, and an estimated $9,170,000 is available for new awards. *Project Period* —The project period for the Health Professions Preparatory Scholarship support is limited to 2 years for full-time students and the part-time equivalent of 2 years, not to exceed 4 years for part-time students. The project period for the Health Professions Pregraduate Scholarship Support is limited to 4 years for full-time students and the part-time equivalent of 4 years, not to exceed 8 years for part-time students. The Indian Health Professions Scholarship support is limited to 4 years for full-time students and the part-time equivalent of 4 years, not to exceed 8 years for part-time students. III. Eligibility Information This announcement is a limited competition for awards made to American Indians (Federally recognized Tribal members, state recognized Tribal members, and first and second degree descendants of Tribal members), or Alaska Natives only. 1. Eligible Applicants The Health Professions Preparatory Scholarship (Section 103) awards are made to American Indians (Federally recognized Tribal members, state recognized Tribal members, and first and second degree descendants of Tribal members), or Alaska Natives who: • Have successfully completed high school education or high school equivalency; • Have been accepted for enrollment in a compensatory, pre-professional general education course or curriculum; and • For initial awards, priority will be given to those who are eligible to continue in the section 104 scholarship program to meet the need of the service to increase the number of Indian health professionals who have an active duty service obligation to work in Indian communities under written contract with the Secretary. The Health Professions Pregraduate Scholarship (Section 103) awards are made to American Indians (Federally recognized Tribal members, state recognized Tribal members, and first and second degree Tribal members), or Alaska Natives who: • Have successfully completed high school education or high school equivalency; • Have been accepted for enrollment or are enrolled in an accredited pregraduate program leading to a baccalaureate degree in pre-medicine, pre-dentistry and pre-podiatry; and • For initial awards, priority will be given to those who are eligible to continue in the section 104 scholarship program to meet the need of the service to increase the number of Indian health professionals who have an active duty service obligation to work in Indian communities under written contract with the Secretary. The Indian Health Professions Scholarship (Section 104) may be awarded only to an individual who is a member of a federally recognized Indian Tribe as provided by section 4(c), and 4(d) of the IHCIA. Membership in a Tribe recognized only by a state does not meet this statutory requirement. To receive an Indian Health Scholarship (Professions) an otherwise eligible individual must be enrolled in an appropriately accredited school and pursuing a course of study in a health profession as defined by section 4(n) of the IHCIA. 2. Cost Sharing/Matching The Scholarship Program does not require matching funds or cost sharing to participate in the competitive grant process. IV. Application and Submission Information 1. Address To Request Application Package Applicants are responsible for contacting and requesting an application packet from their IHS Area coordinator. They are listed on the IHS Web site at *http://www.ihs.gov/JobsCareerDevelop/DHPS/Scholarships/SCoordinator_Directory.asp.* This information is listed below. Please review the following list to identify the appropriate IHS Area coordinator for your state. Application packets may be obtained by calling or writing to the following individuals listed below: IHS area office and states/locality served Scholarship coordinator/address Aberdeen Area IHS, Iowa, Nebraska, North Dakota, South Dakota Ms. Kim Lawrence, IHS Area Coordinator, Aberdeen Area IHS, 115 4th Avenue, SE, Aberdeen, SD 57401. Tele:
(605)226-7532. Alaska Native Tribal Health Consortium, Alaska Ms. Rita Dotomain, Alternate: Ms. Rea Bavilla, IHS Area Coordinator, 4000 Ambassador Drive, Anchorage, Alaska 99508. Tele:
(907)729-1332. Albuquerque Area IHS, Colorado, New Mexico Ms. Cora Boone, IHS Area Coordinator, Albuquerque Area IHS, 5300 Homestead Road, NE, Albuquerque, NM 87110. Tele:
(505)248-4418. Bemidji Area IHS, Illinois, Indiana, Michigan, Minnesota, Wisconsin Mr. Tony Buckanaga, IHS Area Coordinator, Bemidji Area IHS, 522 Minnesota Avenue, NW., Room 209, Bemidji, MN 56601. Tele:
(218)444-0486. Billings Area IHS, Montana, Wyoming Mr. Delon Rock Above, Alternate: Ms. Bernice Hugs, IHS Area Coordinator, Billings Area IHS, Area Personnel Office, P.O. Box 36600, 2900 4th Avenue, North, Suite 400, Billings, MT 59103. Tele:
(406)247-7100. California Area IHS, California, Hawaii Ms. Mona Celli, IHS Area Coordinator, California Area IHS, 650 Capitol Mall, Suite 7-100, Sacramento, CA 95814. Tele:
(916)930-3981. Nashville Area IHS, Alabama, Arkansas, Connecticut, Delaware, Florida, Georgia, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Mississippi, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Vermont, Virginia, West Virginia, District of Columbia Ms. Cora Boone, IHS Area Coordinator, Nashville Area IHS, 5300 Homestead Road, NE, Albuquerque, NM 87110. Tele:
(505)248-4418. Navajo Area IHS, Arizona, New Mexico, Utah Ms. Roselinda Allison, IHS Area Coordinator, Navajo Area IHS, P.O. Box 9020, Window Rock, AZ 86515. Tele:
(928)871-1358. Oklahoma City Area IHS, Kansas, Missouri, Oklahoma Ms. Melissa Westfall, IHS Area Coordinator, Oklahoma City Area IHS, Five Corporate Plaza, 3625 NW. 56th Street, Oklahoma City, Oklahoma 73112. Tele:
(405)951-6040. Phoenix Area IHS, Arizona, Nevada, Utah Ms. Kimberly Honahnie, IHS Area Coordinator, Phoenix Area IHS, Two Renaissance Square, 40 North Central Avenue, Suite #510, Phoenix, AZ 85004. Tele:
(602)364-5253. Portland Area IHS, Idaho, Oregon, Washington Ms. Laurie Veitenheimer, IHS Area Coordinator, Portland Area IHS, 1220 SW Third Avenue, Rm. 476, Portland, OR 97204-2892. Tele:
(503)326-6983. Tucson Area IHS, Arizona, Texas Ms. Reanetta Siquieros, IHS Area Coordinator, Tucson Area IHS, 7900 South “J.” Stock Rd., Tucson, AZ 85746. Tele:
(520)295-2440. 2. Content and Form of Application Submission Each applicant will be responsible for submitting a completed application and 1 copy (Forms IHS-856-1, through 856-8) to their IHS Area Coordinator. Electronic applications are not being accepted for this cycle. The application will be considered complete if the following documents (original and 1 copy) are included. • Completed Signed Application Checklist. • Original Signed Complete Application Form IHS-856 (For Continuation Students—Data Sheet in place of IHS-856). • Current Letter of Acceptance from College/Proof of Application to Health Professions Program. • Official Transcripts for All Colleges. • Cumulative GPA: Applicants Calculation. • Documents for Indian Eligibility. A. If you are a member of a Federally recognized Tribe (recognized by the Secretary of the Interior), provide evidence of membership such as:
(1)Certification of Tribal enrollment by the Secretary of the Interior, acting through the Bureau of Indian Affairs (BIA Certification: Form 4432—Category A or D, whichever is applicable); or
(2)In the absence of BIA certification, documentation that you meet requirements of Tribal membership as prescribed by the charter, articles of incorporation or other legal instrument of the Tribe and have been officially designated as a Tribal member as evidenced by an accompanying document signed by an authorized Tribal official, or
(3)Other evidence of Tribal membership satisfactory to the Secretary of the Interior. B. If you are a member of a Tribe terminated since 1940 or a State recognized Tribe, provide official documentation that you meet the requirements of Tribal membership as prescribed by the charter, articles of incorporation or other legal instrument of the Tribe and have been officially designated as a Tribal member as evidenced by an accompanying document signed by an authorized Tribal official; or other evidence, satisfactory to the Secretary of the Interior, that you are a member of the Tribe. In addition, if the terminated or state recognized Tribe of which you are a member is not on a list of such Tribes published by the Secretary of the Interior in the **Federal Register** , you must submit an official signed document that the Tribe has been terminated since 1940 or is recognized by the state in which the Tribe is located in accordance with the law of that state. C. If you are not a Tribal member but are a natural child or grandchild of a Tribal member, you must submit:
(1)Evidence of that fact, e.g., your birth certificate and/or your parent's birth certificate showing the name of the Tribal member; and
(2)evidence of your parent's or grandparent's Tribal membership in accordance with paragraphs A and B. The relationship to the Tribal member must be clearly documented. Failure to submit the required documentation will result in the application not being accepted for review. Note: If you meet the criteria of B or C, you are eligible only for the Preparatory or Pregraduate Scholarships. • Two Faculty/Employer Evaluations with original signature. • Reasons for Requesting Scholarship. • Delinquent Debt Form. • 2007 W-4 Form with original signature. • Course Curriculum Verification with original signature. • Acknowledgment Card. • Curriculum for Major. Health Professions Applicants Only: • Health Related Experience (MPH only)—Optional Form 3. Submission Dates and Times *Application Receipt Date:* The application deadline for new applicants is Wednesday, February 28, 2007. Applications (original and 1 copy) shall be considered as meeting the deadline if they are received by the appropriate IHS Area Coordinator on the deadline date or postmarked on or before the deadline date. Applicants should request a legibly dated U.S. Postal Service postmark or obtain a legibly dated receipt from a commercial carrier or U.S. Postal Service. Private metered postmarks will not be acceptable as proof of timely mailing and will not be considered for funding. Once the application is received, the applicant will receive an “Acknowledge of Receipt of Application” (IHS-815) card that is included in the application packet. 4. Intergovernmental Review Executive Order 12372 requiring intergovernmental review is not applicable to this program. 5. Funding Restrictions No more than 5% of available funds will be used for part-time scholarships this fiscal year. Students are considered part-time if they are enrolled for a minimum of 6 hours of instruction and are not considered in full-time status by their college/university. Documentation must be received from part-time applicants that their school and course curriculum allows less than full-time status. Both part-time and full-time scholarship awards will be made in accordance with 42 CFR 136.320, 136.330 and 136.370 incorporated in the application materials; and for Health Professions Scholarship Program for Indians. 6. Other Submission Requirements New applicants are responsible for contacting and requesting an application packet from their IHS Area Coordinator. Electronic applications are not being accepted for this award cycle. The Division of Grants Operations will mail continuation students an application packet and if you do not receive this information please contact your IHS Area Coordinator to request a continuation application. V. Application Review Information 1. Criteria Applications will be reviewed and scored with the following criteria: • Needs of the IHS (Health Manpower needs in Indian Country). Applicants are considered for scholarship awards based on their desired career goals and how these goals relate to current Indian health manpower needs. Applications for each health career category are reviewed and ranked separately. • Academic Performance (40 points). Applicants are rated according to their academic performance as evidenced by transcripts and faculty evaluations. In cases where a particular applicant's school has a policy not to rank students academically, faculty members are asked to provide a personal judgement of the applicant's achievement. Health Professions applicants with a cumulative GPA below 2.0 are not eligible to apply. • Faculty/Employer Recommendations (30 points). Applicants are rated according to evaluations by faculty members, current and/or former employers and Tribal officials regarding the applicant's potential in the chosen health related professions. • Stated Reasons for Asking for the Scholarship and Stated Career Goals (30 points). Applicants must provide a brief written explanation of reasons for asking for the scholarship and of their career goals. The applicant's narrative will be judged on how well it is written and its content. • Applicants who are closest to graduation or completion are awarded first. For example, senior and junior applicants under the Health Professions Pregraduate Scholarship receive funding before freshmen and sophomores. • Priority Categories. The following is a list of health professions that will be funded in each scholarship program in FY 2007. • Health Professions Preparatory Scholarships. A. Pre-Clinical Psychology (Jr & Sr undergraduate years). B. Pre-Dietetics. C. Pre-Engineering. D. Pre-Medical Technology. E. Pre-Nursing. F. Pre-Occupational Therapy. G. Pre-Pharmacy. H. Pre-Physical Therapy (Jr and Sr undergraduate years). I. Pre-Sanitation. J. Pre-Social Work (Jr and Sr undergraduate years). • Health Professions Pregraduate Scholarships. A. Pre-Dentistry. B. Pre-Medicine. C. Pre-Podiatry • Indian Health Scholarships (Professions). A. Chemical Dependency Counseling: Baccalaureate and Masters Level. B. Clinical Psychology: Ph.D. Program. C. Coding Specialist. D. Dental Hygiene: B.S. E. Dentistry: D.D.S. or D.M.D. F. Diagnostic Radiology Technology: Certificate, Associate, and B.S. G. Dietitian: B.S. H. Environmental Health & Engineering: B.S. I. Health Care Administration: Bachelors & Masters Level. J. Health Education: Bachelors & Masters Level. K. Health Records: R.H.I.T and R.H.I.A. L. Injury Prevention Specialist: Certificate. M. Medical Technology: B.S. N. Medicine: Allopathic and Osteopathic. O. Nurse: Associate & Bachelor Degrees & advanced degrees in Psychiatry, Geriatric, Women's Health, Pediatric Nursing, Nurse Anesthetist, & Nurse Practitioner. *(Priority consideration will be given to Registered Nurses employed by the Indian Health Service; in a program assisted under a contract entered into under the Indian Self-Determination Act; or in a program assisted under Title V of the Indian Health Care Improvement Act.) P. Occupational Therapy: B.S. Q. Optometry: O.D. R. Pharmacy: Pharm D. S. Physician Assistant: PAC. T. Physical Therapy Assistant: Associate degree. U. Physical Therapy: M.S. and D.P.T. V. Podiatry: D.P.M. W. Public Health: M.P.H. only (Applicants must be enrolled or accepted in a school of public health with concentration in Epidemiology). X. Public Health Nutrition: Masters Level only. Y. Respiratory Therapy: Associate degree. Z. Social Work: Masters Level only (Direct Practice and Clinical concentrations). AA. Ultrasonography (Prerequisite: Diagnostic Radiology Technology). 2. Review and Selection Process The applications will be reviewed & scored by the IHS Scholarship Programs' Application Review Committee appointed by the IHS. Each reviewer will not be allowed to review an application from his/her area or his/her own Tribe. Each application will be reviewed by three reviewers. The average score of the three reviews provide the final Ranking Score for each applicant. To determine the ranking of each applicant, these scores are sorted from the highest to the lowest within each scholarship, health discipline, date of graduation, and score. If several students have the same date of graduation and score within the same discipline, computer ranking list will randomly sort and will not be sorted by alphabetical name. Selections for recommendations to the Director, IHS, are then made from the top of each ranking list to the extent that funds allocated by the IHS among the three scholarships are available for obligation. VI. Award Administration Information 1. Award Notices It is anticipated that applicants will be notified in writing during the first week of July, 2007. An Award Letter will be issued to successful applicants. Unsuccessful applicants will be notified in writing, which will include a brief explanation of the reasons the application was not successful and provide the name of the IHS official to contact if more information is desired. 2. Administrative and National Policy Requirements Regulations at 42 CFR 136.304 provide that the IHS shall, from time to time, publish a list of health professions eligible for consideration for the award of Indian Health Professions Preparatory and Pregraduate Scholarships and Indian Health Scholarships (Professions). Section 104(b)(1) of the IHCIA, as amended by the Indian Health Care Amendment of 1988, Public Law 100-713, authorizes the IHS to determine specific health professions for which Indian Health Scholarships will be awarded. Awards for the Indian Health Scholarships (Professions) will be made in accordance with 42 CFR 136.330. Recipients shall incur a service obligation prescribed under section 338A of the Public Health Service Act (42 U.S.C. 254l) which shall be met by service:
(1)In the Indian Health Service;
(2)In a program conducted under a contract or compact entered into under the Indian Self-Determination Act and Education Assistance Act (Pub. L. 93-638) and its amendments;
(3)In a program assisted under Title V of the Indian Health Care Improvement Act (Pub. L. 94-437) and its amendments; and
(4)In a private practice option of his or her profession, if the practice:
(a)is situated in a health professional shortage area, designated in regulations promulgated by the Secretary; and
(b)addresses the health care needs of a substantial number (51%) of Indians as determined by the Secretary in accordance with guidelines of the Service. Pursuant to the Indian Health Amendments of 1992 (Pub. L. 102-573), a recipient of an Indian Health Professions Scholarship may, at the election of the recipient, meet his/her active duty service obligation prescribed under section 338A of the Public Health Service Act (42 U.S.C. 254l) by a program specified in options (1)-(4) above that:
(i)Is located on the reservation of the Tribe in which the recipient is enrolled; or
(ii)Serves the Tribe in which the recipient is enrolled. In summary, all recipients of the Indian Health Scholarship (Health Professions) are reminded that recipients of this scholarship incur a service obligation. Moreover, this obligation shall be served at a facility determined by the Director, IHS, consistent with IHCIA, Pub. L. 94-437, as amended by Public Law 100-713, and Public Law 102-573. 3. Reporting Scholarship Program Minimum Academic Requirements It is the policy of the IHS that a scholarship recipient awarded under the Health Professions Scholarship Program of the Indian Health Care Improvement Act maintain a 2.0 cumulative grade point average
(GPA)each semester/quarter and be a full-time student (minimum of 12 credit hours considered by your school as full-time). A recipient of a scholarship under the Health Professions Pre-Graduate and Health Professions Preparatory Scholarship authority must maintain a good academic standing each semester/quarter and be a full time student (minimum of 12 credit hours or the number of credit hours considered by your school as full-time). In addition to the two requirements stated above, a Health Professions Scholarship program grantee must be enrolled in an approved/accredited school for a health professions degree. Part-time students for the three scholarship programs must also maintain a 2.0 cumulative GPA and must take at least 6 credit hours each semester/quarter but less than the number of hours considered full-time by your school. Scholarship grantees must be approved for part-time status at the time of scholarship award. Scholarship grantees may not change from part-time status to full-time status or vice versa in the same academic year. The following reports must be sent to the IHS Scholarship Program at the identified time frame. Each scholarship grantee will be provided with an IHS Scholarship Handbook where the below needed reports are located. If a scholarship grantee fails to submit these reports as required, they will be ineligible for continuation of scholarship support and scholarship award payments will be discontinued. A. Recipient's Enrollment and Initial Progress Report Within thirty
(30)days from the beginning of each semester or quarter, scholarship grantees must submit a Recipient's Enrollment and Initial Progress Report (Form F-02 of the student handbook). B. Transcripts Within thirty
(30)days from the end of each academic period, i.e., semester, quarter, or summer session, scholarship grantees must submit an Official Transcript showing the results of the classes taken during that period. C. Notification of Academic Problem/Change If at any time during the semester/quarter, scholarship grantees are advised to reduce the number of credit hours for which they are enrolled below the minimum of 12 (or the number of hours considered by their school as full time) for a full-time student or at least 6 hours for part-time students; or if they experience academic problems, they must submit this report (page F-04 of student handbook). D. Change of Status • Change of Academic Status. Scholarship Grantees must immediately notify the IHS Area Coordinator if they are placed on academic probation, dismissed from school, or voluntarily withdraw for any reason (personal or medical). • Change of Health Discipline. Scholarship Grantees may not change from the approved IHS Scholarship Program health discipline during the school year. If an unapproved change is made, scholarship payments will be discontinued. • Change in Graduation Date. Any time that a change occurs in a scholarship grantee's expected graduation date, they must notify their IHS Area Coordinator immediately in writing. Justification must be attached from the school advisor. VII. Agency Contacts Please address application inquiries to the appropriate IHS Area Coordinator. Other programmatic inquiries may be addressed to Ms. Patricia Lee McCoy, Director, Division of Health Professions Support, Indian Health Service, 801 Thompson Avenue, Suite 120, Rockville, Maryland 20852; Telephone
(301)443-6197. (This is not a toll free number.) For grants information, contact the Grants Scholarship Coordinator, Division of Grants Operations, Indian Health Service, 801 Thompson Avenue, Suite 120, Rockville, Maryland 20852; Telephone
(301)443-0243. (This is not a toll-free number). VIII. Other Information The Public Health Service
(PHS)is committed to achieving the health promotion and disease prevention objectives of *Healthy People 2010* , a PHS-led activity for setting priority areas. This program announcement is related to the priority area of Education and Community-Based Programs. Potential applicants may obtain a copy of *Healthy People 2010* , (Full Report; Stock No. 017-001-00474-0) or Healthy People 2010 (Summary Report; Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 [Telephone
(202)783-3238]. Interested individuals are reminded that the list of eligible health and allied health professions is effective for applicants for the 2007-2008 academic year. These priorities will remain in effect until superseded. Applicants for health and allied health professions not on the above priority list will be considered pending the availability of funds and dependent upon the availability of qualified applicants in the priority areas. Dated: December 4, 2006. Robert G. McSwain, Deputy Director, Indian Health Service. [FR Doc. E6-21026 Filed 12-11-06; 8:45 am] BILLING CODE 4165-16-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. Erythroid Progenitor Cells and Methods for Producing Parvovirus B19 Therein *Description of Technology:* The present technology offers novel methods of cell culture for production of human parvovirus B19 (B19). B19, a common infection of children adults, is the cause of fifth disease. Symptoms of B19 infection are usually mild in otherwise healthy individuals, but some adults can suffer chronic arthopathy. Severe health conditions and mortality may result from B19 infection of immunocompromised individuals and patients with chronic hemolytic anemia such as sickle cell disease. In addition, B19 infection during pregnancy may cause hydrops fetalis and fetal death. There is no specific antiviral drug for B19, and some forms of chronic infection are difficult to diagnose. Vaccination is an effective strategy for other animal parvoviruses and is feasible for B19 in humans. B19 selectively infects erythroid progenitor cells of bone marrow, fetal liver and a small number of specialized cell lines. These specific cell lines demonstrate limited infectability and commonly produce little or no virus following initial inoculation with B19. Current methods for producing infectious B19 require phlebotomy of infrequently available infected donors. The available technology describes a method of producing pure populations of human erythroid progenitor cells that are fully permissive to B19 infection. This discovery uses CD34+ hematopoietic stem cells present in peripheral blood to supply erythroid progenitor cells, which demonstrate a significant increase in viral production after initial inoculation. The ability to efficiently generate significant amounts of infectious B19V in cells is useful for the development of killed or attenuated vaccines, therapeutics and efficient diagnostic tools for prevention and treatment of B19V. Furthermore, this technology would allow development of new diagnostic assays, which use the entire virus as the antigenic target, thus providing more sensitive and accurate results than current diagnostic tools, which rely on antibodies against a single viral protein. *Applications:*
(1)Diagnosis of human parvovirus B19;
(2)Vaccination of individuals at risk for severe effects of parvovirus infection;
(3)Research and development of anti-parvovirus agents. *Development Status:* Preclinical data is available at this time. *Inventors:* Susan Wong and Neal Young (NHLBI). *Related Publications:* 1. MC Giarratana, L Kobari, H Lapillonne, D Chalmers, L Kiger, T Cynober, MC Marden, H Wajcman, L Douay. Ex vivo generation of fully mature human red blood cells from hematopoietic stem cells. Nat Biotechnol. 2005 Jan; 23(1):69-74. 2. JM Freyssinier, C Lecoq-Lafon, S Amsellem, F Picard, R Ducrocq, P Mayeux, C Lacombe, S Fichelson. Purification, amplification and characterization of a population of human erythroid progenitors. Br J Haematol. 1999 Sep; 106(4):912-922. *Patent Status:* U.S. Provisional Application No. 60/808,904 filed 26 May 2006 (HHS Reference No. E-188-2006/0-US-01). *Licensing Status:* Available for non-exclusive or exclusive licensing and commercial development. *Licensing Contact:* Chekesha S. Clingman, Ph.D.; 301/435-5018; *clingmac@mail.nih.gov.* *Collaborative Research Opportunity:* The NHLBI Hematology Branch is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize novel methods to produce parvovirus B19 and use as diagnostic or vaccine. Please contact Dr. Neal Young at 301-496-5093, *YoungNS@mail.nih.gov* for more information. Small Molecules for Imaging Protein-Protein Interactions *Description of Technology:* Imaging techniques like positron emission tomography and photon emission computerized tomography are often used with imaging agents to detect the presence and accumulation of amyloid plaques within the human brain. These imaging agents have high specificity for beta amyloid peptides, and administration of such agents aids in the early detection of amyloid plaques in brains of Alzheimer's victims. However, currently available imaging agents have limited success for detecting pre-plaque beta amyloid proteins because they are small and reside within the tissue for a short period of time. Therefore, new imaging agents are needed for enhanced identification of amyloid deposits. Available for licensing and commercial development are small molecules for imaging protein-protein interactions in Alzheimer's disease. This technology describes a bifunctional molecule with high specificity for beta amyloid proteins that is applicable for in vivo imaging. The molecule contains two moieties with different binding affinities, one moiety has an affinity for amyloid beta proteins, and the other moiety has an affinity for a tissue-specific chaperone. The different moieties of the subject invention are conjoined by an inert linkage group, typically comprised of a hydrocarbon chain, peptide, or carbohydrate. The subject invention is affixed with a label, such as a fluorophore or radioisotope, which adheres to the binding site of the beta amyloid protein, the chaperone, or the linkage group. The choice of label makes the subject invention versatile and employable in several types of imaging modalities such as single photon emission computed tomography (SPECT), positron emission tomography (PET), magnetic resonance imaging (MRI), and computerized tomography
(CT)scans. *Applications:*
(1)Applicable for identification of beta amyloid plaques in patients with or at risk for Alzheimer's disease and pre-plaque amyloid beta proteins;
(2)Applicable for in vivo imaging protein-protein interactions using small molecules;
(3)Applicable for image guided therapy of Alzheimer's disease. *Market:*
(1)Alzheimer's disease affects approximately 4.5 million people within the United States;
(2)The direct and indirect annual costs associated with Alzheimer's disease are at least $100 billion. *Development Status:* Pre-clinical data is available. *Inventors:* King C. Li and S. Narasimhan Danthi (CC). *Patent Status:* U.S. Provisional Application No. 60/815,740 filed 21 Jun 2006 (HHS Reference No. E-046-2006/0-US-01). *Licensing Status:* Available for exclusive or non-exclusive licensing. *Licensing Contact:* Chekesha S. Clingman , Ph.D.; 301-435-5018; *clingmac@mail.nih.gov.* *Collaborative Research Opportunity:* The National Institutes of Health Clinical Center, Laboratory of Diagnostic Radiology Research, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize Small Molecules for Imaging Protein-Protein Interactions. Please contact Betty Tong, Ph.D. at 301-594-4263 for more information. Methods and Systems for Identifying and Classifying Drug Targets *Description of Technology:* Available for licensing and commercial development is a novel method for a-priori evaluation of the therapeutic relevance of gene products for various diseases, in order to make drug development more cost-efficient. In addition, this technology may be used to identify novel therapeutic uses for known drugs. For example, the current invention has the potential to uncover the role of an established cancer drug target, in an alternative disorder such as Alzheimer's disease, thus providing an additional use for the available cancer drug. The multivariable model used by the method, which is based on a training set of targets that have already passed FDA review, is capable of ranking drug targets in terms of prospective clinical success. This innovative approach integrates multiple datasets that describe each single gene product from a broad range of analyses, such as microarrays, x-ray crystallography, and phylogenetics, to rapidly characterize a proteins structure, function, and gene regulation information. An algorithm subsequently scores a protein's potential as a drug target for use in future drug design studies. The resulting set of targets is enriched 28-fold as compared to randomly selected gene products. *Applications:*
(1)Early evaluation of a candidate drug target's potential to yield a therapeutic effect, given the target's inhibitor is provided;
(2)Efficient discovery of novel drugs and drug targets;
(3)Classification of genes according to their involvement in specific diseases. *Development Status:* The technology is ready to be used in drug discovery and development. *Inventors:* Anatoly L. Mayburd (NCI), James L. Mulshine (NCI), et al. *Patent Status:* U.S. Provisional Application No. 60/788,522 filed 31 Mar 2006 (HHS Reference No. E-268-2005/0-US-01). *Licensing Status:* Available for non-exclusive or exclusive licensing. *Licensing Contact:* Cristina Thalhammer-Reyero, Ph.D., M.B.A.; 301-435-4507; *thalhamc@mail.nih.gov.* Systems and Methods for Intelligent Quality Control of Instruments and Processes *Description of Technology:* Available for licensing and commercial development is a cost-effective system and method for evaluation of instruments and processes for real-time detection of error. The subject invention includes the capacity to identify imprecision in a variety of data analysis tools, which may be susceptible to malfunction. Such processes include instrumental analysis of patient specimens, assembly line manufacturing and general plant or factory operation. This system provides an automated platform for the dual purpose of
(1)monitoring data to detect unusual events in real time and
(2)enhancement of human and machine recognition and analysis of improper occurrences based on time-varying patterns of measured values. The scheme of the current system is straightforward and in general the method involves the following steps:
(1)Collection of data elements from an instrument or process
(2)counting data elements having values within predetermined intervals of the data range
(3)applying counts of data to a neural network that monitors data trends and
(4)production of an output based on the neural network, which demonstrates whether the instrument or process is generating results within an appropriate range. This system is advantageous because output is generated in real time and thus available without delay for immediate correction of malfunctions. *Applications:*
(1)Quality control for processes and instruments;
(2)Automated system for real time notification of malfunctions in an instrument or process for immediate correction of the procedure. *Development Status:* The technology is fully developed. *Inventors:* James M. Deleo
(CIT)and Alan T. Remaley (CC). *Patent Status:* U.S. Patent No. 6,556,951 issued 29 Apr 2003 (HHS Reference No. E-042-1997/0-US-03). *Licensing Status:* Available for non-exclusive and exclusive licensing. *Licensing Contact:* Cristina Thalhammer-Reyero, Ph.D., M.B.A.; 301-435-4507; *thalhamc@mail.nih.gov.* *Collaborative Research Opportunity:* The National Institutes of Health Clinical Center, Radiologic and Imaging Sciences, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize Intelligent Quality Control of Instruments. Please contact Elaine Ayres at 301/594-3019 for more information. Sample Delivery System With Laminar Mixing for Microvolume Biosensing *Description of Invention:* The invention is a sample delivery system with at least two microchannels connected to a sample chamber containing a biosensor. Biosensing for studying molecular recognition has become an important biophysical tool for biomedical research. The system aspirates a small sample volume into the microfluidic channels and applies a periodic oscillatory flow pattern to the sample. This prevents sample depletion in the stagnant layer across the sensor surface and results in efficient mixing of the sample during the biosensor measurement. Because the oscillatory flow pattern does not produce a net transport of the sample with time, there is a very long incubation time of the sensor surfaces with a very small sample volume. The new sample delivery system uses sample volumes of only 3 to 8 microliters, compared to the 25 to 200 microliter volumes of conventional systems, which use cuvette principles or continuous flow microfluidics. The present invention is substantially better than existing systems with respect to biosensor contact time and required sample volume. *Application:* Sample delivery for biosensing. *Development Status:* A prototype of the technology is currently being implemented in inventor's lab and technology is ready for commercialization. *Inventor:* Peter Schuck (ORS). *Publication:* M Abrantes, MT Magone, LF Boyd, P Schuck. Adaptation of a surface plasmon resonance biosensor with microfluidics for use with small sample volumes and long contact times. Anal Chem. 2001 Jul 1;73(13):2828-2835. *Patent Status:* U.S. Patent Application No. 10/415,909 filed 05 May 2003, claiming priority to 06 Nov 2000 (HHS Reference No. E-143-2000/0-US-03); European Patent Application No. 01990651.0 filed 11 Jun 2001 (HHS Reference No. E-143-2000/0-EP-04). *Licensing Status:* Available for non-exclusive or exclusive licensing. *Licensing Contact:* Michael A. Shmilovich, Esq.; 301/435-5019; *shmilovm@mail.nih.gov.* *Collaborative Research Opportunity:* The NIH Office of Research Services, Division of Bioengineering and Physical Science, Protein Biophysics Resource, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this Sample Delivery System technology. Please contact Dr. Peter Schuck at 301-435-1950 or *pschuck@helix.nih.gov* for more information. Vaccine for Dengue Virus *Description of Technology:* The claimed invention relates to viable chimeric dengue viruses or their derived recombinant mutants for use as vaccines against dengue and other flavivirus diseases, including tick-borne encephalitis and West Nile encephalitis. Dengue is a mosquito-transmitted viral disease which occurs in tropical and subtropical regions throughout the world. Inactivated whole dengue virus vaccines have been shown to be insufficiently immunogenic and live dengue virus vaccines prepared by serial passage in cell culture have not been shown to be consistently attenuated. A dengue vaccine is still not available. The present invention represents a technical breakthrough, which provides new approaches to dengue vaccines by construction of chimeric dengue viruses of all four serotypes and strategic modification to produce attenuated virus strains. Several fields of use remain available for licensing. *Applications:* Prevention of dengue outbreaks, severe and fatal dengue caused by dengue viruses, a major public health problem in tropical and subtropical regions. *Inventors:* Ching-juh Lai, et al. (NIAID). *Patent Status:* U.S. Patent 6,184,024 issued 06 Feb 2001 (HHS Reference No. E-171-1988/1-US-02); U.S. Patent 6,676,926 issued 13 Jan 2004 (HHS Reference No. E-171-1988/1-US-03). *Licensing Status:* Available for non-exclusive licensing. *Licensing Contact:* Peter A. Soukas, J.D.; 301-435-4646; *soukasp@mail.nih.gov.* Murine Monoclonal Antibodies Effective To Treat Respiratory Syncytial Virus *Description of Technology:* Available for licensing through a Biological Materials License Agreement are the murine MAbs described in Beeler et al, “Neutralization epitopes of the F glycoprotein of respiratory syncytial virus: effect of mutation upon fusion function,” J Virol. 1989 Jul;63(7):2941-2950. The MAbs that are available for licensing are the following: 1129, 1153, 1142, 1200, 1214, 1237, 1112, 1269, and 1243. One of these MAbs, 1129, is the basis for a humanized murine MAb (see U.S. Patent 5,824,307 to humanized 1129 owned by MedImmune, Inc.), recently approved for marketing in the United States. MAbs in the panel reported by Beeler et al. have been shown to be effective therapeutically when administered into the lungs of cotton rats by small-particle aerosol. Among these MAbs several exhibited a high affinity (approximately 109M-1) for the RSV F glycoprotein and are directed at epitopes encompassing amino acid 262, 272, 275, 276 or 389. These epitopes are separate, nonoverlapping and distinct from the epitope recognized by the human Fab of U.S. Patent 5,762,905 owned by The Scripps Research Institute. *Applications:* Research and drug development for treatment of respiratory syncytial virus. *Inventors:* Robert M. Chanock, Brian R. Murphy, Judith A. Beeler, and Kathleen L. van Wyke Coelingh (NIAID). *Patent Status:* HHS Reference No. B-056-1994/1—Research Tool. *Licensing Status:* Available for non-exclusive licensing under a Biological Materials License Agreement. *Licensing Contact:* Peter A. Soukas, J.D.; 301/435-4646; *soukasp@mail.nih.gov.* Dated: December 1, 2006. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6-21028 Filed 12-11-06; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301-496-7057; fax: 301-402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. Noncovalent HIV Env-CD4 Complexes as HIV Vaccines *Description of Technology:* HIV vaccine technology based on HIV envelope protein
(Env)have been less successful than anticipated to date. One possible reason for this is the potential conformational masking of neutralizing epitopes. The current technology combines HIV Env and cell surface polypeptides CD4 in non-covalent complexes to expose epitopes not present on the uncomplexed Env molecules. These complexes can thus be used to elicit neutralizing antibodies when used as vaccines, immunogenic compositions or immunotherapies. The CD4 inducing epitopes found in regions of the virus that are most conserved across clades are unmasked and immune sera generated with this technology neutralized primary HIV-1 viruses from several clades. Additionally, cell surface polypeptide CD4 is in its native conformation and masked by Env, therefore it is unlikely to induce autoantibodies. *Applications and Advantages:*
(1)HIV vaccine based on conformationally masked epitopes;
(2)Presents epitopes to immune system that are the same or similar as with actual HIV infection;
(3)Multiple copies of Env may enhance immune response and limit dosage. *Inventors:* Jinhai Wang and Michael Norcross (CDER/FDA). Patent Status: U.S. Provisional Application No. 60/711,985 filed 25 Aug 2005 (HHS Reference No. E-173-2005/0-US-01); PCT Application filed 25 Aug 2006 (HHS Reference No. E-173-2005/1-PCT-01). *Licensing Contact:* Susan Ano, PhD; 301-435-5515; *anos@mail.nih.gov.* *Collaborative Research Opportunity:* The FDA Center for Drug Evaluation and Research is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize this HIV Env-CD4 technology. Please contact Beatrice A. Droke at 301/827-7008 or *bea.droke@fda.hhs.gov* for more information. Modified Bacterial Strain for Otitis Media Vaccine *Description of the Technology:* This invention relates to a strain of Moraxella catarrhalis containing a gene mutation that prevents endotoxic lipooligosaccharide
(LOS)synthesis and potential use of the mutant for developing novel vaccines against the pathogen, for which there is currently no licensed vaccine. M. catarrhalis is one of the causative agents of otitis media (middle ear infection), sinusitis, and lung infections. The mutant is defective in the lpxA gene, whose enzyme product is relevant in lipid A biosynthesis (lipid A is part of the LOS). The nontoxic mutant was found to elicit high levels of antibodies with bactericidal activity and provided protection against wild type bacterial challenge. Use of this mutant bacterium is envisioned as a new approach for vaccines against M. catarrhalis. *Applications:* Otitis media vaccine, sinusitis, and lung infections. *Inventors:* Xin-Xing Gu and Daxin Peng (NIDCD). *Patent Status:* U.S. Provisional Application No. 60/577,244 filed 04 Jun 2004 (HHS Reference No. E-174-2004/0-US-01); U.S. Provisional Application No. 60/613,139 filed 23 Sep 23 (HHS Reference No. E-174-2004/1-US-01); PCT Application No. PCT/US2005/019479 filed 03 Jun 2005 (HHS Reference No. E-174-2004/2-PCT-01). *Licensing Status:* Available for non-exclusive licensing—biological materials. *Licensing Contact:* Susan Ano, PhD; 301/435-5515; *anos@mail.nih.gov.* *Collaborative Research Opportunity:* The Vaccine Research Section in the National Institute on Deafness and Other Communication Disorders (NIDCD) is seeking statements of capability or interest from parties interested in collaborative research. NIDCD is interested in developing outer membrane proteins (OMP), outer membrane vesicle (OMV), and whole cell vaccines generated from the mutant. The mutant strain can also be used as an effective vehicle to express and deliver protective antigens from other important human pathogens. Please contact Dr. Xin-Xing Gu by phone (301-402-2456) or e-mail ( *guxx@nidcd.nih.gov* ) for more information. A Method With Increased Yield for Production of Polysaccharide-Protein Conjugate Vaccines Using Hydrazide Chemistry *Description of Technology:* Current methods for synthesis and manufacturing of polysaccharide-protein conjugate vaccines employ conjugation reactions with low efficiency (about twenty percent). This means that up to eighty percent of the added activated polysaccharide
(PS)is lost. In addition, inclusion of a chromatographic process for purification of the conjugates from unconjugated PS is required. The present invention utilizes the characteristic chemical property of hydrazide groups on one reactant to react with aldehyde groups or cyanate esters on the other reactant with an improved conjugate yield of at least sixty percent. With this conjugation efficiency the leftover unconjugated protein and polysaccharide would not need to be removed and thus the purification process of the conjugate product can be limited to diafiltration to remove the by-products of small molecules. The new conjugation reaction can be carried out within one or two days with reactant concentrations between 1 and 25 mg/mL at PS/protein ratios from 1:2 to 3:1, at temperatures between 4 and 40 degrees Centigrade, and in a pH range of 5.5 to 7.4, optimal conditions varying from PS to PS. *Application:* Cost effective and efficient manufacturing of conjugate vaccines. *Inventors:* Che-Hung Robert Lee and *Carl E. Frasch* (CBER/FDA). *Patent Status:* U.S. Patent Application No. 10/566,899 filed 01 Feb 2006, claiming priority to 06 Aug 2003 (HHS Reference No. E-301-2003/0-US-10); U.S. Patent Application No. 10/566,898 filed 01 Feb 2006, claiming priority to 06 Aug 2003 (HHS Reference No. E-301-2003/1-US-02); International rights available. *Licensing Status:* Available for non-exclusive licensing. *Licensing Contact:* Peter A. Soukas, J.D.; 301/435-4646; *soukasp@mail.nih.gov.* HIV Entry Inhibitor *Description of Technology:* The technology relates to a chimeric molecule, N <sup>CCG</sup> -gp41, in which the internal trimeric helical coiled-coil of the ectodomain of gp41 is fully exposed and stabilized by both fusion to a minimal ectodomain core of gp41 and by engineered intersubunit disulfide bonds. N <sup>CCG</sup> -gp41 inhibits HIV envelope mediated cell fusion at nanomolar concentrations with an IC <sup>50</sup> of 16 nM. It is proposed that N <sup>CCG</sup> -gp41 targets the exposed C-terminal region of the gp41 ectodomain in its pre-hairpin intermediate state, thereby preventing the formation of the fusogenic form of the gp41 ectodomain that comprises a highly stable trimer of hairpins arranged in a six-helix bundle. Antibodies have been raised against N <sup>CCG</sup> -gp41 that inhibit HIV envelope mediated cell fusion. *Applications:*
(1)Entry inhibitor HIV therapeutic;
(2)HIV/AIDS vaccine;
(3)As a component of a high throughput screening assay for small molecule inhibitors of HIV envelope mediated cell fusion. *Development Status:* The technology is currently in pre-clinical stage of development. *Inventors:* G. Marius Clore et al. (NIDDK). *Publications:* 1. JM Louis et al. Design and properties of N <sup>CCG</sup> -gp41, a chimeric gp41 molecule with nanomolar HIV fusion inhibitory activity. J Biol Chem. 2001 Aug 3;276(31):29485-29489. 2. CA Bewley et al. Design of a novel peptide inhibitor of HIV fusion that disrupts the internal trimeric coiled-coil of gp41. J Biol Chem. 2002 Apr 19;277(16):14238-14245. 3. JM Louis et al. Covalent trimers of the internal N-terminal trimeric coiled-coil of gp41 and antibodies directed against them are potent inhibitors of HIV envelope-mediated cell fusion. J Biol Chem. 2003 May 30;278(22):20278-20285. 4. JM Louis et al. Characterization and HIV-1 fusion inhibitory properties of monoclonal Fabs obtained from a human non-immune phage library selected against diverse epitopes of the ectodomain of HIV-1 gp41. J Mol Biol. 2005 Nov 11;353(5):945-951. *Patent Status:* U.S. Patent Application No. 10/499,094 filed 14 Jun 2004 (HHS Reference No. E-252-2001/0-US-03); EP application 02795951.9 and IN application 1535/CHENP/2004. *Licensing Status:* Available for non-exclusive or exclusive licensing. *Licensing Contact:* Susan Ano, Ph.D.; 301/435-5515; *anos@mail.nih.gov.* Subgenomic Replicons of the Flavivirus Dengue *Description of Technology:* Dengue virus, with its four serotypes Den-1 to Den-4, is the most important member of the Flavivirus genus with respect to infection of human producing diseases that range from flu-like symptoms of dengue fever
(DF)to severe or fatal illness of dengue hemorrhagic fever
(DHF)and dengue shock syndrome (DSS). Dengue outbreaks continue to be a major public health problem in densely populated areas of the tropical and subtropical regions, where mosquito vectors are abundant. This invention relates to the construction of all four types of dengue subgenomic replicons (chromosome and plasmid which contain genetic information necessary for their own replication) containing large deletions in the structural region (C-preM-E) of the genome. Immunization using these replicons should be effective in eliciting not only a humoral-mediated immune response but also a cell-mediated immune response. These replicons should be safer than a live attenuated vaccine because they cannot cause disease in the host and they should be better than subunit vaccines because they can replicate in the host. *Applications:* Prevention of severe and/or fatal human disease caused by dengue virus, a major health concern in tropical and subtropical regions. *Inventor:* Xiaowu Pang (CBER/FDA). *Patent Status:* U.S. Patent Application 10/656,721 filed 05 Sep 2003, claiming priority to 09 Mar 2001 (HHS Reference No. E-228-2000/0-US-03). *Licensing Status:* Available for non-exclusive or exclusive licensing. *Licensing Contact:* Peter A. Soukas, J.D.; 301/435-4646; *soukasp@mail.nih.gov.* Dated: December 1, 2006. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6-21029 Filed 12-11-06; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. ARH3, a Therapeutic Target for Cancer, Ischemia, and Inflammation *Description of Technology:* ADP-ribosylation is important in many cellular processes, including DNA replication and repair, maintenance of genomic stability, telomere dynamics, cell differentiation and proliferation, and necrosis and apoptosis. Poly-ADP-ribose is important in a number of critical physiological processes such as DNA repair, cellular differentiation, and carcinogenesis. Until recently, only one human enzyme, PARG, had been identified that degrades the ADP-ribose polymer. Another ADP-ribose, O-acetyl-ADP ribose, is formed via the deacetylation of proteins, such as acetyl-histone, by proteins in the Sir2 family. Sir2 proteins have been implicated in regulation of chromatin structure and longevity. The NIH announces the discovery of a novel PARG-like enzyme, ARH3. ARH3 possesses PARG activity, yet is structurally distinct from PARG. ARH3 also hydrolyzes O-acetyl-ADP-ribose, and is the only protein recognized to date with such activity. ARH3 thus appears to function in two important signaling pathways, serving to regulate both poly-ADP-ribose and O-acetyl-ADP-ribose levels. It may affect chromatin structure through effects on both pathways. Since ARH3 structures differs from PARG or other enzymes that participate in these pathways, it may be possible to design specific inhibitors to target both the poly-ADP-ribose and Sir2 pathways. These drugs may be used as anticancer agents, radiosensitizers or antiviral agents, or for treating disorders involving oxidative damage, such as acute tissue injury, ischemia, and inflammation. *Applications:*
(1)Development of therapeutics for cancer or disorders associated with excessive DNA damage;
(2)Development of therapeutics for diseases involving oxidative damage, such as acute tissue injury, ischemia and inflammation. *Market:*
(1)Patients with chemotherapy-resistant tumors, or with cancers that are genetically deficient in DNA repair;
(2)Patients with inflammatory or ischemia/reperfusion diseases, particularly those associated with acute cardiovascular disease. *Development Status:* Early stage. *Inventors:* Joel Moss et al. (NHLBI). *Related Publications:* 1. S Oka, J Kato, J Moss. Identification and characterization of a mammalian 39-kDa poly(ADP-ribose) glycohydrolase. J Biol Chem. 2006 Jan 13;281(2):705-713. 2. T Ono, A Kasamatsu, S Oka, J Moss. The 39-kDa poly(ADP-ribose) glycohydrolase ARH3 hydrolyzes *O* -acetyl-ADP-ribose, a product of the Sir2 family of acetyl-histone deacetylases. Proc Natl Acad Sci USA 2006 Nov 7;103(45):16687-16691. Epub 2006 Oct 30, doi 10.1073/pnas.0607911103. *Patent Status:* U.S. Provisional Application No. 60/716,807 filed 12 Sep 2005 (HHS Reference No. E-347-2004/0-US-01); PCT Application No. PCT/US2006/035771 filed 12 Sep 2006 (HHS Reference No. E-347-2004/0-PCT-02). *Licensing Status:* Available for exclusive or non-exclusive licensing. *Licensing Contact:* Tara L. Kirby, PhD; 301/435-4426; *tarak@mail.nih.gov.* *Collaborative Research Opportunity:* The Pulmonary Critical Care Medicine Branch in the National Heart, Lung, and Blood Institute is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize the invention. Please contact Marianne Lynch in the NHLBI Office of Technology Transfer and Development by phone (301-594-4094) or e-mail ( *lynchm@nhlbi.nih.gov* ) for more information. Antisera To Detect Phosphorylated Phosphoinositide-Dependent Kinase 1 (PDK-1) *Description of Technology:* PDK-1 phosphorylates and activates a number of cellular kinases, and plays a major role in insulin and growth factor signaling. PDK-1 also represents a promising drug target for a number of cancers. Autophosphorylation at Ser244 (mouse) or Ser241 (human) is critical for PDK-1 activity. Available for licensing are polyclonal rabbit antisera that specifically detect mouse PDK-1 protein phosphorylated at Ser244. These antisera are also expected to be specific for the human PDK-1 protein phosphorylated at Ser241. *Applications:*
(1)Tool for screening PDK-1 autophosphorylation inhibitors for cancer and other indications;
(2)Tool for studying insulin and growth factor signaling. *Inventor:* Michael J. Quon (NCCAM). *Publication:* MJ Wick, FJ Ramos, H Chen, MJ Quon, LQ Dong, F Liu. Mouse 3-phosphoinositide-dependent protein kinase-1 undergoes dimerization and trans-phosphorylation in the activation loop. J Biol Chem. 2003 Oct 31;278(44):42913-42919. *Patent Status:* HHS Reference No. E-330-2003/0—Research Tool. *Licensing Status:* This technology is available as a research tool under a Biological Materials License. *Licensing Contact:* Tara Kirby, PhD; 301/435-4426; *tarak@mail.nih.gov* *Collaborative Research Opportunity:* The NIH, NCCAM, Diabetes Unit is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize phospho-specific PDK-1 antibody and insulin signaling. Please contact Michael J. Quon, Chief, Diabetes Unit, NCCAM, NIH at *quonm@nih.gov* for more information. Dated: December 6, 2006. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6-21037 Filed 12-11-06; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Library of Medicine; 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 the following meeting. The meeting will be open to the public as indicated below, 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. The portions of the meeting devoted to the review and evaluation of journals for potential indexing by the National Library of Medicine will be closed to the public in accordance with the provisions set forth in section 552b(c)(9)(B), Title 5 U.S.C., as amended. Premature disclosure of the titles of the journals as potential titles to be indexed by the National Library of Medicine, the discussions, and the presence of individuals associated with these publications could significantly frustrate the review and evaluation of individual journals. *Name of Committee:* Literature Selection Technical Review Committee. *Date:* February 22-23, 2007. *Open:* February 22, 2007, 9 a.m. to 11 a.m. *Agenda:* Administrative reports and program discussions. *Place:* National Library of Medicine, Building 38, Board Room, 2nd Floor, 8600 Rockville Pike, Bethesda, MD 20894. *Closed:* February 22, 2007, 11 a.m. to 5 p.m. *Agenda:* To review and evaluate journals as potential titles to be indexed by the National Library of Medicine. *Place:* National Library of Medicine, Building 38, Board Room, 2nd Floor, 8600 Rockville Pike, Bethesda, MD 20894. *Closed:* February 23, 2007, 8:30 a.m. to 2 p.m. *Agenda:* To review and evaluate journals as potential titles to be indexed by the National Library of Medicine. *Place:* National Library of Medicine, Building 38, Board Room, 2nd Floor, 8600 Rockville Pike, Bethesda, MD 20894. *Contact Person:* Sheldon Kotzin, MLS, Associate Director, Division of Library Operations, National Library of Medicine, 8600 Rockville Pike, Bldg 38/Room 2W06, Bethesda, MD 20894, 301-496-6921. *Sheldon_Kotzin@nlm.nih.gov.* 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. In the interest of security, NIH has instituted stringent procedures for entrance into the building by non-government employees. Persons without a government I.D. will need to show a photo I.D. and sign in at the security desk upon entering the building. (Catalogue of Federal Domestic Assistance Program No. 93.879, Medical Library Assistance, National Institutes of Health, HHS) Dated: December 4, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy, NIH. [FR Doc. 06-9631 Filed 12-11-06; 8:45 am]
Connectionstraces to 3
8 references not yet in our index
  • 21 CFR 14
  • 42 CFR 136.320
  • 42 CFR 136.304
  • Pub. L. 100-713
  • 42 CFR 136.330
  • Pub. L. 93-638
  • Pub. L. 94-437
  • Pub. L. 102-573
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Cite21 CFR 14
Cite42 CFR 136.320
Cite42 CFR 136.304
Pub. L.Pub. L. 100-713
Cite42 CFR 136.330
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