Rules and Regulations. Notice

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BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration

(301)443-1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: Office of Health Information Technology, Health Center Controlled Networks Progress Reports—New The Office of Health Information Technology (OHIT), Division of State and Community Assistance (DSCA), plans to collect network outcome measures, conduct evaluation of those measures, and create an electronic reporting system for the following new 2007 grant opportunities: Health Information Technology Planning Grants, Electronic Health Record Implementation Health Center Controlled Networks (HCCN), Health Information Technology Innovations for Health Center Controlled Networks, and High Impact Electronic Health Records Implementation for Health Center Controlled Networks and Large Multi Site Health Centers. In order to help carry out its mission, DSCA has created a set of performance measures that grantees will use to evaluate the effectiveness of their service programs and monitor their progress through the use of performance reporting data. OHIT has developed an electronic performance measurement reporting instrument with HRSA's Office of Information Technology. The instrument will accomplish the following goals: monitor improved access to needed services, evaluate the productivity and efficiency of the networks, and monitor patient outcome measures. Grantees will submit their Progress Reports in a mid-year report and an accumulative annual progress report each fiscal year of the grant. The estimates of burden are as follows: Form Estimated number of respondents Responses per respondent Total responses Hours per response Total burden hours HCCN Progress Reports 46 2 92 6 hrs 552 Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to the desk officer for HRSA, either by e-mail to *OIRA_submission@omb.eop.gov* or by fax to 202-395-6974. Please direct all correspondence to the “attention of the desk officer for HRSA.” Dated: October 18, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7-20939 Filed 10-23-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration

(HRSA)publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on 301-443-1129. The following request has been submitted to the OMB for review under the Paperwork Reduction Act of 1995: Proposed Project: The Nursing Education Loan Repayment Program Application (OMB No. 0915-0140)—Revision This is a request for revision of the Nursing Education Loan Repayment Program (NELRP) application and participant monitoring forms. The NELRP was originally authorized by 42 U.S.C. 297b(h) (section 836(h) of the Public Health Service Act) as amended by Public Law 100-607, November 4, 1988. The NELRP is currently authorized by 42 U.S.C. 297n (section 846 of the Public Health Service Act) as amended by Public Law 107-205, August 1, 2002. Under the NELRP, registered nurses are offered the opportunity to enter into a contractual agreement with the Secretary to receive loan repayment for up to 85 percent of their qualifying educational loan balance as follows: 30 percent each year for the first 2 years and 25 percent for the third year. In exchange, the nurses agree to serve full-time as a registered nurse for 2 or 3 years at a health care facility with a critical shortage of nurses. NELRP requires the following information: 1. Applicants must provide information on their nursing education, employment, and proposed service site; 2. Applicants must provide information on their outstanding nursing educational loans; 3. Applicants must provide banking information from their financial institution; and 4. Employers must provide information on the health care facility and on the employment status of applicants and participants. Estimates of Annualized Hour Burden Are as Follows for Applicants Form Number of respondents Responses per respondent Total responses Hours per response Total burden hours NELRP Application 5,000 1 5,000 1.5 7,500 Loan Verification Form 5,000 3 15,000 1 15,000 Applicant Employment Verification Form 5,000 1 5,000 .5 2,500 Payment Information Form 5,000 1 5,000 1 5,000 Application Checklist 5,000 1 5,000 .5 2,500 Pre-Award Confirmation Checklist 600 1 600 .25 150 Total 5,000 35,600 32,650 Estimates of Annualized Hour Burden Are as Follows for Participants Participant semi-annual employment verification form 1,300 2 2,600 .5 1,300 Total 1,300 2 2,600 .5 1,300 Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to the desk officer for HRSA, either by e-mail to *OIRA_submission@omb.eop.gov* or by fax to 202-395-6974. Please direct all correspondence to the “attention of the desk officer for HRSA.” Dated: October 17, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7-20940 Filed 10-23-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Comment Request In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Public Law 104-13), the Health Resources and Services Administration

(HRSA)publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer on

(301)443-1129. Comments are invited on:

(a)The proposed collection of information for the proper performance of the functions of the agency;

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

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

(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: Ryan White HIV/AIDS Program Core Medical Services Waiver Application Requirements (OMB No. 0915-0307): Revision Title XXVI of the Public Health Service

(PHS)Act, as amended by the Ryan White HIV/AIDS Treatment Modernization Act of 2006 (Ryan White HIV/AIDS Program), requires that grantees expend 75 percent of Parts A, B, and C funds on core medical services, including antiretroviral drugs, for individuals with HIV/AIDS identified and eligible under the legislation, effective fiscal year

(FY)2007. In order for grantees under Parts A, B, and C to be exempted from the 75 percent core medical services requirement, they must request and receive a waiver from HRSA, as required in the Act. Beginning in FY 2008, HRSA will utilize new standards for granting waivers of the core medical services requirement for the Ryan White HIV/AIDS Program. These standards meet the intent of the Ryan White HIV/AIDS Treatment Modernization Act of 2006 to increase access to core medical services, including antiretroviral drugs, for persons with HIV/AIDS and to ensure that grantees receiving waivers demonstrate the availability of such services for individuals with HIV/AIDS identified and eligible under Title XXVI of the PHS Act. The core medical services waiver uniform standard and waiver request process will apply to Ryan White HIV/AIDS Program grant awards under Parts A, B, and C of Title XXVI of the PHS Act. Core medical services waivers will be effective for a one-year period consistent with the grant award period. Grantees must submit a waiver request with the annual grant application containing the certifications and documentation which will be utilized by HRSA in making determinations regarding waiver requests. Grantees must provide evidence that all of the core medical services listed in the statute, regardless of whether such services are funded by the Ryan White HIV/AIDS Program, are available to all individuals with HIV/AIDS identified and eligible under Title XXVI of the PHS Act in the service area within 30 days. The estimated annual burden is as follows: Application Number of respondents Responses per respondent Total responses Hours per response Total burden hours Waiver Request 20 1 20 6.5 130 Total 20 20 130 Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. Written comments should be received within 60 days of this notice. Dated: October 18, 2007. Alexandra Huttinger, Acting Director, Division of Policy Review and Coordination. [FR Doc. E7-20945 Filed 10-23-07; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request; NICHD Research Partner Satisfaction Surveys SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget

(OMB)a request to review and approve the information collection listed below. The proposed information collection was previously published in the **Federal Register** on July 25, 2007, in Volume 72, No. 142, pages 40887-40888, and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The NIH may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented after October 1, 1995, unless it displays a currently valid OMB control number. *Proposed Collection:* *Title:* NICHD Research Partner Satisfaction Surveys. *Type of Information Collection Request:* Extension without change. *Need and Use of Information Collection:* Executive Order 12862 directs agencies that provide significant services directly to the public to survey customers to determine the kind and quality of services they want and their level of satisfaction with existing services. With this submission, the NICHD seeks to obtain OMB's generic approval to conduct customer satisfaction surveys surrounding its research programs and activities. The NICHD was founded in 1963. Its mission is to ensure, through research, the birth of healthy infants and the opportunity for each to reach full potential in adulthood, unimpaired by physical or mental disabilities. The NICHD conducts and supports research on the many factors that protect and enhance the process of human growth and development. The developmental focus of the NICHD means that its research portfolio is unusually broad. NICHD programs include research on infant mortality, birth defects, learning disorders, developmental disabilities, vaccine development, and demographic and behavioral sciences, among others. In addition to supporting basic research, clinical trials, and epidemiological studies that explore health processes, the NICHD forms partnerships with organizations or institutions to ensure effective use of scientific findings and research products. The NICHD utilizes strategic assessments to support Institute planning and policy development, and to help determine programmatic and scientific objectives and priorities. Research partner surveys will augment NICHD's ongoing efforts to assess research-related activities. The two principal objectives are:

(1)To measure the personal satisfaction of research partners with NICHD programs or initiatives, including both responsiveness to scientific aims and convenience of operations to support research and its effective use; and

(2)to learn from research partners the ways in which the NICHD can improve the overall planning and management of it programs and initiatives. Findings will be used to improve NICHD's research programs and initiatives in the following ways:

(1)To assess the effectiveness and efficiency of operations;

(2)to identify opportunities for improving program performance;

(3)to develop plans to incorporate innovations in program management;

(4)to measure partner satisfaction and document program outcomes for governmental accountability reporting; and

(5)to identify the need for creating new programs or initiatives or restructuring existing ones to respond to emerging scientific opportunities. *Frequency of Response:* Annual [As needed on an ongoing and concurrent basis]. *Affected Public:* Members of the public, researchers, practitioners, and other health professionals. *Type of Respondents:* Members of the public; eligible grant applicants and actual applicants (both successful and unsuccessful); clinicians and other health professionals; and actual or potential clinical trials participants. The annual reporting burden is as follows: *Estimated Number of Respondents:* 28,000; *Estimated Number of Responses per Respondent:* 1; *Average Burden Hours per Response:* Varies with survey type, see below; and *Estimated Total Annual Burden Hours Requested:* 5,883. The annualized cost to respondents is estimated at: $109,541.46. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Type of respondents Estimated number of respondents Estimated number of responses per respondent Average burden hours per response Estimated total annual burden hours requested Web-based 24,000 1 0.167 4,008.00 Telephone 2,000 1 0.50 1,000.00 Paper 1,500 1 0.25 375.00 In-person 500 1 1.00 500.00 Total 28,000 5,883.00 *Request for Comments:* Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points:

(1)Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility;

(2)The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

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

(4)Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. FOR FURTHER INFORMATION: To request more information on the proposed project, contact Paul L. Johnson, NIH NICHD Office of Science Policy, Analysis and Communication (OSPAC), 9000 Rockville Pike, Bldg. 31, Rm. 2A-18, Bethesda, Maryland 20892-2425, or call non-toll-free at 301-402-3213. You may also e-mail your request to *pjohnson@mail.nih.gov* . *Comments Due Date:* Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. Dated: October 17, 2007. Paul L. Johnson, Project Clearance Liaison, NICHD National Institutes of Health. [FR Doc. E7-20910 Filed 10-23-07; 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. Novel Micro-RNA Sequence Transforms Non-Functional T-Lymphocytes to Highly Functional: Key to Improved Immunotherapy for the Treatment of Cancers *Description of Technology:* This technology is directed to the therapeutic use of microRNA-181a in the adoptive immunotherapy of cancer. The adoptive transfer of anti-tumor T cells after a lymphodepleting regimen can result in the regression of metastatic cancer both in mouse and human, but the production of highly-reactive, tumor-specific T cells still represents a barrier to broad implementation of T cell-based immunotherapies. This technology enables the use of microRNA (miR)-181a, a recently identified intrinsic modulator of T-cell receptor

(TCR)signaling, to improve anti-tumor T cell responsiveness. Micro-RNAs are short RNA molecules that regulate the activity of genes and appear to control biological processes. We found that genetic engineering of T lymphocytes with miR-181a dramatically augmented the function of poorly responsive human tumor-infiltrating lymphocytes and TCR-engineered peripheral blood lymphocytes, resulting in potent anti-tumor reactivity. Furthermore, in a mouse model, miR-181a increased the function of self/tumor-specific CD8 + T cells enabling effective tumor destruction in the absence of vaccination or exogenous cytokines that were otherwise essential requirements. This technology is the first reported use of a miRNA gene as tool in the treatment of disease. *Applications:* The microRNA sequence (“miR-181a”) can be used to enhance the tumor recognizing capacity of T-lymphocytes against several tumors. This technology can be used for selective treatment of several cancers more effectively. *Advantages:* Proof-of concept pre-clinical data are available and clinical trials are currently being planned. This technology is based on adoptive immunotherapy, which is now an accepted and effective form of cancer treatment. *Benefits:* The microRNA identified has the potential to broaden and enhance the scope of adoptive immunotherapy. *Development Status:* Pre-clinical work has been completed and clinical studies are forthcoming. *Inventors:* Dr. Nicholas P. Restifo et al. (NCI). *Relevant Publication:* Q Li et al. miR-181a is an intrinsic modulator of T cell sensitivity and selection. Cell. 2007 Apr 6;129(1):147-161. *Patent Status:* U.S. Provisional Application filed 25 May 2007 (HHS Reference No. E-224-2007/0-US-01). *Licensing Status:* This technology is available for licensing under an exclusive or non-exclusive patent license. *Licensing Contact:* Michelle A. Booden, PhD; 301/451-7337; *boodenm@mail.nih.gov* . *Collaborative Research Opportunity:* The Surgery Branch of the National Cancer Institute is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize the therapeutic use of microRNA-181a in the adoptive immunotherapy of cancer. Please contact John D. Hewes, PhD at 301-435-3121 or *hewesj@mail.nih.gov* for more information. Use of HDAC Inhibitors for the Prevention and Cure for Brain Metastases of Cancers *Description of Technology:* The increased survival of primary and metastatic cancers consequential of improved therapies has resulted in increased brain metastases. Few treatment options are available for cancer patients with central nervous system

(CNS)metastasis. There is a need for new treatment options for CNS metastases especially brain metastases originating outside the CNS. The present invention provides a method of treating a localized carcinoma CNS metastasis of extra-CNS origin. More specifically, the method comprises of treating a localized carcinoma CNS metastasis of extra-CNS origin with a histone deacetylase

(HDAC)inhibitor (HDACI) originating in one or more organs such as lung, breast, liver, colon, and prostate. The HDACI can be any HDACI that is capable of crossing the blood-brain barrier

(BBB)such as vorinostat. *Advantages:* Vorinostat has been approved by the FDA for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma

(CTCL)who have progressive, persistent or recurrent disease on or following two systemic therapies, and as such, has efficacy and tolerability data. *Benefits:* More than 40,000 breast cancer deaths are estimated to occur in 2007. Majority of these deaths are due to metastases of the breast cancer. Approximately, 10%-20% of women with metastatic breast cancer are estimated to develop brain metastasis and the median survival after brain cancer metastasis is only one year. This technology may effectively treat breast cancer brain metastases and thus improve overall survival and quality of life of patients suffering from cancer. The current cancer chemotherapeutic market is valued at $42 billion and expected to grow. *Inventors:* Patricia S. Steeg et al. (NCI). *Development Status:* *In vivo* animal model data available with vorinostat. *Patent Status:* U.S. Provisional Application No. 60/891,856 filed 02 Feb 2007 (HHS Reference No. E-084-2007/0-US-01). *Licensing Contact:* John Stansberry; 301/435-5236; *stansbej@mail.nih.gov* . Dated: October 11, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E7-20909 Filed 10-23-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice of Meeting: Secretary's Advisory Committee on Genetics, Health, and Society Pursuant to Public Law 92-463, notice is hereby given of the fourteenth meeting of the Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS), U.S. Public Health Service. The meeting will be held from 8:30 a.m. to approximately 5:30 p.m. on Monday, November 19, 2007 and 8:30 a.m. to approximately 5:30 p.m. on Tuesday, November 20, 2007, at the Ronald Reagan Building and International Trade Center—1300 Pennsylvania Avenue, NW., Washington, DC 20004. The meeting will be open to the public with attendance limited to space available. The meeting also will be Web cast. The agenda will focus on three key issues—finalization of the SACGHS report on the opportunities and challenges in realizing the promise of pharmacogenomics; the oversight of genetic testing; and the preparedness of health professionals to incorporate genetic and genomic tests and services into clinical and public health practice. With regard to the oversight of genetic testing, SACGHS' draft report to the Secretary of Health and Human Services will be released for public comment in early November. The Committee will provide an extended period of time during the November meeting for members of the public to provide their perspectives on the oversight issues and comments on the Committee's draft report and recommendations. The Committee will also be briefed about an international analysis of oversight systems for genetic testing with a focus on the U.S. system. As always, the Committee welcomes hearing from anyone wishing to provide public comment on any issue related to genetics, health and society. Individuals who would like to provide public comment should notify the SACGHS Executive Secretary. Ms. Sarah Carr, by telephone at 301-496-9838 or e-mail at *carr@od.nih.gov.* The SACGHS office is located at 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892. Anyone planning to attend the meeting who is in need of special assistance, such as sign language interpretation or other reasonable accommodations, is also asked to contact the Executive Secretary. Under authority of 42 U.S.C. 217a, Section 222 of the Public Health Service Act, as amended, the Department of Health and Human Services established SACGHS to serve as a public forum for deliberations on the broad range of human health and societal issues raised by the development and use of genetic and genomic technologies and, as warranted, to provide advice on these issues. The draft meeting agenda and other information about SACGHS, including information about access to the Web cast, will be available at the following Web site: *http://www4.od.nih.gov/oba/sacghs.htm.* Dated: October 17, 2007. Jennifer Spaeth, Director, NIH Office of Federal Advisory Committee Policy. [FR Doc. 07-5240 Filed 10-23-07; 8:45 am]

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