SWAN Repository III

Fomi于2012年6月30日获批OMBNo.0925-0001 卫生与公众服务部 公共卫生服务 少年派：苗圃，玛丽弗兰理事会：2010年10月 显示12159591个ONS。2 U01 AG017719-11 A2 IPF：1506502 双人： 1.我的头衔，..^.、..、a、AK、Es。包括空格ANC IRG：ZAG1 SRC(99)已收到：03/15/2010 天鹅信息库III 2.对申请或计划公告或征集的具体请求作出回应^否D是 (如果“是”。州编号和头衔) 编号：标题： 3.项目主任/首席调查员 3A.姓名(姓、名、中)3b.学位(S)3h。Era Commons用户名 苗圃，玛丽弗兰博士硕士 3C。职位头衔3D。邮寄地址(街道、城市、州、邮政编码) 密歇根大学教授 3E。公共卫生学院系、服务、实验室或同等学系 流行病学 华盛顿高地1415号，1846室 3F。主要分部 安娜堡，毫升48109 公共卫生学院 3G。电话和传真(区号、号码和分机)电子邮件地址： 电话：734-936-3892传真：734-764-6250 4.人体研究4a。研究豁免如果是，豁免否。 D否S是^否n是 4B.联邦保险编号4C。临床试验4d。NIH定义的第三阶段临床试验 FWA00004969^否D是^否D是 5.脊椎动物E]否D是5a。动物福利保障编号A3114-01 6.最初请拨的拟议期间的日期8.请拨的拟议费用 支持(月IAV.Vear-MM/DD/YY)预算期支助期间 从7a开始。直接成本(70亿美元)。总成本(美元)8a。直接成本($)80亿。总成本(美元) 12/1/2010 11/30/2015$1,301,056$1,594,812$5,306,630$6,616,873 9.申请组织10.组织类型 说出密歇根大学公共分校的校董：-&&gt；n Federal State？ 地址：3003 South State Street Private：-“LJ Private非营利组织 1044房间 营利性：-*[]普通和小企业 安娜堡，密歇根州48109-1274I i妇女拥有的LJ在社会和经济上处于不利地位 11.实体识别号 1386006309A1 邓氏073133571号依康。地区MI-015 12.作出裁决时通知行政官员13.申请组织的正式签字 姓名：杰里·麦克斯韦尔姓名：大卫·M·普拉昌 职称项目代表，DRDA职称管理项目代表 密歇根大学地址密歇根大学 南道富3003号1040室3003Soutti道富1044室 安娜堡，邮编：48109-1274；安娜堡，邮编：48109-1274 电话：734-764-7246传真：734-764-8510电话：734-936-1289 电子邮件：Tmax(gumlch.edu E-Mat^trt^@ui7tich.edu 14.申请组织认证及验收：本人证明本公司9fGNaturt 据我所知，这里的陈述是真实、完整和准确的， I 4OK 接受遵守公共卫生服务条款和条件的义务 作为这项申请的结果被授予。我知道任何虚假的、虚构的或欺诈的 声明或索赔可能会使我受到刑事、民事或行政处罚。 小灵通398(6/09版)首页表格第1页 项目主任/首席调查员(最后、第一、中间)：苗圃，玛丽弗兰 项目总结(见说明)： 此竞争续订申请旨在为持续维护及相关活动提供支持 利用天鹅的血清、血浆、尿液、DNA和转化细胞的储存库 对来自5个民族的3302名妇女进行的研究，她们在此之前每年都会接受评估， 在更年期过渡期间和之后。这些资料库是妇女健康研究的一个分支 旨在支持、促进和扩展核心天鹅；此外， 资源库提供了一种机制，可以向更大的科学界开放Swan的资源。 执行与本次竞争性更新的三个拟议具体目标相关的活动将1) 用于继续管理目前的170万份资料库标本和额外的 将在2009年至2014年部署天鹅四号所产生的标本；2)扩大DNA储存库， 由于我们对细胞的投资，最常被请求的样本类型是唯一可再生的 永垂不朽；3)促进关于天鹅研究及其数据和 通过开发两级基于网络的“数据仓库”来储存资源；4)提供 继续管理标本利用的申请审查程序和行政管理 管理标本分发，包括材料转让协议；5)参与制定战略，以 促进标本的利用；以及，6)扩大与 《天鹅研究及其资料库》。 相关性(请参阅说明)：

Fomi Approved Through 6/30/2012 OMBNo. 0925-0001 Department of Health and Human Services Public Health Services PI: SOWERS, MARYFRAN Council: 10/2010 12159591 ons indicated. 2 U01 AG017719-11 A2 IPF: 1506502 Dual: 1. TITLE OF I , .. ^., ,..,a,aK.,ers. including spaces anc IRG: ZAG1 SRC(99) Received: 03/15/2010 SWAN Repository III 2. RESPONSE TO SPECIFIC REQUEST FOR APPLICATIONS OR PROGRAM ANNOUNCEMENT OR SOLICITATION ^ NO D YES (If "Yes." state number and title) Number: Title: 3. PROGRAM DIRECTOR/PRINCIPAL INVESTIGATOR 3a. NAME (Last, first, middle) 3b. DEGREE(S) 3h. eRA Commons User Name Sowers, MaryFran PhD mfsowers 3c. POSITION TITLE 3d. MAILING ADDRESS (Street, city, state, zip code) Professor University of Michigan 3e. DEPARTMENT, SERVICE, LABORATORY, OR EQUIVALENT School of Public Health I Epidemiology 1415 Washington Heights, Room 1846 3f. MAJOR SUBDIVISION Ann Arbor, Ml 48109 School of Public Health 3g. TELEPHONE AND FAX (Area code, number and extension) E-MAIL ADDRESS: TEL: 734-936-3892 FAX: 734-764-6250 mfsowers(gumich.edu 4. HUMAN SUBJECTS RESEARCH 4a. Research Exempt If "Yes," Exemption No. D No S Yes ^ No n Yes 4b. Federal-Wide Assurance No. 4c. Clinical Trial 4d. NIH-defined Phase III Clinical Trial FWA00004969 ^ No D Yes ^ No D Yes 5. VERTEBRATE ANIMALS E] No D Yes 5a. Animal Welfare Assurance No. A3114-01 6. DATES OF PROPOSED PERIOD OF COSTS REQUESTED FOR INITIAL 8. COSTS REQUESTED FOR PROPOSED SUPPORT (month. iav. vear-MM/DD/YY) BUDGET PERIOD PERIOD OF SUPPORT From Through 7a. Direct Costs ($) 7b. Total Costs ($) 8a. Direct Costs ($) 8b. Total Costs ($) 12/1/2010 11/30/2015 $1,301,056 $1,594,812 $5,306,630 $6,616,873 9. APPLICANT ORGANIZATION 10. TYPE OF ORGANIZATION Name The Regents of The University of Michigan Public: -> n Federal ¿ State O Local Address 3003 South State Street Private: -" LJ Private Nonprofit Room 1044 For-profit: -* [] General n Small Business Ann Arbor, Ml 48109-1274 I I Woman-owned LJ Socially and Economically Disadvantaged 11. ENTITY IDENTIFICATION NUMBER 1386006309A1 DUNS NO. 073133571 Icong. District MI-015 12. ADMINISTRATIVE OFFICIAL TO BE NOTIFIED IF AWARD IS MADE 13. OFFICIAL SIGNING FOR APPLICANT ORGANIZATION Name Jerri Maxwell Name David M. Plawchan Title Project Representative, DRDA Title Managing Project Representative, DRDA Address University of Michigan Address University of Michigan 3003 South State Street, Room 1040 3003 Soutti State Street, Room 1044 Ann Arbor, Ml 48109-1274 Ann Arbor, Ml 48109-1274 Tel: 734-764-7246 FAX: 734-764-8510 Tel: 734-936-1289 FAX: 734-763-4053 E-Mail: tmax(gumlch.edu E-Mat^ trt^@ui7tich.edu 14. APPLICANT ORGANIZATION CERTIFICATION AND ACCEPTANCE: I certify that 9fGNATURt OF Cf FICIAL the statements herein are true, complete and accurate to Ihe best of my knowledge, and ure not i 4ok accept the obligation to comply with Public Health Services terms and conditions if a grani is awarded as a result of this application. I am aware that any false, fictitious, or fraudulei statements or claims may subject me to criminal, civil, or administrative penalties. PHS 398 (Rev. 6/09) Face Page Form Page 1 Program Director/Principal Investigator (Last, First, Middle): SowerS, MaryFran PROJECT SUMMARY (See instmctions): This competing renewal application is to provide for ttie continued maintenance of and activities associated with the SWAN Repositories of serum, plasma, urine, DNA and transformed cells generated from a 10-year study of a population of 3302 women from 5 ethnic groups who have been evaluated annually prior to, during and following the menopausal transition. These Repositories, an arm of the Study of Women's Health Across the Nation (SWAN), is meant to support, facilitate and extend the Core SWAN; additionally, the Repositories provide a mechanism for opening the resources of SWAN to the greater scientific community. Implementing activities associated with three proposed specific aims of this competing renewal will 1) provide for the continued management of the current 1.7 million Repository specimens and the additional specimens that will accrue as a result of fielding SWAN IV in 2009 to 2014; 2) expand the DNA Repository, the most frequently requested specimen type that is uniquely renewable because of our investment in cell immortalization; 3) promote effective information interchange about the SWAN Study, its data and the Repository resources through development of a 2-level web-based "data warehouse"; 4) provide for continued administration of the application review process for specimen utilization and administrative management of specimen distribution including Material Transfer Agreements; 5) engage in strategies to promote utilization of specimens; and, 6) expand the scope of the genetics studies associated with the SWAN study and its Repository. RELEVANCE (See Instructions):