SWAN Repository III

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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):