SOLICITATION NOTICE
A -- The Study of Women's Health Across the Nation (SWAN) Biorepository
- Notice Date
- 7/16/2010
- Notice Type
- Presolicitation
- NAICS
- 621991
— Blood and Organ Banks
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Mental Health, Contracts Management Branch, 6001 Executive Blvd, Rm 8154, MSC 9661, Bethesda, Maryland, 20892-9661
- ZIP Code
- 20892-9661
- Solicitation Number
- HHS-NIH-NIDA(AG)-RFP-10-131
- Archive Date
- 8/14/2010
- Point of Contact
- Rosanne S Wilson, Phone: 301-443-4433
- E-Mail Address
-
wilsonr@mail.nih.gov
(wilsonr@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Institutes of Health (NIH), National Institute on Aging (NIA), intends to negotiate, under authority of FAR 6.302-1, on a noncompetitive, sole source basis, with the Regents of the University of Michigan, DRDA for the Study of Women's Health Across the Nation (SWAN) Biorepository requirement. This notice of intent is not a request for competitive proposals. However, responsible sources may express their interest by submitting a capability statement or proposal. All capability statement/proposals received within fifteen days after date of publication of this synopsis will be considered by the government. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. This effort will be one base year with four option years (12 months for each performance year). The SWAN Biorepository is in accordance with the authority 41 U.S.C. 252(c)(1), as set forth in FAR 6.302-1. The Regents of the University of Michigan has continued to support the SWAN Biorepository activities related to receiving, storing, cataloging, preserving and distributing specimens to qualified investigators. The Contractor used a grant mechanism to design the repository and has assiduously provided services for the SWAN study over the past ten (10) years. The Contractor is the sole proprietor of the specific version of the inventory management system developed for and used by the SWAN repository; therefore, there is limited access to the data management system itself. The Contractor shall obtain services from SeraCare Life Sciences since the frozen biospecimens are housed in sixty-five (65) 80⁰C mechanical freezers at SeraCare. There are 1.7 million irreplaceable and highly perishable biological specimens (whole blood, serum, plasma, urine, extracted DNA, buccal cells, immortalized cells) contained in these freezers. To relocate the large repository from SeraCare's location can pose high risks by damaging the viability of cells and progress made over the last ten years of the SWAN study. The Regents of the University of Michigan has the unique capability to provide these required services to NIA for the SWAN BioRepository. Inherent duplication of cost to the Government and unacceptable delays in completing the project makes competition unfeasible for this study. The objectives of the requirement are detailed below. Background and Purpose of the SWAN Biorepository: The National Institute on Aging (NIA) continues to have a need for collecting, storing, monitoring and distributing blood, urine and DNA samples for the Study of Women's Health Across the Nation (SWAN). The SWAN Biorepository has been supported since 2000 by a NIH research project grant mechanism (to the University of Michigan) which is separate from the SWAN clinical field sites, coordinating center and central laboratory. This requirement shifts the SWAN award mechanism from a grant to a contract. SWAN is an ongoing multi-ethnic longitudinal study conducted by seven (7) clinical field sites, a data coordinating center and a central laboratory. It is designed to characterize the physiological and psychosocial changes that occur during menopause and beyond. SWAN has an extensive base of well characterized data and a repository of biological specimens from 3,300 African American, Chinese, Caucasian, Japanese and Hispanic women with over twelve years of annual follow-up visits that describe the endocrinology of the menopause transition and other factors relevant to midlife health and aging. The women, who ranged in age from 42 to 52 years at enrollment in 1996-97, will continue to be followed until they are 59-69 years old under an existing grant mechanism which expires in 2014 (and is separate from this repository requirement). SWAN has the capability to link the expansive biological, medical, social, behavioral, and demographic data it has collected over seventeen years to the development of both positive and deleterious health conditions, disorders and diseases in early old age. The major thematic areas of SWAN include 1) Physical Functioning; 2) Bone/Osteoporosis; 3) Cognitive Function/ Symptoms/ Mental Health; 4) Diabetes/Cardiovascular disease; 5) Physical functional performance and 6) Osteoarthritis, The SWAN repository samples were meticulously collected and managed from 3,302 women from five race/ethnic groups followed annually prior to, during and after the menopausal transition. The SWAN Biorepository is an integral arm of SWAN intended to support and facilitate (the collection, processing and storage of new specimens from the ongoing study) and extend the SWAN core study to allow the efficient evaluation of new and untested existing hypotheses. The repository specimens consist of 578,000 serum, plasma and urine samples, one million urine samples from the Daily Hormone Study (an annual study of hormone patterns across a full menstrual cycle nested within the parent study) and 26,300 DNA samples (including 7,928 vials of immortalized cells from more than 1,500 participants). SWAN will continue participant follow-up visits and longitudinal data collection between 2010 and 2014. As a result, it is anticipated that an additional 113,792 new serum, plasma and urine samples will be generated for in the SWAN repository. The SWAN Biorepository is a component of the SWAN Study. The purpose of the SWAN Biorepository is to provide a resource designed to receive, store, catalog, preserve and distribute specimens to qualified investigators. The SWAN Biorepository is needed to 1) support collection and storage of biological specimens from planned follow-up visits in the ongoing SWAN study; 2) provide for the continued management of the current biorepository specimens; 3) provide for continued administration of the review process for requests for specimens and management of specimen distribution; and 4) develop strategies to promote utilization of specimens. The contract shall provide and implement Quality Assurance/Quality Control procedures for prospective evaluation of short and long term specimen management, including identification and removal of non-useful specimens as well as refinement of specimen cataloging. This proposed acquisition was previously publicized under sources sought notices HHS-NIH-NIDA(AG)- SBSS-10-131 and HHS-NIH-NIDA(AG)-RDSS-10-131. The estimated contract award date will be on or about June 30, 2011.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIMH/HHS-NIH-NIDA(AG)-RFP-10-131/listing.html)
- Place of Performance
- Address: United States
- Record
- SN02207855-W 20100718/100716234451-d160e64206adacc494cf66533baa3e0d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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