MODIFICATION
A -- The Study of Women's Health Across the Nation (SWAN) Biorepository
- Notice Date
- 8/3/2010
- Notice Type
- Modification/Amendment
- 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
- 9/2/2010
- Point of Contact
- Rosanne S Wilson, Phone: 301-443-4433, Craig D. Sager, Phone: 301-443-1193
- E-Mail Address
-
wilsonr@mail.nih.gov, csager@mail.nih.gov
(wilsonr@mail.nih.gov, csager@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 purpose of this acquisition is to continue to support SWAN Biorepository activities related to receiving, storing, cataloging, preserving and distributing specimens to qualified investigators. The collection of biospecimens are frozen and currently housed in the SWAN Biorepository (in Frederick, MD) in sixty-five (65) 80oC mechanical freezers purchased by the University of Michigan (funds from a federal grant supporting the SWAN Biorepository). 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. The contractor will continue to provide sufficient freezer capacity (using these freezers) at the Frederick, MD location in order to 1) avoid redundant freezer and relocation costs and 2) reduce the risk of loss of viability of cells and progress made by SWAN over the last ten years. The Contractor shall use the existing electronic inventory management system developed for and used by the SWAN Biorepository to manage the biospecimen inventory. This Specimen Inventory Management System) shall include the following features: 1) biospecimen management; 2) requisition/workflow tracking; 3) freezer/inventory management; 4) comprehensive reporting; 5) shipment and discrepancy tracking; and 6) security features. The inventory system shall be customizable to meet the changing needs of the SWAN Biorepository. The Contractor shall maintain and update electronic systems and procedures to ensure data security and to prevent loss of inventory data in case of physical damage or equipment failure. The Contractor shall maintain and update electronic and physical systems that prevent access to biospecimens and data by unauthorized individuals. The University of Michigan 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 maintain/obtain the required shipping licenses and permits from local, State, Federal and international authorities for the safe import, storage and distribution of biological specimens, according to current regulatory guidelines, as applicable. The Contractor shall provide proof of required licenses prior to contract award. The Contractor shall maintain and update as necessary, the "SWAN Data Warehouse", a searchable, concept-driven website to promote understanding of the SWAN Study and its data and biospecimen resources, provide access to SWAN data and support all Biorepository utilization functions. The website must comply with Section 508 of the Rehabilitation Act or the Electronic and Information Technology Accessibility Standards pertaining to all of 36 CFR 1194.21 and 36 CFR 1194.22. Relocating sixty five freezers to another location would pose a considerable risk to the SWAN project and the 1.7 million irreplaceable and highly perishable biological specimens housed in the freezers; the current specimen inventory management system is based on proprietary software which is of limited access; a potential change between contractors would entail costly delays and disruptions in performance and potential loss of valuable data, specimens or specimen integrity. An award issued to a contractor other than the incumbent would include redundant spending by the Government to purchase and develop a new data management system and an additional set of 65 freezers (both of which are outside the funding limitations for this requirement). In summary, inherent risk of loss of perishable resources, duplication of cost to the Government and unacceptable delays in completing the project make competition unfeasible for this study. 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 National Institutes of Health (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 3,302 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 has accrued 1.7 million samples of serum, plasma, urine, DNA that 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 Study of Women's Health Across the Nation (SWAN) Biorepository is a component of the Study of Women's Health Across the Nation (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)
- Record
- SN02226716-W 20100805/100803235221-46a2241d0d646e44c17cd5d032bddc59 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |