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FBO DAILY ISSUE OF JANUARY 15, 2012 FBO #3704
SOLICITATION NOTICE

A -- Towards Maximizing the Scientific Return on the Women’s Health Initiative Biological Resource – Round III

Notice Date
1/13/2012
 
Notice Type
Presolicitation
 
NAICS
541712 — Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
 
Contracting Office
Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
 
ZIP Code
20892-7902
 
Solicitation Number
NHLBI-CSB-WH-13-01-ST
 
Point of Contact
Stacy C. Turner, Phone: (301) 435-6676
 
E-Mail Address
turners@nhlbi.nih.gov
(turners@nhlbi.nih.gov)
 
Small Business Set-Aside
N/A
 
Description
The National Heart, Lung, and Blood Institute (NHLBI) is seeking institutions to propose and define specific work requirements to: • Support the primary goal of the Women’s Health Initiative (WHI) 2010-2015 extension study, which is to study the determinants of an increased risk of CVD in older women (and conversely factors contributing to healthy aging with absence of CVD); • Employ multiple technologies (using biospecimens) in an integrated fashion; • Be hypothesis driven. The WHI program has set aside bloods (serum and plasma) and DNA samples for the purpose of this requirement. Serial bloods and physical measurements over an extended period of time allow for examination of long-term determinants of health status. They provide an important opportunity to study questions related to aging such as the absence or presence of cardiovascular disease and/or risk factors, maintaining good physical and cognitive function, and the predictors of change in biomarkers, metabolic markers, DNA methylation and RNA expression, and telomere length, and the interrelationships of markers in their association with health status. It is anticipated the laboratory assays may include integration of newer high-throughput technologies such as those from genomics, proteomics, metabolomics, and multiplex assays of adipokines and cytokines in order to elucidate pathways towards health or disease. The use of multiple technologies rather than a single technology is strongly encouraged. Examples include using multiple technologies to try to elucidate a series of markers in a common etiologic pathway, or to develop a risk assessment profile that integrates markers from parallel etiologic pathways. Offerors are encouraged to integrate existing data (e.g., GWAS, exome sequencing) where applicable. Offerors are expected to contribute new laboratory data using one or more technologies. The technologies need to have been validated in other studies prior to their application on the WHI samples. A combination of new data and existing data can be used to meet the goal of multiple [at least two] technologies. This solicitation is intended to support targeted hypothesis-driven rather than hypothesis-generating research. In order to put these resources to the best use, the investigations funded by these awards should not duplicate completed investigations or approved investigations already funded within the WHI, unless there are compelling reasons why replication would be desirable (for example, replication may be necessary for some genomics and proteomics investigations). Offerors should review the information on www.whiscience.org and on dbGAP for updated information on completed or funded investigations and publications. This is the third round of planned Broad Agency Announcement (BAA) awards using these resources. Proposals should include: • The hypothesis(es) being tested • Agreement to abide by NHLBI policies for data distribution and confidentiality • Plans for collaboration with WHI investigators, if any • Plans for enhancing the development of early stage investigators • Data dissemination plan • The potential importance of the findings on public health, such as likelihood of leading to screening and mitigation of cardiovascular risk, and/or drug development. • Reasons why this cohort is particularly or uniquely suitable for the proposed study • The number of cases and controls requested for specific outcome(s) • Statistical power calculations • Sample amounts, including steps taken to conserve sample • Total amount and concentration of DNA and RNA, and amount of serum, plasma, citrated plasma, urine, and packed red cells requested • Information on sample handling, shipping, and storage • Ability to perform the laboratory analyses within the period of performance • A summary of the technologies to be used and how multiple technologies will be integrated in the research • Documentation of proficiency with the proposed technologies • Documentation of sensitivity, reproducibility, variability, consistency with external laboratories and standards, sample success rates, locus success rates, as appropriate for the type of technology • Quality assurance steps to be included in this program (see www.whiscience.org for guidance) • Documentation of ability to perform statistical analyses of the laboratory findings, or that suitable arrangements for statistical analyses through collaboration or subcontract have been negotiated • Plans for transmission of an electronic dataset to the WHI Clinical Coordinating Center (CCC) as an interim step in order to receive additional data elements for analysis. Additionally, plans for transmission of a final electronic dataset to the WHI CCC and/or dbGaP, BioLINCC or other repository as directed by NHLBI, on or before the end of the funding period • Signed agreement to abide by the policies and procedures for publications of the WHI and the NHLBI • Travel for two trips per year e.g., one to meet with collaborators if multiple investigators from different sites are involved, and the other to present results at scientific meetings The anticipated period of performance of the awarded contracts is March 15, 2013 through March 14, 2016. It is anticipated that 2 to 4 cost reimbursement contracts will be awarded. This is a Pre-solicitation Notice in advance of a Solicitation, and the Government is not committed to award a contract pursuant to this announcement. The NHLBI intends to issue a solicitation under full and open competition through a BAA. The solicitation will be available on the Federal Business Opportunities website at http://fedbizopps.gov on or about January 27, 2012. No paper solicitation will be available. Proposals will be due on or about June 8, 2012. Offerors are responsible for downloading their own copy of the solicitation and amendments that may be issued by the Government.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-CSB-WH-13-01-ST/listing.html)
 
Record
SN02654508-W 20120115/120113234342-b8f643a8657f2be81a539b0dc5f0ba30 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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