Human Laboratory Paradigms

This is a Small Business Sources Sought. This is NOT a Request for Proposals (RFP) and does not commit the Government to award a contract now or in the future. No solicitation is available at this time. The purpose of this synopsis is to identify small business organizations with requisite qualifications to provide the services stated herein. Based on capability statements received in response to this Sources Sought Announcement this acquisition may be solicited as a 100% small business set-aside. All small business organizations (SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB) are encouraged to respond to this notice. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned a code of 541712 in the North American Industry Classification System (NAICS), and the small business size standard for such requirements is 500 employees or less. The National Institutes of Health (NIH), National Institute of Alcohol and Alcohol (NIAAA), seeks capability statements from interested and qualified potential laboratory sites capable of conducting human laboratory paradigms on non-treatment seeking individuals with alcohol use disorders that will examine the impact of putative alcoholism therapeutics on key components of alcohol use disorders on a task order basis. The NIAAA has supported both pre-clinical and clinical medications development activities and continues to further expand this research area with the addition of human laboratory paradigms. To carry out this task, NIAAA intends to develop a network of clinical sites capable of conducting multiple human laboratory paradigms on non-treatment seeking alcohol use disorder individuals that will examine the impact of putative alcoholism therapeutics on key components of the alcohol use disorder. All subjects will be diagnostically characterized using enhanced alcohol-relevant individual diagnostic criteria, as well as employing the family history method to characterize their familial risk status. Furthermore, subjects will receive a standardized battery of assessments prior to entry into the medications studies in order to delineate their baseline characteristics. Lastly, blood samples will be obtained from all subjects and stored in a "biobank" for later analyses of therapeutic drug levels, biomarkers, DNA, and other relevant biological features. Organizations that submit capability statements in response to this notice must demonstrate and document: 1. The qualifications and experience of the institution's staff to organize and manage human laboratory studies as well as the ability to recruit and retain subjects. 2. Experience in alcohol research through multiple human laboratory paradigms. 3. Experience in conducting clinical studies in compliance with a) Good Clinical Practice and FDA guidelines for the conduct of clinical trials; b) the overall clinical trials process; c) the data acquisition, data monitoring and data management processes; and d) protection of patient confidentiality and data security. 4. Experience with the development and implementation of a detailed management plan organizing the work, including staff hours or days planned per task and scheduling of deliverables that is reasonable and timely. 5. Experience with respect to similar projects, including project dates and sponsors, specific responsibilities with respect to these projects. 6. Ability to serve as a repository for biological samples and clinical data. Interested organizations that believe they possess the capabilities necessary to undertake this project should submit electronic copies in addition to four (4) hard copies of their capability statement, addressing the areas above. Please limit responses to fifteen (15) pages or less, excluding resumes. Any proprietary information should be so marked. Written capability statements should be received by the Contract Specialist by no later than 3:00PM local time on November 25, 2013. Capability statements must identify your small business status (SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB). NO COLLECT CALLS WILL BE ACCEPTED.