Human Laboratory Paradigms (HLAB)

This is a Research & Development (R&D) Sources Sought Notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations 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 notice is to obtain information regarding the availability and capability of all qualified sources interested in performing a potential R & D requirement. The National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (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. 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, and will employ 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, and specific responsibilities with respect to these projects. 6. Ability to serve as a repository for biological samples and clinical data. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published via the Federal Business Opportunities website. However, responses to this notice will not be considered adequate responses to a solicitation. 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 Contracting Officer by no later than 2:00PM local time on September 3, 2014. NO COLLECT CALLS WILL BE ACCEPTED.