SOURCES SOUGHT
A -- Conduct Second Follow-up of Patients Enrolled in the Combining Medications and Behavioral Interventions (COMBINE) Study
- Notice Date
- 12/22/2006
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Alcohol Abuse and Alcoholism, R&D Contracts Management Branch, 5635 Fishers Lane Room 3016, MSC 9304, Bethesda, MD, 20892-9304, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- NIAAA-07-07
- Response Due
- 1/10/2007
- Archive Date
- 1/25/2007
- Description
- The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking capability statements from organizations (NAICS 541710, small business size standard is 500 employees) with experience with the Combining Medications and Behavioral Interventions (COMBINE) study. This is not a solicitation announcement. This is a sources sought synopsis only. The purpose of this sources sought synopsis is to gain knowledge of potential qualified sources and their size classification as a HUB Zone 8(a), 8(a), HUBzone, Small Disadvantaged Small Business, Service Disabled Veteran Owned, Veteran Owned, and Women-Owned Business relative to the NAICS code. One project is envisioned to conduct the second Combining Medications and Behavioral Interventions (COMBINE) follow-up study using a single contractor (RTI) and telephone interviews. One task will be to help design and gain Institutional Review Board (IRB) approval of the study. Confidential contact information will be used to track currently-enrolled subjects. Subjects will be provided with details of the new follow-up study and asked to provide informed consent for the new study. Half-hour telephone interviews will be administered to consenting subjects. Development of the interviews will be done by personnel familiar with the COMBINE and first follow-up instruments. As in the first follow-up study, subjects will be asked for their consent to link the data from COMBINE and the first follow-up studies with the second follow-up study. These procedures require access to confidential identifiers and other data. Requirements and Tasks: Design and gain Institutional Review Board (IRB) approval of the study. Track currently-enrolled subjects using confidential contact information. Provide subjects with details of the new follow-up study and asked to provide informed consent for the new study. Administer half-hour telephone interviews, planned at yearly intervals, to consenting subjects. Develop interviews with the COMBINE and first follow-up instruments. Ask subjects for their consent to link the data from COMBINE and the first follow-up studies with the second follow-up study. Information Requested: Submitted information should be relevant and specific in the technical area under consideration, on each of the following qualifications: (1) Experience: Experience with the original COMBINE study, access to data collected on patients enrolled in the COMBINE study, access to COMBINE study records to contact subjects for follow up, design of IRB approval documents, obtaining IRB approval, tracking enrolled subjects, conducting telephone interviews, obtaining informed consent from subjects; (2) Personnel: Name, professional qualifications and specific experience of scientists and/or technical personnel who may be assigned as principal investigator and other key positions; and (3) Facilities: Availability and description of facilities and equipment required to conduct the follow up study. Any other specific and relevant information that would improve our consideration and evaluation of the information presented is desirable. The Capability Statements must: (1) Demonstrate experience with and access to information collected on study subjects, including data from questionnaires over several time points, tissue samples and genetic analyses and data collection instruments for the COMBINE study. (2) Demonstrate expertise, knowledge and experience with the COMBINE research protocol. (3) Demonstrate expertise, knowledge and experience with COMBINE in follow up of subjects who were previously enrolled in this multi-center randomized clinical trial of combined medication and behavioral therapy for alcoholism. Information Requested: Submitted information should be relevant and specific in the technical area under consideration, on each of the following qualifications: (1) Experience: An outline of previous work specific to the requirements listed above; (2) Personnel: Name, professional qualifications and specific experience of scientists and/or technical personnel who may be assigned as principal investigator and other key positions; and (3) Facilities: Availability and description of facilities and equipment required to conduct the necessary tests. Any other specific and relevant information that would improve the Government's consideration and evaluation of the information presented is desirable. Your responses will assist the Government in selecting the appropriate acquisition mechanism. Responses to this notice shall include the organization's name, address, point of contact, size of business pursuant according to the North American Industrial Classification Code (NAICS) and must address all the technical information requested. Additionally, the response must provide answers to the following questions: (1) Is your organization a small business under the NAICS code? (2) Does your firm qualify as a small disadvantaged small business? (3) If disadvantaged, specify if your firm is certified under section 8(a) of the Small Business Act. (4) Are you considered a certified HUBZone firm? (5) Are you considered a woman-owned or operated business? (6) Are you a certified Service-Disabled Veteran Owned or Veteran Owned business? This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. This is not a request for proposals. The Government does not intend to award a contract based on responses under this announcement nor otherwise pay for preparing any information sent or the Government's use of the information. Any proprietary information should be so marked. Interested organizations presenting a capability statement in response to this sources sought announcement must identify their size status. Please submit written capability statements by January 10, 2007 to the NIAAA Contracting Officer.
- Record
- SN01201825-W 20061224/061222220258 (fbodaily.com)
- Source
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