SOURCES SOUGHT
A -- RECOVERY - The Action to Control Cardiovascular Risk in Diabetes (ACCORD) – Memory in Diabetes (MIND) follow-up study to acquire a third Magnetic Resonance Images (MRI)
- Notice Date
- 3/12/2010
- Notice Type
- Sources Sought
- 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 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)-RDSS-10-124
- Archive Date
- 4/8/2010
- Point of Contact
- Teresa A. Baughman, Phone: (301) 443-1193, Sara Mclaurin, Phone: 301-443-9154
- E-Mail Address
-
baughmat@nida.nih.gov, mclaurinsm@mail.nih.gov
(baughmat@nida.nih.gov, mclaurinsm@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The purpose of this Sources Sought notice is to seek information on all sources capable of responding to a potential new solicitation. This is NOT a solicitation for proposals, proposal abstracts, or quotations. BACKGROUND: The National Institute on Aging (NIA) is conducting a follow-up study to the clinical trial titled "The Action to Control Cardiovascular Risk in Diabetes (ACCORD) - Memory in Diabetes (MIND)". The follow-up study will be a two-year effort to follow-up the original ACCORD-MIND subset of patients to acquire a third Magnetic Resonance Images (MRI) of the brain. ACCORD-MIND MRI is a sub-study in ACCORD, a randomized, multi-center, factorial designed clinical trial in 10,251 participants with type 2 diabetes mellitus. MIND MRI included 620 of these participants, and was conducted at four sites, and was managed through a central coordinating office and four clinical networks. The Coordinating Center includes a central MRI quality control and reading center. The goal of the ACCORD-MIND trial was to address the question as to whether three complimentary treatment strategies could reduce the risk for cognitive decline, or adverse changes in brain structure measured on MRI. The treatment strategies administered as a part of the main ACCORD trial were designed to compare standard vs intensive control glycemia targeted to near-normal levels (target HbA1c < 6), to compare to placebo the effect of fibrates, which increase HDL-cholesterol and lower triglycerides, in the context of good LDL-C control, and of intensive BP control targeting the normal range (SBP< 120 mmHg). Specifically, ACCORD-MIND evaluates intensive glucose, blood pressure and lipid management as means to reduce detrimental changes in the brain structure and function. PURPOSE AND OBJECTIVES: This contract will follow up MIND participants to acquire an additional measure of brain structure, and to expand the outcomes of the study to nursing home placement and to new clinical events that follow or precede measures of the brain. The objective of following up MIND participants is to further delineate how diabetes affects the brain. The aging of the cohort, longer follow-up and an additional MRI allow the study of the longitudinal effects of diabetes-related factors on the brain, and to investigate how these factors, in combination with older age, interact leading to worse outcomes. Specifically: the contract will investigate: 1) What changes and what is the trajectory of change in brain structure? 2) What are the risk factors associated with increased, as well as reduced risk for adverse changes in brain structure or function? 3) Do these changes increase the risk for dementia, nursing home placement or death? 4) How do the brain changes co-vary with the development of other diabetes co-morbidities such as retinopathy, nephropathy and neuropathy? and, 5) Do the changes predict prospectively collected data on fasting levels of glucose, A1C levels, and hypoglycemic events? PROJECT REQUIREMENTS: The Contractor shall have overall responsibility for the coordination of Magnetic Resonance Imaging (MRI) activities that are a fundamental part of the ACCORD MIND Follow-Up Study. These activities include: 1) Recruitment of participants who previously participated in the ACCORD MIND sub-study. Recruitment muse be done in concert with the staff at the ACCORD clinics that are following the participants as part of the ACCORD Follow-up Study (NHLBI); 2) Acquisition, quality control, analysis, archiving, and retrieving of scans; 3) Updating and reviewing web-based activities; writing annual reports as required by the funding agency; 4) Deposition of data into a centralized database that houses other data from the ACCORD MIND MRI sub-study; 5) Analysis and collaboration on manuscripts based on this study and the previous ACCORD MIND MRI sub-study; 6) Monitor the progress of MRI field site activities, including: recruitment goals, successful scheduling for MRI appointments, completion of scan protocol, transmission of the scans to the Coordinating Center and adherence of quality control and reporting techniques; training and re-training of MRI staff as needed. Training of MRI technicians for the brain MRI should include the MRI scan protocol, scheduling and screening for participant MRI eligibility; quality control and transmission protocols; 7) Organize and implement training of staff at the local clinic that is following the MIND participants as a part of the larger main trial. Training should include: the purpose of the MRI, the logistics of identifying eligible participants, scheduling and rescheduling of appointments, and the process for addressing other issues that may routinely arise from participant questions or reasons for refusal; 8) Design and implement a Quality Control (QC) procedure for the MRI field sites that is appropriate for the four networks that have previously participated in the ACCORD MIND MRI sub-study; 9) Demonstrate comparability between the acquisition and analysis of MRI scans to the previously acquired and analyzed scans that are part of the ACCORD MIND MRI sub-study. Additionally, the Contractor shall collaborate with the MRI Study Data Coordinating Center (DCC) (MRI CC - Nick Bryan, Univ Pennsylvania) to design and maintain: 1) a web link with the main study; 2) a procedure to identify and track participants eligible for the MRI study; 3) a statistically appropriate method to generate quality control statistics; 4) production of quality control reports and uploading to web-site; 5) statistical analyses for primary publications. REPORTS AND DELIVERABLES: The following reports will be required: Monthly Technical Progress Report, Annual Technical Progress Report, and Final Report. ANTICIPATED PERIOD OF PERFORMANCE: The anticipated period of performance is two (2) years (09/30/10 through 09/29/12). OTHER IMPORTANT CONSIDERATIONS: The North American Industry Classification System (NAICS) Code 541712 with a size standard of 500 employees is being contemplated. CAPABILITY STATEMENT/INFORMATION SOUGHT: Respondents to this notice must provide, as part of their responses, a capability statement to include the following: (1) information regarding the respondents' (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and, (e) examples of prior completed Government contracts, references, and other related information; (2) respondents' DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc.) pursuant to the applicable NAICS code; and, (4) any other information that may be helpful in developing or finalizing the OPDIV's acquisition requirement. INFORMATION SUBMISSION INSTRUCTIONS: Respondents should provide responses accordingly: (1) submit information both electronically and by mail. No telephone or facsimile responses will be accepted; (2) format capability statements using Microsoft Word or Adobe PDF including attachments, resumes, charts, etc. Use single space, 12 font minimum and 8 ½ x 11 size paper; (3) organize material in such a manner that clearly identifies and address capability requirements and provide an executive summary; (4) capability statement should not exceed ten (10) single sided pages including references; (5) respondents must send two original copies via mail and one electronic copy via email; (6) responses should be received no later than March 24, 2010 at 1:00 PM Local Time; (7) include respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses; and (8) send responses to this notice via email to baughmat@mail.nih.gov. The original statements mailed using the U.S. Postal Service should be sent to ATTN: Teresa A. Baughman, National Institutes of Health, Office of Acquisitions - NIDA Neuroscience COAC, NIA R&D Contracts Management Section, 6001 Executive Boulevard, Room 8154, MSC 9661, Bethesda, MD 20892-9661. If using a courier service such as the UPS, Federal Express, etc., change the City, State and Zip Code to Rockville, MD 20852. (Please be aware that the U.S. Postal Service's "Express Mail" DOES NOT deliver to the Rockville, Maryland address.) DISCLAIMER AND IMPORTANT NOTES. 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 in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. CONFIDENTIALITY. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
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