Attachment 1 - Purchase Description.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

PURCHASE DESCRIPTION

1. Statement of Need and Purpose: The Molecular Imaging Branch, NIMH is currently interested in replacing and updating its aging two gamma counters. These counters are used on a daily basis to assay the radioactivities in the blood samples obtained from human and non-human primates. These obtained metrics are used in conjunction with the brain imaging data to allow the Branch to quantify brain receptor densities in healthy and pathological conditions in the hope of converting the measure of psychiatric illness into quantitative measures. The requested instrumentations will be part of the research and development efforts as well as part of clinically applied research. For research, the Branch screens radioactively labeled compounds for their pharmacokinetics in nonhuman primates and rodents and further screens their physicochemical properties to allow the selection of the best candidate radioactive compounds to be used in human studies. Human studies provide accurate quantification of the arterial plasma input function to be merged with the dynamic brain imaging to be able to quantify studied brain targets such as brain receptors.

All these mentioned endeavors rely on the accurate measurements and quantification of radioactivity. The Branch has been so far successful with its part of providing such crucial supportive information with no interruptions. Failure to provide such information during a human study may risk turning such studies into misadministration of radioactivity to a human participant. Misadministration is considered when radioactivity is administered to a human with no meaningfully obtained data. All the Branch’s investigational human research is approved by the FDA under specific protocols in which they are expected to avoid misadministration of radioactive doses. Therefore, it is very important to update its counting equipment with more reliable, more efficient, and more proven instrumentation.

2. Background Information and Objective: The Branch’s current equipment, which is in

Building 49 (Rm B1A59) and Building 10 (Rm B3C355) is more than nineteen years old. A new system is urgently required to replace the current equipment to circumvent failure during a study and avoid misadministration.

3. Generic Name of Product: Radiometric assay of radioactivity with automatic gamma scintillation counting.

The salient physical, functional, or performance characteristics that “equal” products must meet are specified in the purchase description below.

4. Purchase Description: Wizard2 Gamma Counter or Equal

Product Part Number: 2480-0010

Product URL: https://www.perkinelmer.com/product/wizard2-gamma-counter-1-detw-3-1k-sampl-2480-0010 https://www.perkinelmer.com/product/wizard2-gamma-counter-1-detw-3-1k-sampl-2480-0010 https://www.perkinelmer.com/product/wizard2-gamma-counter-1-detw-3-1k-sampl-2480-0010

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

5. Salient characteristics: The following salient characteristics are necessary for the requested gamma counters:

1. The feasibility of up to 1,000 sample deck capacity. This allows potential high throughput counting.

2. Must be an FDA-approved instrument.

3. Monitors nine detector parameters and automatically provides documentation for review.

4. A computer built within the gamma counter complete with a Microsoft Windows

10 package.

5. Minimum one-year warranty to include all parts, labor, and travel.

6. End-user training to be conducted within 30 days of installation.

6. Quantity: Two (2) Gamma Counters

7. Delivery Date: No later than 60 days after receipt of order

8. Period of Performance: Includes installation, training within 30 days of installation, and one-year warranty

9. Places of Acceptance:

One (1) Gamma Counter to Bldg. 49, Covent Dr., Rm B1-A59, Bethesda, MD 20892

One (1) Gamma Counter to Bldg. 10, Center Dr., Rm B3-C355, Bethesda, MD 20892

10. Option(s): N/A