Attachment 4_Purchase Description.pdf

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

NIMH-20-002962 Attachment 4

PURCHASE DESCRIPTION

1. Statement of Need and Purpose: The NIMH/PET Radiopharmaceutical Sciences Section (PRSS), since its inception in 2002, has had six hot-cells for experimental radiochemistry and radiotracer production for animal experiments in support of its main remit – the development of novel radiotracers with utility for the study of neuropsychiatric disorders and related drug development. These hot-cells are now replete with automated apparatus for performing certain types of radiochemistry (e.g., 11C-methylation, 18F-radiofluorination) and for the use of this radiochemistry to produce candidate radiotracers for evaluation in animals (mouse, rat, monkey) with positron emission tomography (PET) experiments. Over the last two decades, important methodological advances have been made in radiochemistry with cyclotron-produced short-lived carbon- 11 (t1/2 = 20 min) and fluorine-18 (t1/2 = 110 min) which expand the chemical space for developing PET radiotracers. From our own laboratory, major advances include methods for synthesizing and applying [11C]fluoroform, [18F]fluoroform, and [11C]fluorophosgene. Extra hot-cell space is needed to exploit these advances for producing new candidate PET radiotracers for evaluation with PET in animals and to augment possibilities for further methodological advances in radiochemistry.

2. Background Information and Objective: All PET radioligands developed by PRSS within MIB are first evaluated in animals before being studied in humans. The new radioligands benefit all who use them, including intramural collaborators as well as numerous extramural and international PET centers. In addition, we use monkey PET imaging to help extramural sites develop new radioligands. As an example, we are currently helping an extramural investigator at Harvard University develop a PET radioligand for orexin receptors. The collaborator performs the medicinal chemistry and we perform radiochemistry and PET imaging to evaluate the candidates. As another example, we have recently started to collaborate with Yale University, which has recently become a NIMH-funded Center for PET radioligand development. We are helping them develop new and improved radioligands for the NMDA receptor.

In order to expand our capacity for PET radiochemistry development and for the synthesis of new candidate PET radiolignds, we propose to purchase an extra pair of hot-cells of very similar custom design to those that have served us exceedingly well over the last 18 years. Our plan is to reconfigure the present laboratory suite on the B3 level of Building 10 adjacent to the cyclotron facility to house the two new hot-cells. This construction project has recently been set in motion. The acquisition of the new hot-cells has been supported by successive BSC reviews of Dr. Pike, including the latest in February 2019.

3. Generic Name of Product: Radiochemistry Hot-cells

4. Purchase Description: The purchase will be a pair of custom-made adjoined research hot-cells and an electrical cabinet. The design will be very similar to those of the three pairs of hot-cells purchased from Von Gahlen in 2002.

5. Salient characteristics: The main purpose of these hot-cells will be to provide radiation protection to chemists who will be controlling automated radiosynthesis apparatus conducted within the hot-cells. The following requirements are to support experimental radiochemistry within the hot-cells.

1) Allow rear and front entry with motorized vertically moving 75-mm thick lead doors, one at front and one at rear of each hot -cell

2) Front door to be fitted with lead glass window (350 x 300 mm; W x H)

3) Side door opening in one hot-cell (206 x 246 mm; W x H), and one lead glass window

4) 2 ports in each front door

5) Allow measurement of radioactivity with a 75 mm lead-shielded commercial ionization chamber with entry into the floor of the hot-cell

6) Allow shelving etc. to be installed on bread-boards mounted at internal back and sides of each hot-cell

7) Include within each hot-cell an internal ceiling-mounted filter for exhaust gas, for safe removal of volatile radioactive material

8) Include penetrations to be specified for entry/transfer of radioactive material, electrical, and power cables

9) Be designed for entry of five laboratory gases, with external switch control on the face of the hot-cell

10) Be equipped to support external shelves above the doors of each hot-cell

11) Have open space under each hot-cell for housing equipment associated with the radiochemistry to be conducted within the hot-cell

12) Be equipped with power outlets on the roof of the hot-cell, within the hot-cell and under the hot cell for powering radiosynthesis equipment

13) each hot-cell to have internal LED lighting

14) The external dimensions of each hot-cell are not to exceed 1552 x 1214 x 2650 mm

(W x D x H), and internal dimensions 1200 x 820 x 744 (W x D x H)

15) Be designed for safe (lead-shielded) entry of cyclotron-produced radioactive (i.e., carbon-11 labeled) gases

16) Wall mounted electrical cabinet with angled topper (to prevent dust collection) with external dimensions to not exceed 800 x 400 x 1800 (W x D x H) . Electrical Cabinet needs to be shipped to NIH prior to hot cell delivery/installation so it can be incorporated in the construction.

The vendor is expected to construct the hot-cells in preparation for inspection at the factory within six months of award. Once the hot cells are assembled, the Principal

Investigator (Dr. Pike) or his assigned representative will travel to the contractor’s work site for the Factory Acceptance Testing in order to inspect the hot cells and give his approval prior to shipping to the NIH.

In the event that the Principal Investigator or his assigned representative are precluded from safe travel to the factory (e.g. COVID-19 pandemic), arrangements for virtual acceptance testing should be considered and arranged. Subsequent to satisfactory acceptance, the disassembled hot-cells should be shipped to NIH within one month. Additionally, the vendor must arrange for shipment of the required electrical supply box with a NIMH representative once the approval of the hot-cells has occurred at the factory so that it can be installed in the laboratory that will house the hot-cells prior to the arrival of the hot-cells.

The vendor will be responsible for in-house storage of the hot-cells up to four months prior to shipping to NIH if the renovated space in NIMH is not ready for installation.

For the Hot-cells install:

1) The installation contractor will have a Certified Industrial Hygienist (CIH) on staff and draft the Accident Prevention Plan (APP) compliant to the Army Corps of Engineers EM385-1-1, Indoor Air Quality (IAQ) Plan, and material handling practices to verify implementation and compliance to NIH, OSHA, and EPA requirements throughout the project to prevent government property from becoming contaminated and exposure to NIH occupants.

2) The installation contractor will be responsible for having the final electrical connections performed by a qualified electrical contractor, and the final piping connections performed by a qualified mechanical contractor.

3) The installation contractor will coordinate activities with the NIH 3rd Party Oversight Contractor for verification of compliance to plans, NIH requirements, and Federal/State/Local regulations and standards. Funds for NIH 3rd Party Oversight, through DOHS, will be provided by the IC.

4) Contamination of government property will require prompt remediation in accordance with the NIH “Lead COC Chart” attached and coordinated through NIH DOHS and

NIH DEP.

5) The contractor will be strictly responsible for complying with the 29 CFR 1910.1025 and 29 CFR 1926.62.

6) The installation contractor will complete and submit the signed AFFIRMATION OF DELIVERABLES form and its deliverables, to the project officer and DOHS, a minimum of two weeks prior to commencing onsite activities for review and comments.

a) Obtain copies of OSHA 10-hour cards for all employees working onsite.

https://www.ors.od.nih.gov/sr/dohs/Documents/Affirmation%20of%20Contractor%20Safety%20Deliverable.pdf https://www.ors.od.nih.gov/sr/dohs/Documents/Affirmation%20of%20Contractor%20Safety%20Deliverable.pdf

b) Verify that the contractors and subcontractors complete the www.constructsecure.com registration and has a score >80 prior to commencing work.

c) Ensure that the installation contractor Site Accident Prevention Plan (APP) is compliant with OSHA and the Army Corps of Engineers.

Activity Hazard Analysis (AHA) must be included with a diagram of the activity area(s) (i.e. staging, transport, install, etc.).

d) Obtain CV/resume for contractor Site Safety and Health Officer (SSHO), defined by the Army Corps of Engineers EM385-1-1 definition 01.A.17, and 01.A.19. Note: The SSHO is to be onsite at all times that work is occurring.

Site Requirements:

1. The hot cell contractor is responsible for all unloading of delivery trucks and transport of material and equipment to an on-campus container storage and/or job site staging area via the P3 parking garage entrance. The delivery truck may only enter the NIH campus via Rockville Pike Inspection Entrance in coordination with the NIH Police Dept.

2. Parking of contractor vehicles is regulated by the NIH Contractor Parking Guidelines.

3. The hot cell contractor is responsible for security of any and all tools, equipment and materials on and off the job-site.

4. The hot cell contractor is advised that material and equipment transported through the P-

3 Parking Garage will be subject to vehicle traffic. Especially during morning and afternoon rush hours.

5. NIH will provide a material storage / lay-down area inside the parking garage near the job-site.

6. Transport of materials in and out of the job-site will be through existing doors and thoroughfares. Hot cell contractor is responsible for any and all damage to existing conditions during project.

7. Hot cell contractor responsible to transport packing and normal construction waste to NIH-provided dumpsters. NIH will coordinate removal or hazardous material waste with

NIH DOHS.

8. Hot cell contractor responsible for daily and final clean-up of any and all areas of work – including but not limited to jobsite, store and lay-down areas.

i. Quantity: One adjoined pair of two hot-cells and an electrical cabinet.

ii. Delivery Date: Purchase within fiscal year 2020. Delivery is anticipated in Fall 2020 but will depend on acceptance of assembled hot-cells and readiness of the reconstructed laboratory area in PRSS for reassembly of delivered hot-cells (in disassembled format).

iii. Period of Performance: No software items pertain to this purchase. A maintenance http://www.constructsecure.com/ https://www.ors.od.nih.gov/sr/dohs/Documents/Activity%20Hazard%20Analysis.pdf https://www.publications.usace.army.mil/Portals/76/Publications/EngineerManuals/EM_385-1-1.pdf agreement is not part of this purchase (our current hot-cells are not covered under a maintenance agreement). The hot-cells must have at a minimum a one-year manufacturer warranty.

iv. Option(s): There will be no further options on this purchase.

NIMH-20-002962 Attachment 4