Purchase of Two Custom Research Hot-Cells

Closed Solicitation Posted

This opportunity was awarded. See the award notice from .

Solicitation number
NIMH-20-002962
Agency
National Institute on Drug Abuse National Institutes of Health, Department of Health and Human Services
Responses due
Set-aside
No set-aside

Opportunity facts

NAICS code
332312 Fabricated Structural Metal Manufacturing
PSC
9999 Miscellaneous Items
Place of performance
Bethesda MD 20814 USA

Notice details come from SAM.gov. Updated .

About this opportunity

This combined synopsis/solicitation requests proposals for the purchase of two custom research hot-cells and an electrical cabinet. The National Institute of Mental Health seeks to expand radiochemistry development capacity and synthesis of new positron emission tomography radioligands. Offerors must demonstrate the ability to construct hot-cells meeting specifications within six months of award, including front and rear lead shielding doors with windows, internal shelving and lighting, ventilation filters, and power and gas connections. Proposals will be evaluated on technical merit, price, and past performance, with responses due no later than May 25, 2020.

The requirement has no set-aside designation, with a NAICS code of 621511 and size standard of $35 million. Delivery and installation of the hot-cells and electrical cabinet shall take place at the National Institutes of Health campus in Building 10, Bethesda, Maryland by Fall 2020. The total quantity is one pair of adjoining hot-cells not exceeding 1552 x 1214 x 2650 mm and one electrical cabinet no larger than 800 x 400 x 1800 mm, with the award made on a firm-fixed price basis for an indefinite dollar amount. Storage costs must be included if installation is delayed more than four months after delivery.

Notice text

3 versions

Update #3 · Latest ·

This is a combined synopsis/solicitation for commercial items, prepared in accordance with format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation: No. NIMH-20-002962 includes all applicable provisions and clauses in effect through FAR Federal Acquisition Circular (FAC) 2020-05 (effective March 30, 2020) simplified procedures for commercial items. This acquisition will be conducted under the procedures for acquiring commercial items authorized in FAR Part 12 and under the authority to use simplified procedures for commercial requirements as provided in FAR 13.501.

This requirement is assigned North American Industry Classification System (NAICS) code 621511 with a size standard of $35.0 million dollars. 
Only one award will be made because of this solicitation. This will be awarded as a firm fixed price type contract.
BACKGROUND
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 radioligands, 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 salient characteristics that apply to this acquisition are as follows: 
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 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.
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.
7)    Please include the cost of storing the hot-cells in the United States if the time frame to install the hot-cells were to exceed four months.


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.
8)    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.
9)    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.  


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

PAYMENT
Payment shall be made upon the delivery and acceptance of all required items in accord with the Prompt Payment Act.


DELIVERY / INSTALLATION
The Contractor shall begin construction on the hot-cells immediately upon award. 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).

Delivery shall be to:
10 Center Drive
Building 10, B3C
Bethesda, MD 20892

Offeror is to propose FOB terms. Shipping and installation costs must be included in the quote. 

CONTRACT CLAUSES/PROVISIONS
The following Federal Acquisition Regulation and Health & Human Services Acquisition
Regulation Provisions/Clauses apply to this acquisition:


FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)
This solicitation incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): http://www.acquisition.gov/far/ and/or http://www.hhs.gov/policies/hhsar/.
Clause No. Title
FAR 52.212-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL ITEMS (OCT 2018)
FAR 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS-COMMERCIAL ITEMS (OCT 2018)
FAR 52.212-4 CONTRACT TERMS AND CONDITIONS-COMMERCIAL ITEMS (OCT 2018)
FAR 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS-COMMERCIAL ITEMS (JAN 2019).
The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.
The following FAR clauses cited in paragraph (b) of the clause at FAR 52.212-5 are also applicable to this acquisition:

FAR Clause 52.204-10 Reporting Executive Compensation and First Tier Subcontract 
Awards
FAR Clause 52.209-6 Protecting the Government's Interest When Subcontracting with 
Contractors Debarred, Suspended, or Proposed for Debarment
FAR Clause 52.209-9 Updates of Publicly Available Information Regarding 
Responsibility
FAR Clause 52.219-28 Post Award Small Business Program Representation
FAR Clause 52.222-3 Convict Labor
FAR Clause 52.222-19 Child Labor-Cooperation with Authorities and Remedies
FAR Clause 52.222-21 Prohibition of Segregated Facilities
FAR Clause 52.222-26 Equal Opportunity
FAR Clause 52.222-36 Affirmative Action for Workers with Disabilities
FAR Clause 52.222-40 Notification of Employee Rights Concerning Payment of Union 
Dues or Fees
FAR Clause 52.223-18 Encouraging Contractor Policies to Ban Text Messaging while 
Driving
FAR Clause 52.225-3 Buy American Act -Free Trade Agreements - Israeli Trade
Act
FAR Clause 52.225-13 Restrictions on Certain Foreign Purchases
Far Clause 52.232-33 Payment by Electronic Funds Transfer-System for Award 
Management
FAR Clause 52.204-25_Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment
FAR Clause 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Please complete and resubmit with offer)
FAR Clause 52.246-2 Inspection of Supplies-Fixed Price
FAR 52.216-4 Economic Price Adjustment-Labor and Material


EVALUATION
Offers will be evaluated for technical criteria, price, and past performance using a comparative approach. A contract will be awarded to the offer that is determined to be most advantageous to the Government. Responses to this solicitation must address the Technical Evaluation Criteria set forth in Attachment 2.


RESPONSES AND PRICE PROPOSAL
Responses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. Such factors may include: past performance; special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations.

The Offeror shall prepare a price proposal that contains all information necessary to allow for a comprehensive evaluation of the prices quoted. Specifically, your quote must include the following: Federal Tax Identification Number (TIN); Data Universal Numbering System (DUNS) Number; and Business Size (e.g., small or large).

Contracting Office Address: 
301 North Stonestreet Avenue
Bethesda, MD 20892
United States 

Primary Point of Contact.: 
Michelle Cecilia
michellececilia.cecilia@nih.gov
Phone: 301-827-7199

Secondary Point of Contact: 
Valerie Whipple,
Contracting Officer
valerie.whipple@nih.gov
Phone:  301-827-5218


SUBMISSION INFORMATION
All quotes must include the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All Offerors must have an active registration in the System for Award Management (SAM) “www.sam.gov.” 


Please submit an executed copy of Attachment 6. 


All responses must be received by 2:00 P.M., Eastern Standard Time, on May 25, 2020, and reference number NIMH-20-002962. Responses must be submitted electronically via electronic mail at michellececilia.cecilia@nih.gov and valerie.whipple@nih.gov .

AMENDMENT 1: Question and Answer Period

AMENDMENT  2:  Two Questions Posed During Question and Answer Period

Questions will be accepted until May 19, 2020 at 12:00  p.m. EST.

Fax responses will not be accepted. 

Update #2 ·

This is a combined synopsis/solicitation for commercial items, prepared in accordance with format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation: No. NIMH-20-002962 includes all applicable provisions and clauses in effect through FAR Federal Acquisition Circular (FAC) 2020-05 (effective March 30, 2020) simplified procedures for commercial items. This acquisition will be conducted under the procedures for acquiring commercial items authorized in FAR Part 12 and under the authority to use simplified procedures for commercial requirements as provided in FAR 13.501.

This requirement is assigned North American Industry Classification System (NAICS) code 621511 with a size standard of $35.0 million dollars. 
Only one award will be made because of this solicitation. This will be awarded as a firm fixed price type contract.
BACKGROUND
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 radioligands, 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 salient characteristics that apply to this acquisition are as follows: 
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 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.
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.
7)    Please include the cost of storing the hot-cells in the United States if the time frame to install the hot-cells were to exceed four months.


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.
8)    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.
9)    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.  


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

PAYMENT
Payment shall be made upon the delivery and acceptance of all required items in accord with the Prompt Payment Act.


DELIVERY / INSTALLATION
The Contractor shall begin construction on the hot-cells immediately upon award. 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).

Delivery shall be to:
10 Center Drive
Building 10, B3C
Bethesda, MD 20892

Offeror is to propose FOB terms. Shipping and installation costs must be included in the quote. 

CONTRACT CLAUSES/PROVISIONS
The following Federal Acquisition Regulation and Health & Human Services Acquisition
Regulation Provisions/Clauses apply to this acquisition:


FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)
This solicitation incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): http://www.acquisition.gov/far/ and/or http://www.hhs.gov/policies/hhsar/.
Clause No. Title
FAR 52.212-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL ITEMS (OCT 2018)
FAR 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS-COMMERCIAL ITEMS (OCT 2018)
FAR 52.212-4 CONTRACT TERMS AND CONDITIONS-COMMERCIAL ITEMS (OCT 2018)
FAR 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS-COMMERCIAL ITEMS (JAN 2019).
The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.
The following FAR clauses cited in paragraph (b) of the clause at FAR 52.212-5 are also applicable to this acquisition:

FAR Clause 52.204-10 Reporting Executive Compensation and First Tier Subcontract 
Awards
FAR Clause 52.209-6 Protecting the Government's Interest When Subcontracting with 
Contractors Debarred, Suspended, or Proposed for Debarment
FAR Clause 52.209-9 Updates of Publicly Available Information Regarding 
Responsibility
FAR Clause 52.219-28 Post Award Small Business Program Representation
FAR Clause 52.222-3 Convict Labor
FAR Clause 52.222-19 Child Labor-Cooperation with Authorities and Remedies
FAR Clause 52.222-21 Prohibition of Segregated Facilities
FAR Clause 52.222-26 Equal Opportunity
FAR Clause 52.222-36 Affirmative Action for Workers with Disabilities
FAR Clause 52.222-40 Notification of Employee Rights Concerning Payment of Union 
Dues or Fees
FAR Clause 52.223-18 Encouraging Contractor Policies to Ban Text Messaging while 
Driving
FAR Clause 52.225-3 Buy American Act -Free Trade Agreements - Israeli Trade
Act
FAR Clause 52.225-13 Restrictions on Certain Foreign Purchases
Far Clause 52.232-33 Payment by Electronic Funds Transfer-System for Award 
Management
FAR Clause 52.204-25_Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment
FAR Clause 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Please complete and resubmit with offer)
FAR Clause 52.246-2 Inspection of Supplies-Fixed Price
FAR 52.216-4 Economic Price Adjustment-Labor and Material


EVALUATION
Offers will be evaluated for technical criteria, price, and past performance using a comparative approach. A contract will be awarded to the offer that is determined to be most advantageous to the Government. Responses to this solicitation must address the Technical Evaluation Criteria set forth in Attachment 2.


RESPONSES AND PRICE PROPOSAL
Responses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. Such factors may include: past performance; special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations.

The Offeror shall prepare a price proposal that contains all information necessary to allow for a comprehensive evaluation of the prices quoted. Specifically, your quote must include the following: Federal Tax Identification Number (TIN); Data Universal Numbering System (DUNS) Number; and Business Size (e.g., small or large).

Contracting Office Address: 
301 North Stonestreet Avenue
Bethesda, MD 20892
United States 

Primary Point of Contact.: 
Michelle Cecilia
michellececilia.cecilia@nih.gov
Phone: 301-827-7199

Secondary Point of Contact: 
Valerie Whipple,
Contracting Officer
valerie.whipple@nih.gov
Phone:  301-827-5218


SUBMISSION INFORMATION
All quotes must include the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All Offerors must have an active registration in the System for Award Management (SAM) “www.sam.gov.” 


Please submit an executed copy of Attachment 6. 


All responses must be received by 2:00 P.M., Eastern Standard Time, on May 25, 2020, and reference number NIMH-20-002962. Responses must be submitted electronically via electronic mail at michellececilia.cecilia@nih.gov and valerie.whipple@nih.gov .

AMENDMENT 1: Question and Answer Period

Questions will be accepted until May 19, 2020 at 12:00  p.m. EST.

Fax responses will not be accepted. 

Update #1 ·

This is a combined synopsis/solicitation for commercial items, prepared in accordance with format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation: No. NIMH-20-002962 includes all applicable provisions and clauses in effect through FAR Federal Acquisition Circular (FAC) 2020-05 (effective March 30, 2020) simplified procedures for commercial items. This acquisition will be conducted under the procedures for acquiring commercial items authorized in FAR Part 12 and under the authority to use simplified procedures for commercial requirements as provided in FAR 13.501.

This requirement is assigned North American Industry Classification System (NAICS) code 621511 with a size standard of $35.0 million dollars. 
Only one award will be made because of this solicitation. This will be awarded as a firm fixed price type contract.
BACKGROUND
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 radioligands, 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 salient characteristics that apply to this acquisition are as follows: 
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 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.
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.
7)    Please include the cost of storing the hot-cells in the United States if the time frame to install the hot-cells were to exceed four months.


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.
8)    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.
9)    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.  


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

PAYMENT
Payment shall be made upon the delivery and acceptance of all required items in accord with the Prompt Payment Act.


DELIVERY / INSTALLATION
The Contractor shall begin construction on the hot-cells immediately upon award. 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).

Delivery shall be to:
10 Center Drive
Building 10, B3C
Bethesda, MD 20892

Offeror is to propose FOB terms. Shipping and installation costs must be included in the quote. 

CONTRACT CLAUSES/PROVISIONS
The following Federal Acquisition Regulation and Health & Human Services Acquisition
Regulation Provisions/Clauses apply to this acquisition:


FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)
This solicitation incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): http://www.acquisition.gov/far/ and/or http://www.hhs.gov/policies/hhsar/.
Clause No. Title
FAR 52.212-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL ITEMS (OCT 2018)
FAR 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS-COMMERCIAL ITEMS (OCT 2018)
FAR 52.212-4 CONTRACT TERMS AND CONDITIONS-COMMERCIAL ITEMS (OCT 2018)
FAR 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS-COMMERCIAL ITEMS (JAN 2019).
The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.
The following FAR clauses cited in paragraph (b) of the clause at FAR 52.212-5 are also applicable to this acquisition:

FAR Clause 52.204-10 Reporting Executive Compensation and First Tier Subcontract 
Awards
FAR Clause 52.209-6 Protecting the Government's Interest When Subcontracting with 
Contractors Debarred, Suspended, or Proposed for Debarment
FAR Clause 52.209-9 Updates of Publicly Available Information Regarding 
Responsibility
FAR Clause 52.219-28 Post Award Small Business Program Representation
FAR Clause 52.222-3 Convict Labor
FAR Clause 52.222-19 Child Labor-Cooperation with Authorities and Remedies
FAR Clause 52.222-21 Prohibition of Segregated Facilities
FAR Clause 52.222-26 Equal Opportunity
FAR Clause 52.222-36 Affirmative Action for Workers with Disabilities
FAR Clause 52.222-40 Notification of Employee Rights Concerning Payment of Union 
Dues or Fees
FAR Clause 52.223-18 Encouraging Contractor Policies to Ban Text Messaging while 
Driving
FAR Clause 52.225-3 Buy American Act -Free Trade Agreements - Israeli Trade
Act
FAR Clause 52.225-13 Restrictions on Certain Foreign Purchases
Far Clause 52.232-33 Payment by Electronic Funds Transfer-System for Award 
Management
FAR Clause 52.204-25_Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment
FAR Clause 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Please complete and resubmit with offer)
FAR Clause 52.246-2 Inspection of Supplies-Fixed Price
FAR 52.216-4 Economic Price Adjustment-Labor and Material


EVALUATION
Offers will be evaluated for technical criteria, price, and past performance using a comparative approach. A contract will be awarded to the offer that is determined to be most advantageous to the Government. Responses to this solicitation must address the Technical Evaluation Criteria set forth in Attachment 2.


RESPONSES AND PRICE PROPOSAL
Responses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. Such factors may include: past performance; special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations.

The Offeror shall prepare a price proposal that contains all information necessary to allow for a comprehensive evaluation of the prices quoted. Specifically, your quote must include the following: Federal Tax Identification Number (TIN); Data Universal Numbering System (DUNS) Number; and Business Size (e.g., small or large).

Contracting Office Address: 
301 North Stonestreet Avenue
Bethesda, MD 20892
United States 

Primary Point of Contact.: 
Michelle Cecilia
michellececilia.cecilia@nih.gov
Phone: 301-827-7199

Secondary Point of Contact: 
Valerie Whipple,
Contracting Officer
valerie.whipple@nih.gov
Phone:  301-827-5218


SUBMISSION INFORMATION
All quotes must include the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All Offerors must have an active registration in the System for Award Management (SAM) “www.sam.gov.” 


Please submit an executed copy of Attachment 6. 


All responses must be received by 2:00 P.M., Eastern Standard Time, on May 25, 2020, and reference number NIMH-20-002962. Responses must be submitted electronically via electronic mail at michellececilia.cecilia@nih.gov and valerie.whipple@nih.gov .

Fax responses will not be accepted. 

Attachments

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Notice history

Notices posted for this opportunity, newest first
Notice Type Posted
Purchase of Two Custom Research Hot-Cells Award Award Notice
Purchase of Two Custom Research Hot-Cells This notice · Latest solicitation Solicitation
Purchase of Two Custom Research Hot-Cells Original Pre-Solicitation

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