2082766 - J and A Addendum (COVID)_Redacted.pdf

Addendum to HHS Class J&A for COVID-19 Acquisition

A copy of the HHS Class J&A and this addendum shall be included in every applicable contract file.

The following information supplements the HHS Class J&A for this immediate acquisition by providing supporting detail and rationale as indicated in the Class J&A. Complete all fillable fields. Where needed, instructions are provided in (RED BOLD UNDERLINED). Continuation page is included for any additional space required to complete this form.

1. Identification of the agency and contracting activity.

a. Federal agency and contractingactivity.

Health & Human Services/ National Institutes of Health/(COAC):

b. Sponsoring organization.

HHS/NIH/(Funding IC):

(OR For assisted acquisitions complete below)

Other Agency:

2. Nature and/or description of the action being approved.

See HHS Class J&A.

3. Description of the supplies or services required to meet the agency’s needs (including estimated value and period of performance).

a. Project Title:

COVID-19 Response – Specific Project Title:

Contract Period of Performance:

(Note the total Period of Performance, inclusive of options, is not to exceed 12 months.

Base Period Option Period Option Period Option Period Option Period

Total Period of Performance

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b. Project Description:

• Requirement type. (Select all that apply)

Research & Development(R&D)

R&D Support Services

Support Services (non-R&D)

Supplies/Equipment

Information Technology (IT)

Construction

Architect-Engineer (A & E)Services

Design-Build

Other (Specify any additional requirements as needed to support recovery efforts related tothis national emergency):

• Type of action. (Select one)

New requirement

Follow-on

Other (specify):

• Proposed contract/ordertype.

Pricing arrangement (Select one or more):

Firm Fixed Price

Cost-Reimbursement

Time and Material

Labor Hour

Other (Select only as applicable):

Indefinite-Delivery/Indefinite-Quantity

Letter

• Contract number, Delivery/Task Order Number or other Acquisition identification number.

• Date of Award or Anticipated date of award:

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c. Total estimated dollar value of option period and/or quantities:

Base Period/Qty Option Period/Qty Option Period/Qty Option Period/Qty Option Period/Qty

Total Estimated Value

4. Identification of the statutory authority permitting other than full and open competition See HHS Class J&A.

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

(Briefly describe the nature of the acquisition and unique qualifications of the proposed contractor(s) under unusual and compelling circumstances.)

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6. Actions taken under the authority of this class J&A shall include documentation that the proposed contractor is found to be responsible to perform the work.

Check to verify this is addressed in the Summary of Negotiations and included in the contract file.

Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a Contract Opportunities notice was or will be publicized in beta.SAM.gov as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

Check to verify no synopsis in accordance with FAR 5.202(a)(2) or describe below.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

Check to verify file includes complete documentation of the price/cost analysis conducted and that the proposed price is fair and reasonable.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Check to verify this is addressed in the Summary of Negotiations and included in the contract file.

Any other facts supporting the use of other than full and open competition.

See HHS Class J&A.

9. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

Non

Check to verify this is addressed in the Summary of Negotiations and included in the contract file.

10. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

See HHS Class J&A.

Contracting Officer (CO) Signature Approver Signature: One level above the CO

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Any Additional Information:

Page 6 of 6 06/13/2020

Addendum to HHS Class J&A for COVID-19 Acquisition

The following information supplements the HHS Class J&A for this immediate acquisition by providing supporting detail and rationale as indicated in the Class J&A. Complete all fillable fields. Where needed, instructions are provided in (RED BOLD UNDERLINED). Continuation page is included for any additional space required to complete this form.

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity.

Health & Human Services/ National Institutes of Health/(COAC):

b. Sponsoring organization.

HHS/NIH/(Funding IC):

(OR For assisted acquisitions complete below)

Other Agency:

2. Nature and/or description of the action being approved.

See HHS Class J&A.

3. Description of the supplies or services required to meet the agency’s needs (including estimated value and period of performance).

a. Project Title:

COVID-19 Response – Specific Project Title:

Contract Period of Performance: (Note the total Period of Performance, inclusive of options, is not to exceed 12 months.

Base Period

Option Period

Option Period

Option Period

Option Period

Total Period of Performance

b. Project Description:

· Requirement type. (Select all that apply)

Research & development (R&D)

R & D support services

Support services (non-R&D)

Supplies/equipment

Information technology (IT)

Construction

Architect-engineer (A & E) services

Design-build

Other (Specify any additional requirements as needed to support recovery efforts related to this national emergency):

· Type of action. (Select one)

New requirement

Follow-on

Other (specify):

· Proposed contract/order type.

Pricing arrangement (Select one or more):

Firm Fixed Price

Cost-Reimbursement

Time and Material

Labor Hour

Other (Select only as applicable):

Indefinite-Delivery Indefinite-Quantity

Letter

· Contract number, Delivery/Task Order Number or other Acquisition identification number.

· Date of Award or Anticipated date of award.

c. Total estimated dollar value:

Base Period

Option Period

Option Period

Option Period

Option Period

Total Estimated Value

4. Identification of the statutory authority permitting other than full and open competition

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

b. Nature of the acquisition and proposed unique qualifications of the contractor(s). (Briefly describe the nature of the acquisition and unique qualifications of the proposed contractor(s) under unusual and compelling circumstances.)

6. Actions taken under the authority of this class J&A shall include documentation that the proposed contractor is found to be responsible to perform the work.

Check to verify this is addressed in the Summary of Negotiations and included in the contract file.

Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a Contract Opportunities notice was or will be publicized in beta.SAM.gov as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

Check to verify no synopsis in accordance with FAR 5.202(a)(2) or describe below.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

Check to verify file includes complete documentation of the price/cost analysis conducted and that the proposed price is fair and reasonable.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Check to verify this is addressed in the Summary of Negotiations and included in the contract file.

Any other facts supporting the use of other than full and open competition.

9. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

Non

Check to verify this is addressed in the Summary of Negotiations and included in the contract file.

10. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

See HHS Class J&A.

Contracting Officer (CO) Signature Approver Signature: One level above the CO

Any Additional Information:

2303 Lindbergh St.

Auburn, CA 95602-9562

NatureOfAcquisition: The MACSQuant Tyto cell sorter system equipment is vital to COVID-19 research, and the nature of the disease's current spread across the United States means there is an unusual and compelling urgency to make to acquisition. Furthermore, this equipment is the only system that meets the technical requirements and compatibility requirement of Program. Miltenyi Biotech, Inc. is the manufacturer and the sole vendor of this product, so a sole source acquisition is appropriate.

Due to the emergency status of the current COVID-19 pandemic, these cell sorters will aid in Program's research of Sars-CoV-2 (COVID-19) that is of utmost importance for US disease research efforts. More specifically, the RTB-Cytometry Core will utilize the Tyto equipment to safely sort the aptamer-bead complexes which show the highest affinity to various SARS-CoV-2 spike proteins. Nucleic acid aptamers have been identified as a promising solution for disease diagnosis and therapeutic use. SELEX (screened via capillary electrophoresis (CE)-based systematic evolution of ligands by exponential enrichment) is a method used to identify DNA aptamers. This study will screen these aptamers which recognize SARS-CoV-2 alpha and beta spike proteins and novel variant spike proteins can be used.

Program is also investigating the efficacy and immune cell responses to a newly developed live-attenuated Salmonella vaccine platform following oral inoculation. This platform is a plasmid-based vaccine that delivers the DNA code of the SARS-CoV-2 spike protein to Antigen Presenting Cells in the intestinal tract to

Thus, because Program is working to research and combat the COVID-19 pandemic and requires this equipment to help accomplish this, there is an unusual and compelling for this acquisition. NIH-NIAID has been given authority under the class Justification & Approval (class J&A) to limit sources for acquisitions of unusual and compelling urgency in order to meet the time sensitive requirements of COVID-19 research. If sources are not limited, it would cause Program significant research delays which would seriously injure the government and its objectives under its fight against the COVID-19 pandemic.

Furthermore, only Miltenyi Biotech, Inc. is able to provide the MACSQuant Tyto equipment that meets Program's needs. Program has specific technical requirements for their cell sorters, and alternative equipment cannot meet these requirements. (See specifications document or Market Research Memo for more details) For example, two of the important requirements includes containing media sorting abilities and having a close cartridge system that allows the sample to remain in the closed cartridge throughout the sorting process until the time of post sort recovery. The closed system allows the sample to not interact with the instrument or any fluidics outside the cartridge and also eliminates any chance for sample-to-sample contamination and ensures operator safety as there is no risk of exposure to aerosolized sample. This is important to the safety of the operator when dealing with diseases, pathogens, etc such as COVID-19. Alternative equipment that were examined cannot meet these requirements because they lack media selection and/or they generate [potentially dangerous] aerosols that requires the use of a large bio-safety cabinet to contain the equipment. Program does not the dedicated space of a large and empty biosafety cabinet and thus cannot use these alternative equipment.

Compatibility with existing Tyto equipment is also a requirement. Program currently has a Tyto device in their Bio-safety level 3 (BSL-3) laboratory. The ability to have another Tyto cell sorter in a BSL2 laboratory provides the ability to sort on the same instrument to provide side by side data in two different BSL environments. The Tyto is an instrument that Program will assess to incorporate into Program's BSL4 laboratory in the future. The ability to interchange the sort cartridge to eliminate cross contamination between samples is ideal in these high containment situations. All other instruments utilize a stream in air sorting mechanism, which produce aerosols even with their safety systems. Aerosols require the instruments to be placed within large biosafety cabinets which cannot be accommodated in the space that Program has dedicated. Program currently has a validated Tyto in their BSL3 lab. To maintain experimental reproducibility between BSL2/3 laboratories is imperative and important to their study of diseases

Thus, for all of these reasons, Program can only use the MACSQuant Tyto cell sorter from Miltenyi Biotech, Inc., and a sole source acquisition from Miltenyi Biotech, Inc. is appropriate.

See Market Research Memo for more details.