J and A final Support Services for Pharmaceutical Managment Branch redacted.pdf

The Statement of Work is included as Attachment #1.

c. Requirement type.

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): ____________________

Type of action.

New requirement Follow-on Other (specify): Evaluation of Option to Extend Services under FAR 52.217-8.

Proposed contract/order type.

Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): __________ Other (specify): ___________ Completion Form Term form

Acquisition identification number.

HHSN261201700007C-Modification P00010

d. Total estimated dollar value and performance/delivery period.

The current total estimated value of the contract inclusive of all options is:

The total estimated value of the contract action is:

The period of performance will start May 1, 2022, and not go beyond October 31, 2022.

The following market research efforts were conducted:

A Pre-Solicitation Notice was Published on March 18, 2022 with a response date of April 1, 2022. No Capability Statements were received.

Based on the market research detailed above, the Contracting Officer has determined that there is not a reasonable expectation that this requirement can be performed by a source other than EDJ Associates Inc. under the existing contract, without substantial risk of non-performance, delays in performance, duplication of costs, and duplication of effort.

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

The use of other than full and open competition for this contract action will also allow the NCI to ensure continuity of services in the event of a post-award protest or any other unforeseen delay to the ongoing acquisition for re-procurement of the services. The period of time being added is the minimal period of time needed to award a contract in response to the RFP 75N91021R00030 and, in the event of a post-award protest, for the time needed to respond to the protest or take corrective action (e.g., reprocuring the services). An acquisition package and solicitation are available for competition from the current solicitation if the need arises. No future extensions are anticipated at this time.

Should the services not be extended, patient safety would be directly impacted.

Investigational agent orders would not be able to be processed in compliance with the protocol requirements. Investigator/ sub-investigators registrations would not be able to be processed or updated per CTEP requirements for credentialling. Maintaining qualifications of investigators and sub-investigators is required under the Investigational New Drug (IND) requirements described in the Code of Federal Regulations.

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

No other sources have expressed an interest, in writing, in the proposed acquisition.

11. 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.

There are no known barriers to competition and all future acquisitions are anticipated to be procured using full and open competition or full and open competition after exclusion of sources.

in response to the RFP 75N91021R00030 for the re-competition of the Support Services for Pharmaceutical Management Branch requirement. The only reason for this contract action not being competed is that EDJ Associates is the only vendor capable of providing services as a bridge action to ensure continuity of services in case the award of re-competition is delayed beyond the expiration date of the contract.