Adenovirus Notice of Intent.pdf

DEPARTMENT OF THE ARMY

US ARMY MEDICAL RESEARCH ACQUISITION ACTIVITY

820 CHANDLER STREET

FORT DETRICK MD 21702-5014

FCMR-AAA-SD 11 FEBRUARY 2020

Notice of Intent to Award Sole Source

Evaluation of Operations and Processes of the Adenovirus Vaccine Manufacturing

1. Issue Date: 11 February 2020

2. Requiring Activity: U.S. Army Medical Research Acquisition Activity (USAMRAA) for the U.S. Army Medical Materiel Development Activity

(USAMMDA)

3. Description of Requirement:

This is a Firm Fixed Price (FFP) contract to evaluate the operations and processes of the Adenovirus vaccine manufacturing for areas of improvement and increased efficiencies. The gap analysis of existing manufacturing processes will be used to identify areas which require optimization necessary to ensure sustainability of an FDA licensed Adenovirus vaccine for Military use.

4. Notice of Intent to Sole Source:

This Notice of Intent to award to Barr Laboratories (CAGE Code: 56490) as the regulatory sponsor of the Biologic License Application (BLA). Their vaccine was Food and Drug Administration (FDA) approved in March 2011 and they will continue to manufacture, market, and distribute the Adenovirus Vaccine under the Full Rate Production Contract. The statutory authority for this acquisition is FAR citation 6.302-1(a)(2).

The contract shall be firm fixed price.

The period of performance of this contract is an estimated 365 days from the award.

5. Place of Performance:

The Performance for this contract will be at the vaccine manufacturing facilities.

6. Specific Tasks:

The contractor shall evaluate the operations and processes of the Adenovirus vaccine manufacturing for areas of improvement and increased efficiencies. This gap analysis of existing manufacturing processes will be used to identify areas

-2-which require optimization necessary to ensure sustainability of an FDA licensed Adenovirus vaccine for Military use.

Anticipated activities may include (but are not limited to):

1) Assess the need for implementing quality by design methods for process improvements to optimize Adenovirus vaccine production.

2) Assess the need to transfer the virus manufacturing to a Continental

United States location.

3) Assess the need to optimize the virus manufacturing to increase efficiency, throughput and maintain sustained efficacy.

4) Assess overall equipment effectiveness by analyzing efficiency and productivity.

5) Conduct a risk mitigation analysis in the event manufacturing changes are required.

7. Information to Industry:

This is a Notice of Intent to Sole Source for informational purposes only in accordance with (IAW) Federal Acquisition Regulation (FAR) 5.201 and not a request for competitive proposals. Therefore, no solicitation document exists for this requirement. Interested parties should submit a Capability Statement and pricing information for this requirement within fourteen (14) days of public notice to be considered by the Government.

A determination to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government. Responses received will be considered solely for the purpose of determining whether to conduct a competitive requirement.

8. Response Due Date:

Interested vendors should submit the Capability Statement in response to this Notice of Intent to Sole Source electronically by 3 PM (EST) 25 February 2020 via e-mail to the Contract Specialist, Timothy J. Kelly at timothy.j.kelly169.civ@mail.mil. No phone calls will be accepted.

9. Notice Closes:

This Notice of Intent to Sole Source closes on 25 February 2020 at 3 PM (EST).

10. Confidentiality:

No proprietary, classified, confidential, or sensitive information should be included in response to this notice. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

11. Primary Point of Contact:

Timothy J. Kelly, mailto:timothy.j.kelly169.civ@mail.mil

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Contract Specialist timothy.j.kelly169.civ@mail.mil

12. Contracting Office Address:

Attn: FCMR-AAA-SD 820 Chandler Street Frederick, MD 21702 mailto:timothy.j.kelly169.civ@mail.mil