J-and-A-Other-Than-Full-and-Open_75A50121R00024 _FINAL.pdf

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

Acquisition Title: Assessing Correlates Of Protection In Rhesus Macaques Administered Various Vaccine Candidates Designed to

Agency: ASPR

Acquisition Year (FY): 21

Author and Title: Jeffrey Brown, Contracting Officer

2. Description of Action:

Nature: New Requirement Follow-on Requirement

Modification to Existing Purchase Order/Contract Number:

Pricing: Firm-Fixed Price Time & Materials Cost

Other:

Funds: OMA Other Funds:

Name of Proposed Contractor(s): Battelle Memorial Insitute

Street Address: 2555 International St, City, State, Zip: Columbus, OH 43228 USA

3. Description of Services or Supplies:

Basis for Approval (FAR 6.303-1(d)): Individual Basis Class Basis

The total estimated value of the proposed action, including all options is $ $3,977,119

The objective of this study is to explore immune correlates of protection in rhesus macaques across different vaccines with diferent doses being evaluated within each vaccine. Vaccine candidates will be provided by Moderna, Novavax, Janssen and Sanofi Pasteur.

The study will be conducted under an approved quality management plan. The study will be conducted in compliance with 21CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies), Office of Laboratory Animal Welfare (OLAW) regulations and BARDA Project Quality Requirements. Exceptions to GLP compliance will be described in the study protocol.

4. Authority and Rationale: Identify the statutory authority, FAR title and FAR citation permitting other than full and open competition. It may be one of the following most commonly used citations by the operating divisions of the Department of Health and Human Services (HHS), but other exceptions may apply per FAR Subpart 6.3.

Actions other than simplified acquisition procedures (select only one and provide an explanation):

FAR 6.302-1: Only one responsible source and no other supplies or services will satisfy agency requirements, 41 U.S.C.

3304(a)(1)

Only Battelle is capable to perform this task as it is a continuation of previous work issued under contract 75A50121P00027. Battelle is the only organization that has the current capabilities and capacity to ensure timely execution of the studies without a gap period. In addition, any attempt of another organization seeking to perform this study would cause substantial duplication of cost and time to establish the study, which would present to the Government and unacceptable delays in fulfilling the agency’s requirements. Significant time and money have been invested in developing, optimizing, qualifying and validating the assay that are to be used for the analysis of the samples from the NHPs in the correlates of protection study. Developing these assays and getting to a validated stated at another facility would take at least a year and several million dollars, which is not in the best interest of the Government, especially during a pandemic. Data from this study will further inform the ongoing human clinical studies. The correlates of protection is a variable measure post vaccination that can be used to predict protection from SARS-CoV-2 infection.

FAR 6.302-2: Unusual and compelling urgency, 41 U.S.C. 3304(a)(2)

FAR 6.302-5: Authorized or Required by Statute, 41 U.S.C. 3304(a)(5)

Other (See FAR Subpart 6.3 for additional authority)

Provide a full explanation to justify use of the exception.

5. Agency Actions to Take or Remove Barriers That Led to Other Than Full and Open Competition (If applicable):

Describe the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration prior to any subsequent acquisition for the supplies of services is made. If no such actions have been taken, explain why.

COVID 19 response requires a rapid response, no other capable sources were identified to immediately fullfill what is an urgent need.

6. Bridge Contracts:

Not applicable.

7. Actions to Increase Competition:

A pre-solicitation notice was published to beta.sam.gov, seeking any capable potential offerors. There were no timely responses provided to the notice.

8. Market Research:

A pre-solicitation notice of intent to sole source was posted to beta.sam.gov, providing opportunity for potential offerors to provide capabilities for completing the required tasks. There were no timely responses from any potential offerors. Battelle was determined to be the only organization who had the current capability to provide the necessary services for this time sensitive project. Battelle has performed under 75A50121P00027, which this contract is a follow on too.

BARDA conducts ongoing Market Research and has a comprehensive understanding of nearly all technological advancements in the biomedical R&D industry in general, including the MCM manufacturing space.

Some of the tools used by BARDA to conduct market research include webinars, stakeholder meetings, live video conferences, and BARDA Industry Day to inform potential respondents of the goals in order to provide an opportunity for potential respondents to determine their applicability to BARDA's mission and requirements.

Other market research techniques include reviewing similar awards, scientific meetings and conferences, and information available on the Internet. The market research helps to promote competition and to understand potential respondents’ capabilities.

Prospective respondents may also participate in the BARDA TechWatch/CoronaWatch program or schedule calls/exchange emails with the Program Managers from the appropriate area of interest to better understand if the proposed technology aligns with the area of interest.

9. Procurement History:

Purchase order or contract number: 75A50121P00027

Was action competed? Yes No

If action was not competed, state the cited authority, summarize rationale, and describe the actions that were supposed to be taken to increase competition and the results thereof:

This contract was awarded under the HHS class J&A for Unusual and Compelling Urgency. Due to the need for COVID 19 response competing would be unlikely to identify any other capable sources and would have led to a delay in award.

10. Additional Information to support the justification:

11. Technical / Requirements Certification: By my signature below, I certify that the supporting data included in this J&A is accurate and complete.

Program Manager

Name: Tanima Sinha

Position Title: Lead Interdisciplinary Scientist

Email address: Tanima.Sinha@hhs.gov

Phone: 202-205-0643

Program Manager Supervisor (or one level above Program Manager)

Name: April Brys

Position Title: Director, Nonclinical Development

Email address: April.Brys@hhs.gov

Signature:

Date:

12. Fair and Reasonable Price/Cost Determination: As Contracting Officer, by my signature below, I hereby determine that the anticipated price/cost to the Government for this contract action will be fair and reasonable.

The price of the contract was reviewed and determined to be fair and reasonable based on current market prices and past pricing on the prior contract.

Name: Jeffrey Brown, Contracting Office Phone: 202-730-8662

Signature: Date: Jun 25, 2021

April M. Brys -S Digitally signed by April M. Brys -S Date: 2021.06.25 16:17:50 -04'00'

Jeffrey E. Brown -S Digitally signed by Jeffrey E.

Brown -S Date: 2021.06.25 15:02:19 -04'00'

13. Contracting Officer's Approval (Required for proposed contract not to exceed $700,000 (value calculated including all options)): I hereby certify that this justification is accurate and complete to the best of my knowledge. I approve this justification subject to availability of funds, and provided that the services and supplies herin describe have otherwise been authorized for acquisition.

Name: Jeffrey Brown Phone: 202-730-8662

Signature: Date: Jun 25, 2021

14. Legal Review:

N/A

15. OPDIV Competition Advocate Approval (Required for proposed contract over $700,000 but not exceeding $13.5 million value calculated including all options)):

I have reviewed this justification and find that it adequately supports other than full and open competition.

Name: Steven Green Phone: 240-907-8295

Signature: Date: 06/28/2021

16. Office of Small and Disadvantaged Business Utilization:

I have reviewed this justification and find that it adequately supports other than full and open competition.

Name: Phone:

Signature: Date:

17. OPDIV HCA Approval (Required for proposed contract over $13.5 million but not exceeding $68 million value calculated including all options)):

Name: Phone:

Signature: Date:

18. Department Competition Advocate:

Concur: Non-Concur:

Name: Phone:

Signature: Date:

Jeffrey E. Brown -S Digitally signed by Jeffrey E.

Brown -S Date: 2021.06.25 16:20:54 -04'00'

Steven G. Green -S Digitally signed by Steven G. Green - S Date: 2021.06.28 12:15:32 -04'00'

(The below approval paragraph is required if the cumulative contract value, including all options, exceeds $68 million.)

19. HHS Senior Procurement Executive (SPE) Approval:

Based on the foregoing justification, I hereby approve other than full and open competition for the above stated procurement, subject to the availability of funds, and provided that the services herein described have otherwise been authorized for acquisition.

State supplies/services being procured:

The objective of this study is to explore immune correlates of protection in rhesus macaques across different vaccines with diferent doses being evaluated within each vaccine. Vaccine candidates will be provided by Moderna, Novavax, Janssen and Sanofi Pasteur.

The study will be conducted under an approved quality management plan. The study will be conducted in compliance with 21CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies), Office of Laboratory Animal Welfare (OLAW) regulations and BARDA Project Quality Requirements. Exceptions to GLP compliance will be described in the study protocol.

State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304:

N/A

Name: Phone:

Signature: Date: