J-and-A-Other-Than-Full-and-Open_NHP Purchase_75A50122Q00001_FINAL.pdf

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

Acquisition Title: Procurement of Nonhuman Primates in Support of BARDA Animal Model Task Orders

Agency: ASPR

Acquisition Year (FY): 22

Author and Title: April Brys, Director of Nonclinical Development

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): Envigo

Street Address: 8520 Allison Pointe Blvd #400

City, State, Zip: Indianapolis, IN 46250

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 $ $12,683,783

BARDA has a new contract requirement for Nonhuman Primates (NHPs) to support nonclinical studies for the advancement of various vaccines, therapeutics and diagnostics in the BARDA Chemical, Biological, Radiological and Nuclear (CBRN) and Influenza and Emerging Infectious Diseases (IEID) Programs. These include antibacterial candidates for anthrax, tularemia, glanders and melioidosis; antiviral candidates for smallpox and hemorrhagic fevers caused by filoviruses and coronaviruses including SARS- CoV-2; diagnostics for anthrax, Ebola and radiation exposure; vaccine candidates for filoviruses; and medical countermeasures for radiological/nuclear and burn agents. The new contract will provide and house 397 NHPs during the one-year base period and provide continued housing during Option Year 1.

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)

The SARS-CoV-2 pandemic launched worldwide research and development efforts to support MCM development, including worldwide acquisition of NHPs for SARS-CoV-2 preclinical studies. This, in turn, has led to increasing difficulty in obtaining NHPs for further SARS-CoV-2 MCM development as well as ongoing preclinical studies for other infectious diseases, such as Ebola and anthrax. BARDA DNCD has current task orders that require NHPs in order to obtain preclinical data for efficacy, natural history, and/ or immunogenicity of the candidates mentioned in Box 3. In addition, as new SARS-CoV-2 variants continue to emerge and new therapeutics and vaccines are developed, NHPs are needed to obtain preclinical data for EUAs and IND filings with the FDA. The availability of high quality animals is a critical risk to these efforts, as failure to acquire NHPS could result in delays or stoppage in candidate development efforts and/or IND filings with the FDA. Securing the purchase of animals as quickly as possible will ensure adequate animals are available to support ongoing preclinical studies performed under multiple BARDA task orders. Based on extensive market research, Envigo is the only source identified that has the resources and availability of NHPs to fulfill this requirement in the necessary time frames given the current shortage of domestic NHPs due to the global pandemic. Therefore, in accordance with FAR 6.302-1, only one source, Envigo, is capable of satisfying BARDA’s requirements.

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

N/A

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

N/A

Other (See FAR Subpart 6.3 for additional authority)

N/A

Provide a full explanation to justify use of the exception.

N/A

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.

During market research BARDA requested quotes from 4 companies to identify multiple sources to provide NHPs in preparation for issuing a solicitation and only two responses were received. Of the two, Envigo was the only company that could meet BARDA’s requirements. The main barrier to competition is the immediate domestic availability of NHP to fulfill this requirement. In accordance with FAR 5.204, a Pre-Solicitation notice of Intent to Sole Source was posted to www.SAM.gov on September 30, 2021 for 15 days. No responses were received. Given the pressing need for on-going research, the government’s timeline to procure NHPs cannot be delayed without compromising BARDA’s mission. After award of this contract action, the approved/signed justification will be posted pursuant to FAR 6.305.

6. Bridge Contracts:

N/A

7. Actions to Increase Competition:

The Contracting Officer sought quotes from four known providers of NHP and only two responses were received. Of the two responses, Envigo was the only source found to have the capabilities to perform the requirements of the acquisition. A Pre- Solicitation Notice of Intent posted to SAM.GOV provided notice to all potential offerors of the Government's intent to sole source to Envigo and offered an opportunity for offerors to submit a capability statement or request the solicitation. No responses were received. Due to the immediate need for the NHP availability no further actions to increase competition were feasible. With urgency surrounding COVID-19, the immediate domestic availability of NHPs is essential to support ongoing preclinical studies.

8. Market Research:

During market research BARDA requested quotes/capabilities statements from 4 companies. The companies solicited were Envigo, World Wide Primate, PreLabs, and Charles Rivers. Only Envigo and World Wide Primates submitted responses. Envigo was the only offeror capable of performing the requirements of this acquisition. In accordance with FAR 5.204, a Pre- Solicitation Notice of Intent to sole source to Envigo was posted on www.SAM.GOV on September 30, 2021 for 15 days and no responses were received.

9. Procurement History:

Purchase order or contract number: N/A

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:

N/A

10. Additional Information to support the justification:

N/A

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: Ashley Smith

Position Title: Biologist

Email address: Ashley.Smith1@hhs.gov

Phone: (202) 205-4662

Program Manager Supervisor (or one level above Program Manager)

Name: April Brys

Position Title: Director, Nonclinical Development Division

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 cost of the quote provided by Envigo was reviewed from reasonableness and was found to be a fair and reasonable price.

Name: Jeffrey Brown Phone: 202-730-8662

Signature: Date: Oct 27, 2021

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.

April M. Brys -S Digitally signed by April M. Brys -S Date: 2021.10.27 10:40:03 -04'00'

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

Brown -S Date: 2021.10.27 10:56:04 -04'00'

Name: Jeffrey Brown Phone: 202-730-8662

Signature: Date: Oct 27, 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:

Signature: Date:

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: 2021.10.27 10:56:45 -04'00'

Steven G. Green -S Digitally signed by Steven G. Green - S Date: 2021.10.27 13:10:20 -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:

HHS SPE Approval is not required for this procurement.

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

Name: Phone:

Signature: Date: