A03_JA-18-108_Final_20180418_Redacted.pdf

Control No: JA-18-108

Justification and Approval for Other Than Full and Open Competition

1. Contracting Activity: The Contracting Activity responsible for this action is the U.S. Army Medical Research Acquisition Activity in support of the U.S. Army Medical Materiel Development Activity (USAMMDA).

2. Description of Action: This approval is being requested for a new Cost Plus Fixed Fee contract using FY17 and 18 Army Research Development, Test, and Evaluation (RDTE), and FY18 Defense Health Program RDTE funds.

3. Description of Services/Supplies: USAMMDA Office of Regulated Activities (ORA) has a requirement to obtain electronic Common Technical Documents (eCTD) submission support. The Contractor will be required to assemble and publish submissions and documents that meet the requirements for publishing and work with ORA and/or regulatory agency software programs including but not limited to LiveLink, Liquent Insight Publisher (eCTD), and FDA Electronic Submission Gateway (ESG), and eSubmitter (eCOPY). The publishing submissions are for 80 open Food and Drug Administration (FDA) Applications which include Investigational New Drugs, Drug Master Files and Orphan Drug Applications with approximately 70 ongoing clinical trial efforts; of the 70 ongoing clinical trial efforts, approximately 35 of those are actively enrolling, while the other ~35 are either in study start up or close out phases. The services will also include developing statistical models using clinical and biological data that will inform clinical trial design (e.g., overall design schema, sample size calculations, screening, randomization, inclusion/exclusion criteria, etc.) in support of the Neurotrauma and Psychological Health Program Management Office.

The estimated value of this contract, including options, is $192,238.40. The required period of performance is five (5) months (1 May 2018 – 30 September 2018) plus a one

(1) month option period (1 October 2018 – 31 October 2018).

4. Authority Cited: The statutory authority permitting other than full and open competition is 10 U.S.C 2304(c)(2) as implemented in Federal Acquisition Regulation (FAR) 6.302-2, Unusual and Compelling Urgency.

5. Reason for Authority Cited: In accordance with FAR 6.302-2, the USAMMDA’s need for these services is of such an unusual and compelling urgency that the Government would be seriously injured unless the agency is permitted to limit the number of sources from which it solicits proposals. A contract must be in place for these services no later than 1 May 2018. Without this support in place by this date, required communication with the FDA will not happen, which impacts the support of the USAMMDA’s Office of the Surgeon General (OTSG) Sponsored Products and the filings of the Investigational New Drugs (INDs), Investigational Device Exemptions (IDEs), New Drug Application (NDAs), Master Files, and 510k submissions. As a result, the USAMMDA would be in violation of the Prescription Drug User Fee Act (PDUFA) IV and there would be a complete work stoppage for all OTSG Sponsored Products. This severely compromises ongoing clinical trials worldwide, as well as support to USAMRMC and to outside mission partners. The USAMMDA ORA have participants in clinical trials all over the world and their follow up care is essential to their health.

In order to ensure the contract is in place within the required timeframe, competition must be limited to as many potential sources as is practicable under the circumstances.

Under the current circumstances, it is only practicable to solicit an offer from one source, Pharmaceutical Product Development LLC (PPD). Further competition would lead to a delay in the award of a contract, which would result in serious injury to the Government.

6. Efforts to Obtain Competition: Not applicable. Due to urgency, it is only practicable to solicit an offer from one source capable of performing the required services without unacceptable delay and serious injury to the Government.

a. Effective competition. Not applicable. No effective competition is anticipated for this acquisition.

b. Subcontracting competition. Not applicable. No subcontracting opportunities are anticipated.

7. Actions to Increase Competition: Due to urgency, it is not possible to compete the current acquisition. In order to increase competition, this requirement is limited to shortterm support. The long-term requirement will be included in an upcoming competitive solicitation. The competitive contract is expected to be awarded no later than 31 August 2018 with full performance expected to begin no later than 30 September 2018.

8. Market Research: Due to urgency, market research efforts were limited to USAMMDA’s knowledge of previous contracts for similar services. These included two

(2) previous task orders (W81XWH-11-D-0008 Task Orders 0003 and 0036) that were performed by PPD. PPD’s performance record was Satisfactory or better on both of these task orders.

9. Interested Sources: To date, no other sources have written to express an interest in the requirement. The notice required by FAR 5.201 shall be published, and any responses received shall be considered.

10. Other Facts:

a. Procurement history. These services are not currently being performed under any contract. The services have previously been included in larger, more comprehensive requirements. However, the scope of this particular requirement differs substantially from that of any previous procurements; thus, there is no comparable, relevant procurement history data available.

b. Other facts. Not Applicable.

11. Technical Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Typed Name: _Jami Clevenger ___________ Date: _______18 Apr 18_____

CLEVENGER.JAMI.M Digitally signed by CLEVENGER.JAMI.MARIE.1229258 Title: __Contracting Officer’s Representative_ Signature:

_______________________ARIE.1229258318 318Date: 2018.04.18 06:53:48 -04'00'

12. Requirements Certification: I certify that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Typed Name: ____Jami Clevenger__________ Date: __18 Apr 18______________ CLEVENGER.J Digitally signed by

CLEVENGER.JAMI.MARIE

AMI.MARIE.12 .1229258318

Date: 2018.04.18 Title: __Contracting Officer’s Representative_ Signature:

______________________29258318 06:54:06 -04'00'

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

Basis for determination: Price analysis techniques will include comparison with the independent government estimate, as well as a comparison with PPD’s established ceiling rates under their Medical Product Research and Development contract (W81XWH-15-D-0038), which were previously determined fair and reasonable.

Certified cost or pricing data will not be required; the estimated value is below the threshold of $750,000 found in FAR 15.403-4(a)(1).

Typed Name: ____Samantha L. Connors____________ Date: ______18 April 2018

Title: __Contracting Officer___ Signature: ____________________________________

14. Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

18 April 2018 Typed Name: ____Samantha L. Connors____________ Date: ___________________

Title: __Contracting Officer___ Signature: ____________________________________