JA_Germany_Cohort_Study_19_Oct_2017_redacted.pdf

FOR OFFICIAL USE ONLY

Control No: JA17299

Justification Review Document for Other Than Full and Open Competition (Required for actions $650,000 and up)

Program/Equipment: HIV Vaccine Program

Authority: 10 United States Code 2304(c)(1), as implemented in the Federal Acquisition Regulations (FAR) at 6.302-1(a)(2): Only one responsible source and no other supplies or services will satisfy agency requirements.

Estimated Amount: $2,039,264

Prepared by:

Typed Name: Elizabeth A. Heger DSN: 343-7853 Title: HIV Vaccine Product Manager Date: 12 Oct 2017 E-mail: elizabeth.a.heger.civ@mail.mil

Contracting Officer:

Typed Name: Kelly R. Green DSN: 343-1346 E-Mail: Kelly.R.Green.civ@mail.mil Date Reviewed: 12 Oct 2017

Technical Representative:

Typed Name: Elizabeth A. Heger DSN: 343-7853 Title: HIV Vaccine Product Manager Date Reviewed: 12 Oct 2017

Requirements Representative:

Title: HIV Vaccine Product Manager Date Reviewed: 12 Oct 2017 mailto:elizabeth.a.heger.civ@mail.mil mailto:Kelly.R.Green.civ@mail.mil

Reviews: I have reviewed this justification and find it adequate to support Other Than Full and Open Competition.

Program Manager:

Signature: ____________________ Date: 12 Oct 2017

Legal Counsel:

Typed Name: Scott Luu DSN: 343-9879

Signature: ____________________ Date: 16 Oct 2017

Control No: JA17299

Justification and Approval for Other Than Full and

Open Competition Justification

1. Contracting Activity: The Contracting Activity responsible for this action is the U.S.

Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, Maryland 21702, in support of the U.S Army Medical Material Development Agency.

2. Description of Action: This action is for a new cost plus fixed fee contract that will be supported with FY17, FY18 and FY19 Army 6.4 RDT&E funds.

3. Description of Supplies/Services: This contract will enable establishment of up to 10 clinical sites for a cohort study that seeks to recruit and retain 1000 men who have sex with men that exhibit high risk sexual behavior. The purpose of the study is to establish new clinical sites for future efficacy studies of HIV vaccines, and to estimate the incidence of HIV in this population, and the potential for conducting an HIV vaccine study in this population in the future. The estimated total value of this award is $2.04 million USD. The period of performance is 15 October 2017 through 14 October 2019.

4. Authority Cited: The statutory authority permitting Other Than Full and Open Competition is 10 United States Code 2304(c)(1), as implemented in the Federal Acquisition Regulations (FAR) at 6.302-1(a)(2): Only one responsible source and no other supplies or services will satisfy agency requirements.

5. Reason for Authority Cited: The US Army is pursuing development of a subtype B HIV vaccine, and is developing new clinical sites for future efficacy studies. The HIV epidemic in Germany is predominantly subtype B, similar to the epidemic in US military personnel and in the general US population. The establishment of new sites in Germany will augment those already available in the US, and will ensure that the Army has sufficient numbers of clinical sites with access to a high-risk population for future HIV vaccine efficacy trials. In order to develop additional sites and train staff to conduct HIV vaccine trials, an observational cohort study in the target population will be executed.

The University of Duisberg-Essen has recruited investigators throughout Germany to conduct the cohort study, which will enroll 1000 men who have sex with men and transgender women to determine the incidence of HIV infection and their willingness to participate in a vaccine trial. The University of Duisberg-Essen’s Institute for HIV Research has established a collaboration with the German government Robert Koch Institute (equivalent to the US CDC), the Center for Infectious Disease Research (DZIF), the University of Cologne, and other non-governmental organizations to develop co-funding mechanisms to support the objectives of the cohort study. The University of Duisberg-Essen has been instrumental in bringing together academic, government and non-governmental organizations to support this study, resulting in cost-sharing agreements for multiple diagnostic assays, research assays, and site costs. This co-funding is available only with the collaborations achieved by the University of Duisberg- Essen; otherwise, the Government would be required to bear the full cost of the study.

The University has written a final clinical protocol that has been reviewed by the local IRB; approval is pending. It has also prepared a manual of procedures to ensure the sites are consistent in their execution of the study, and study staff has received training on both the protocol and procedures. In addition, the University has recruited investigators in each city, who have agreed to collaborate on this study, saving an estimated 6 to 12 months for site recruitment. The University of Duisberg-Essen is uniquely positioned to support the US Military in its development of a subtype B vaccine because of the Institute led by Dr. Streeck, and the collaborations already established within Germany. As such, the University of Duisberg-Essen is the only source capable of meeting this requirement because it owns the existing protocol and manual of procedures which staff have already been trained on, in addition to its ability to maintain a unique collaboration with subject matter experts required to meet the Government’s need in a truly cost effective manner.

6. Efforts to Obtain Competition: Not Applicable. No effort will be made to solicit offers from as many potential sources as is practicable as there is only one source capable of performing the required services.

a. Effective competition. No effective competition is anticipated.

b. Subcontracting competition. Not Applicable. There is no anticipated subcontracting for this requirement.

7. Actions to Increase Competition: No efforts will be made to increase competition;

this is a one-time action and is not expected to reoccur.

8. Market Research: Market research was conducted and there are no other centers in Germany dedicated to HIV research other than the Institute for HIV Research at the University of Duisburg-Essen. Internet research was conducted on 17 July 2017, using the following terms: Germany, HIV, Vaccine, and Research.

9. Interested Sources: On 6 April 2017, a preliminary Request for Information related to this requirement was sent to the Medical Product Research and Development (MPRD) Prime Contract holders – PPD Development LP; Leidos, Inc.; Dynport Vaccine Company; and Engility Corporation – for a period of 21 days determine if this requirement could be competed under the MPRD multiple award, indefinite delivery indefinite quantity contracts. Four responses were received with two proposals showing strong capabilities. However, when the USAMMDA was generating its requirement documents, more intricacies related to the aforementioned collaborations in already in existence were discovered that were not known at the time of the MPRD RFI release.

This supported a change in the recommended acquisition strategy to a sole source requirement. The Contract Specialist issued a combined Sources Sought and Notice of Intent to www.fbo.gov (FBO) on 25 Aug 2017 for a period of seventeen (17) days. Only one response was received. The response was from Leidos, Inc.,. inquiring as to why the Government has chosen a sole source vehicle over the MPRD vehicle. The http://www.fbo.gov/ response from Leidos did not meet the response requirements of the FBO Posting;

Leidos simply forwarded its previous MPRD specific RFI response. This response did not demonstrate a capability to achieve the desired collaborations. The Contracting Officer and Contract Specialist spoke to Chris Sherman on 14 Sept 2017 via telephone to obtain advice on the path forward, given the single, questionable response. Mr.

Sherman suggested posting another RFI to FBO to be compliant with USAMRAA’s local 17-05 policy. The additional public RFI was posted on 18 Sept 2017 for a period of 4 days. The reasons for sole sourcing as stated above were also reiterated to Leidos via email on 18 Sept 2017. Leidos responded to the explanation with thanks and asked no further questions. No responses to the final RFI were received from Leidos or any other firms. As such, to date, no other sources have written to express an interest to date.

The notices required by FAR 5.201 have been published and the responses receive have been considered and determined incapable of meeting this unique requirement.

10. Other Facts:

a. Procurement history. Reasonable efforts to retrieve the following items from computer records, contract files, competition advocate office files or other sources are expected:

(1) Contract Number and Date of last several contracts: This is a new requirement and no previous contracts have been awarded through the US Army for HIV vaccine study site development.

(2) Competitive status of these actions: Not applicable, as there have been no previous procurements.

(3) Authority previously used for less than full and open competition. Not applicable

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results. Not applicable

(5) If any prior award was accomplished by full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources. Not applicable

(6) An explanation of any unusual patterns which may be revealed by the history, e.g., several consecutive, urgent buys. Not applicable

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the buy and whether there have been any significant changes. Not applicable

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: Elizabeth A. Heger Date: 12 Oct 2017

Title: HIV Vaccine Product Manager Signature:

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: Elizabeth A. Heger Date: 12 Oct 2017

Title: HIV Vaccine Product Manager Signature:

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. To determine this, certified cost and pricing data will be required. A cost analysis will be completed to determine cost realism and the proposal will be compared to the Government’s independent cost estimate.

Typed Name: Kelly R. Green Date: 12 Oct 2017

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.

Typed Name: Kelly R. Green Date: 12 Oct 2017

Title: Contracting Officer Signature:

15. Legal Sufficiency: Include the following determination:

Based on the information provided in this document, I hereby determine this justification for other than full and open competition to be legally sufficient.

Typed Name: Scott Luu Date: 16 Oct 2017

Title: Contract & Acquisition Attorney Signature:

Approval

Based on the foregoing justification, I hereby approve the procurement of research and development support for the Germany Human Immunodeficiency (HIV) Cohort Study on an Other Than Full and Open Competition basis pursuant to the authority of 10 U.S.C.2304(c, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Typed Name: Christopher Sherman Date: 10/19/2017

Title: Special Advocate for Competition Signature: