A2.01.JASoleSource.Final_Redacted_1.pdf

JUSTIFICATION AND APPROVAL

FOR USE OF OTHER THAN FULL AND OPEN

COMPETITION

Upon the basis of the following justification, I hereby approve the issuance of the contractual action described below:

JUSTIFICATION

1. Identification of Agency and Contracting Activity.

Department of the Navy Office of Naval Research 875 North Randolph Street Arlington, VA 22203

2. Description of the Action Being Approved.

This justification and approval (J&A) authorizes and approves the issuance of a sole source contract with the Biomedical Research Alliance of New York, LLC (BRANY), Collaborative Institutional Training Initiative (CITl) Program for Web-Based Training for Department of Navy (DON) personnel in the area of Human Subject Research Protection. BRANY is the only responsible source and no other supplier or services can meet the DON’s requirements described in paragraph 3 below.

3. Description of Supplies/Services.

This effort will fulfill or meet the requirements to accomplish the DON and the Office of Naval Research (ONR) mission by providing DON-wide access to a web-based training program containing subject matter content specifically addressing Human Research Protection (HRP) requirements under Federal regulation and Department of Defense (DOD) directives and DON policies. Web access permits training of CONUS and OCONUS personnel ashore, afloat and in remote locations, meeting the broad training mandates of SECNAVINST 3900.39 series and DoDI 3216.02 applicable to individuals conducting research or involved in the process of approving or administering biomedical and socio-behavioral Human Research Protection Program (HRPP) efforts. As training is required prior to the performance, review, administration and approval of human subject research, timely access is necessary to enable the uninterrupted and responsible conduct of DON research in accordance with SECNAVINST

3900.39 series and DoDI 3216.02 (further delineated in the Minimum Education Requirements for DoD Personnel Involved in Human Research Protection issued by the Office of the Assistant Secretary of the Defense in 2012). CITI enables users to acquire initial and ongoing training commensurate with their roles in the HRPP. CITI also provides proficiency testing and course completion certificates that are recognizable by a wide audience and transferable across commands and services.

The proposed total value for this requirement is over five (5) years. The five-year period of performance includes a twelve-month base and four, twelve month option periods. The contract type for this award will be Firm Fixed Price.

4. Identification of Statutory Authority.

The statutory authority permitting other than full and open competition is:

Title 10 U.S.C. 2304(c) (I), One source, as implemented by the Federal Acquisition Regulation (FAR) 6302-1 -- Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

5. Rationale Justifying Use of Cited Statutory Authority.

BRANYs CITI Program (hereafter referred to as CITI) is the only known source with the capability and unique expertise to meet the DON's HRPP training requirements. Various other businesses, non-profits, and non-DoD Government agencies who offer similar training do not include the DoD-specific regulatory content required in Human Resource Protection training, such as specific conduct of DoN human subject research in accordance with SECNAVINST 3900.39 series and DODI 3216.02. As stated in the Minimum Education Requirements (MERF) for DoD Personnel Involved in Human Research Protection: “While commercial vendors may provide many of the educational topics, they do not typically provide DoD-specific regulatory content, nor may they be commensurate for the duties and responsibilities of each role requiring that educational topic.” CITI has worked closely with DON HRPP to provide this DoD/DON unique content and ensure DoD-specific regulatory content is incorporated into its training modules and courses.

Currently over 2,000 organizations are subscribed to CITI and it is considered the industry standard. CITI has created and developed four existing DoD/DON modules and three DoD/DON courses, so continued use avoids the manpower cost at DON HRPP to re-create these modules and courses. Because CITI has already created training modules/course structured for specifically meeting DoD/DONs needs, they have the ability, if needed, to quickly tailor and modify training to address any emerging DoD and DoN needs that may result from updates to policy/regulation.

6. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable.

A notice of intent to sole source, N00014-19-R-SS17, was posted to FedBizOps (FBO) on 11 July 2019, and no responses or questions were received.

Additional market research was conducted by ONR HRPP Personnel and it was determined that of the seven providers of web-based HRP training, only CITI can accomplish this effort and award must therefore be made to BRANY. This requirement has been procured on a sole source basis in the past due to the lack of other responsible sources having the ability to provide DoD-specific regulatory continent in their HRP training.

7. Determination of Fair and Reasonable Cost.

The Contracting Officer will determine that the contract price is fair and reasonable using price analysis techniques in accordance with FAR 15.404-1(b). An Independent Government Estimate (IGE) was prepared and provided by the Program Office. The contract issued under this justification will be awarded at a fair and reasonable price based on the Government’s IGE and the Contracting Officer’s price analysis to be performed once a quote is received.

8. Actions to Remove Barriers to Future Competition.

For reasons set forth in Paragraph 5, ONR has no plans at this time to compete future contracts for the effort covered by this document. If another potential source emerges, ONR will assess whether competition for future requirements is feasible.