J&A_Parallel6.docx

Justification and Approval for Sole Source

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity.

HHS. NEl/OFVFG/eyeGENE®

b. Sponsoring organization.

National Eye Institute, Ocular Genetics and Visual Function Branch, eyeGENE®

c. Project Officer information.

Santa J. Tumminia, Ph.D.

Associate Director for Strategic Science Initiatives & Programs Office of the Director National Eye Institute National Institutes of Health Bldg 31, Rm 6A03 31 Center Drive MSC 2510 Bethesda, MD 20892 Phone (301) 496-2234 Fax (301) 496-9970 Email: tumminias@nei.nih.gov

1. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives. When eyeGENE® was initiated in 2004, the program scope was narrowly defined as relating to only vision research. Since that time, both Institutional and Review Board leadership has requested an expanded scope of the consent agreement to include end-points that may not be strictly vision related or that may have unknown biological consequences. This change in requirement requires that the program staff contact over 6,000 participants to get consent for the types of research that is desired. Additionally, the program has new requirements related to patient engagement as it seeks to obtain additional clinical information from participants. The program seeks to implement and acquire a software license for Clinical6 software solution to address the new program requirements.

b. Project background. Simple electronic document and delivery is insufficient for ensuring that patients are fully-aware of the research involving testing their entire genome and exome. It would be both time and financially inefficient for the eyeGENE® staff qualified to provide consent (two FTE's) to consent 6,400 participants. The eyeGENE® Program plans to add an electronic consent software solution including

c. Total estimated dollar value and performance/del ivery period.

Project

Com ponent

FY

Option

(FY1

8)

Option

(FY1

9)

Task

Platform

License

Task

Platform

Deployment

(one-ti me set u p fee) n/a n/a Task

Technica l and

Clinical

Services /hr) (600 hrs) (est.

h rs) est hrs) Total )Period of Performance: Award - September 30, 2017. Option years include standard rate of inflation of 2%.

Identification of the statutory authority permitting other than full and open competition.

0 This acquisition is conducted under the authority of 41 United

· States Code (U.S.C.) 253(c)(_) as set forth in Federal Acquisition Regulation (FAR) 6.302- _.

x This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

0 This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

3. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s). Parallel6, Inc.

3655 Nobel Drive, Suite 650 San Diego, CA 92122 Mobile: 703-915-9900 Office: 619-452-1747 www.parallel6.com

b. Nature of the acquisition and proposed unique qualifications of the contractor(s). Parallel6, Inc is the only source of the Clinical6 electronic Consent software solution.

4. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies. The eyeGENE® Program Manager researched electronic consent options and solicited four vendors. Three of the four vendors did not follow through with multiple requests for demonstrations.

Demonstrations were required to ensure that the solution would be compliant with government level security, privacy and human (Pll) research requirements and that the solution would be assessable with screen reading software.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable. Cost reasonableness was determined by comparison to a similar contract for software services for the eyeGENE® program and through consultation with the NEI Internet and Technology Branch. A laboratory management software solution on a R&D contract included a monthly subscription fee of $4,166 compared to the Clinical6 fee per month, which is lower. The hourly rate for the SOW for technical and clinical services is commensurate with the current market rate.

8. Description of the market research conducted (see FAR Part 10) and the results,or a statement of the reasons market research was not conducted. The eyeGENE Program Manager reviewed literature and contacted colleagues within the clinical research community for vendor contacts on existing electronic consent products.The Program Manager also enlisted the assistance of the NEI IT Management Branch to identify vendors and evaluate if the solution to new program requirements could be met through in-house software development. The ITMB determined that novel development would be costly and inefficient and did name two vendors (mytrus and iMedConsent) to contact. A discussion was also held with the NIH CNS IRB to determine if any other Institutes or Centers had used a similar software solution to meet the requirements. Some had, but in a very limited capacity and outside of the NIH clinical capacity (extramural research) . The IRB had no vendor names to share.

The eyeGENE® Program Manager determined that there were very few vendors for electronic consent through web searching and that most were associated with electronic health systems exclusively. The Program Manager did solicited information from four vendors (mytrus, iMedConsent, Quorum, Parralel6) in October and November of 2016, however, only Parralel6 responded to the requests for demonstration. Initially, mytrus, Inc did respond to email solicitation which was followed up with a phone conversation with the Program Manager in November. However, the vendor did not follow up with the Program Manager request for a demonstration.

9. Any other facts supporting the use of other than full and open competition. N/A

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

NIA

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

NIA

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel,including supporting information and/or data verifying the Government's minimum needs, schedule requirements and other rationale for other than full and open competition,are accurate and complete.

Project Officer

Project Officer's Immediate Supervisor

Head of the Sponsoring Program Office

13. Contracting Officer Certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Contracting Officer

14. Chief of the Contracting Office and Head of the Contracting Activity signature(s). The Chief of the Contracting Office (CCO), if applicable, and the HCA shall indicate review of, and concurrence with, any J & A over $700 ,0001 by providing the information required below and signing in the applicable block.

Chief of the Contracting Office

Head of the Contracting Activity

15. Competition Advocate signature. The designated OPDIV Competit ion Advocate (CA), upon acceptance of the rationale provided in the J & A, shall complete the information req'uired below and sign in the block provided as the approving official for any J & A over $700,000 but not exceeding $68 million2• However, if the CA does not meet the requirements of FAR 6.304(a)(3)( ii) for a J & A over $13.5 million, but not exceeding $68 million, an individual other than the CA shall exercise the approval authority .

The signature of the CA, or that of an individual meeting FAR 6.304(a)(3)(ii) requirements for a J & A over $13.5 million, but not exceeding $68 million, shall serve as concurrence on any J & A over $68 million that requires the approval of the HHS SPE.

Competition Advocate

16. ( )HHS Senior Procurement Executive signature. The HHS SPE, upon acceptance of the rationale provided in the J & A, shall complete the information required below and sign in the block provided as the approving official for any J & A over $68 million3

1 This review and concurrence requirement is applicable to the dollar ranges over $700,000 cited in the FAR, specifically : (i) over $700 ,000 but not exceeding $13 .5 million; (ii) over $13.5 million but not exceeding $68 million; and (iii) over $68 million - see FAR 6.304(a)(2) through (4) and 13.501(a)(2)(ii) through (iv).

2 This approval authority is applicable to the following dollar ranges cited in the FAR, specifically : (i) over $700,000, but not exceeding $13.5 million; and (ii) over $13.5 million, but not exceeding $68 million - see FAR 6.304(a)(2) . See FAR 6.304(a)(3)(ii) this approval authority, 3 see FAR 6.304(a)(4) and 13.501(a)(2)(iv).

HHS Senior Procurement Executive image1.jpeg