JA_Pragmatic_9_20_2016_version.pdf

Justification for Other than Full and Open Competition

1. Agency: Food and Drug Administration (FDA), Department of Health and Human Services

a. Program Office/Center/Mail Code: OC/OCS/OHI

b. Project Officer: Lonnie Smith

c. Contracting Activity: Office of Acquisitions & Grants Services (OAGS)

2. Nature of Action Being Proposed for Approval:

This is a sole source contract to Pragmatic Data for the annual software licensing, maintenance, and professional services.

3. Title and Description of Supplies or Services and Estimated Value:

a. Project Title: Pragmatic Data HL7 Data Exchange Service

b. Contract/Order No: Requisition 1163170

c. Description of supplies or services:

• Maintenance for perpetual license for Pragmatic Data Integrator and Pragmatic® Regulated Product Labeling Listing and Registration System (PRPLLR) modules,

• Renewal of the Annual License and Maintenance for the Pragmatic Review and Edit Module with Xforms and Adverse Event Module Renewal of annual license for the Pragmatic Testing Environment

• System operations and maintenance for the Pragmatic Data HL7 Data Exchange Service

• Professional Services Support of Pragmatic Data Integrator and PRPLLR Module

d. Estimated Dollar Value: $700,000 (September 20, 2016, to September 19, 2017)

4. Statutory Authority:

This acquisition is conducted under the authority of 41 U.S.C. 3304(a)(1) as set forth in FAR 6.302-1(a), “Only one responsible source and no other supplies or services will satisfy the agency requirements”.

5. Contractor's Unique Qualifications to Provide the Services or Supplies and/or Why The Nature of the Acquisition Requires Use of the Authority Cited.

Currently, the FDA has a perpetual license for the Pragmatic Data Integrator and PRPLLR module. The FDA also has an annual license and maintenance for the Pragmatic Review and Edit Module with Xforms and Adverse Event Module, and the Pragmatic Data Standards Testing Environment.

In order to effectively maintain the use of the perpetual licenses FDA requires software maintenance for the Pragmatic Data Integrator and PRPLLR modules. In order to continue regulatory submission processing the FDA needs to renew their annual licenses and maintenance for the Pragmatic Review and Edit Module with Xforms and Adverse Event Module. The Data Standards Testing Environment license and maintenance will allow FDA to continue evaluating and testing of HL7 data exchange standards.

In addition to the aforementioned software licenses and maintenance requirements, the FDA requires professional services to support Pragmatic Date Integrator and PRPLLR modules;

and to operate and maintain the Pragmatic Data HL7 Data Exchange. These professional services will provide predictive, preventive and corrective maintenance at the service level agreements for the Pragmatic Data Integrator and PRPLLR modules; and permit the FDA to continue to request customization of the system to meet its business/regulatory needs.

Pragmatic Data has proprietary rights and is the sole provider of software license and maintenance; and support for all of the Pragmatic products associated with this acquisition.

There is no other source that can provide maintenance, releases, and software documents. For the professional services, because the code is proprietary software Pragmatic Data is the sole provider that can operate and maintain the Pragmatic Data Integrator and PRPLLR modules; and enhance the Pragmatic Data HL7 Data Exchange. If this software package maintenance and operations and maintenance is not purposed it will impact the processing of several FDA mission critical initiations such as submissions containing information such as drug establishment and drug listing, lot distribution data, biologic and drug products’ electronic content of labeling data. In the event FDA was to use a different software product, years of development and millions of dollars would be lost.

6. Description of Efforts Made to Ensure Offers Are Solicited from As Many Potential Sources As Practicable.

Only one source will be solicited for the reason stated in Section 5 above.

7. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable.

Prior to the award of the proposed contract, pricing information will be obtained from the contractor and price analysis will be performed and documented to sufficiently determine that the order represents the best value and fair and reasonable price to the Government.

8. Description of the Market Survey Conducted and the Results, or Statement of the Reasons a Market Survey was not conducted.

A notice of intent was posted to Federal Business Opportunities on July 15, 2016. No sources inquired about this requirement. Through research FDA is not aware of any other licenses for software which has the required functionality of the Pragmatic Data system or operations and maintenance support for that system.

9. Other Relevant Facts Supporting the Proposed Noncompetitive Acquisition.

In the event the FDA doesn’t continue its Pragmatic Data maintenance or operations and maintenance support, FDA would not be able to process submissions which have data that is used for FDA initiatives such as the need to review information needed to permit the import of biologic and drug products, provide content of labeling in a structured format to the National Library of Medicine to be used in the generation of codes included in electronic prescribing systems, therefore impacting its ability to better protect the public health.

10. Sources that have Expressed Interest in the Acquisition in Writing. No other sources have expressed interest in this requirement.

11. Statement of Actions, if any, to Remove or Overcome Barrier to Competition Before any Subsequent Acquisition for the Supplies or Services.

If there is a need to replace this software, the Government will continue to conduct market research to determine if other solutions may become available to replace these items.

At the moment, no other company can provide maintenance to support these modules;

therefore, no actions can be taken by the Government to remove or overcome barriers to competition. FDA will continue to monitor the marketplace for new technologies. In the event that a new technology with similar or better functionality comes to market, FDA will adjust the acquisition strategy for future procurements accordingly.

12. Provide a statement that indicates that the use of the Justification for procuring this supply or service is not a result of a lack of planning or the expiration of funds.

The use of the Justification for procuring these services is not a result of the lack of planning or the expiration of funds.

Certification and Signatures:

Program Office Certification:

This is to certify that the data supporting this justification is the responsibility of the undersigned program office personnel, including verifying the Government's minimum needs or schedule requirements or other rationale for other than full and open competition justification (pursuant to 6.303-2(b)) which form a basis for this justification, and that such data and rationale are accurate and complete.

Lonnie Smith Date Project Officer

Elaine Johansson Date Project Officer's Supervisor

Todd Simpson Date CIO (IT Purchases)

Contracting Officer Certification:

I certify that this submission is accurate and contains complete data necessary to support the recommendations for approval. The contracting officer further certifies that an award of this contract action from this requirement will be made only if the price or cost to the Government is determined to be fair and reasonable.

Contracting Officer Date

Approved:

Division Director Date

2016-09-20T16:17:29-0400