Justification_and_Approval.pdf

Justification and Approval for Use of Other than Full and Open Competition

This document contains proprietary or procurement sensitive information related to the conduct of a federal agency procurement and shall not be disclosed to any person other than a person authorized by the contracting officer to receive such information.

1. Identification of the Agency and Contracting Activity:

Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS).

a. Program Office/Center/Mail Code

Office of Computational Science (OCS) Center for Drug Evaluation and Research (CDER)

b. Project Officer/Address/Telephone Number:

John Ho

WO BLDG 21 RM 1516

10903 New Hampshire Ave Silver Spring, MD 20993 301-796-2982

2. Nature and/or Description of the Action Being Proposed for Approval:

The FDA, OCS, specifically through CDER plans to acquire services from Pinnacle 21 Corporation for the performance of operations, maintenance, license, and enhancement of the OpenCDISC Enterprise software and services to avoid the loss of services and capability provided by this system at the FDA.

3. Description of Supplies or Services and Estimated Value:

a. Project Title

DataFit Operations, Maintenance, and Enhancement

b. Contract/Order No.

A new Indefinite Delivery/Indefinite Quantity (IDIQ) contract will be established for this requirement.

c. Description of supplies or services:

The DataFit program provides the FDA, specifically CDER, with a dashboard-driven, data standards checking platform. DataFit affords the ability to assess data quality and perform data validation for standards compliance of electronic clinical and non-clinical trial study submission data through a web interface for the selection of data based on the submission, set of studies, or standalone studies.

DataFit validates submission data for compliance with the Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (SDTM) and Standard for Exchange of Nonclinical Data (SEND) standards. The system generates reports that display the conformance results and provide an overview of the quality of the submission data. DataFit enables reviewers to assess and understand the quality of incoming submission data at a summary level in hours, a process which would otherwise take a reviewer several days or weeks to accomplish during a manual review.

These assessments help indicate the ability of submission data to support actual review activities. DataFit measures compliance by evaluating whether:

Appropriate variables are available and values are populated in the expected places; and, Standard terminology is used throughout.

FDA requires services to provide Operations and Maintenance (O&M) support to maintain CDER’s DataFit system. FDA also requires enhancements to the DataFit system and support for CDER’s JumpStart service. JumpStart is a service that provides New Drug Application/Biologics License Application (NDA/BLA) Review Teams with SDTM clinical trial data analyses early in the review process to assess data composition, quality, analyses options, and tools for the analyses, so reviewers have the information to conduct an effective and efficient review.

d. Estimated Dollar Value:

The total estimated value of the Indefinite Delivery / Indefinite Quantity (IDIQ) contract over the next five (5) years is not to exceed $5,000,000.

4. Identification of the Statutory Authority Permitting Other Than Full and Open Competition:

The statutory authority permitting other than full and open competition is 41 U.S.C.

3304(a)(1) as implemented by the Federal Acquisition Regulation (FAR) Subpart 6.302- 1(a)(2)(ii) entitled, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. This justification is prepared in accordance with the requirements of FAR 6.303-2 to support the recommendation that the FDA OAGS use other than full and open competition for the issuance of an IDIQ contract for DataFit and JumpStart support as described in paragraph 3 above.

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.

In order to avoid loss of services to the DataFit validation system, it is necessary for the FDA to contract with Pinnacle 21 Corporation, the sole owner, seller and developer of the Open CDISC Enterprise software that performs the data validation for the DataFit program. DataFit validation of electronic clinical and non-clinical study submission data is a mission critical component of the FDA’s JumpStart service. DataFit is also the FDA program of record for standards compliance and data-quality evaluation of electronic submission data. The DataFit custom installation version of Open CDISC Enterprise enables the FDA to perform large scale data validation, data quality reporting, and utilize platform management tools, all of which the non-enterprise version of the OpenCDISC software does not support. Pinnacle 21 is the only source capable of providing the enterprise level of support and services needed as described below in paragraph 8.

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

A Notice of Intent to Sole Source to Pinnacle 21 Corporation was published on the Federal Business Opportunities (FEDBIZOPPS) website on April 3, 2015 with a response date of April 20, 2015. No responses were received from the Notice of Intent to Sole Source.

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

Prior to the award of the contract, a thorough price analysis will be performed and documented to sufficiently ensure that the pricing for this acquisition is fair and reasonable.

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

FDA CDER OTS/OCS has performed an exhaustive search of Federal Business Opportunities for similar or equal services which produced no results within the last 365 days. A similar search of the open internet produced no results that meet the FDA’s unique needs.

9. Other Relevant Facts Supporting the Proposed Noncompetitive Acquisition.

Reproducing the additional capabilities and services which the OpenCDISC enterprise version currently provides would cost the Government a substantial amount of money and time. The Government estimates the cost to reproduce the above capabilities would be approximately $1.25 million and take between 1 and 2 years of time. This option would not be advantageous or cost-effective to the Government.

10. Sources that have Expressed Interest in the Acquisition in Writing.

No other sources have expressed interest to this acquisition.

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

The FDA will continue to perform market research in the attempt to identify new vendors who are able to provide the licenses and services required. In addition, the FDA will notify the public of FDA’s continual needs prior to establishing a contract with Pinnacle 21 Corporation. This will allow potential vendors the opportunity to identify their interest in future acquisitions.

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 this justification is not a result of lack of planning or the expiration of funds.

Certification, Concurrences and Approval 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 limited sources (pursuant to 8.405- 6(e)(2)(x)) or 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.

John Ho Date Contracting Officer’s Representative

Lilliam Rosario Date Contracting Officer’s Representative’s Supervisor

Chief Information Officer, FDA Date (IT Acquisitions only)

Bradford Wintermute Deputy

John C. Ho -S Digitally signed by John C. Ho -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=John C. Ho -S, 0.9.2342.19200300.100.1.1=2000391966 Date: 2015.04.24 12:37:07 -04'00'

Lilliam A. Rosario -S Digitally signed by Lilliam A. Rosario -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=2000560610, cn=Lilliam A. Rosario - S Date: 2015.04.28 14:57:17 -04'00'

Bradford Wintermute -S

Digitally signed by Bradford Wintermute -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=2000389106, cn=Bradford Wintermute -S Date: 2015.04.28 16:24:49 -04'00'

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.

Steven Chang Date Contract Specialist

Sherry Solodkova Date Contracting Officer

Reviewed and Concur:

Sandra Bellinger Date Division Director

Glenda F. Barfell Date Director, Office of Acquisitions and Grants Services

Approved:

Walter Harris Date Competition Advocate

Tzeleong Chang -S Digitally signed by Tzeleong Chang -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Tzeleong Chang -S, 0.9.2342.19200300.100.1.1=2001236121 Date: 2015.04.28 16:39:04 -04'00'

Sherry Solodkova -S Digitally signed by Sherry Solodkova -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=2000089477, cn=Sherry Solodkova -S Date: 2015.04.29 09:26:43 -04'00'

Sandra Bellinger - S

Digitally signed by Sandra Bellinger -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=2000089313, cn=Sandra Bellinger -S Date: 2015.05.06 19:15:07 -04'00'

Glenda Barfell -S

Digitally signed by Glenda Barfell -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Glenda Barfell -S, 0.9.2342.19200300.100.1.1=2000089688 Date: 2015.05.07 14:22:40 -04'00'

Walter S. Harris -S Digitally signed by Walter S. Harris -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1000468093, cn=Walter S. Harris -S Date: 2015.05.19 23:05:46 -04'00'