JOFOC.pdf

Justification for Other than Full and Open Competition at or Below the Simplified Acquisition Threshold

Project Title: Maintenance Support Renewal for Parexel Liquent Software

I . Identification of the agency and contracting activity

DHHS, NIH, NIAID/OD/OSMO/OCICB/SEB

Requestors name: Andrew Blagaich Requestors phone number: 240.669.2065 Requestors email address: andrew.blagaich@nih.gov Address of the requesting lab/office: Rockville, MD

II. Description of the project, and supplies or services required to meet the agency’s needs (including the estimated value) A. Type of action: (check the appropriate box)

☐ New requirement

☒ Follow‐on

Name of the previous contractor(s): Parexel

Sequence number, if available: Not available

Was the initial and any subsequent awards competed? ☒ Yes ☐ No B. AMBIS Sequence number for this requirement: TO BE DETERMINED C. Total estimated dollar value of the requirement (including options, if applicable): $44,548.00 D. Period of performance, inclusive of options: 03/31/2015 – 03/30/2016 E. Project Background

The Office of Cyber Infrastructure and Computational Biology (OCICB) requires renewal of maintenance for Parexel Liquent Software. Liquent InSight is software used to prepare, manage, and submit electronic Common Technical Document (eCTD) versions of Investigational New Drug (IND) applications. This is a requirement by the Food and Drug Administration (FDA).

F. Description of Supplies/services to be purchased Maintenance Support Renewal for Parexel Liquent Software

III. Identification of the statutory authority permitting other than full and open competition (SELECT ONE)

☒ 41 USC 253(c)(1) and FAR Pa r t 6 . 3 0 2 ‐1 : Only one responsible source ☐ FAR Pa r t 8 . 4 0 5 ‐6 : Federal Supply Schedule (FSS), limited competition

☐ An urgent and compelling need exists, and following the procedures would result in unacceptable delays

☒ Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized and must be maintained by the original manufacturer.

☐ In the interest of economy and efficiency, the new work is a logical follow‐on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order or BPA must not have been previously issued under sole‐source or limited‐sources procedures.

Important Note: The statutory authorities listed below will rarely ever be used in NIH. Before selecting one of these authorities, please ensure that you have read and understood the citation and discussed it with the cognizant Contracting Officer.

☐ 41 USC 253(c)(2) and FAR Pa r t 6 . 3 0 2 ‐2 : Unusual & compelling urgency ☐ 41 USC 253(c)(3) and FAR Pa r t 6 . 3 02 ‐3 : Industrial mobilization; or engineering, developmental, or research capability; or expert services ☐ 41 USC 253(c)(4) and FAR Pa r t 6 . 3 0 2 ‐4 : International agreement

☐ 41 USC 253(c)(5) and FAR Pa r t 6 . 3 02 ‐5 : Authorized or required by statute

☐ 41 USC 253(c)(6) and FAR Pa r t 6 . 3 0 2 ‐6 : National security

☐ 41 USC 253(c)(7) and FAR Pa r t 6 . 3 0 2 ‐7 : Public interest

IV. 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):

Parexel International Horsham, PA

B. Describe why only the requested supply/service will meet the government’s needs Liquent InSight is a software used to prepare, manage, and submit eCTD versions of IND applications and New Drug Application (NDA) to regulatory agencies worldwide, including the Food and Drug Administration (FDA). This software is the industry/FDA standard and must be utilized for applications. With that being said, the Division of Acquired Immunodeficiency Syndrome (DAIDS) and the Vaccine Research Center (VRC) prepare and submit several hundred IND applications annually. Maintenance of this software is crucial to this application process. Please note without this maintenance to ensure software is operational, applications of lifesaving drugs research and could very well be held up. This potential risk to research is too high in this situation and this software maintenance must be acquired. There are no other alternatives at this time. The program office and the Contracting Officer have determined that only one source and no other source will satisfy agency requirements.

C. Describe why only the proposed contractor is capable of providing the requested supply/service Software updates and fixes provided through this maintenance are proprietary and are not sold by any other company.

V . Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

Price reasonableness determination will be included in the acquisition file.

VI. 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 my request and approval by Julienne M. Keiser of is accurate and complete.

Official Name & Title Signature Date

Requestor Certification

Contracting Officer Approval

JULIENNE M. KEISER

SUPERVISOR PROCUREMENT ANALYST