NONMEM_JA.PDF_Redacted.pdf

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TMPLT 2016.06-011

Justification for Other than Full and Open Competition

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

Food and Drug Administration (FDA), Department of Health and Human Services

b. Sponsoring organization.

CDER/OTS/OCP

c. Contracting Officer’s Representative (COR)/Requiring Activity Point of Contact (POC) information.

i. Name: Kirk Roy

ii. Mailing address: Building 51, Rm 3195, 10903 New Hampshire Avenue, Silver

Spring, MD 20993

iii. E-mail address: William.Roy@fda.hhs.gov iv.

Telephone number: 301-796-1596

2. Nature and/or description of the action being approved. Office of Clinical Pharmacology - Renewal of ICON NONMEM.

a. Acquisition purpose and objectives.

The U.S. Food and Drug Administration intends to negotiate and award on a sole source basis to ICON Clinical Research LLC. This acquisition is in support of the FDA’s drug and biologics review functions.

b. Project background.

The FDA receives Investigational New Drug (IND), New Drug Applications (NDA) Biologics Licensing Applications (BLA), Abbreviated New Drug Applications (ANDA), and other submissions from sponsors. Within these submissions sponsors include clinical pharmacology and pharmacometric data (PK/PD modeling, non-linear mixed effects modeling, in vivo-in vitro correlations, and trial simulation) output from ICON NONMEM. These data must be independently analyzed and verified by Office of Clinical Pharmacology reviewers and pharmacometricians. ICON NONMEM provides the necessary tools to perform these data analyses.

This software is essential to the review of sponsor submissions. These reviews are on strict schedules with timelines that must be met per the various user fee acts governing such work

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(Prescription Drug User Fee Act, Generic Drug User Fee Act, Biosimilars User Fee Act) and other FDA Mission-critical functions. These activities have a direct impact on public health.

The following requisitions have been posted to FBO with no bids outside of ICON Clinical Research LLC: 2017 - HHSF223201710221A, 2016 - HHSF223201610241A, 2015 - HHSF223201510096A, 2014 - HHSF223201400487P, 2013 - HHSF223101300650P.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

ICON NONMEM software and support, $10,000.00

a. Project title.

Office of Clinical Pharmacology - Renewal of ICON NONMEM

b. Project Description.

SMG 2610.7 is attached.

Requirement type.

☐ Research & Development (R&D)

☐ R&D support services

☐ Support services (non-R&D)

☐ Supplies/equipment

☒ Information Technology (IT)

☐ Construction

☐ Architect-Engineer (A&E) services

☐ Design-build

☐ Other:

Type of action.

☐ New requirement

☒ Follow-on

☐ Other:

Proposed contract/order type.

☒ Firm-fixed-price

☐ Other fixed-price:

☐ Cost-plus-fixed-fee

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☐ Other cost reimbursement:

☐ Time and materials ☐

Indefinite delivery:

☐ Other:

☐ Completion Form

☐ Term Form

Acquisition identification number.

ICON NONMEM Software and Support

c. Total estimated dollar value and performance/delivery period.

$10,000.00 with a performance period of 7/15/2018 – 7/14/2019

4. Identification of the statutory authority permitting other than full and open competition. Check the applicable block below based on the acquisition circumstance.

Federal Acquisition Regulation (FAR):

☐ 6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(1) or 41 U.S.C. 3304(a)(1).

☐ 6.302-2 Unusual and compelling urgency. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(2) or 41 U.S.C. 3304(a)(2).

☐ 6.302-3 Industrial mobilization; engineering, developmental, or research capability; or expert services. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(3) or 41 U.S.C. 3304(a)(3).

☐ 6.302-4 International agreement. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(4) or 41 U.S.C. 3304(a)(4).

☐ 6.302-5 Authorized or required by statute. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(5) or 41 U.S.C. 3304(a)(5).

☐ 6.302-6 National security. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(6) or 41 U.S.C. 3304(a)(6).

☐ 6.302-7 Public interest. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(7) or 41 U.S.C. 3304(a)(7).

☒ 13.501(a)(1)(ii) Sole source, including brand name, under Simplified Procedures for Certain Commercial Items. This acquisition is using this justification format, modified to reflect that the procedures in FAR subpart 13.5 were used in accordance with 41 U.S.C. 1901 or the authority of 41 U.S.C. 1903.

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5. 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).

ICON Clinical Research LLC 2100 Pennbrook Parkway North Wales, PA 19454-4105

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

Sponsors (pharmaceutical companies, academic institutions, and individuals) submit

Investigational New Drug (IND), New Drug Applications (NDA) Biologics Licensing Applications (BLA), Abbreviated New Drug Applications (ANDA), and other submissions for FDA approval. The tools provided in ICON NONMEM are unique in their application and breadth. In particular sponsor submissions created using ICON NONMEM require the same software be used to provide independent validation of sponsor results.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies.

The following requisitions have been posted to FBO with no bids outside of ICON Clinical Research LLC: 2017 - HHSF223201710221A, 2016 - HHSF223201610241A, 2015 - HHSF223201510096A, 2014 -

HHSF223201400487P, 2013 - HHSF223101300650P.

7. Determination by the Contracting Officer that the anticipated cost/price 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 a fair and reasonable price to the Government.

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 following requisitions have been posted to FBO with no bids outside of ICON Clinical Research LLC: 2017 - HHSF223201710221A, 2016 - HHSF223201610241A, 2015 - HHSF223201510096A, 2014 -

HHSF223201400487P, 2013 - HHSF223101300650P.

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

No other sources have expressed interest in this requirement.

10. 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.

https://www.acquisition.gov/far/html/Subpart%205_2.html https://www.acquisition.gov/far/html/Subpart%205_2.html https://www.acquisition.gov/far/html/Subpart%205_2.html https://www.acquisition.gov/far/html/Subpart%205_2.html https://www.acquisition.gov/?q=browse/far/10 https://www.acquisition.gov/?q=browse/far/10

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Signature:____________________________________

COR/Requiring Activity POC

COR/POC Immediate Supervisor

Head of the Sponsoring Program Office

11. 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

Justification for Other than Full and Open Competition