JOFOC.pdf

C

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/OSP

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

i. Name: Gurpreet Singh

ii. Mailing address: Building 32, Rm 4108, 10903 New Hampshire Avenue, Silver Spring, MD

20993

iii. E-mail address: Gurpreet.Singh@fda.hhs.gov

iv. Telephone number: 240-402-4907

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

Phoenix Quantum software licenses and maintenance

a. Acquisition purpose and objectives.

The U.S. Food and Drug Administration intends to negotiate and award on a sole source basis to Certara USA, Inc. This acquisition is in support of the FDA’s drug review, biologics review, veterinary medicines review, and tobacco products review functions.

b. Project background.

The FDA receives lnvestigational 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 pharmacometrics data (Pl</PD modeling, non-linear mixed effects modeling, in vivo-in vitro correlations, and trial simulation) output from Phoenix Quantum. Phoenix Quantum is critical for OGD meeting the strict schedule related to ANDA review under Generic Drug User Fee Act (GDUFA) II agreements. Every bioequivalence reviewer in OGD is trained to use Phoenix to evaluate and confirm the sponsor’s analysis of the pivotal bioequivalence data submitted in ANDAs.

These activities have a direct impact on public health. Phoenix Quantum includes Phoenix WinNonlin, NLME, IVIVC, Connect, and Trial Simulator which provide the necessary tools to perform these data analyses.

mailto:Gurpreet.Singh@fda.hhs.gov

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

Phoenix Quantum software and support

a. Project title.

CDER - Phoenix Quantum software licenses and maintenance

b. Project Description.

The purchase of Phoenix Quantum software licenses and maintenance.

Requirement type.

☒ Information Technology (IT)

Type of action.

☒ New requirement

Proposed contract/order type.

☒ Firm-fixed-price

Acquisition identification number.

CIN Number: CDER-PGD-23-C-1406

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

Base Year: $154,424.00 Option Year 1: $162,754.00 Option Year 2: $167,636 Option Year 3: $172,629 Option Year 4: $177,824 Total Estimate: $835,267

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.) 41 U.S.C. 3304(a)(1).

https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim

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).

Certara USA, Inc 5511 Capital Center Blvd. Suite 204, Raleigh, NC 27606

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 Phoenix Quantum are unique in their application and breadth. There is no other program that allows the unbiased analysis of drugs in one platform utilizing a graphical user interface, that combines pharmaceutical, mathematical, biological, and software development knowledge without the use of a computer programmer. Quantum Phoenix’s proprietary algorithm incorporates stakeholders/ end user data and requirements. The amount of historical data and research already collected would be lost should another company develop a new algorithm.

It is estimated that it would take 5 full time PhD clinical pharmacologists 3 years to replace the functionality of Phoenix at a cost of $400,000 per year to total $1,200,000. The historical data and research already collected would still be lost in this scenario.

Another unique qualification is it is imperative that the FDA use the same software for all sponsor submissions so that it provides independent and consistent validation of sponsor results. The FDA has been utilizing Phoenix Quantum for the last 5 years and any change in this software could potentially thwart all analysis of prior sponsor submissions. Also, any delay in analyzing data submitted by sponsors would affect PDUFA deadlines and approvals.

In terms of impact of not having Phoenix available, OGD reviewers have been trained to use Phoenix to evaluate and confirm the sponsor’s analysis of pivotal bioequivalence data submitted in ANDAs. Without access to the software, OGD would have to retrain its staff on alternative tools and this would slow down analysis of pending ANDAs (OGD receives approximately 750 ANDAs per year that contain in vivo bioequivalence studies). This may result in ANDA deadlines being missed and causing OGD to fail to meet commitments under GDUFA II.

Certara is the sole proprietor of Phoenix Quantum and does not have any resellers of their product nor utilizes any best-in-class vehicles.

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 Contract Specialist has performed a survey of potential and archived acquisitions of Phoenix Quantum on FBO (now SAM.gov). The only solicitations found and listed were archived and were posted by the FDA beginning in 2012.

The following solicitations were posted to FBO (now SAM.gov) as “brand name or equivalent” with no bids outside of Pharsight (now Certara): 2016 Order HHSF223201610294A $153,470.00, 2015 Order HHSF223201510609A $148,999.29, 2014 Order HHSF223201400453P $57,698.00, 2013 Order HHSF223201300457P $54,950. 2017 was procured via Government purchase card and Ratification;

2018 Order HHSF223201820140A - $151,470.39. The Contract specialist (CS) posted a Notice of Intent to Sole source to SAM.gov (used to be FBO) on June 16, 2023, for 15 days in accordance with FAR Part

5.203 (a), but no interested parties have come forward with the intent to compete.

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. The CS will review the prior contracts beginning in 2015 and continuing through the present and perform a price analysis broken down by each singular license. Also, Contract Specialist will confirm with public pricing versus government pricing or request the Contractor to provide a redacted invoice to a commercial customer for the same items acquired by the Government in this procurement. In the documentation for the historical procurements there is documentation of the discounted prices provided to the government versus the public.

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.

Market Research has shown that there are no vendors out there that are resellers of the product. Best in class ordering vehicles GSA, NASA SEWP, and NITAAC do not provide the Phoenix Quantum product from Certara.

CS posted Request for Information on SAM.gov on May 2, 2023, to find out if there is any commercially available product compatible to Certara’s Phoenix Quantum and if there is any small business capable to meet the Government’s needs. Thirty days after the posting of RFI, CS did not receive any response to the RFI for a compatible product nor could CS identify any small business capable of meeting the Government’s need.

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

Certara is the sole proprietor of the software and the only business that can provide the needed licenses and maintenance of Phoenix Quantum. All previous and current orders were posted to FBO as 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

“brand name or equivalent” with no quotes outside of Pharsight which is now Certara.

1 0 . Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No other sources except Certara USA, Inc (located at 5511 Capital Center Blvd. Suite 204, Raleigh, NC 27606) have expressed interest in this requirement.

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.

The Government will perform periodic market research to identity any compatible product.

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.

Signature:____________________________________

Gurpreet Singh COR/Requiring Activity POC

Tessa Brown

COR/POC Immediate Supervisor

CDER ADCIO

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.

Lilibeth Deato Contracting Officer