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FBO DAILY - FEDBIZOPPS ISSUE OF JUNE 27, 2019 FBO #6425
SOLICITATION NOTICE

R -- Phoenix Quantum Licenses and Support or Equal

Notice Date

6/25/2019
 

Notice Type

Combine Synopsis/Solicitation
 

NAICS

511210 — Software Publishers
 

Contracting Office

4041 Powder Mill Road Beltsville MD 20705
 

ZIP Code

20705
 

Solicitation Number

FDA-SOL-19-1213138
 

Response Due

7/2/2019
 

Point of Contact

Mark L. Brady, Contract Specialist, Phone 2404027404, - Phillip K. Frame, Phone 3018277169
 

E-Mail Address

mark.brady@fda.hhs.gov, Phillip.Frame@fda.hhs.gov
 

Small Business Set-Aside

N/A
 

Description

The Office of Science receives tobacco product applications through multiple regulatory pathways including Substantial Equivalence (SE), Modified Risk Tobacco Product Applications (MRTPA), and Premarket Tobacco Applications (PMTA). Within these submissions sponsors include pharmacology and pharmacometric data (PK/PD modeling, non-linear mixed effects modeling, and other such data). These data must be independently analyzed and verified by Office of Science reviewers. Phoenix Quantum includes Phoenix WinNonlin, NLME, IVIVC, Connect, and Trial Simulator which provide the necessary tools to perform these data analyses. CTP is seeking to purchase 29 licenses for Phoenix Quantum or equivalent to allow Office of Science reviewers to complete the review of SEs, MRTPAs, PMTAs, and other submissions from sponsors, which is the primary role of the Office. This is a combined synopsis/solicitation for commercial software and services prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (25-JUN-2019); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
 

Web Link

Link To Document
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-19-1213138/listing.html)
 

Place of Performance

Address: 11785 Beltsville Drive., Rm 5409B calverton, MD

Zip Code: 20705

Country: US
 

Record

SN05351569-F 20190627/190625230035 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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