Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF JUNE 11, 2021 SAM #7132
SOLICITATION NOTICE

66 -- Purchase of One (1) each Smoking Machine and Exposure System (SMES)

Notice Date

6/9/2021 1:33:54 PM
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

334516 — Analytical Laboratory Instrument Manufacturing
 

Contracting Office

FDA Office of Acquisitions and Grants Services Rockville MD 20857 USA
 

ZIP Code

20857
 

Solicitation Number

RFQ-FDA-1241526
 

Response Due

6/18/2021 8:00:00 AM
 

Archive Date

07/03/2021
 

Point of Contact

Sarah Hussain
 

E-Mail Address

Sarah.Hussain@fda.hhs.gov
(Sarah.Hussain@fda.hhs.gov)
 

Description

The Food and Drug Administration (FDA), the Center for Drug Evaluation and Research (CDER) is in need of an in vitro exposure system and smoking machine to facilitate the research of human cell cultures in direct exposure to airborne substances such as smoke generated by electronic cigarettes. One of the goals of the CDER research governance counsel is to maintain scientific readiness to address public health threats and to support the treatment of those with opioid use disorder. To support this goal, CDER id studying the risk of vaping opioid drugs by developing an in vitro method to estimate the bioavailability of opioid drugs after vaping. The requested system will allow determining the epithelial permeability as an estimate for bioavailability of opioid drugs after vaping using human cell culture. This in vitro exposure system will be connected to smoking machine for vaping study but also the exposure system can be adapted to other aerosols generating instruments. These criteria will help in comparing the epithelial permeability after vaping of opioids with epithelial permeability of marketed nasal products. The Smoking Machine and Exposure System (SMES) will provide valuable information regarding safety and quality of drug products and support CDER�s mission critical missions.
 

Web Link

SAM.gov Permalink
(https://beta.sam.gov/opp/82e2a1236da441589dc97bd94ab05055/view)
 

Place of Performance

Address: Silver Spring, MD 20993, USA

Zip Code: 20993

Country: USA
 

Record

SN06026966-F 20210611/210609230121 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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