Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF APRIL 09, 2022 SAM #7435
SOLICITATION NOTICE

B -- Evaluation of the Microbial Parameters of E-Liquids (ENDS)

Notice Date

4/7/2022 11:55:47 AM
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

541720 — Research and Development in the Social Sciences and Humanities
 

Contracting Office

FDA OFFICE OF ACQ GRANT SVCS Beltsville MD 20705 USA
 

ZIP Code

20705
 

Solicitation Number

75F4012R00023
 

Response Due

4/28/2022 7:00:00 AM
 

Archive Date

05/13/2022
 

Point of Contact

Pamela T Lee, Phone: 240-402-3847
 

E-Mail Address

Pamela.Lee@fda.hhs.gov
(Pamela.Lee@fda.hhs.gov)
 

Description

The Food and Drug Administration (FDA), Center for Tobacco Products (CTP) requires a contractor to provide microbiological analyses of the following parameters in electronic nicotine delivery systems (ENDS) e-liquids: water activity (aw) antimicrobial effectiveness testing (AET) total aerobic microbial counts (TAMC)/total yeast and mold count (TYMC) endotoxin (1?3)-?-D-glucan N-nitrosnornicotine (NNN) and 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) The purpose of this project is to determine baseline levels of each parameter in a variety of ENDS e-liquids.� We will test laboratory-prepared e-liquids first, in order to examine the role of specific parameters (PG/VG levels, nicotine levels, flavors) in anti-microbial properties of the e-liquid.� Next, we will test commercial e-liquid samples (at least three batches per e-liquid).� Samples will be stored at ambient temperature in original containers and may be pooled by batch using aseptic techniques in order to obtain enough volume for all testing.�� Triplicate samples will be tested for each parameter at defined time points from initiation of study in order to provide data over a simulated stability period.� Expiry of each product should be noted at the time of purchase prior to initiation of the study.� The contractor needs to have the following skills/capabilities: Ability to perform work as stated in the SOW. Ability to have the equipment and facilities necessary to perform the work and be ISO 17025 certified. The Contractor is expected to complete these tasks within�18 months of the award. We anticipate delivery of samples within two monthsafter the award. This may provide the contractor time to access validated methods and methods that need to be validated.
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/e608175cbc48474aa1f4edf486c94e4b/view)
 

Place of Performance

Address: Beltsville, MD 20705, USA

Zip Code: 20705

Country: USA
 

Record

SN06292051-F 20220409/220407230059 (samdaily.us)
 

Source

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

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