Evaluation of the Microbial Parameters of E-Liquids (ENDS)
Closed Solicitation Posted
- Solicitation number
- 75F4012R00023
- Agency
- FDA Office of Acquisition and Grant Services Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541720 Research and Development in the Social Sciences and Humanities
- Place of performance
- Beltsville, Maryland 20705, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The Food and Drug Administration's Center for Tobacco Products seeks analytical testing services to determine baseline levels of various microbial parameters in electronic nicotine delivery system e-liquids over an 18-month period. Services include validating test methods, conducting antimicrobial effectiveness testing, measuring water activity, and testing laboratory-prepared and commercial e-liquid samples for total aerobic counts, endotoxins, glucans, and nitrosamines. The contractor must be ISO 17025 certified and have the capability to analyze all required parameters. Proposals will be evaluated based on scientific merits of methods, ability to perform all analyses, fair pricing, and reasonable timeline. Samples must be delivered within two months of award by May 5, 2022.
There is no set-aside designation for this opportunity. Services are covered under NAICS 541715 and PSC Q202. Testing will occur in Calverton, Maryland and involve at least 36 laboratory-prepared samples and commercial batches from three manufacturers. The contractor must provide monthly updates and final reports within 30 days of completion.
Notice text
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)-β-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.
Attachments
| File | Type | Posted |
|---|---|---|
| Microbial QA.pdf | ||
| Micro ENDS SOW analyses testing FINAL v1 10.25.21.docx | DOCX document |
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