Questions and Responses for Solicitation 75F40124Q00126.xlsx
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- Solicitation number
- 75F40124Q00126
About this file
This document contains questions and responses related to Solicitation 75F40124Q00126 for a comprehensive toxicity analysis of individual ENDS flavor ingredient chemicals alone and in complex with metals using high throughput approaches.
The key details are:
- The solicitation requires the contractor to conduct various studies using differentiated primary human airway epithelial cell cultures, including measuring cell viability, barrier integrity, and inflammatory mediators in response to exposure to ENDS flavor chemicals and metals.
- The contractor will not have a role in recruiting expert committee members, providing honoraria, or convening meetings, as those will be handled by the government.
- The contractor can use a modified 5x5 matrix instead of the 10x10 matrix specified in the solicitation, with justification.
- The contractor can store conditioned basal medium at -80°C instead of -20°C, and use cell viability methods other than trypan blue, with appropriate justification.
- The government will not provide any government-furnished equipment for this requirement.
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| File | Type | Posted |
|---|---|---|
| RFQ-75F40124Q00126.docx | DOCX document |
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Sheet1
| FDA Solicitation 75F40124Q00126- Questions | ||||
| No. | Solicitation Reference | Section/Page | Question | Response |
| Task 4 | Section 3.4, page 6 | Protocols will be reviewed by an expert external committee. Please verify the Contractor's role in recruiting committee members, providing honoraria, and convening meetings? | The commitee may have some questions directed to the Contractor, but there is no contractor's role in recruiting committee members, providing honoraria, and convening meetings. | |
| Task 5 | Page 7 | The RFQ specify a 10x10 matrix for measuring metal-flavor combinations. However, the dose range (flavor ingredients from 0.1 to 1000 uM at factors of 10 & metals from 0.1 to 500 uM, also in factors of 10) results in a 5x5 matrix. The difference is a factor of 4 in labor and materials for this particular task. Could you specify which one we should budget for? | Use half logs of metal concentration in the range that covers up to a toxic dose. | |
| Task 6 | Page 10 | The RFQ states that conditioned basolateral medium should be stored at -20 C following collection. Does conditioned basal medium collected for the evaluation of inflammatory mediators have to be stored at -20 C? Could conditioned medium samples be stored at -80 C instead? | Storage of the conditioned medium at -80 C can be provided with justification and a reference source. | |
| Task 6 | Page 10 | The RFQ states that cell viability, "shall be examined using trypan blue assay…"; however, the trypan blue assay is not well-suited for applications involving differentiated primary airway epithelial models of the upper airways. Can cell viability be analyzed by methods other than trypan blue? | Provide a scientific justification and rationale for your method of choice. | |
| Task 6 | Page 10 | The RFQ states that barrier integrity, "shall be examined using TEER every day post-exposure and permeability assay (identify and quantify levels of active efflux)." Can FDA clarify whether they want barrier integrity to be assassed by TEER, as well as a separate epithelial permeability assay? Additionally, TEER and typical permeability assays measure passive flux across an epithelial barrier. Does FDA also want an assay included to measure active flux? If so, can FDA specify the types of molecule(s) (generally or specifically) that they are interested in assessing (e.g., ions in general or sodium specifically)? | No active flux required during daily TEER measurements, but active flux may be required in case of loss of membrane barrier integrity. | |
| Task 6 | Page 10 | The RFQ states that barrier integrity. "shall be examined using TEER every day post-exposure…". Does FDA have a preference for how long after each exposure TEER should be measured? | Justify the time points where you want to measure TEER for the assesment of a baseline and of a exposure effect (check this in the protocol specific tiems) | |
| Task 6 | Page 10 | The RFQ indicates the use of commercial airway epithelium cultures; however, there is no indication of the number of donors to be used. Given the published literature indicating inter-individual variability and the existance of responder/non-responder phenotypes in differentiated primary human airway epithelial cell cultures following inhaled toxicant exposures, Does FDA have an expected number of donors that should be used for each air liquid interface exposure condition in this study? | For this study, one donor is fine for each test article and its corresponding controls. | |
| Task 6 | Page 10 | The RFQ indicates exposures will be three times a week for 21 days. Does FDA want three consecutive days or exposures on a Monday, Wednesday, Friday exposure schedule? | The exposure regimen can be modified according to observed cytotoxicity and other endpoints. | |
| Task 6 | Page 10 | The RFQ indicates exposures will be carried out in an ALI exposure system. Given the sensitivity of these models to slight changes in culture conditions, such as pH, will basolateral medium be buffered with HEPES or will CO2 be filtered through the exposure system? | Keep protocol according to the manufacturer of cells and compatible with the exposure regimen. | |
| Task 6 | Page 10 | The RFQ specifies "upper airway epithelium." Could you please specify whether you mean tracheal or bronchial epithelium? | Bronchoepithelial cells are prefered. | |
| Task 6 | Page 10 | The RFQ states a preliminary exposure study can be done to determine the final exposure protocol. The next sentence defines specific air dilution flows. Do we have the flexibility to start with CRM 81 and develop our own exposure protocol to achieve RFP objectives? | Yes, and provide scientific justification for the exposure that will be developed. | |
| Instructions | Section 7 | Can FDA provide the evaluation criteria for each of the proposal Factors? How many points is each Factor worth? | The evaluation factors and confidence ratings definitions are listed in section 7.1 of the solicitation | |
| Instructions | Section 7 | Can figures, references, and project timeline appear as an appendix, not counting toward page limit of 15? | Yes, this can be included as an appendix | |
| Instructions | Section 7 | There is no guidance on providing CVs of the key personnel. Are they required? Can they be included in the appendix? Is the NIH format of CVs acceptable? | Yes, CVs of the key personnel are required. Format is open, it can be added as appendix. | |
| Volume III | Business Proposal | Some equipment (such as instruments) may need to be purchased to conduct the studies-- is this an acceptable cost to include in the business proposal as a ODC? | No | |
| Volume III | Business Proposal | What GFE will the government provide to support this requirement ? | There will be no GFE for this requirement |
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