MODIFICATION
B -- Collection of Physiological Data Prior to Shock
- Notice Date
- 8/1/2014
- Notice Type
- Modification/Amendment
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-SOL-1130616
- Archive Date
- 7/13/2015
- Point of Contact
- Tomeka Evans, Phone: 240-402-7575
- E-Mail Address
-
Tomeka.Evans@fda.hhs.gov
(Tomeka.Evans@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- The purpose of this amendment is to answer questions received from potential offerors. Offerors shall acknowledge receipt of this Q&A amendment. All other terms and conditions remain unchanged. Question: Are we allowed to use probiotics and antibiotics upon delivery of animals? Answer: If necessary, the use of antibiotics/probiotics upon delivery of the animals is permitted to provide a healthy animal for the experiments. Justification for the use should be provided to the FDA and use should be minimized to the amount necessary to reduce the risk of infection. Antibiotic/probiotic treatment should be stopped prior to initiation of the experiments. Question: Do you want pictures? Answer: Pictures of sensor placement and the function of physiological monitors will be required. Question: Where will the sheep be coming from for the Collection of Physiological Data Prior to Shock? Will transportation to the facilities also be a part of the cost? Answer: The contractor is responsible for obtaining sheep for the experiments. Transportation costs are a part of the contract and shall be borne by the contractor. Question: What happens if a test sheep dies at any point in the process? I would of course report the death, count that as a loss and continue with the remaining test sheep; but the study is for 8 sheep. PART II: Will I be required to purchase additional sheep which can, at any time, replace the sheep that died? Answer: All deaths during the experiments shall be reported. The contract is for eight (8) completed sheep, and you should expect to deliver that number. If multiple deaths occur the FDA may work with the contractor to re-evaluate and modify the protocol and/or contract as necessary. Question: Am I allowed to give the test sheep antibiotics and prebiotics during the 7 days before catheter insertion? Answer: If necessary, the use of antibiotics/probiotics upon delivery of the animals is permitted to provide a healthy animal for the experiments. Justification for the use should be provided to the FDA and use should be minimized to the amount necessary to reduce the risk of infection. Antibiotic/probiotic treatment should be stopped prior to initiation of the experiments. End of Questions & Answers
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-1130616/listing.html)
- Place of Performance
- Address: The place of performance will be at the contractor's facility., United States
- Record
- SN03447214-W 20140803/140801235317-421c19ed3a7914a685190012f9e74846 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |