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FBO DAILY ISSUE OF APRIL 05, 2009 FBO #2687
SOLICITATION NOTICE

B -- Rhesus monkey study

Notice Date
4/3/2009
 
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 Field Finance & Acquisition Services, HFT-320, 3900 NCTR Road, Jefferson, Arkansas, 72079-9502
 
ZIP Code
72079-9502
 
Solicitation Number
FDA-SOL-09-00018
 
Archive Date
4/21/2009
 
Point of Contact
Nicholas E Sartain,, Phone: 870-543-7370
 
E-Mail Address
nick.sartain@fda.hhs.gov
 
Small Business Set-Aside
Total Small Business
 
Description
Questions and answers 1.Can this study be conducted in our preclinical facility in China? Response-No, location must be within the United States. 2.Does this toxicity study require GLP? Response-No 3.The solicitation states that monkeys will be lightly sedated with ketamine (10 - 20 mg/kg, im) for the 0 time blood and urine sample collections and oral dosing. Is this a requirement that will affect comparisons of the data collected with past study data? If not, would it be acceptable to use a restraint chair for these procedures including gavage as is typically done in NHP facility? Response- This is acceptable. 4.For the 3rd study, we have concerns with sedating and isolating the neonatal males. Is this a requirement that will affect comparisons of the data collected with past study data? If not, we recommend that on the day of dosing the dam should be lightly sedated to facilitate hand capture of the neonate. While the animal is manually restrained a urine sample can be obtained via catheterization, the animal can be bled via the femoral vein, and the dose can be administered via orogastric or nasogastric gavage. The neonate would need to be recaptured multiple times for the blood collections and returned to the dam immediately after each timepoint. The dam will likely have to be lightly sedated multiple times during the day (see #3 above). After the 24 hour blood collection a second urine sample can be obtained via catheterization. Would these procedures be acceptable in place of those requested in the solicitation? Response-This is acceptable.
 
Web Link
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=9f0bf2c037aa7b5db08addd578da7136&tab=core&_cview=1)
 
Place of Performance
Address: 3900 NCTR Road, Jefferson, Arkansas, 72079, United States
Zip Code: 72079
 
Record
SN01785789-W 20090405/090403221516-9f0bf2c037aa7b5db08addd578da7136 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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