Added: Apr 10, 2008 2:19 pm
Requisition Number: FDA1042142
The Food and Drug Administration (FDA) is seeking Small Business sources that can rent 20-25 canine Collies for a 6-8 month period of performance. FDA s clinical study is entitled Pharmacogenomics of the MDR-1 Gene Mutation and the Effect on P-Glycoprotein Substrates in Dogs and Other Veterinary Species . The goal of the FDA is to determine whether the comparative pharmacokinetics of several known P-gp substrates are substantially different when administered to dogs that are homozygous recessive, heterozygous or the wild-types. The MDR-1 gene encodes for P-gp, a transmembrane efflux protein that affects the absorption, distribution and elimination of certain drugs. P-gp is a member of the ATP-Binding Cassette (ABC) transport protein family, which are efflux pumps that remove select agents from within the cell. P-gp is part of a family of efflux transporters found along the intestinal tract, in the kidneys, biliary system, brain and other organs. A mutation in the MDR-1 gene is known to occur in several dog breeds. Since P-gp is an important efflux transporter for a wide range of compounds, dogs homozygous recessive for the MDR-1 mutation may have altered pharmacokinetic and toxicity profiles for P-gp substrates including avermectins. Most importantly, life threatening toxicity has been reported when certain P-gp substrates are administered to dogs that are known to be homozygous for the MDR-1 mutation. In addition, there are anecdotal reports of heterozygote animals also expressing toxicity to some P-gp substrates and a small set of homozygous recessive genotype animals do not express the expected sensitive phenotype. The animal phase will determine the pharmacokinetics of a small set of known P-gp substrates in known wild-type dogs versus dogs that are either heterozygous or homozygous recessive for the MDR-1 mutation. For the contract to be awarded, the vendor is required to deliver the following:
1. A colony of 20-25 homozygous recessive, heterozygous ivermectin-sensitive (MDR-1 mutants) collies.
2. FDA must be able to genotype the potential dogs (at our expense) prior to delivery to determine the suitability of the collies for the study.
3. FDA must be able to have the collies on site for 6-8 months.
4. FDA must be able to obtain tissue biopsies from the liver and kidneys of the collies.
5. May need to select collies from different venders to achieve the desired number of MDR-1 mutants.
This is a REQUEST FOR QUOTATION (RFQ). This announcement constitutes the only solicitation and a written solicitation will not be issued. QUESTIONS DEADLINE: all questions must be received by email (david.kordel@fda.hhs.gov) before 5:00 pm (1600) EST on April 16, 2008. All responsible sources must be registered in the Central Contractor Registry System (CCR) at www.ccr.gov to be considered. FDA intends to make an award soon after the response date of this notice and all bids must be submitted via email and be received by 10:00 AM (1000) EST on 25 April 2008 to the attention of David Kordel, david.kordel@fda.hhs.gov. Evaluation/Award will be based on the technically acceptable quote that offers the best value to the Government. The award will be made in accordance with FAR Part 13, Simplified Acquisition Procedures.
