Q.doc

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Nonhuman primates
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1074542
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Quantity change and and Q's and A's

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Primates Questions and answers.doc DOC document
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The purpose of this amendment is to:

1. Change the quantities required to read as follows;

Part 2 – Supplies or services and Prices/Costs

2. Description of Supplies & Services

2.1. The FDA has a requirement for Primates- Rhesus Monkeys.

2.2. Contract Type

2.2.1. Firm-Fixed Price Contract.

2.1.2 Rhesus Monkeys EA:____________

2.1.3 Shipping round trip, Rhesus Monkeys EA___________

Requirement is for 18 pregnant females (14 male fetuses) and (4 female fetuses) ** Please note the quantity change from 16 to 18**

2. To answer the following questions and answers:

Q: The primary remaining question that we have not received a direct answer to, which affects our decision to submit a proposal, is when the animals will be required. I understand that these animals are seasonal breeders, but in which breeding season are you expecting to receive them? The answer to that question has not yet been given in terms of a calendar date. If you could provide me with an expected delivery time, in terms of month/year, it would be most helpful to our decision making process and very much appreciated. We want to be certain that we are able to fully deliver on the FDA's expectations.

A: We understand that these animals are seasonal breeders and, thus, did not designate specific dates; what we would prefer is to receive these animals in groups of 6 in 3 separate shipments, 2 to 3 months apart, if possible, with delivery dates to NCTR determined primarily by availability of pregnancies but all within one year of the beginning of the contract and with a couple of weeks advance notice.

Q: How long will the infants be on the dam after birthing?

A: No more than one week.

Q: What is considered unsuitable or not of serviceable condition?

A: Stillborn/dead fetus or severely ill dam during pregnancy.

Q: In developing a breeding and shipping time chart, we have set it up to include 3 animal shipments, each with 6 animals per shipment with the required fetal sex. In the event of unsuitability or loss of animal, the SOW states that the vendor would be fully responsible for replacement. We would anticipate this in a 4th "extra" breeding and shipment period, which would occur after the primary 3 and would be solely for replacement if deemed necessary. This 4th "extra" shipment would fall at the end of the contract term, August 2011 if this contract begins August 2010. Is this an appropriate way to interpret the FDA's requirements?

A: Yes Q: The SOW says time-mated, does this requires a single controlled mating episode, or is a plan for harem breeding over 2-5 days acceptable?

A: Either a controlled mating or harem breeding is fine, however, we prefer a 3 day window for knowing date of impregnation.

We understand that these animals are seasonal breeders and, thus, are not designating specific dates for delivery to NCTR; what we would prefer is to receive these animals in groups of 6 in 3 separate shipments, 2 to 3 months apart, if possible, with delivery dates to NCTR determined primarily by availability of pregnancies but all within one year of the beginning of the contract and with a couple of weeks advance notice. We would like to receive the first group of 6 as soon a possible.

All other amendments and conditions remain unchanged by this amendment.

File details come from the government source that posted it. Updated .