amendment3.pdf

RFP Number : N01CM07014-39 Amendment 3

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OFFICE OF ACQUISITIONS

NATIONAL CANCER INSTITUTE

REQUEST FOR PROPOSAL NUMBER: N01CM07014-39

Amendment No.: 3

Date of Issuance: 5/27/2010

The above numbered Request For Proposal (RFP) is amended as set forth below. The hour and date specified for receipt of Offerors remains unchanged.

Offerors MUST acknowledge receipt of the amendment prior to the hour and the date specified in the solicitation or as amended, by separate letter, telegram, or Electronic Mail which includes a reference to the RFP and Amendment number(s). For your convenience, the Proposal Intent Response Form is provided in SECTION J - List of Attachments of this RFP, for this purpose.

FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERORS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.

This Amendment revises the RFP as stated below:

The following answers are hereby provided in repsonse to these questions:

1. For the Technical Proposal Direct Cost Summary form that is to be included in the technical section of the proposal, would the Government allow this to be provided in MS Excel Format? Given the extensive nature of the information to be provided, we believe MS Excel would offer the government a more legible format to review.

The Direct Cost Summary can be constructed in MS Excel, a printout should be submitted with any submitted proposal.

2. For pricing the cancellation costs, should proposers assume that the government would stop work immediately or want existing tasks finished and work stopped thereafter? Should there be the assumption that all cancellation activities be finished within three to six months after last day of any program year except for year 1?

For pricing cancellation costs, proposers should assume that the government would stop work immediately.

Cancellation ceilings only apply to contract years two through five. All program years except contract year one are subject to cancellation. The Contracting Officer shall notify the contractor that funds are not available for performance of subsequent years.

3. RFP Page 43, Past Performance. "Offerors shall submit the following information as part of their Business proposal.

A list of the last 3 contracts completed during the past year that are similar in nature to the solicitation workscope."

Would the government be willing to change the Past Performance contracts time period from "the past year" to the past three years?

If you have no past performance completed in the last year, please provide past performance information for the three

(3) most recent contracts.

4. Attachment 15, E (1). "Animals particularly rats and mice may be supplied by the Government when available." Are animals supplied by the Government provided at no cost to the contractor?

Animals provided by the government are provided at no cost to the contractor.

5. Attachment 22, WA 3. The task description indicates that "Pharmacokinetic studies should be conducted in mice…" Should this be in males or females or both? How many time points and replicate animals per time point should be included? What age should the mice be?

RFP Number : N01CM07014-39 Amendment 3

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Attachment 22 indicates that for an actual WA, the details of the study design would be discussed in advance with the Project Officer. For this exercise, assume one sex (either) and mice 6-7 weeks of age; 12 timepoints and 3 mice per timepoint.

6. Attachment 22, WA 3. The task description indicates that "Pharmacokinetic studies should also be conducted in F344 rats…" Should this be in males or females or both? How many time points and replicate animals per time point should be included? What age should the rats be?

For this exercise, assume one sex (either) and rats 7-8 weeks of age; 12 timepoints and 3 replicates per timepoint; the number of animals will depend on your laboratory's procedures for rat sampling (e.g., number of samples per rat).

7. Attachment 22, WA 3. The task description indicates that the full validation of the method should be conducted. Is it expected that the studies in WA 3 are conducted to the GLPs?

No, GLP is not required.

8. Attachment 22, WA 2 and WA3. Will formulation analysis be required for the pharmacokinetic studies? If so, will validated methods be required?

Assume formulation analysis will not be required for these studies.