RFP_N02CM37002_05_amendment1_q a.pdf

RFP N02CM37002‐05

Amendment 1 Questions and Answers

1. How many different products (i.e. are some the same product in different strengths?)

There are drug products with different strengths which are on stability. The total number of lots on stability is given in the RFP under the technical proposal instructions and on the attached document “Technical Proposal Instructions”

2. Are these controlled or Potent compounds?

These are potent anti-cancer agents.

3. How many require dissolution testing?

a. What type of product? (extended release vs. immediate release)?

There are no extended release products on stability currently.

b. Specifications would be very helpful.

The release specifications will be provided at the time of the award.

4. The Conditions for storage?

The stability storage conditions are given in the RFP under the technical proposal instructions and on the attached document “Technical Proposal Instructions”

5. The package type/size/number and orientation of parenteral and Oral dosage forms?

a. This is important for determining storage needs.

The total storage requirement under various stability conditions is specified in the RFP under the technical proposal instructions and on the attached document “Technical Proposal Instructions”

6. Will these studies start all together or will these be staggered over time?

The stability start date is different for different lots and staggered over time.

7. Please define what “Dedicated” means as it relates to Statement of Work 08/08/12, Section B, Paragraph 4.

RFP N02CM37002‐05

Amendment 1 Questions and Answers

The RFP calls for HPLC instruments which are readily available to carry out the analyses as stability samples are pulled.

8. Is the drug product owned by NCI?

All stability batches are produced by NCI contractors and for agents being studied by NCI.

9. Regarding past performance information, is the Government requesting only information concerning contracts completed within the past “One year”? Or should the past performance information include a period longer than the past One year? Also, can you clarify the term “completed”. For example, does “completed” mean only contracts that have ended and been completed by the Contractor within the past One year (with no possible additional periods of performance), or does “completed” include contracts where an incremental contract year was completed, but which may have additional incremental contract years to be performed depending on the Government’s contract authorization?

Completed within the last year means the contract is finished with no work being performed. But any ongoing contract that is for similar work is acceptable to include even if it was awarded more than one year ago.