RFP_N02CM57002_05_amendment_2.pdf

RFP Number : N02CM57002-05 Amendment 2

- 1 -

OFFICE OF ACQUISITIONS

NATIONAL CANCER INSTITUTE

REQUEST FOR PROPOSAL NUMBER: N02CM57002-05

Amendment No.: 2

Date of Issuance: 03/04/2015

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:

Amendment 2 provided answers to the following questions:

Question 1. Are we expected to put together the business and technical proposals specifically for the sodium esmailate capsules TORFP? Or are you looking a proposal that covers both oral and topical development and manufacturing?

Answer 1. We need a price and technical proposal for the sample Task AND we need a technical proposal that covers the Oral and Topical development and manufacturing as described in the Statement of work.

Question 2. Is this RFP going to be used for choosing a contractor for future NIH TORFP work? Or will this RFP only cover the manufacturing of sodium esmailate capsules?

Answer 2. This RFP is intended to award a contract for all the types of work described in the Statement of Work.

The Sample Task order is just one example of what a task will look like.

Question 3. For the example TORFP provided in the solicitation, the primary focus of the work would be GMP manufacturing. Are you also expecting us to include cost for technical transfer batches, analytical method development/qualification, or analytical method transfer?

Answer 3. Yes your proposal should consider both manufacturing from scratch and the manufacturing a batch from the given formulation.