Attachment 1.pdf

Solicitation N01CN25001-26 Amendment #1 – Questions and Responses

Preclinical In Vitro and In Vivo Agent Development Assays

Amended item #1: Attachment 9, Additional Technical Proposal Instructions, Page 4, Article B., items 1. c) and d), and item 2. are deleted or revised as follows:

Deleted:

c) Sample Task Order – mechanistic studies following screens of Chemopreventive agents In vivo.

d) Sample Task Order – Pharmacokinetics and pharmacodynamics in experimental animals.

2. Describe the approach to the development of analytical procedures for the assay of a drug in plasma, urine, and tissues.

Revised:

c) Sample Task Order – mechanistic studies, including pharmacodynamics, following screens of Chemopreventive agents In vivo.

Article B of Attachment 9 - TECHNICAL APPROACH - will, therefore, now read as follows:

B. TECHNICAL APPROACH

Offerors shall submit a proposal that addresses all areas in the Statement of Work. Only proposals from offerors who demonstrate the capability to perform all aspects of the Statement of Work, either at their institution or through their subcontractors, will be considered for award. If the proposed approach will involve a subcontracting arrangement, then the offeror shall include a letter(s) of commitment from the subcontractor(s), plus documentation of subcontractor’s expertise, qualifications and prior performance, as well as a narrative describing how the contractor will manage the subcontractor(s).

1. Describe the procedures to be used for carrying out the types of preclinical In vivo/In vitro studies indicated in the Statement of Work, including criteria for moribund sacrifice, method and equipment to be used for euthanasia, collection, handling and storage of blood samples for clinical pathology and plasma drug analysis, necropsy and histopathology procedures, and analytical chemistry procedures.

Please provide a response to each of the below sample task orders for the following types of assays, as described in the Statement of Work:

a) Sample Task Order – In Silico/cell free high throughput screens.

b) Sample Task Order – mechanistic studies following screens of Chemopreventive agents In vitro.

c) Sample Task Order – mechanistic studies, including pharmacodynamics, following screens of Chemopreventive agents In vivo.

See also the Additional Business Proposal Instructions regarding development of budgets for each sample Task Order response.

2. Describe the features and capabilities of data management, including software programs currently in use.

3. Describe proposed plans for oversight of data management functions, including protection of Intellectual property and confidentiality of compound data.

4. Describe the operation of the Quality Assurance Unit within your organization concerning auditing of critical study events, raw data and study reports. Indicate when these audits take place in relation to the generation of data and reports.

5. Provide a copy of Standard Operating Procedures (SOPs) relating to the conduct of the type of work found in the Statement of Work, including laboratory SOPs.

Amended Item #2: Attachment 15 “Additional Business Proposal Instructions”, Section 2, item number 1. is revised as follows:

Deleted:

Sample Task Order – Pharmacokinetics and pharmacodynamics in experimental animals.

Assume that 200 rodents (mice and rats)* will be used/per year.

Sample Task Order – mechanistic studies following screens of Chemopreventive agents

In vivo. Assume that 200 rodents (mice and rats)* will be used/per year.

Revised:

Sample Task Order – mechanistic studies, including pharmacodynamics, following screens of Chemopreventive agents In vivo. Assume that 200 rodents (mice and rats)* will be used/per year.

SECTION 2 – COST OR PRICE SUPPORT, item 1. will now, therefore, read as follows:

1. Sample Task Order Budgets:

Please provide budgets for each of the following Sample Task Orders.

Sample Task Order – In Silico/cell free high throughput screens. Assume no animals will be used.

Sample Task Order – mechanistic studies following screens of Chemopreventive agents

In vitro. Assume no animals will be used.

Sample Task Order – mechanistic studies, including pharmacodynamics, following screens of Chemopreventive agents In vivo. Assume that 200 rodents (mice and rats)* will be used/per year.

* Assume $24,000 per year to purchase rodents.

Note: Actual task order budgets will be negotiated at the time of issuance.

3. Will there be a teleconference to go over the RFP and explain it in more detail?

There will NOT be a teleconference. If you have any questions, please send them to Rukshani Fernando at rf212s@nih.gov.

4. Is the award a maximum of 2 years and $9.9 million?

The award is for a maximum of $9.9 Million for 2 years across 4 possible contacts (if all are awarded). We don’t believe that one contractor will be awarded all the Task Orders. (Please refer to pg. 4 of the RFP – Article B.2. Price/Costs)

5. Section J attachment links are not working.

Some of the links may not work, but all the attachments are included as a part of the RFP, at the end.

6. Am I correct in that the basic structure is that there are 3 basic parts: An administrative part, Task I (in vitro) and Task 2 (in vivo). From the current N01 structure, my interpretation is that this means an administrative work assignment (Work Assignment 1). However, for Task 1 and Task 2, if there are several projects for each Task and several PIs, should each project (sub-Task) have a separate budget, or is it a combined Task budget?

Per the Statement of Work (SOW-Attachment 3) – there are two general Task Areas, In Vitro and In Vivo. Task Areas within the SOW are not the same as Task Orders for specific projects.

Please refer to Attachment 9 (Additional Technical Proposal Instructions) and Attachment 15 (Additional Business Proposal Instructions) for information on the structure of the Sample Task Orders and their associated budgets. There is not an intended administrative Task Order; each Task Order will include individual, associated administrative costs.

7. Whom can I ask about technical questions?

All questions regarding this solicitation, technical and otherwise, must be directed to the Points of Contact listed in the RFP: Rukshani Fernando is the primary Point of Contact. We will make sure that all questions are answered, either directly or through amendments to the RFP.

8. My reading of the Instructions to Offerors in Section L indicates that selected contractors, of which there are expected to be 4, will respond to each Task Order Request for Proposal on a competitive basis, and no costs outside of the task order will be allowed. This appears consistent with past methods of operation and does not appear to allow for a consortium management work assignment in support of subcontracting to collaborating investigators. Please confirm or correct my understanding.

The intent is to make up to four awards and each Task Order will be awarded on a competitive basis. The prime contractor is allowed to have subcontractors: per Attachment 9 (Additional Technical Proposal Instructions), “If the proposed approach will involve subcontracting arrangements, then the offeror shall include a letter of commitment from each subcontractor, plus documentation of subcontractor’s expertise, qualifications and prior performance, as well as a narrative describing how the contractor will manage the subcontractors.” There are additional references to subcontractors within this Attachment.