Amendment 0001 - PTTP RampOn QandA.pdf

Responses to Questions

1. Attachment No. 12 of the RFP requests Past Performance Information questionnaires to be completed by either the Contracting Officer, Contract Specialist, Project Officer or other responsible officials from other companies or Government agencies. Historically, theses questionnaires are completed, sealed and provided directly to the procuring contracting agency. In this instance, these questionnaires are to be returned to the bidder for submission with their proposal. Can you please clarify/confirm which practice is to be utilized for this procurement?

Past performance questionnaires can be submitted either way, directly from the contracting officials that completed the questionnaire or by the offeror along with the proposal.

2. For the PK studies (Sample Tasks 2a, 2b, and 2c) – we are assuming these are to be conducted non-GLP. Can you please confirm?

Yes, the PK studies (sample tasks 2a, 2b, and 2c) are to be conducted non-GLP.

3. We did not see anything in the RFP about SEND. We assume the SEND datasets will be provided

(required) for the GLP-compliant tox studies. Can you please confirm if SEND is also required for any non-GLP studies (PK or dose range-finding tox studies)?

SEND datasets will be required only for dose range-finding tox studies.

4. For Sample Tasks 2d and 2e, histopathology is being evaluated from “major organ systems” – we noticed there were no immune system organs listed (spleen, thymus). Should the inclusion of these organ also be considered for pricing purposes?

Yes, the immune system organs should also be considered for pricing purposes.

5. For Sample Task 2d, the experimental design table only shows males for Groups 1, 2, and 4 and both sexes for Group 3. We are assuming that both sexes are required for this study and the exclusion of females in those 3 groups was a typo since the text below the table indicates both males and females are be used. Can you please confirm?

This is not a typo; the design is to get an indication of differences in TK and finding in females in the DRF at a mid-dose.

6. For the “28 Day GLP Toxicity Evaluation (Rat)” study of Sample Task 2f:

• The days of necropsy are not indicated. We are assuming it would be day 29 for the main animals and day 57 for the recovery animals just like for the dog 28-day study design. Can you please confirm?

Yes, it would be day 29 for the main animals and day 57 for the recovery animals just like for the dog 28-day study design.

• It indicates that a “Complete read [on] all organs from control and high dose and target organs at low and mid doses.” Is the complete read for both main and recovery animals in the control and high dose groups or just the main animals (with the recovery animals and the main animals in the low and mid doses being included during evaluation of targets)? Please confirm.

It is the complete read for both main and recovery animals in the control and high dose groups and target tissue in the mid and low doses.

7. For the “28 Day GLP Toxicity Evaluation (Dog)” study of Sample Task 2f, it indicates that a “Complete read on all organs from control and high dose and target organs at low and mid doses.” We are assuming both main and recovery animals are to be evaluated in the control and high dose groups. Can you please confirm or indicate if only the main animals in the control and high dose groups are subjected to complete microscopic evaluation, with the recovery animals and the main animals in the low and mid doses being included during evaluation of targets?

All tissues and all doses in main, recovery and control groups.

8. For the “GLP Safety Pharmacology” studies of Sample Task 2f (cardiovascular in dogs; CNS and pulmonary in rats) – can you specify if these studies are to be performed in both sexes or just one sex?

One sex should be used, typically males for FOB and CV and females for respiratory.