HEAL PK Testing Services Questions_Answers.pdf

HEAL PK Testing Services Questions & Answers

1. In one of the documents provided it seems to be assumed that the Quoter will use an internal vivarium for the in-life phase. Is this a strict requirement? XXXXXXX does not have a vivarium but we are able to place the in-life phase at a provider who can provide all of the documentation that is requested relating to animal welfare, procedures and certification of their vivarium. Is this a consideration that the NIH might approve of?

The Government will consider offers that include subcontracts to meet the needs of the Statement of Work. It is at the discretion of the offeror to provide a response that they believe fulfills the requirement. Please refer to the OLAW provisions and requirements which are applicable to this requirement.

2. Can you confirm if you would require the recent RFP [75N95024R00115] to be specific for n-

GLP or GLP?

These studies are non-GLP.

3. In regard to the past performance technical factor:

We have an NIH Pain study that completed in early 2018 with a similar complexity and magnitude as a PK study but did not have a PK component. Would this be acceptable as one of the two supporting awards?

Please refer to the Technical Evaluation Criteria (Attachment 3) – Past Performance element.

While no disease indication was specified, recent examples of PK studies involving CNS disorders within the past couple of years would be ideal.

4. In regard to the past performance technical factor:

We can provide a PK study from a commercial customer but would need to redact the confidential and sensitive information of our clients as covered within the NDA and MSA agreement with them. Is this acceptable?

Yes, this is acceptable.

5. Are the four foundational PK studies intended to cover both mice and rats, resulting in eight total studies? Or are they designed for either mice or rats exclusively? If the latter, how many studies are allocated for each species?

The base requirement is for 4 rodent PK studies total, specifically 2 mice and 2 rats PK studies.

Please see the revised SOW.

6. Several of the documents require total/firm-fixed price for performance of all work (including options). It will be difficult to provide pricing for the Base, since the only specification is 4 rodents. 4 mouse? 4 rat? Some other combination? The cost for the mouse and rat study designs will not be the same.

Please provide pricing for the base requirement as 2 rats and 2 mice PK studies. Please see the revised SOW.

• Will pricing for one rat vs. one mouse be acceptable in lieu of pricing for 4 rodent studies?

Please provide pricing for one rat study vs. one mouse study. The total price must be clearly stated and represent a firm-fixed-price amount for performance of all work during the purchase order’s period of performance (including options). Please refer to the Price Evaluation under section (ix) of the Solicitation.

• Additionally, Option 1 may be exercised for up to 5 times (that will certainly change the pricing depending on whether it is exercised once or five times)

Please provide the cost for one Option quantity of “Option 1” (one price for rat and one price for mouse). If the Government requires the option quantity, it will be exercised at the price agreed upon at the time of Purchase Order award, in the quantity required. (such as one rat, one mouse, or 3 rat, etc. - depending on the Government’s need).

7. The background section of the SOW focuses on blood and plasma, as does the Mouse PK Study Design section. However, the rat PK Study Design states:

For the purposes of quotation development, assume that a bioanalytic method is not available and must be developed. The expected LLOQ is 1ng/mL for plasma and 5ng/mL for brain.

This is the only mention in the entire SOW of brain. Please confirm if brain collections and bioanalysis are required for these study designs.

Brain analysis is not required for this requirement. Please see the revised SOW.

8. Technical Response Format:

Quoter responses shall be no more than ten (10) single-sided pages in length and submitted in PDF format.

This page limit does NOT include:

1. Price Quote/Narrative

2. Representations and Certifications – we are not sure what is needed for this item. Please clarify what is requested.

See Attachment 3, specifically, FAR 52.212-3, FAR 52.204-24, and FAR 52.204-26.

3. Supplemental Documentation – Is anything besides the VAS needed here?

For this requirement, the only supplemental documentation needed is the VAS.

(x) The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications—Commercial Items, with its offer.

Is there a particular form that needs to be completed?

The provision can be found at the link below:

https://www.acquisition.gov/far/52.212-3

(xv) Special Contract Requirements The services under this contract involves live vertebrate animals. Quoters must have an active OLAW Animal Welfare Assurance. In addition, Quoters must include with its quotation:

1. Vertebrate Animal Section (VAS) (see below)

2. Institutional Animal Care and Use Committee (IACUC) project approval. The date of IACUC approval must not be more than 36 months prior to the anticipated date of award.

We would like to confirm that proof of IACUC approval must be included with our offer/response? Or is this provided after notice of award?

Yes, please provide proof of IACUC approval with your offer.

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HEAL PK Testing Services Questions & Answers