Amendment 1 RFP 75N93019R00021_1-8-2020.pdf

AMENDMENT #1 RFP No. 75N93019R00021 1

Amendment No. 1 RFP No. 75N93019R00021

“Preclinical Services for HIV Therapeutics”

Solicitation Number: 75N93019R00021

Amendment Number: One (1)

Amendment Issue Date: January 8, 2020

Proposal Due Date/Time: Thursday, March 5, 2020 at 3:00 PM, Local Time (Unchanged)

Issued By: Patrick Finn

Contracting Officer

OA/DEA/NIAID/NIH/DHHS

5601 Fishers Lane, Room 3D10, MSC 9821 Bethesda, Maryland 20892-9821

Points of Contact: PRIMARY patrick.finn@nih.gov Patrick Finn, Contracting Officer Phone: 240.669.5401

SECONDARY

manouelj@mail.nih.gov John R. Manouelian, Contracting Officer Phone: 240.669.5152

Please note that we do NOT intend to extend the due date for submission of proposals as a result of this amendment. The date specified for receipt of proposals remains unchanged.

Offerors must acknowledge receipt of this Amendment by identifying the amendment number and the date of the amendment on each copy of the submitted proposal. Failure to receive your acknowledgement may result in the rejection of your proposal. Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

The purpose of this Amendment is to provide responses to questions from potential offerors, regarding the solicitation.

RESPONSES TO QUESTIONS FROM POTENTIAL OFFERORS:

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Question 1 Should the Technical Proposal contain a Statement of Work section? Should we have Statements of Work for both the Base Contract and the Sample Task Order? If so, where should these be placed in the Technical Proposal?

Response to Question 1 The Statement of Work document for the Base Contract is provided in the RFP (Attachment 3), and the Statement of Work document for each Sample Task Order are provided in the RFP (Attachments 4-10). We are not requesting that you submit a Statement of Work in your response. Please refer to Section L – Instructions, Conditions, and Notices to Offerors, Technical Proposal Instructions, and Attachment 11 – Additional Technical Proposal Instructions.

Question 2 Should the “Breakdown of Proposed Estimated Costs” excel sheet be submitted in PDF format as part of the Business Proposal or uploaded separately from the Business Proposal PDF as an Excel document, or both?

Response to Question 2 Attachment 1, “Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website”, explains the details regarding the Technical and Business Proposal formatting and page limitations. Please submit the Breakdown of Proposed Estimated Costs as part of the Business Proposal in both PDF and Excel format.

Question 3 On page 6 of Attachment 11, under product testing, the instructions state to “…Provide a justification for the products proposed for testing and describe the methods to be used to evaluate the proposed candidate products…” It is our understanding that we would be provided with a long-acting ART product to test. What product are we supposed to provide a justification for?

Response to Question 3 The Offeror is supposed to provide a justification for the long-acting drug or drug combination proposed in the Sample Task Order in Attachment 6. The Sample Task Order will not be awarded and serves only for technical review purposes and to evaluate proposed costs. The Offeror should also provide a justification for products tested in the past if preliminary data will be included in the proposal. The reason for this is that NIAID and the reviewers will need to make a judgement that the Offeror understands HIV and HBV biology and the mechanism of action of the proposed compounds. It is correct that, when real task orders will be awarded in the future, the compounds to be tested will be provided by NIAID, but the Offeror still may need to provide the control compounds.

Question 4 In Attachment 6, paragraph B., Technical Requirements, item 4. Model Improvement (on page 2 of the attachment), it states that “The Contractor shall make improvements to extend the use of the model proposed under paragraph 4.a. for use in in vivo product evaluations, which may

AMENDMENT #1 RFP No. 75N93019R00021 3 include adapting the model for testing additional therapeutics for HIV and/or modifications to evaluate therapeutics in the context of HIV/HBV co-infections.”

But then on page 3 of the attachment, it says, “Specifically, the Contractor shall:

a. Develop a model xenografted with human cells/tissues that meet the quality control standards established in the Contractor’s laboratory and can accommodate HIV and HBV infection.

b. Test a long-acting drug or drug combination in the HIV/HBV co-infection model.”

So, can these tests be for HIV alone or do they have to be for an HIV/HBV co-infection?

Response to Question 4 The sample task order is an example of task orders that we would issue under the contract. The Offeror must submit a proposal for the sample task order that covers the entire Statement of Work and will be included in the overall proposal. The Offeror should follow the outline and headings in the sample task order and should respond to all the bullets under each heading in narrative form. Specifically, under ‘Product Evaluation’, the Offeror should provide a humanized mouse model only for HIV. Under ‘Model Improvement’, the Offeror should provide a humanized mouse model for HIV/HBV co-infection. Project management and Reports and Deliverables also need to be addressed.

The main purpose of the contract is to test compounds in an HIV humanized mouse model, but NIAID is also interested in testing compounds in an HIV/HBV co-infection model. The contractor should demonstrate abilities to test compounds either for HIV alone or in an HIV/HBV co-infection model. If an Offeror only proposes HIV models, the proposal will still be reviewed, but it could impact the technical score because NIAID is interested in both treating HIV alone, as well as HIV/HBV co-infection.

Question 5 Would this contract restrict our investigators and other personnel from working on other NIAID/NIH grants/funding opportunities?

Response to Question 5 Only if working on the proposed contract will be an over-commitment of their time/effort. Please refer to page 81 of the RFP, SECTION L – Instructions, Conditions, and Notices to Offerors., Paragraph 1., General Information., paragraph b., Technical Proposal Instructions, subparagraph 1., Technical Discussions., item b. Personnel, which states the following: “Offerors should assure that the Principal Investigator, and all other personnel proposed, shall not be committed on Federal Grants and Contracts for more than a total of 100% of their time. If the situation arises where it is determined that a proposed employee is committed for more than 100% of his or her time, the Government will require action on the part of the Offeror to correct the time commitment.”

AMENDMENT #1 RFP No. 75N93019R00021 4

Question 6 Confirm that the TOs offered under Task Area C would not need our labs to be GLP and GMP compliant. In Attachment 3 - Statement of Work for Base Contract, Section C - General Task Order Requirements, it notes in several subsections the need for GLP, GMP compliance:

o Subsection 5, Material Receipt, Storage, Shipping, and Inventory (p 5): “Develop and maintain effective procedures to support contract activities for receiving, storing, shipping and inventory of products …; including the secure, safe and stable storage of these contract materials under the required conditions (e.g., Biosafety Level, aseptic, Good Manufacturing Practice (GMP), etc.)” o Subsection 6, Regulatory Compliance (p 6): “When required, all activities supporting specific regulatory requirements shall be conducted in compliance with Good Laboratory Practice (GLP; 21 CFR 58), current Good Manufacturing Practice (cGMP; 21 CRF 210- 211).”

o Subsection 8, Quality Assurance/Quality Control (p 7): “When applicable and as required by the Task Order, the Contractor shall have and implement the appropriate QA/QC infrastructure (facilities, processes and training) in place to ensure compliance with GLP, cGMP and GCP regulations.”

Response to Question 6 Please note that the section of the RFP you have referenced, Attachment 3 – Statement of Work for Base Contract, Section C, General Task Order Requirements, lists requirements that may be applicable to the various Task Areas. GLP or GMP capabilities are NOT required for Task Area C. Subsections 5, 6, and 8 are generic and state, “only when applicable to the Task Area”. They do not apply to Task Area C.

Question 7 Is there a specific requirement under Task Area C for BSL 3 certified staff? The RFP calls for description of training, but we need clarification on certification requirements.

o Article C.2 Reporting Requirements (page 9 of the RFP): “If the IBC or equivalent body or institutional biosafety official has determined for example, by conducting a risk assessment, that the work that has been performed or is planned to be performed under this contract may be conducted at a biocontainment safety level that is lower than BSL3, a statement to that affect shall be included in each Monthly Progress Report.”

o Article H.25 – Highly Pathogenic Agents (page 43 of RFP), “The determination of the applicability of this clause will be made at the Task Order level. The work being conducted under this contract may involve a Highly Pathogenic Agent (HPA). The NIAID defines an HPA as a pathogen that, under any circumstances, warrants a biocontainment safety level of BSL4 or higher.”

In a search of the RFP and attachments, the following Task Orders are specifically noted as potentially needing BSL 3 o Task Area D (RFP, p 102; Attach 3, p 12) o Task Area G (Attach 10, p 2)

AMENDMENT #1 RFP No. 75N93019R00021 5

Response to Question 7 Please note that Article H.25 – Highly Pathogenic Agents (page 43 of RFP), cites that “the NIAID defines an HPA as a pathogen that, under any circumstances, warrants a biocontainment safety level of BSL3 or higher…” (not “BSL4 or higher”).

Task Area C requires working with replication-competent HIV and HBV in cell culture and in small animals. It would be up to the institution to decide what BSL or ABSL level and practices are required. A statement from a biosafety officer of the institution can be included in the proposal. (A)BSL-3 is not specifically required for Task Area C as long as the laboratories can accommodate working with replication-competent HIV and HBV in cell culture as well as in small animals.

Question 8 Are the Technical Proposal and Business Proposal for the Tasks supposed to have the Sample Task Orders embedded in them?

For example, is Sample Task Order E-1 costing and technical supposed to be included in the base Business and Technical proposals or is it a separate submission?

If yes, the result is 2 submissions per Task Area. If no, the result is 4 submissions per Task Area.

Response to Question 8 Per Attachment 11, Additional Technical Proposal Instructions, under Technical Proposal – Table Of Contents (second paragraph under page 1 of the attachment), the following is stated: “Offerors may submit proposals in response to one or more Task Area(s) of their choosing, and are not expected to respond to all Task Areas. Offerors responding to multiple Task Areas must provide separate Technical and Business Proposals for each Task Area.

Proposals for each Task Area will be reviewed independently. The total page count of the Technical proposal for each Task Area shall not exceed 150 pages (please see solicitation Attachment #1, Packaging and Delivery of Proposals, for more information).”

Further, under Attachment 11, Additional Technical Proposal Instructions, under Technical Proposal – Table Of Contents, Section 3: Technical Plan/Approach For Each Task Area (page 3 of the attachment), the following is stated:

“In addition to the information provided in Section L, offerors should demonstrate their capabilities to fulfill the activities specified in the Task Area Statement of Work (SOW) within each proposal that is submitted for a given Task Area. The capability of the Offeror to fulfill the requirements of the Task Area SOWs will be assessed based on the Offeror’s response to the Sample Task Order(s) (Attachments 2-7) and the actual Task Order (Attachment 8). The Technical Plan should be sufficiently organized to clearly identify the specific responses to each of the Task Areas and Task Order or Sample Task Orders within that area. Responses to the Task Order and/or Sample Task Orders should be well integrated. Offerors should not duplicate technical responses for activities covered in both the base contract and Sample Task Order SOWs. If an activity is covered in both, the technical responses should only be addressed in the

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Sample Task Order. Other activities identified only in the base contract SOW should be addressed in a separate section clearly indicating the Task Area.”

Therefore, you are required to submit one technical and one business proposal in response to each Task Area in which you choose to submit a proposal for. As stated in the instructions referenced above, “responses to the Task Order and/or Sample Task Orders should be well integrated”.

END OF AMENDMENT NO. 1, RFP No. 75N93019R00021