Amendment 1 RFP 75N93022R00029.pdf

AMENDMENT #1 RFP No. 75N93022R00029 1

Amendment No. 1

RFP No. 75N93022R00029

“Cellular Immunology Core Laboratory”

Solicitation Number: 75N93022R00029

Amendment Number: One (1)

Amendment Issue Date: February 14, 2023

Proposal Due Date/Time: March 17, 2023, at 3:00 PM, EST (Unchanged)

Issued By: Ashley Kinderdine

Contracting Officer

OA/DEA/NIAID/NIH/DHHS

5601 Fishers Lane, Room 3D10, MSC 9821

Bethesda, Maryland 20892-9821

Points of Contact: PRIMARY

Kimberly.dormer@nih.gov

Kim Dormer, Contract Specialist

Phone: 301-761-6391

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:

1. M.Tb & other pathogens work- is this expected to be done under BSL-2 or BSL-3 conditions?

Response: For uniform cost assumptions, assume work will be done under BSL-2.

mailto:Kimberly.dormer@nih.gov

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2. What type of specimens are expected from M.Tb studies? Only PBMC or also tissue samples such as bronchoalveolar lavage, lung tissue, granulomas?

Response: For uniform cost assumptions, assume only PBMC’s.

3. Will M.Tb study samples require evaluation of vaccine-specific cellular responses or also infection-induced cellular responses?

Response: For uniform cost assumptions, assume only vaccine specific responses.

4. If BSL-3 work is required, need clarification on scope of work in BSL-3 for budgeting purposes, e.g., under attachment 5, pg 2, #g, “the offerors should assume performance of up to 500 flow-cytometric-based ICS assays……. on NHP samples from M.Tb studies per year”. How many of these would be samples requiring processing and staining in a

BSL-3 lab?

Response: For uniform cost assumptions, assume only BSL-2 work, therefore BSL-3 work is not required.

5. TNPRC has a high-performance research core which processes samples in the BSL-3 lab

(including staining for flow cytometric based assays). If BSL-3 work is required, can we budget for those assays being performed by the TNPRC high performance core based on their assay charges?

Response: For uniform cost assumptions, assume only BSL-2 work, therefore BSL-3 work is not required.

6. For the purpose of budgeting for flow-cytometric based assays to evaluate M-Tb-specific

T cell responses, what antigens should we budget for? Attachment 4, pg 2, last sentence of (b) states Mtb peptides, Mtb lysate (BEI), BCG or MTB300 peptide pool.

Response: Per Uniform Cost Assumptions in Attachment 5, section 2 (f) (g), offerors are to include the costs of phenotypic flow cytometric assays, not for particular peptides.

These flow assays are based on the cost of antibodies that were used on the flow panel demonstrated in the technical approach section.

7. With respect to peptide ordering (Attachment 5, 2) Technical Cost Assumptions, #c), should we budget for purchase of 1mgm each of the listed peptides every year, or budget for purchase of 7mgm (7-years of contract) at one time for the duration of the contract?

Response: One time purchase.

8. Please confirm that the verbiage regarding model organisms component (Pages 80-81) is not applicable for this contract.

Response: No model organisms.

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9. Aside from commitment letters from potential consultants, are letters of support from PIs of task orders to attest to past performance allowed? Specifically, regarding the verbiage on page 96, “The evaluation will be based on information obtained from references provided by the offeror…..”: Does the term “references” mean letters or simply contact information for those individuals?

Response: Letters of support from PI’s are allowable and can be included in the business proposal; however, the verbiage in page 96 is referring to PI contact information, contract/Task Order #, title, and COR/CO contact information.

With regard to references/contact information, please refer to:

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

13. Past Performance Information

10. Are other letters (e.g., institutional letter of support) allowed?

Response: Letters of support are allowed.

11. Do letters count towards the 200-page limit of the technical proposal?

Response: Yes.

12. Do letters, and personnel resumes count towards the page limit?

13. Is a listing of SOPs sufficient, or the detailed final SOPs need to be included in the proposal?

Response: Final SOP’s are required.

14. Are appendices allowed and are they counted towards the page limit?

Response: Appendices are allowed and counted towards the page limit.

15. Where should SOPs be included? If in the technical proposal, do they count towards the

200-page limit?

Response: SOP’s should be included in the technical proposal and count towards the page limit

16. Can SOPs and letters be included as appendix items outside of the 200-page limit?

AMENDMENT #1 RFP No. 75N93022R00029 4

Response: The total page count of 200 pages is inclusive of all proposal information.

Anything over 200 pages will not be included in the review.

17. Article B.3, Pg 6, and pages 81- 83 specifies several items such as travel costs, conferences and meetings etc. Are these items allowed in the budget for this contract or would these require approval by the contracting office (COAs) as is the case for the current contract?

Response: Travel should not be budgeted for. Travel may only be approved if funds are available and decisions will be made at that time. The COR will make that decision based on each circumstance. COA approval will be needed.

18. Do projected consultant costs get included in the budget (page 83, #j)?

19. What items can be budgeted for Annual Site Visits? Refer Attachment 5, page 3, #1

Response: Budgets should not be submitted for others to come do annual site visits. Site visits can be virtual or a COA will be required at that time if there is budget availability.

20. Does the budget need to include a budget for the transition plan?

Response: Yes, a transition plan should be included in the budget. Please refer to information in SOW.

21. Clarification on what can be budgeted for “Storage” – refer Attachment 5, page 3, #5.

Response: Offerors can provide budgets for storage costs as they feel are necessary to perform the activities stated in the Statement of Work. The Government cannot provide an estimate based on individual facility setups.

22. Clarifications on budget items under Technical Cost Assumptions (Attachment 5, page 2)

a. Item c. with respect to three HIV or SIV envelope glycoproteins: which HIV and SIV strains should be included?

Response: Assume SIV MAC239.

b. Item c. includes peptides for SIV Env, Gag, Tat, Nef, Rev and Vif. However, peptides for Pol, Vpr and Vpx are not included. Is that intentional?

c. Do the peptide costs require quotes from a preferred vendor?

AMENDMENT #1 RFP No. 75N93022R00029 5

Response: Quotes are to be provided for all material costs to determine the basis of the costs. At least 1 is ok.

d. For budgeting for ELISPOT plates and ICS assays, do we budget for extra tests for controls that would be run concurrently with the requested test assays?

Response: Offerors are only to budget for 25 plates, as stated on attachment 5, page 2, a.

e. Can we budget for isolation and cryopreservation and storage of lymphocytes required for antibody titrations, assay optimizations, and reference controls?

Response: No, for the purposes of the uniform cost assumptions, only budget for up to

4,500 flow assays.

f. Can analysis software be included as a budget item?

Response: This can be budgeted for; however, there are no specific requirements for a particular software.

23. Clarification on the format of the resumes for key personnel? Does the format have to be a NIH biosketch?

Response: Resumes of all key personnel must indicate educational background, recent experience, specific or technical accomplishments, and a listing of relevant publications.

For uniformity, a biosketch is preferred, but specific format is not required.

24. Is a resume required for all technical staff?

Response: Resumes of all key personnel must indicate educational background, recent experience, specific or technical accomplishments, and a listing of relevant publications.

For uniformity, a biosketch it preferred, but specific format is not required.

25. In response to the following verbiage from the "3. Additional Personnel” section on pg.79: “For all proposed personnel who are not currently members of the offeror's staff, a letter of commitment or other evidence of availability is required. A resume does not meet this requirement.” We understand that letters are required for this category of personnel. Is a resume also required for these letter providers?

Response: In addition to the letters of commitment, please include a resume for all additional personnel.

26. Clarification on whether data sharing is allowed or restricted under the rules of the contract.

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Response: Data sharing will be restricted due to confidentiality of the work and COR approval is necessary.

27. Is the box drive platform acceptable for data sharing or data transfer to the NIH as part of transition plan?

Response: As long as appropriate security exists for this platform to prevent a breach of the confidential information.

28. Please explain why the start date of new contract is March 1, 2024, whereas the current contract end date is May 31, 2024.

Response: The start date of the new contract is currently proposed as March 1, 2024 is to allow for transition in the event that it is required. All budgets should assume a March 1, 2024 start date.

END OF AMENDMENT NO. 1, RFP No. 75N93022R00029