Amendment 2_RFP 75N93019R00021_2-13-2020.pdf

AMENDMENT #2 RFP No. 75N93019R00021 1

Amendment No. 2 RFP No. 75N93019R00021

“Preclinical Services for HIV Therapeutics”

Solicitation Number: 75N93019R00021

Amendment Number: Two (2)

Amendment Issue Date: February 13, 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:

(1) provide responses to questions from potential offerors, regarding the solicitation; (2) amend The Schedule, SECTION B and SECTION I to update the minimum quantity amount of the proposed contract; (3) amend Attachment 4, Statement of Work and Deliverables for Sample Task Order A-1, to address concerns raised by potential offerors;

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(4) amend Attachment 6, Statement of Work and Deliverables for Sample Task Order C-1, to address questions raised by potential offerors; (5) amend Attachment 11, Additional Technical Proposal Instructions, Format for Technical Proposal, and Table of Contents, to change text in response to offeror’s questions; and (6) revise Attachment 12, Additional Business Proposal Instructions and Uniform Cost Assumptions, to amend text as a result of questions from offerors.

RESPONSES TO QUESTIONS FROM POTENTIAL OFFERORS:

Question 1 Does the application need to provide a model for HIV, HBV and HCV or can they apply for each one individually? Is it beneficial during the review process if a group could provide a model for HIV and HCV rather than just HIV alone?

Response to Question 1 Please be advised that we cannot provide guidance on how an Offeror should propose; it is entirely up to the Offeror to determine how they should develop their proposal. An Offeror must demonstrate their ability to meet all requirements in the Statement of Work, including the associated sample Task Orders, for the Task Area(s) in which they choose to submit a proposal under.

Question 2 The distinction between “Base Contract” and “Sample Task Order” is not clear. Example, page#196, under Section 3 states that, “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 Sample Task Order. Other activities identified only in the base contract SOW should be addressed in a separate section clearly indicating the Task Area”. Here the distinction between Task Area, Task Order or Sample Task Order and the Base contract are not clear.

Response to Question 2 The distinction between the Statement of Work (SOW) for the Base Contract, Task Areas, and Task Order and/or Sample Task Orders is as follows:

The SOW for the Base Contract includes a description of the seven individual Task Areas, Task Areas A-G (including the scope and requirements for each Task Area), and the general Task Order requirements, which apply to all Task Orders, as applicable.

The SOW for each Task Order/Sample Task Order are specific to their related Task Area. The Task Order/Sample Task Order SOW may not include all of the activities that are listed in the Base Contract SOW for that Task Area. As stated in the Attachment 11, Additional Technical Proposal Instructions, Section 3., Technical Plan/Approach for Each Task Area, 2nd paragraph, “if an activity is covered in both, the technical responses should only be addressed in the Sample

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

Question 3 How to propose/present the budget for the “Base Contract” and the “Sample Task Order”? Do they need to be prepared in two different formats?

Response to Question 3 No, Offerors should submit a budget only for the Task Order/Sample Task Order for each Task Area that they are submitting a proposal under (there is no budget to propose for the Base Contract).

Question 4 What is the format for an “Alternate Proposal” and does the overall page limit for the technical proposal (~150 pages) includes this section, if proposed?

Response to Question 4 As stated in Section L – Instructions, Conditions, and Notices to Offerors, item 2.a.5. Alternate Proposals (on page 65 of the solicitation), “you may, at your discretion, submit alternate proposals, or proposals which deviate from the requirements; provided, that you also submit a proposal for performance of the work as specified in the statement of work. Such proposals may be considered if overall performance would be improved or not compromised and if they are in the best interests of the Government. Alternative proposals, or deviations from any requirements of this RFP, shall be clearly identified.” If an Offeror submits an alternate proposal, the same page limitation and format requirements (as that of the proposal submitted for performance of the work specified in the statement of work) applies.

Question 5 Are we required to submit an HHS 508 template form (Solicitation Attachment 19) if we are not proposing for Task Area G? Would a letter from our signing official assuring compliance be sufficient? If the form is required, could we submit it as part of the business proposal due to the page number limitation of the technical proposal?

Response to Question 5 The HHS Section 508 Product Assessment Template only applies to Task Area G. See SECTION M, Evaluation Factors for Award, paragraph 9, Evaluation of Electronic and Information Technology Accessibility – Section 508. The HHS "Section 508 Product Assessment Template” should be submitted as an attachment to the Technical Proposal.

Question 6 Are we asked to submit only a sample budget for the Task Area which we are applying for or is an overarching Task Area budget required? If a Task Area budget is required in addition to the sample Task Order budget, should we assume the number of Task Orders per year outlined in attachment 12, section 3?

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Response to Question 6 The Offeror is required to submit a budget for the Task Order/Sample Task Order, in addition, the Offeror should submit an estimated Task Area budget using the estimated number of Task Orders per year for the particular Task Area (See Attachment 12: “Additional Business Proposal Instructions and Uniform Cost Assumptions”, Section 3 – Uniform Cost Assumptions).

Question 7 If the proposed subcontractor(s) are affiliated with a different institution from the prime contractor, are we required to submit total compensation plans, annual reports, disclosure of lobbying activities, travel policies, reps and certs, and/or adequate accounting system certifications for the subcontractor's institution in addition to these documents for the prime contractor's institution?

Response to Question 7 You are not required to submit with your initial Business Proposal total compensation plans, annual reports, disclosure of lobbying activities, travel policies, reps and certs and/or adequate accounting system certifications for subcontractors.

Please refer to Section L, Instructions, Conditions, Notices to Offerors, paragraph 2, Instructions to Offerors, paragraph c., Business Proposal Instructions, subparagraph 3, Data Other than Certified Cost or Pricing Data, paragraph b.3., Subcontracted Items, which states: Include parts, components, assemblies, and services that are to be produced or performed by others in accordance with offeror's design, specifications, or direction and that are applicable only to the prime contract. For each subcontract over $750,000, the support should provide a listing by source, item, quantity, price, type of subcontract, degree of competition, and basis for establishing source and reasonableness of price, as well as the results of review and evaluation of subcontract proposals when required by FAR 15.404-3.

Also, please refer to Section L, Instructions, Conditions, Notices to Offerors, paragraph 2, Instructions to Offerors, paragraph c., Business Proposal Instructions, subparagraph 12, Subcontractors, which states: If subcontractors are proposed, please include a commitment letter from the subcontractor detailing:

a. Willingness to perform as a subcontractor for specific duties (list duties).

b. What priority the work will be given and how it will relate to other work.

c. The amount of time and facilities available to this project.

d. Information on their cognizant field audit offices.

e. How rights to publications and patents are to be handled.

f. A complete cost proposal in the same format as the offeror's cost proposal.

Question 8 What documentation regarding "Information Security and/or Physical Access Security", referenced on pages 31 and 69, and the "Homeland Security Presidential Directive (HSPD)-12", referenced on pages 69-79 must be included in our proposals prior to award?

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Response to Question 8 PLEASE NOTE: The requirements outlined in Section L, Instructions, Conditions, and Notices to Offerors, paragraph 2, Instructions to Offerors, describe what documentation should be submitted with your proposal. In regard to the Information Security and/or Physical Access Security, documentation should only be submitted by those offerors submitting proposals for Task Area G. The requirements related to Information Security and/or Physical Access Security on page 31 of the RFP are included in The Schedule, which is a sample contract, and includes those clauses related to the contract. In this particular case, the due dates for these items are after contract award; nothing is required prior to award. Additionally, it is stated in the solicitation that the determination of the applicability of this clause will be made at the Task Order level.

Question 9 Section L.2.15 – Page 69, IMPORTANT NOTE TO OFFERORS – Please confirm the “Information Security” section should be located ONLY in the Business Volume.

Response to Question 9 Per page 69, Section L - Instructions, Conditions, and Notices to Offerors., Paragraph 2., Instructions To Offerors, paragraph a. General Instructions, subparagraph 15., HHS Security and Privacy Language for Information and IT Procurements, it states that the “…information shall be addressed in a separate section of the Business Proposal, entitled, "Information Security."

PLEASE NOTE: Information Security only applies to Task Area G and Task Order G-1.

Question 10 Please identify the “radioactive materials” for which licenses and permits need to be obtained (see solicitation references below).

Solicitation References: Attachment 3: “Statement of Work for Base Contract” Section C.

General Task Order Requirements, paragraph 5. Material Receipt, Storage, Shipping, and Inventory, subparagraph b, (page 5) – “Obtain and maintain the appropriate licenses and permits required by international, federal, state, and local authorities for the safe storage and shipping, of products, drugs, biologics, pathogens, specimens and reagents for the safe import or export, storage, handling, transportation, and distribution”; and Attachment 10: “Statement of Work and Reporting Requirements for Task Order G-1”, Section C. Technical Requirements, paragraph 2. Reagent Program Activities, subparagraph b., item 6., (page 4) – “Obtain the appropriate interstate, intrastate and foreign import/export shipping licenses and permits for transporting biohazardous and/or radioactive reagents and drugs”.

Response to Question 10 Please be advised that we are not requesting a budget for the storage/transport/disposal of radioactive materials, and the Offeror is not required to store/transport/dispose of radioactive materials at the beginning of the contract. However, this capability could be asked for at a later time point. At the current time, we cannot provide a list of radioactive isotopes that would require storage and disposal under appropriate conditions. However, we would notify the contractor in a timely manner, so they can obtain a radioactive license for the isotope prior to storage, if not already available. We would also only ask for storage of commonly used radioisotopes.

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Please also review the following regulations on radioactive materials:

10 CFR 31: General Domestic License for By-Product Materials 10 CFR 33: Specific Domestic License of Broad Scope for By-Product Materials 10 CFR 71: Packaging of Radioactive Materials for Transport and Transportation of Radioactive Materials Under Certain Conditions 40 CFR 173 Subpart I – Radioactive Materials The United States Postal Service regulates the shipment of radioactive materials in the mail (39

CFR 124)

See also OSHA (29 CFR 1910.96), state and local regulations.

Question 11 Please identify the types of tissues to be included in the Reagent Program (see solicitation references below).

Solicitation Reference: Attachment 10: “Statement of Work and Reporting Requirements for Task Order G-1”, Section C. Technical Requirements, paragraph 1, Manage and Maintain Reagent Program, subparagraph g., item 2, (page 2) – “For the purposes of this Task Order, the range of materials to be procured, acquired, authenticated, produced, and/or expanded include the following examples: 2) Other infectious agents and pathogens including NIAID Category A- C Priority Pathogens that require Biosafety Level (BSL)-2/3 facilities. NOTE: work that requires BSL-4 level facilities will not be supported by this contract.

Response to Question 11 Storage of tissues is not a requirement at the beginning of the contract, but this capability could be asked for at a later time point. Examples of tissues that may require storage for the purpose of extracting viral isolates or other biological materials include animal or human biopsy samples from lymph nodes, gut, spleen, liver, kidney, brain, etc.

Question 12 No items are provided following this instruction (see bolded language in the solicitation reference provided below). Please identify the “following items” this is referring to.

Solicitation Reference: Attachment 11: “Additional Technical Proposal Instructions, Format for Technical Proposal, and Table of Contents”, Section 8: Other Considerations, paragraph B.

“Section L of the RFP provides minimum documentation requirements for the following items.

The required information described in Section L should be assembled together, in the following clearly marked sections of the Technical Proposal. Refer to Section L of the RFP for specific requirements”.

Response to Question 12 Attachment 11: “Additional Technical Proposal Instructions, Format for Technical Proposal, and Table of Contents”, Section 8: Other Considerations, paragraph B., is revised to read as follows:

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Section L of the RFP provides minimum documentation requirements for the following items (see listing below). The required information described in Section L should be assembled together, in the following clearly marked sections of the Technical Proposal. Refer to Section L of the RFP for specific requirements. Read the following information carefully. In some cases, Offerors may be asked to provide documentation, which is in addition to the minimum requirements identified in Section L:

1. Biohazard Safety and Security The Technical Proposal should include a Health and Safety plan, detailing policies and procedures to ensure a safe and secure workplace. This applies only to Task Areas A, C, D, E, F, and G.

2. Obtaining and Disseminating Biomedical Research Resources Section L of the RFP specifies the minimum documentation requirements for this element.

The Technical Proposal should document all information necessary to evaluate this issue.

This applies only to Task Area G.

3. Sharing Research Data (Plan) Section L of RFP specifies the minimum documentation requirements for Data Sharing.

All related documentation should be included in the proposal in this clearly marked section. The Technical Proposal should include a plan for Data Sharing, as required by this RFP. This applies to ALL Task Areas.

4. Sharing of Model Organisms for Biomedical Research (Plan) Section L of the RFP specifies the minimum documentation requirements for Model Organism sharing. All related documentation should be included in the proposal in this clearly marked section. The Technical Proposal should include a plan for sharing Model Organisms, as required by this RFP. This applies only to Task Area G.

5. Care and Use of Live Vertebrate Animals Section L of the RFP specifies the minimum documentation requirements for Animal Welfare compliance. All related documentation should be included in the proposal in this clearly marked section. The Technical Proposal should document all information necessary to evaluate Animal Welfare issues. This applies only to Task Areas C, D, and F.

Please see revised Attachment 11, Additional Technical Proposal Instructions, Format for Technical Proposal, and Table of Contents, attached.

Question 13 Regarding Task Order G-1, there appears to be a discrepancy between Subparagraphs 5 and 7 (see solicitation reference below). Please confirm costs for acquisitions should be provided following subparagraph 7 A-H (total 330 items per year).

Subparagraph 5., “Receipt, labeling, inventorying, and distribution for 1,000 new reagents per year. Assume that 95% of the materials received will need further production/authentication.”

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Subparagraph 7., items A-H requests a total of 330 items per year. Subparagraph 5 requests a total of 1,000 items per year.

Solicitation Reference: Attachment 12: “Additional Business Proposal Instructions and Uniform Cost Assumptions”, Section 3 – Uniform Cost Assumptions, paragraph A., Technical Cost Assumptions, subparagraph 7., Technical Cost Assumptions for Task Order G-1, items 5 & 7 (on page 10 of Attachment 12).

Response to Question 13 Regarding Attachment 12: “Additional Business Proposal Instructions and Uniform Cost Assumptions”, Section 3 – Uniform Cost Assumptions, paragraph A., Technical Cost Assumptions, subparagraph 7., item 7., sub-items a.-h., remain unchanged. However, subparagraphs 7., items 4., 5., and 6., are revised to read as follows:

4. If applicable, initial transfer/storage of 150,000 units total, from 10,000 unique inventory items, from the incumbent contractor’s facility to your facility.

5. Receipt, labeling, and inventorying for approximately 400 new reagents per year in 150 shipments (including new inventory items or replenishment of existing inventory items).

Assume that 95% of the materials received will need further production/authentication.

6. Packaging and shipping for distribution of requested inventory units to registered users:

500 non-domestic shipments per year 2,000 domestic shipments per year

Please see revised Attachment 12, Additional Business Proposal Instructions and Uniform Cost Assumptions, attached.

Question 14 Regarding Task Order G-1, for the synthetic peptide sets, how many peptides are in each of the five sets? How many peptides are in each of the peptide pools? [see solicitation reference below]

Solicitation Reference: Attachment 12: “Additional Business Proposal Instructions and Uniform Cost Assumptions”, Section 3 – Uniform Cost Assumptions, paragraph A., Technical Cost Assumptions, subparagraph 7., Technical Cost Assumptions for Task Order G-1, item 7.

Reagent acquisitions, c. Synthetic Peptides (on page 10 of Attachment 12), “Assume that five (5) sets of viral peptides will be synthesized each year and that 100 vials of each individual peptide (1 mg/vial/peptide) plus 100 vials of pooled peptides (10-15 mg/vial) will be produced. Assume that five (5) individual peptides, between 8 and 25 amino acids in length at 1mg/vial, will be produced. Each peptide will be purified to >80%, quantified, characterized with regard to size and sequence (HPLC and mass spec) and solubility, and aliquoted for distribution.”

Response to Question 14 Assume that the peptide sets contain 25 to 250 peptides, with an average of 100 peptides, and that the peptide pools also contain an average of 100 peptides.

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Please see revised Attachment 12, Additional Business Proposal Instructions and Uniform Cost Assumptions, attached.

Question 15 Regarding Task Order G-1, for “Special Shipping and Packaging”, what percentage of international vs. domestic shipments should be assumed for costing (see solicitation reference below)?

Solicitation Reference: Attachment 12: “Additional Business Proposal Instructions and Uniform Cost Assumptions”, Section 3 – Uniform Cost Assumptions, paragraph A., Technical Cost Assumptions, subparagraph 7., Technical Cost Assumptions for Task Order G-1, item 10.

Special Shipping and Packaging (on pages 11-12 of Attachment 12):

a. Shipping estimates: “The Contractor will be responsible for shipping charges associated with receipt of reagents that are donated to the ARP, which is estimated at 100 reagents per year. In the case of donated cell lines, assume that 2 shipments will use portable liquid nitrogen dewars. However, all fees for shipping of reagents to requestors will be borne by the registered end user, including international customs fees.

b. Packaging for shipment: The Contractor will be responsible for providing appropriate shipping containers for hazardous and biohazardous materials, and all associated packing materials, including dry ice. Assume approximately 2,500 shipments per year.

Assume that 80% of these shipments will require dry ice, 10% will require wet ice, and 10% will be shipped at room temperature. Of the dry ice shipments, approximately 25% will include biohazardous material. Assume shipment of approximately 5 reagents per shipment. Assume that 20% of these shipments currently go to international recipients.

Response to Question 15 As stated in the last sentence of item 10.b., “Assume that 20% of these shipments currently go to international recipients.”

Question 16 There appears to be a discrepancy between items 6 and 10. Item 6 requests costs for domestic and international distribution shipments. Item 10 indicates the fees for shipping reagents to requestors will be borne by registered end users. Please confirm whether the freight costs for distribution shipping is covered by the end user for both domestic and international shipments (as stated in item 10).

Solicitation Reference: Attachment 12: “Additional Business Proposal Instructions and Uniform Cost Assumptions”, Section 3 – Uniform Cost Assumptions, paragraph A., Technical Cost Assumptions, subparagraph 7., Technical Cost Assumptions for Task Order G-1, item 6 “Packaging and shipping for 400 non-domestic shipments per year; and 2,100 domestic shipments for packaging per year” (page 10), and item 10. “Special Shipping and Packaging”, (on page 11-12 of Attachment 12).

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Response to Question 16 Yes, we confirm that the freight costs for distribution shipping is covered by the end user for both domestic and international shipments (as stated in item 10). Item 6., was revised to read as follows: “Packaging and shipping for distribution of requested inventory units to registered users: 500 non-domestic shipments per year, and 2,000 domestic shipments per year”.

Please see revised Attachment 12, Additional Business Proposal Instructions and Uniform Cost Assumptions, attached.

Question 17 Regarding the requirements for Task Area F, can we get clarity as to the meaning of “Develop, validate, and/or perform analytical assays for characterization of active pharmaceutical ingredients (APIs), degradation products, or metabolites in biological samples (e.g., plasma, blood, urine, feces, tissues)” (on page 16 of Attachment 3)? Are you looking for bioanalytical quantitative assays or analytical characterization assays (purity, structural identity, stability, etc.)

or both?

Response to Question 17 Under Task Area F, we are looking for analytical assays for pharmacology and toxicology studies as stated.

Question 18 In the Statement of Work for the Base Contract, under Section D., Description for Individual Task Areas, subparagraph 1. Task Area A: In Vitro Testing and Screening Resource for Therapeutics, item b. Requirements for Task Area A, subitems 4)-5), it states that the contractor should “acquire and store a library of 100,000 chemical compounds…” and “perform HTS on at least 700,000 compounds a year in cell based or biochemical assays...” However, in the sample Task Order, the solicitation says the contractor should acquire a library of 10,000 compounds and screen 10,000 compounds. Should our proposal include a technical approach to both sets of numbers stated in the base contract and sample Task Order? Should we assume that the base contract will involve 7 individual HTS campaigns?

Response to Question 18 As stated in our response to Question 2., above, the SOW for each Task Order/Sample Task Order are specific to their related Task Area. The Task Order/Sample Task Order SOW may not include all of the activities that are listed in the Base Contract SOW for that Task Area. As stated in the Attachment 11, Additional Technical Proposal Instructions, Section 3. Technical Plan/Approach for Each Task Area, 2nd paragraph, “if an activity is covered in both, the technical responses should only be addressed in the Sample Task Order. Other activities identified only in the base contract SOW should be addressed in a separate section clearly indicating the Task Area”.

Question 19 In Attachment 3: Statement of Work for Base Contract, Section D: Description for Individual Task Areas, the solicitation says that contractors responding to Task Area A should “…conduct lead identification and optimization studies using in vitro screening and cytotoxicity studies with

AMENDMENT #2 RFP No. 75N93019R00021 11 the objective of identifying and characterizing agents with anti-viral activity. The hit-to-lead progression studies should include one, or all, of the following activities…” The list includes 9 activities. Would an application that address all 9 activities be more favorable compared to one that addresses 1 activity? Is there a particular activity that interests NIAID most?

Response to Question 19 Please be advised that we cannot provide guidance on how an Offeror should propose; it is entirely up to the Offeror to determine how they should develop their proposal. An Offeror must demonstrate their ability to meet all requirements in the Statement of Work, including the associated Sample Task Orders, for the Task Area(s) in which they choose to submit a proposal.

Question 20 For Sample Task Order A-1, can NIAID provide any additional information about the type of primary assay that will be used for HTS?

Response to Question 20 We have revised Sample Task Order A-1, Article C.1, “Statement of Work”, Paragraph B.

“Technical Requirements”, item 2., such that the primary assay to be adapted to a HTS format for HTS screening and subsequent dose response studies should be a cell-based assay and focus on prevention of HIV infection, inhibition of HIV-1 replication, depletion of virus reservoirs, or elimination of latency. Please note that offerors must have the capability to develop and adapt both biochemical and cell-based assays to an HTS format.

Sample Task Order A-1, Article C.1., paragraph B., item 2., now reads as follows:

“Adapt one assay, as specified by the Contracting Officer’s Representative (COR), from a standard (i.e., 96-well format) to an HTS format (i.e., 384- or 1536-well format). The assay shall be a cell-based assay and focus on prevention of HIV infection, inhibition of HIV-1 replication, depletion of virus reservoirs, or elimination of latency.”

Please see revised Attachment 4, Statement of Work & Deliverables for Sample Task Order A-1, attached.

Question 21 For Sample Task Order A-1, is there a particular HIV clade that NIAID prefers for the confirmatory testing?

Response to Question 21 For Sample Task Order A-1, there is no particular clade that NIAID prefers. It would be up to the Offeror to propose and justify the virus clade used for the confirmatory testing.

Question 22 Regarding Section L – Instructions, Conditions, and Notices to Offerors, paragraph 2., Instructions to Offerors, subparagraph c., Business Proposal Instructions, item 6., Small Business Subcontracting Plan (pages 89-91 of the solicitation), we have the following questions:

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If our total budget (prime contractor budget plus subcontractor budget) exceeds $750,000, and the prime contractor's budget exceeds $750,000 but the subcontractor's budget is below $750,000, do we submit a small business subcontracting plan for both the prime contractor and the subcontractor or just the prime contractor?

If neither the prime, nor the subcontract budget exceeds $750,000 alone, but do exceed $750,000 together, are we required to submit a small business subcontracting plan?

If we only submit a small business subcontracting plan for the prime contractor, do we base our small business subcontracting plan goals on the total budget or just the prime contractor's budget?

If we are required to submit a small business subcontracting plan for both the prime contractor and the subcontractor, do we submit a single small business plan or a separate small business plan for each entity?

If a separate small business plan is required for the subcontractor, would they need to meet the 33% small business subcontracting goals independently?

Response to Question 22 For ease of reference, our response to each question is below, in red font, next to each question:

If our total budget (prime contractor budget plus subcontractor budget) exceeds $750,000, and the prime contractor's budget exceeds $750,000 but the subcontractor's budget is below $750,000, do we submit a small business subcontracting plan for both the prime contractor and the subcontractor or just the prime contractor?

RESPONSE: The Subcontracting Plan must be based on the Maximum quantity of the contract as stipulated in ARTICLE B.1., Prices/Costs, included in Part I of the solicitation, The Schedule. A Small Business Subcontracting Plan is only required from the prime contractor; however, as stated in item 6.d.9. (on page 90 of the solicitation), each plan must include “Assurances that the offeror will include in all subcontracts, the contract clause ‘Utilization of Small Business Concerns.’ Assure that all subcontractors, other than small businesses, in excess of $700,000 adopt a plan similar to the plan agreed upon by the offeror.” However, please be sure that your proposal complies with all requirements of item 6., Small Business Subcontracting Plan (pages 89-91 of the solicitation) and FAR Clause No. 52.219-9, Small Business Subcontracting Plan, incorporated herein by reference in the Solicitation

If neither the prime, nor the subcontract budget exceeds $750,000 alone, but do exceed $750,000 together, are we required to submit a small business subcontracting plan?

RESPONSE: Please see our responses to the questions above.

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If we only submit a small business subcontracting plan for the prime contractor, do we base our small business subcontracting plan goals on the total budget or just the prime contractor's budget?

RESPONSE: Please see our responses to the questions above.

If we are required to submit a small business subcontracting plan for both the prime contractor and the subcontractor, do we submit a single small business plan or a separate small business plan for each entity?

RESPONSE: A Small Business Subcontracting Plan is only required from the prime contractor (please also see our responses to the questions above).

If a separate small business plan is required for the subcontractor, would they need to meet the 33% small business subcontracting goals independently?

RESPONSE: Please see our responses to the questions above. In regard to HHS’s anticipated minimum goals for this RFP (found on pages 90-91 of the solicitation), as stated in item 6.d.9. (on page 90 of the solicitation), each plan must include “Assurances that the offeror will include in all subcontracts, the contract clause ‘Utilization of Small Business Concerns.’ Assure that all subcontractors, other than small businesses, in excess of $700,000 adopt a plan similar to the plan agreed upon by the offeror.”

Question 23 Regarding Attachment 3: Statement of Work for Base Contract, paragraph C., General Task Order Requirements, item 2., Intellectual Property (on page 4 of the attachment), it indicates that the "Contractor shall develop an Intellectual Property Plan outlining for how intellectual property will be handled, as well as the disposition of data/materials developed under Task Orders...A copy of the Plan shall be provided to the COR within 30 days of initiation of the Task Order." Do we include a general Intellectual Property Plan in this proposal or are the Intellectual Property Plans only submitted after Task Orders are initiated?

Response to Question 23 The Intellectual Property Plan should be included in your proposal if it is applicable to the Task Area/Task Order to which you are responding. We have revised Attachment 11, Additional Technical Proposal Instructions, Format for Technical Proposal, and Table of Contents, to reflect this information as indicated below.

Attachment 11, Additional Technical Proposal Instructions, Format for Technical Proposal and Table of Contents, Section 3, Technical Plan/Approach for Each Task Area, is hereby revised as follows:

Paragraph 1, Task Area A: In Vitro Testing and Screening Resource for Therapeutics, 3rd paragraph, is hereby revised to read as follows:

The Technical Proposal for Task Area A should address all elements in the Task Area A

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Statement of Work (SOW), including the general requirements applicable to the Task Area, and provide a detailed technical plan to address each of the activities within the Scope of Task Area A.

Paragraph 2, Task Area B: Synthesis of Therapeutic Agents for Treatment of Infectious Diseases, 2nd paragraph, is hereby revised to read as follows:

The Technical Proposal for Task Area B should address all elements in the Task Area B Statement of Work (SOW), including the general requirements applicable to the Task Area, and provide a detailed technical plan to address each of the activities within the Scope of Task Area B.

Paragraph 3, Task Area C: Small Animal Models for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus ((HCV), 3rd paragraph, is hereby revised to read as follows:

The Technical Proposal for Task Area C should address all elements in the Task Area C Statement of Work (SOW), including the general requirements applicable to the Task Area, and provide a detailed technical plan to address each of the activities within the Scope of Task Area C.

Paragraph 4, Task Area D: Small Animal Models of Mycobacterium Infection, 3rd paragraph, is hereby revised to read as follows:

The Technical Proposal for Task Area D should address all elements in the Task Area D Statement of Work (SOW), including the general requirements applicable to the Task Area, and provide a detailed technical plan to address each of the activities within the Scope of Task Area D.

Paragraph 5, Task Area E, Formulation Development and Manufacture of Clinical Dosage Forms, 3rd paragraph, is hereby revised to read as follows:

The Technical Proposal for Task Area E should address all elements in the Task Area E Statement of Work (SOW), including the general requirements applicable to the Task Area, and provide a detailed technical plan to address each of the activities within the Scope of Task Area E.

Paragraph 6, Task Area F: Preclinical Pharmacology and Toxicology Services, 3rd paragraph, is hereby revised to read as follows:

The Technical Proposal for Task Area F should address all elements in the Task Area F Statement of Work (SOW), including the general requirements applicable to the Task Area, and provide a detailed technical plan to address each of the activities within the Scope of Task Area F.

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Paragraph 7, Task Area G: Reagent Program for HIV and other Infectious Diseases, 3rd paragraph, is hereby revised to read as follows:

The Technical Proposal for Task Area G should address all elements in the Task Area G Statement of Work (SOW), including the general requirements applicable to the Task Area, and provide a detailed technical plan to address each of the activities within the Scope of Task Area G.

Please see revised Attachment 11, Additional Technical Proposal Instructions, Format for Technical Proposal, and Table of Contents, attached.

Question 24 Regarding Attachment 3: Statement of Work for Base Contract, paragraph C., General Task Order Requirements, item 3., Technology Transfer (on page 4 of the attachment), it states the following: "As required by the Task Order and as specified by the COR, the Contractor shall prepare and submit to the COR for review and approval, technology transfer packages for the transfer of assays, processes, methods, Standard Operating Procedures (SOPs), reagents, animal models, and/or any other material or documentation generated under the contract, to any third party designated by the COR, or directly to the COR..." There does not appear to be any Task Order specific technology transfer requirements for the Sample Task Order for Task Area C. Is this correct? Do, we need to include a general Technology Transfer package for the Task Area?

Response to Question 24 The Technology Transfer Package should be included in your proposal if it is applicable to the Task Area/Task Order to which you are responding. We have revised Attachment 11, Additional Technical Proposal Instructions, Format for Technical Proposal, and Table of Contents, to reflect this information. See response to Question 23 above and revised Attachment 11 attached.

Question 25 Attachment 3: Statement of Work for Base Contract, paragraph C., General Task Order Requirements, item 8., Quality Assurance/Quality Control (QA/QC), subitem a. (on page 7 of the attachment), indicates that "the Contractor shall have and implement a written Quality Plan and program to monitor all operations and processes, develop, implement and evaluate SOPs; define metrics to assess performance; methods to identify and address deficiencies and resolution of issues; and QA training of staff. Project-specific QA/QC requirements will be specified in each Task Order." There do not appear to be any project-specific QA/QC requirements specified for the Sample Task Order for Task Area C. Is this correct? Also, do we include a general Quality Plan for the Task Area?

Response to Question 25 The Quality Assurance/Quality Control Plan should be included in your proposal if it is applicable to the Task Area/Task Order to which you are responding. We have revised Attachment 11, Additional Technical Proposal Instructions, Format for Technical Proposal, and Table of Contents, to reflect this information. See response to Question 23 above and revised Attachment 11 attached.

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Question 26 Which proposal (technical or business) should we include responses to the General Task Order Requirements 1-10 in Attachment 3?

Response to Question 26 Please note, as stated above, your proposal need only address those General Task Order Requirements applicable to the specific Task Area. Your responses to these requirements should be included in the Technical Proposal.

Question 27 Given the limit of 150 pages for the technical proposal, do we need to supply step-by-step protocols in it or are detailed methods sufficient? It is our understanding, based on the RFP, that step-by-step protocols will not be due until a Task Order is awarded. Is this correct?

Response to Question 27 Please refer to Section L, Instructions, Conditions, and Notices to Offerors, as well as Attachment 11, Additional Technical Proposal Instructions, Format for Technical Proposal, and Table of Contents for information that should be submitted in your Technical Proposal. Please use your best judgement keeping in mind the page limitation.

Question 28 Virtually all human liver chimeric mouse models require approximately 5 months after administration of human hepatocytes to sufficiently engraft for susceptibility to Hepatitis infection. How should we structure the timeline of experiments to complete the model improvement portion of Sample Task Order C-1, which only provides a 6-month duration, to produce the xenografted, improved mouse model, co-infect the mice, allow the co-infection to establish, administer the drug, collect samples for drug and viral analyses, necropsy the animals, and perform histopathology and other post-mortem analyses? Can the liver mice production be outsourced so that they can be available at the beginning of the 6 months allocated for this task?

Response to Question 28 The 6-month timeline would start once the humanized mice been made and are sufficiently engrafted. Non-fetal tissues sources need to be used for the Sample Task Order. The Offeror can either produce the humanized mice themselves or outsource it. The estimated cost for producing the humanized mice (outsourced or not) should be included with a brief explanation. Day 0 would be the day when the humanized mice are available and sufficiently engrafted to start the experiments.

Attachment 6: Statement of Work and Deliverables for Sample Task Order C-1, has been revised to reflect this information.

Question 29 Regarding Sample Task Order C-1, I have a question regarding the budget for the improvements of the model. I believe it cannot be included in the budget for the contract for a Task Order. Is the budget for model development also on cost reimbursement agreement? We already

AMENDMENT #2 RFP No. 75N93019R00021 17 developed dual reconstituted human immune system and human liver mice for HIV/HBV infections, however there is room for improvements on increasing the liver engraftment. Over the years we have been working on modifying the humanized mouse models with greater success, still there are instances where anticipated results are not achieved. How will the cost reimbursement work with model modifications proposed?

Response to Question 29 The Contractor can only be reimbursed for work that is required under the Task Order Statement of Work. Please be advised that this is a Sample Task Order and the purpose is to evaluate the offeror’s understanding of and ability to complete all requirements involved in the Sample Task Order and Task Area. The Contractor should propose costs based upon all requirements of the Sample Task Order. For budget purposes, the Offeror should use their best judgement based on the mouse models that they already have available and how they can be improved and structure the budget accordingly. After award, when request for Task Orders are issued, contractors will be informed about whether the anticipated Task Order is cost reimbursement or firm fixed price.

Question 30 In ARTICLE B.2. provisions applicable in direct costs include conferences, meeting, promotional items, acquisition of items (-80 freezer, computers, server), alterations in facilities (secure areas with card entry, partitioning the certain lab areas for security), travel costs, and consultant costs. Where should we include the budget for these provisions?

Response to Question 30 Please note that while you may propose these costs in your budget, this clause applies to costs that cannot be reimbursed without prior Contracting Officer’s approval. Offerors should utilize the template provided in the solicitation [see Attachment 22: Breakdown of Proposed Estimated Costs (plus fee) w/Excel Spreadsheet], which explains the format how costs should be presented/broken out. By clicking on the attachment link (https://oamp.od.nih.gov/content/breakdown-proposed-estimated-cost-plus-fee-and-labor-hours), it will take you to the “Breakdown of Proposed Estimated Cost (Plus Fee) And Labor Hours” page, where halfway down the page, is a link entitled, “ELECTRONIC CONTRACT BUSINESS PROPOSAL”; by clicking this link, it will provide you with the actual Microsoft Excel template.

Question 31 Would the Government please provide additional details regarding the Labor Categories; for example, please provide expectations regarding years of experience and degrees needed for each Labor Category.

Response to Question 31 The Government does not provide expectations in the solicitation regarding years of experience and degrees needed for each labor category rather the Government requests that your proposal include information that describes the “…adequacy of the experience, expertise, education, training, and proposed levels of effort of the Principal Investigator, and scientific and technical staff…” Please refer to Section M of the solicitation and Attachment 11, Additional Technical Proposal Instructions, Format for Technical Proposal, and Table of Contents.

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Question 32 Regarding Attachment 12: “Additional Business Proposal Instructions and Uniform Cost Assumptions”, Section 3 – Uniform Cost Assumptions, paragraph A., Technical Cost Assumptions, subparagraph 7., item 5., it cites “…1,000 new reagents per year.” Please clarify the types of reagents that comprise this amount. Are these new reagents in addition to those listed in subparagraph 7., item 7., Reagent acquisitions? Would the government please clarify what is meant by the term "new”?

Response to Question 32 “New” includes both new lots of material to replenish existing inventory items and new donations or purchases that must be added to the inventory. The new donations are estimated in subparagraph 7., item 10., sub-item a. (on pages 11-12 of the attachment) as 100 reagents per year, or 25% of the total in the revised subparagraph 7., item 5. The majority of the number for subparagraph 7., item 5. (now revised to reflect “400 new reagents per year”, by virtue of this amendment – see our response to Question 13., above) includes the categories and quantities listed in subparagraph 7., item 7.

Question 33 In regard to the packaging and shipping numbers represented (see solicitation reference, below), please describe in further detail what is being shipped and where these shipments may be going.

Is the Reagent Program expected to pay for not only the packaging, but also the shipping?

Solicitation Reference: Attachment 12: “Additional Business Proposal Instructions and Uniform Cost Assumptions”, Section 3 – Uniform Cost Assumptions, paragraph A., Technical Cost Assumptions, subparagraph 7., Technical Cost Assumptions for Task Order G-1, item 6 (on page 10 of Attachment 12).

Response to Question 33 Regarding Attachment 12: Additional Business Proposal Instructions and Uniform Cost Assumptions, Section 3 – Uniform Cost Assumptions, paragraph A., Technical Cost Assumptions, subparagraph 7, item 6., there was an error with the numbers of packaging and shipping for non-domestic and domestic shipments per year, and were revised by virtue of this amendment – see our response to Question 15., above) to read as follows:

6. Packaging and shipping for distribution of requested inventory units to registered users:

500 non-domestic shipments per year 2,000 domestic shipments per year

Shipments would include units of inventory items, including, but not limited to, what currently appears in the online catalog (https://www.aidsreagent.org). Shipments would be going to registered users from approximately 65 countries worldwide. As indicated in Attachment 12:

Additional Business Proposal Instructions and Uniform Cost Assumptions, Section 3 – Uniform Cost Assumptions, paragraph A., Technical Cost Assumptions, subparagraph 7, item 10., sub-item a. (on page 12 of the attachment), Reagent Program is not expected to pay shipping costs for user-requested shipments of inventory items.

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See attached for Attachment 12, Additional Business Proposal Instructions and Uniform Cost Assumptions, which has been revised to reflect these changes.

Question 34 Would the Government please provide the number of domestic and non-domestic shipments expected (see solicitation reference below)?

Solicitation Reference: Attachment 12: “Additional Business Proposal Instructions and Uniform Cost Assumptions”, Section 3 – Uniform Cost Assumptions, paragraph A., Technical Cost Assumptions, subparagraph 7., Technical Cost Assumptions for Task Order G-1, item 10 (on page 12 of Attachment 12).

Response to Question 34 Regarding item 10a., which discusses the “receipt of reagents that are donated to the ARP, which is estimated at 100 reagents per year,” offerors should assume that all 100 reagents per year will be domestic…