RFP 75N93019R00023 Amendment 3.pdf

AMENDMENT #3, RFP No. 75N93019R00023 1

Amendment No. 3 RFP No. 75N93019R00023

“Preclinical and Translational Vaccine Development Support for HIV and Other Candidate Agents”

Solicitation Number: 75N93019R00023

Amendment Number: Three (3)

Amendment Issue Date: July 21, 2020

Proposal Due Date/Time: August 14, 2020 at 3:00 PM, Eastern Standard Time (Unchanged)

Issued By: Kishan Patel

Contracting Officer

OA/DEA/NIAID/NIH/DHHS

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

Points of Contact: PRIMARY Kishan Patel, Contracting Officer Email: patelki@niaid.nih.gov Phone: 240.669.5157

SECONDARY

Michelle Scala, Contracting Officer Email: mscala@niaid.nih.gov Phone: 240.669.5156

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 answer questions from offerors and to revise Attachment 12 – Additional Business Proposal Instructions and Uniform Cost Assumptions, to provide clarification on the submission of a cost proposal for Task Order A-1 and Sample Task Orders B-1, C-1, D-1, E-1, F-1, and G-1.

mailto:patelki@niaid.nih.gov mailto:mscala@niaid.nih.gov

AMENDMENT #3, RFP No. 75N93019R00023 2

RESPONSES TO QUESTIONS FROM POTENTIAL OFFERORS:

PLEASE NOTE: The due date for receipt of questions related to this RFP has passed. The date was set so that we could answer questions to allow for timely submission of contract proposals.

The due date for submission of proposals remains unchanged.

QUESTION 1: Since Sample Task Orders will not be awarded at the time of contract award, are separate cost proposals required for the Sample Task Orders?

RESPONSE: When an offeror submits a Technical Proposal for a specific Task Area, a separate Cost Proposal should be included with the offeror’s Business Proposal submission for that Task Area. The solicitation has been revised to reflect this clarification. Please refer to revised Attachment 12, Additional Business Proposal Instructions and Uniform Cost Assumptions (attached).

END OF AMENDMENT NO. 3, RFP No. 75N93019R00023

ATTACHMENT 12 - ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS

AND UNIFORM COST ASSUMPTIONS, Revised 7-21-2020 Page 1 of 10

ATTACHMENT 12: ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS

AND UNIFORM COST ASSUMPTIONS

PRECLINICAL AND TRANSLATIONAL VACCINE DEVELOPMENT SUPPORT

FOR HIV AND OTHER CANDIDATE AGENTS

RFP NUMBER 75N93019R00023

In addition to the format requirements for the Business Proposal that are contained in Section L of the solicitation, the information presented in this section of the RFP is intended to provide uniform cost assumptions and business clarifications.

Offerors are advised to give careful consideration to the Statements of Work for Actual and Sample Task Orders for Task Areas A through G, all reference material provided as attachments, the Technical Evaluation Criteria, and, the RFP as a whole, in the development of your proposal. The information requested in these instructions should be used as a guide for the development and formatting of your Business Proposal. Offerors should consider and include the information requested here, as well as any other information which will benefit the proposal.

BUSINESS PROPOSAL – TABLE OF CONTENTS

The Business Proposal must contain sufficient information to allow the Government to perform a basis analysis of the proposed cost or price of the work. This information should include the amount of the basic elements of the proposed cost or price. These elements will include, as applicable, direct labor, fringe benefits, overhead, travel, materials, subcontracts, purchased parts, shipping, indirect costs and rates, profit/fee.

SECTION 1 – PROPOSAL COVER SHEET (use form NIH 2043 identified in Section J of the solicitation)

SECTION 2 – COST OR PRICE SUPPORT

Section L of the RFP specifies the minimum documentation requirements for cost data and all cost related support. All related documentation should be included in the proposal in a clearly marked section.

SECTION 3 – GENERAL INSTRUCTIONS

The Government intends to award multiple-award IDIQ contracts to support these activities. Task Orders will be issued in the following areas:

• Research and Development Product Storage and Shipping (Task Area A)

• Safety and Immunogenicity Studies (Task Area B)

• Feasibility Studies and Early Manufacturability Assessments (Task Area C)

• Analytical Characterization and Method Development (Task Area D)

• Process Development, CGMP Manufacturing, and Stability (Task Area E)

• Fill-Finish, Packaging, and Labeling (Task Area F)

• Scientific, Quality, and Regulatory Support Services (Task Area G)

AND UNIFORM COST ASSUMPTIONS, Revised 7-21-2020 Page 2 of 10

It is anticipated that NIAID will award Base contracts to one or multiple contractors for each of the Task Areas listed (A, B, C, D, E, F, and G). NOTE: Task Area G is set aside for small business concerns (see Section L of the solicitation for more information).

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.

SECTION 4 below includes Uniform Cost Assumptions for Task Order A-1 and Sample Task Orders B-1, C-1, D-1, E-1, F-1, and G-1. Offerors who submit a Technical Proposal for Task Area A, should submit a Business Proposal that includes a Cost Proposal based on the Uniform Cost Assumptions for Task Order A-1. This applies to other Task Areas as well. Although Sample Task Orders will NOT be awarded, Offerors are to include in their Business Proposals for each Task Area, a Cost Proposal for each Sample Task Order that relates to the Task Area.

NIAID recognizes that no single organization or institution may have the expertise and facilities required to perform all of the tasks mentioned above. Therefore, the Contractor may need to utilize the expertise and resources of subcontractors and specialized consultants to provide the full spectrum of requested activities. The Contractor shall be responsible for ALL work performed under this contract, including that performed by any subcontractors and consultants.

The Contractor shall ensure that any and all processes meet international, federal, local and state regulations to ensure the continuity and validity of the resulting product.

NIAID anticipates that contract awards for the Base contracts will be on or about June 9, 2021.

The ordering period for these contracts will be from June 9, 2021 through June 8, 2028.

Contractors will not be required to make any deliveries under the contracts after June 8, 2031.

Task Orders issued against the IDIQ contracts will be cost reimbursement and/or firm fixed price. While the Base IDIQ contract will not have options, options may be included at the individual Task Order level.

SECTION 4 – UNIFORM COST ASSUMPTIONS

A. Technical Cost Assumptions

The Government anticipates awarding the following number of Task Orders each year. This list is provided to indicate the general scope of the work to be performed and should be considered an estimate only.

Task Area Title

Estimated No.

of

Task Orders Per Year

A Research and Development Product Storage and Shipping

2 awards will be made for a 7-

AND UNIFORM COST ASSUMPTIONS, Revised 7-21-2020 Page 3 of 10 year period of performance

B Safety and Immunogenicity Studies 3

C Feasibility Studies & Early Manufacturability 2

D

Analytical Characterization and Method Development 2

E Process Development, CGMP Manufacturing and Stability 5

F Fill-Finish and Labeling 4

G Scientific, Quality and Regulatory Support Services 1

Immediately, upon award of the Base contracts for this multiple award IDIQ, the Government anticipates awarding two Task Orders as follows:

Task Order #A -1, Research and Development Product Shipping and Storage

1. Technical Cost Assumptions for Task Order A-1, Research and Development Product

Storage and Shipping:

a. We anticipate awarding a cost-reimbursement, level of effort/term type Task Order.

The period of performance of this Task Order will be June 9, 2021 through June 8, 2022. The requirement will be the delivery of 1.45 Full Time Equivalents (FTEs) for the base period (Year 1). Options to extend the term of the Task Order will be included in the Task Order award. Assume that the scope and types of activities as outlined herein (i.e., for year one of the Task Order) would be continued for each succeeding annual Task Order period up to 7 total years. If Options to extend the term are exercised, the Contractor shall provide 1.45 FTEs per year for Options 1 through

6. Please note that the number of FTEs is inclusive of subcontractor and consultant effort.

b. Level of Effort: Below is the level of effort required for this Task Order. The level of effort is stated in terms of FTEs. The labor mix is provided as an estimate and is not meant to be restrictive. The Contractor may propose a different labor mix for carrying out the SOW of the Task Order but must meet the total FTE requirement.

Labor Category Estimated FTEs/Year Principal Investigator 0.01 Project Manager 0.40 Other Professionals 0.09 Technical Support 0.95 Total 1.45

AND UNIFORM COST ASSUMPTIONS, Revised 7-21-2020 Page 4 of 10

c. Offerors should estimate costs based on storing CGMP products such as approximately 200,000 vials of cell banks, reagents, filled DP, adjuvants and reference standards, viral strain stocks for adventitious agents testing, and 200 bottles of 750-1 liter capacity to store BDS;

• 1 CGMP storage unit at room temperature.

• 1 CGMP storage unit at 2 to 8°C.

• 2 CGMP storage freezers at -15 to 25°C.

• 6 CGMP storage units at -70 to -90°C.

• 1 CGMP storage unit for liquid nitrogen (LN2).

• 1 non-CGMP storage unit at 2 to 8°C.

• 1 non-CGMP storage unit at -70 to -90°C.

Offerors should anticipate a unit is 25 to 30 cubic feet and plan for a 10% increase annually in the number of reagent samples/aliquots stored and be able to accommodate this expansion in storage capacity.

d. Offerors should estimate costs for 100 shipments per year: assume 90 shipments are cross-country domestic and 10 shipments are international (5 to Europe, and 5 to South Africa). The Contractor is responsible for providing appropriate shipping containers for hazardous and biohazardous materials, and all associated packing materials, including dry ice. Assume that 80% of these shipments will require dry ice.

Assume that 10% will require wet ice and 10% will be shipped at room temperature.

Of the dry ice shipments, approximately 25% will include biohazardous material.

e. Offerors should estimate costs for 1-hr monthly teleconferences with the COR.

f. Provide separate budgets covering all costs associated with carrying out the functions specified in the SOW for each of the twelve-month periods of the Base Period and Options 1-6 that may be exercised.

g. Do not assume any labeling or label overwrapping activities in the costing.

h. Within 10 calendar days of Task Order award, plan for the PI and a PM to participate in an Initiation/Kick-Off Meeting via Teleconference to review the Task Order/Study requirements and timelines, discuss Task Order/ technical plans and approaches, and identify any anticipated problems/obstacles to completing the Task Order requirements.”

Separate Cost Assumptions are provided below for each Sample Task Order included in this solicitation.

2. Technical Cost Assumptions for Sample Task Order B-1: Safety and Immunogenicity Studies for an HIV-Env Protein Vaccine Candidate:

a. The proposed Sample Task Order will be a cost-reimbursement, completion type

AND UNIFORM COST ASSUMPTIONS, Revised 7-21-2020 Page 5 of 10

Task Order. The period of performance of the Sample Task Order will be for 18 months. Assume a start date of August 1, 2021.

b. Estimate of Effort: Below is the estimate of effort for this Task Order for the 18-months performance period. The level of effort is stated in terms of FTEs. The amount of effort and the labor mix are provided as an estimate and are not meant to be restrictive. The Contractor may propose the level of effort and labor mix deemed most appropriate for carrying out the SOW of the Task Order.

Labor Categories Estimated FTEs Principal Investigator 0.01 Other Professionals 0.38 Technical Support 0.09 Total 0.48

c. The HIV-Env protein antigen and alum adjuvants shall be supplied by the

Government and provided to the Contractor upon Task Order award.

d. Offerors should estimate costs for 2 domestic cross-country shipments (from New York, New York to San Francisco, California).

e. Offerors should estimate costs for 1-hr weekly teleconferences with the COR during the duration of the Task Order.

f. Within 10 calendar days of Task Order award plan for the PI and PM to participate in an Initiation/Kick-Off Meeting via Teleconference to review the Task Order/Study requirements and timelines, discuss Task Order/ technical plans and approaches, and requirements.

g. Offerors should estimate travel costs for one vendor audit in San Francisco, California. The audit should include at least two experts/consultants. Assume the audit will take 2 days and 2 travel days.

3. Technical Cost Assumptions for Sample Task Order C-1, Feasibility Studies and

Early Manufacturability Assessment of Production of HIV-1 gp120 Env in a Mammalian Cell Line:

a. The proposed Sample Task Order will be a cost-reimbursement, completion type

Task Order. The period of performance of this Sample Task Order will be for 18

b. Estimate of Effort: Below is the estimate of effort for this Task Order. The level of effort is stated in terms of FTEs. The amount of effort and the labor mix are provided as an estimate and are not meant to be restrictive. The Contractor may propose the

AND UNIFORM COST ASSUMPTIONS, Revised 7-21-2020 Page 6 of 10 level of effort and labor mix deemed most appropriate for carrying out the SOW of the Task Order.

Principal Investigator 0.02 Co-Investigator 0.03 Project Manager 0.20 Other Professionals 0.07 Technical Support 0.04 Total 0.36

c. The HIV-Env protein and/or other products for assessment shall be supplied by the

Government and provided to the Contractor upon Task Order award.

d. Offerors should estimate costs for 2 domestic cross-country shipments, cross-country from New York, New York to San Francisco, California.

f. Offerors should estimate costs for travel for one vendor audit in San Francisco, California. The audit should include at least two experts/consultants. Assume at least two days for the audit, and two days of travel.

4. Technical Cost Assumptions for Sample Task Order D-1, Analytical

Characterization and Method Development to Determine the Glycosylation of an HIV Env Vaccine Candidate:

a. The proposed Sample Task Order will be a cost-reimbursement, completion type

Task Order. The period of performance of this Sample Task Order will be for 18 as an estimate and are not meant to be restrictive. The Contractor may propose the

Principal Investigator 0.10 Co-Investigator 0.20 Project Manager 0.20 Other Professionals 0.49 Technical Support 0.65 Totals 1.64

AND UNIFORM COST ASSUMPTIONS, Revised 7-21-2020 Page 7 of 10

c. The HIV-Env protein for assessment shall be supplied by the Government and provided to the Contractor upon Task Order award.

d. Offerors should estimate costs for 2 domestic cross-country shipments from New York, New York to San Francisco, California.

f. Within 10 calendar days of Task Order award, plan for the PI and PM to participate in an Initiation/Kick-Off Meeting via Teleconference to review the Task Order/Study requirements and timelines, discuss Task Order/ technical plans and approaches, and

g. Offerors should estimate costs for travel for one vendor audit in San Francisco, California. The audit should include at least two experts/consultants. Assume at least two days of audit, and two days of travel.

5. Technical Cost Assumptions for Sample Task Order E-1, CGMP Manufacturing of

HIV-1 GP120 Envelope (ENV):

a. The proposed Sample Task Order will be a cost-reimbursement, completion type Task

Order. The period of performance of this Task Order will be for 3 years. Assume a start date of August 1, 2021.

as an estimate and are not meant to be restrictive. The Contractor may propose the

Labor Categories Estimated FTEs/Year Principal Investigator 0.10 Co-Investigator 0.15 Project Manager 0.30 Other Professionals 0.57 Technical Support 0.55 Total 1.67

c. The HIV-Env protein shall be supplied by the Government and provided to the

Contractor upon Task Order award.

d. Offerors should estimate costs for 2 domestic cross-country shipments from New York, New York to San Francisco, California.

AND UNIFORM COST ASSUMPTIONS, Revised 7-21-2020 Page 8 of 10

f. Within 10 calendar days of Task Order award, plan for the PI and PM to participate in requirements and timelines, discuss Task Order/technical plans and approaches, and

g. Offerors should estimate costs for travel for two vendor audits per Task Order -one to U.S. west coast (San, Francisco, California) and one international audit to Delhi (India). Each audit should include at least two experts/consultants, for at least two days of audit and two to five days travel respectively for by each auditor, depending on domestic or international location.

6. Technical Cost Assumptions for Sample Task Order F-1, Fill-Finish, Release, and

Stability Testing of HIV-1 GP120 Proteins:

a. The proposed Task Order will be a cost-reimbursement, completion type Task Order.

The period of performance of this Task Order will be for 18 months. Assume a start date of August 1, 2021.

as an estimate and are not meant to be restrictive. The Contractor may propose the

Principal Investigator 0.02 Co-Investigator 0.02 Other Professionals 0.13 Technical Support 0.10 Totals 0.27

c. The HIV-Env protein BDS shall be supplied by the Government and provided to the

Contractor upon Task Order award.

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

e. Offerors should estimate costs for 2 domestic cross-country shipments, cross-country, from New York, New York to San Francisco, California.

f. Offerors should estimate costs for 1-hr weekly teleconferences with the COR during

AND UNIFORM COST ASSUMPTIONS, Revised 7-21-2020 Page 9 of 10

g. Within 10 calendar days of Task Order award, plan for the PI and PM to participate in requirements and timelines, discuss Task Order/technical plans and approaches, and

h. Offerors should estimate costs for travel for one vendor audit -- to San Francisco, California per Task Order. The audit should include at least two experts/consultants, for at least two days of audit and two days of travel by each auditor.

i. Offerors should estimate costs for filling 10,000 vials of DP. Specifications should assume: 2R glass vials, with a fill volume of 0.7mL +/- 0.1mL; 13mm Stopper; 13mm Aluminum crimp cap; finish product label, rated for appropriate storage and shipping conditions.

7. Technical Cost Assumptions for Sample Task Order G-1, Scientific, Quality and

Regulatory Support Services:

a. The proposed Task Order will be a cost-reimbursement, level of effort type Task

Order. The period of performance of this Task Order will be August 1, 2021 through July 31, 2022. The requirement will be the delivery of 0.80 FTE.

b. Level of Effort: To assist you in the preparation of your proposal, the Government considers the required level of effort to be 0.80 FTE, including subcontractor and consultant effort. The personnel categories in the Level of Effort table below are provided as an estimate and are not meant to be restrictive. Offerors may propose a different labor mix deemed most appropriate to carry out the SOW. However, Offerors must, provide the specified total level of effort.

Labor Category Estimated FTEs Principal Investigator 0.05 Project Manager 0.40 Other Professional Support 0.10 Technical Support 0.25 Total FTEs 0.80

c. Offerors should estimate costs for 3 Out-of-Specification (OOS) investigations: 1

OOS for pH measurements, 1 incidence of particulate matter, and 1 temperature excursion.

d. Offerors should estimate costs for 5 CGMP audits: 4 audits in San Diego, California, USA, and 1 audit in Munich, Germany. The audit should include at least two experts/consultants, for at least two days of audit, and two days of travel.

AND UNIFORM COST ASSUMPTIONS, Revised 7-21-2020 Page 10 of 10

e. Offerors should estimate costs for 2 GLP audits, to be conducted in San Diego, California. The audit should include at least two experts/consultants, for at least two days of audit, and two days of travel.

f. Offerors should estimate cost for the review of 30 Master Batch Record (MBR) files.

g. Offerors should estimate costs for the writing of 1 Investigator’s Brochure and 3 eCTD-compliant CMC sections for IND submission.

h. Offerors should assume two 1-hr weekly teleconferences with the COR

i. Within 10 calendar days of Task Order award, plan for the PI and PM to participate in requirements and timelines, discuss Task Order/ technical plans and approaches, and

B. Government Furnished Equipment (GFE): Government furnished equipment is available to be transferred from the incumbent contract (see attached Schedule II-A).

SECTION 4 – OPTIONS

Each Option must be budgeted separately within the Business Proposal. All uniform cost assumptions associated with Options are delineated above and in the Task Order SOWs.

SECTION 5 - TABLE OF CONTENTS FOR DOCUMENTATION REQUIRED UNDER

SECTION L OF THE SOLICITATION

Refer to Section L of the solicitation for documentation requirements. All relevant documentation should be included in a clearly marked section of the proposal.