Attachment_8_-_Business_Proposal_Inst_revised.pdf
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- Solicitation number
- 75N93024R00019
About this file
This document is Additional Business Proposal Instructions and Uniform Cost Assumptions for the Evaluation and Testing Services (ETS) for Vaccines and Other Biologics for Infectious Diseases federal contract opportunity, Solicitation Number 75N93024R00019.
The key details are:
- The contract has a Minimum Guaranteed Award of $10,000 and a Maximum Potential Value of $136,588,701, with Task Orders awarded under four main task areas: Administrative and Management Support, Assay Development, Clinical and Non-clinical Testing, and Safety and Toxicity Testing.
- For task orders, the document provides uniform cost assumptions such as meeting requirements, sample volumes, shipping, and travel for site visits. It also specifies that no costs will be provided for facility renovation or construction.
- The document provides instructions for the Business Proposal, including required sections and documentation to be submitted.
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ATTACHMENT 8: ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS
AND UNIFORM COST ASSUMPTIONS
EVALUATION AND TESTING SERVICES (ETS) FOR VACCINES AND OTHER
BIOLOGICS FOR INFECTIOUS DISEASES
75N93024R00019
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 Statement of Work, 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
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 a clearly marked section of the proposal.
SECTION 3 – UNIFORM COST ASSUMPTIONS
1) Technical Cost Assumptions
No costs will be provided to support the renovation or construction of facilities.
A. Contract Value
This contract will have a Minimum Guaranteed Award of $10,000 and a Maximum Potential Value of $136,588,701.00 based on an estimate of the maximum number of Task Orders that could be awarded for each Task Area. The Maximum Potential Value is not guaranteed, but represents the potential for additional funding through Task Order awards under the contract during the ordering period, up to the Maximum Potential Value.
B. Scope of Activities
The list below represents the average number of specific, non-severable tasks offerors should assume will be awarded under the contract. Task Order A will be severable. This list is provided to indicate the general scope of work of this contract.
Assume that the period of performance of task orders may range from less than one year to multiple years.
Task Area Title
Estimated No.
of
Awards/year
A Administrative and Management Support Activities – Task Area A
To each awardee
B Assay Development – Sample Task Area B 2 B Clinical and Non-clinial Testing –Sample Task Area B 2
C Immunogenicity & Efficacy Testing – Sample Task Area C 2
D Safety and Toxicity Testing – Sample Area D 3 This Table represents the estimated number of task orders. Some of the task orders will crossover from one area to another.
C. Cost Proposal for Task Orders
Task Order A (Administration and Management Support Activities)
Immediately upon award of the basic contract, NIAID anticipates issuing a single Task Order for Task Area A – Administration and Contract Management Support Activities.
The Contractor must be capable of initiating this Task Order upon award.
Provide a detailed task-budget for the proposed Task Order using the following assumptions:
Duration: Task Order A shall be awarded for a Base Period of 12 months, with up to nine Options to extend for additional 12 month periods of performance.
Contract initiation meeting: Meeting shall occur within 2 months after contract Base period award and will occur virtually.
Level of effort for Base year for initiation meeting will be higher than for subsequent years where the requirements for subcontractor audits will be dependent on the number of subcontracts anticipated.
Sample Task Order B (Assay Development and Clinical and Non-clinical Sample Testing)
Duration: No greater than 24 months.
Task Order initiation meeting: Meeting shall occur virtually.
Periodic updates & ad hoc meetings: 44 Progress Review Meetings and 4 ad hoc meetings; meetings shall occur virtually.
Shipment: materials shall be received from a US source.
Sample Testing: 90 non-human primate serum and mucosal samples shall be tested using the humoral assays. 300 human serum and mucosal samples shall be tested with the humoral assays. 100 samples of frozen human PBMC shall be tested in cellular assays.
Travel: If a subcontractor is proposed for assay development, work travel for one day site visit of the proposed subcontractor may be included.
Shipment: materials shall be received from a US source.
Travel/Audit: If a subcontractor is proposed for sample testing for a one day site visit of the proposed subcontractor may be included.
Sample Task Order C (Immunogenicity and Efficacy Testing)
Duration: No greater than 24 months.
Task Order initiation meeting: Meeting shall occur virtually.
Periodic updates & ad hoc meetings: 44 Progress Review Meetings and 4 ad hoc meetings; meetings shall occur virtually.
Shipment: materials shall be received from a US source; any shipments will be to a US location.
Travel/Audit: If a subcontractor is proposed for immunogenicity and/or efficacy studies, travel for site visits for baseline assessment of quality systems, critical phase monitoring and final study audits may be included.
Sample Task Order D (Safety and Toxicology Testing)
Duration: No greater than 12 months.
Task Order initiation meeting: Meeting shall occur virtually.
Periodic updates & ad hoc meetings: 22 Progress Review Meetings and 1 ad hoc meeting; meetings shall occur virtually.
Travel/Audit: If a subcontractor is proposed for safety and toxicity testing for a two day site visit of the proposed subcontractor may be included.
2) Travel
As appropriate, travel requirements are included above in Task Order or Sample Task Order Technical Cost Assumptions.
3) Special Shipping and Packaging
As appropriate, shipping requirements are included above in Sample Task Order Technical Cost Assumptions.
4) Government Furnished Property
Government Furnished Property is offered for this acquisition.
No Government Furnished Property is offered for this acquisition.
The purchase of Government Furnished Property will not be authorized as a direct charge under the resultant Task Order.
SECTION 4 – OPTIONS (This applies only to Task Order A)
Each Option for Task Order A: Options 1-9 must be budgeted separately within the Business Proposal.
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.
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