Attachment 7 - Additional Business Proposal Instructions.pdf

ATTACHMENT 6: ADDITIONAL BUSINESS PROPOSAL

INSTRUCTIONS AND UNIFORM COST ASSUMPTIONS

INTERVENTIONAL AGENTS SAFETY AND PHARMACOKINETIC SERVICES (IASPS)

75N93024R00003

BUSINESS PROPOSAL – TABLE OF CONTENTS

Note: Offerors are not required to propose to all Task Areas but may respond to a combination of two or more Task Areas. Offerors must propose to Task Area F and at least one Task Area from Task Areas A-E. The offerors shall submit one business proposal for each proposed Task Area. A separate excel spreadsheet shall be submitted for each proposed Task Area. Please ensure proper labeling of proposals.

Task Area F will only be evaluated for cost and past performance and will not be peer reviewed. Task Area F will be awarded at time of parent contract award.

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 FOR SAMPLE TASK ORDERS

1) Technical Cost Assumptions

No costs will be provided to support the renovation or construction of facilities.

Sample Task Order A: Product Development Planning and Evaluation

Duration: No greater than 12 months.

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.

Sample Task Order B: Non-GLP in vitro Preclinical Safety Studies

Shipment: Shipment will be to a US location.

Sample Task Order C: Non-GLP in vivo Preclinical Microbiological, Safety, Toxicology, and Pharmacokinetic Services

Shipment: Shipments will be to a US location.

Sample Task Order D: GLP Preclinical Microbiological, Safety, Toxicology and Pharmacokinetics Services

Duration: No greater than 12 months Shipment: Shipments will be to a US location, Split shipments will be required for GMP-grade materials.

Sample Task Order E: Commercial Off-the-Shelf Screening for Absorption, Distribution, Metabolism, and Excretion (ADME), Safety, and Pharmacokinetics (PK)

Duration: No greater than 12 months Shipment: Shipments will be to a US location Assume a Firm Fixed Price Task Order using the pricing list below.

Assume studies will be performed as follows:

Number of Units Price per

Unit Total Price

ADMET Profiling Package 1 (Including Aqueous Solubility and Microsomal Metabolic/Plasma Stability three species selected from mice/rat/human/dogs/NHP)

$0,000 $0,000

ADMET Profiling Package 2 (Including Plasma Protein Binding, Caco-2 Permeability, Cytochrome P450 Inhibition and Cytotoxicity)

Cytotoxicity (stand-alone assay format) 1 CYP Induction

(Panel of 3 CYP enzymes with both qPCR and activity assessment)

Secondary Pharmacology Profiling (Panel of ~50 mammalian receptors/enzymes;

Single-concentration inhibition screen and IC50 follow up of 5 hits)

Cardiac Channel Profiling 1

(Panel of 8 assays with six ion channels; IC50 assessment using 5 concentrations of test compound)

Rodent PK Screening Package 1 (Including bioanalysis and PK parameters from each of 2 dose groups in mice or rats)

Rodent PK Screening Package 2 (Including bioanalysis and PK parameters from each of 2 dose groups in hamsters or guinea pigs)

Rodent MTD Package 1 (In mice or rats with up to 5 dose groups and max of 15 total animals per study; in-life observations for signs of acute toxicity and/or autonomic effects to establish MTD for future studies)

Rodent MTD Package 2 (In hamsters or guinea pigs with up to 5 dose groups and max of 15 total animals per study; in-life observations for signs of acute toxicity and/or autonomic effects to establish MTD for future studies)

Total Price: $

Task Order F – Contract Kick-Off Meeting Period of Performance – Exact dates TBD. Anticipated to occur within 1 month after parent contract award.

Assume 1 teleconference.

No travel anticipated.

2) Special Shipping and Packaging

As appropriate, shipping requirements are included above in Sample Task Order Technical Cost Assumptions.

3) Storage

There are no long-term storage requirements outside normal performance as directed in the Sample Task Orders.

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.

5) Travel

A. N/A

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.