Attachment No. 5 Technical Proposal Budget Templates_revised.xlsx

XLSX spreadsheet 39 KB Posted

Attached to
Pharmacology and Toxicology for Therapeutics Program (PTTP)
Solicitation number
75N95022R00003
Issued by

About this file

This document package includes technical proposal budget templates and details for a federal solicitation seeking preclinical pharmacology and toxicology testing services. Awardees will support the National Institute on Neurological Disorders and Stroke Pharmacology and Toxicology for Therapeutics Program in assessing compounds from lead discovery through regulatory filings. Templates provide estimated costs for single and multiple dose rodent and non-rodent pharmacokinetic studies, dose range findings, safety pharmacology, genotoxicity, and IND-enabling toxicology packages. The National Institutes of Health solicitation seeks multiple IDIQ contracts for pharmacology services over 10 years to inform candidate selection and clinical evaluation for therapeutics development. Responses are due per the solicitation details.

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File Type Posted
Attachment No. 8 Propos Summary NIH-2043_revised.pdf PDF
Attachment No. 3 Statement of Work_revised.pdf PDF
Amendment0001_75N95022R00003-S.pdf PDF
RFP 75N95022R00003 PTTP Ramp-On_revised.pdf PDF
Attachment No. 13 Disclosure of Lobbying_revised.pdf PDF
Attachment No. 15 NIH(RC)-2-2_revised.pdf PDF
Attachment No. 22 Project Objectives NIH-1688-1_revised.pdf PDF
Attachment No. 23 Financial Questionnaire_revised.pdf PDF
Attachment No. 11 Offeror Pts of Contact.pdf PDF
Attachment No. 12 Wage Determination November 2021.pdf PDF
Attachment No. 23 Financial Questionnaire.pdf PDF
Attachment No. 14 NIH Customer Perf Survey.pdf PDF
Attachment No. 1 Pack and Delivery of Proposal.pdf PDF
Attachment No. 7 VAS Contracts worksheet.pdf PDF
Attachment No. 15 NIH(RC)-2-2.pdf PDF
Attachment No. 5 Technical Proposal Budget Templates.xlsx XLSX spreadsheet
Attachment No. 21 Electronic Invoicing Instructions 20210210.pdf PDF
Attachment No. 4 Section K Reps.pdf PDF
Attachment No. 10 Business Proposal Budget Templates.xlsx XLSX spreadsheet
Attachment No. 16 NIH (RC)-4.pdf PDF
Attachment No. 18 Nondisclosure Agreement.pdf PDF
Attachment No. 3 Statement of Work.pdf PDF
RFP 75N95022R00003 PTTP Ramp-On.pdf PDF
Attachment No. 17 Privacy Act SORN 09-25-0124.pdf PDF
Attachment No. 2 Propsal Intent Response Sheet.pdf PDF
Attachment No. 9 Small Business Subcontracting Plan.pdf PDF
Attachment No. 19 Suitability Roster.xlsx XLSX spreadsheet
Attachment No. 6 Summary of Related Activities.pdf PDF
Attachment No. 13 Disclosure of Lobbying.pdf PDF
Attachment No. 8 Propos Summary NIH-2043.pdf PDF
Attachment No. 22 Project Objectives NIH-1688-1.pdf PDF
Attachment No. 20 Employ Sep Checklist.pdf PDF
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PA 1 Summary Technical Proposal Budget Template - ATTACHMENT #5a

Sample Task Order 1(b): Performance Area 1 - Management and Operations Support

Contract Type: Fixed-Price

SCHEDULE OF CHARGES FOR PERFORMANCE AREA 1

Description of ItemUnitPeriod of PerformancePrice/UnitUnitsTotal Price
Performance Area 1, "Management and Operations Support"MonthDate of Award - 09/12/2022$4$

Performance Area 1, "Management and Operations Support" Month 09/13/2022 - 09/12/2023 $ 12 $

Performance Area 1, "Management and Operations Support" Month 09/13/2023 - 09/12/2024 $ 12 $

Performance Area 1, "Management and Operations Support" Month 09/13/2023 - 09/12/2024 $ 12 $

Performance Area 1, "Management and Operations Support" Month 09/13/2025 - 09/12/2026 $ 12 $

Total Price $

PA 1 Breakdown Technical Proposal Budget Template - Attachment #5b

Sample Task Order 1(b): Performance Area 1 - Management and Operations Support

Base Year of Contract (Year 1 )
% effort or # of hoursTotal
Labor Costs - (List individuals by name / labor category. DO NOT Indicate/provide hourly rate )
Project Director/Principal Investigator0.83% or 17.5 hours
Senior Professional Information Technology0.42% or 8.75 hours
Administrative Operations Coordinator0.17% or 3.5 hours

Subtotal Direct Labor $

Fringe Benefits $

Subtotal Direct Labor & Fringe $

Other Direct Costs (List as Necessary)

Materials & Supplies$
Travel:Est. 1/12 of 1 trip per year or option term$

Subtotal Other Direct Costs $

Total Price $

PA 2 Summary Technical Proposal Budget Template - ATTACHMENT #5c

COST SUMMARY FOR PERFORMANCE AREA 2 - PHARMACOLOGY AND TOXICOLOGY STUDIES
ASSUMPTIONS: It is estimated that 10 lead optimization stage projects and 5 GLP stage projects will be competed and awarded during each year of the 10 year contract program. The mix of study types and numbers typically conducted for each lead optimization stage and development/GLP stage project is as follows:
Lead Optimization Stage Project - 10 Projects Per Year - Estimated Mix & Number of Study Types Per Individual Project:COST PER STUDY# PER PROJECT# PROJECTS PER YEARYEARLY ESTIMATE
Single Dose Rodent Pharmacokinetic Study – 5$510$
Single Dose Non-Rodent Pharmacokinetic Study – 2$210$
Multi-Dose Rodent Pharmacokinetic Study – 2$210$
Rodent Dose Range Finding Study – 1$110$
Non-Human Primate Dose Range Finding Study$110$

Yearly Estimate for Lead Optimization Stage $

Development/GLP Stage Project - 5 Projects Per Year - Estimated Mix & Number of Study Types Per Individual Project: COST PER STUDY # PER PROJECT # PROJECTS PER YEAR YEARLY ESTIMATE

IND Toxicology and Safety Pharmacology package (includes chronic toxicity studies in two species, Safety Pharmacology (CNS, cardiovascular, pulmonary), genotoxicity assessment, and hERG activity assessment) – 1 $ 1 5 $

Yearly Total for Lead Optimization Stage and Development/GLP Components $

Single Dose Rodent (Rat) PK Technical Proposal Budget Template - ATTACHMENT #5d

Performance Area 2 - Pharmacology and Toxicology Studies

Single Dose Rodent (Rat) Pharmacokinetic Study
% effort or # of hoursTotal
Labor Costs - (List individuals by name / labor category. DO NOT indicate/provide hourly rate for each.)
$
$
$

Subtotal Direct Labor $

Fringe Benefits $

Subtotal Labor & Fringe $

Other Direct Costs (List and Itemize as Necessary)

Subtotal Other Direct Costs $

Total Estimated Direct Cost $

Single Dose Dog PK Technical Proposal Budget Template - ATTACHMENT #5e

Performance Area 2 - Pharmacology and Toxicology Studies

Single Dose Dog Pharmacokinetic Study
% effort or # of hoursTotal
Labor Costs - (List individuals by name / labor category. DO NOT indicate/provide hourly rate for each.)
$
$
$

Subtotal Direct Labor $

Fringe Benefits $

Subtotal Labor & Fringe $

$
Other Direct Costs (List and Itemize as Necessary)
Subtotal Other Direct Costs
$

Total Estimated Direct Cost $

Multi-Dose Rodent (Rat) PK Technical Proposal Budget Template - ATTACHMENT #5f

Performance Area 2 - Pharmacology and Toxicology Studies

Multi-Dose Rodent (Rat) Pharmacokinetic Study
% effort or # of hoursTotal
Labor Costs - (List individuals by name / labor category. DO NOT indicate/provide hourly rate for each.)
$
$
$

Subtotal Direct Labor $

Fringe Benefits $

Subtotal Labor & Fringe $

$
Other Direct Costs (List and Itemize as Necessary)
Subtotal Other Direct Costs
$
Total Estimated Direct Cost$
Fee

Total Estimated Cost Plus Fee

Rodent (Rat) Dose Range Finding Technical Proposal Budget Template - ATTACHMENT #5g

Performance Area 2 - Pharmacology and Toxicology Studies

Rodent (Rat) Dose Range Finding (DRF) Study
% effort or # of hoursTotal
Labor Costs - (List individuals by name / labor category. DO NOT indicate/provide hourly rate for each.)
$
$
$

Subtotal Direct Labor $

Fringe Benefits $

Subtotal Labor & Fringe $

$
Other Direct Costs (List and Itemize as Necessary)
Subtotal Other Direct Costs
$
Total Estimated Direct Cost$
Fee

Total Estimated Cost Plus Fee

Non-Human Primate Dose Range Technical Proposal Budget Template - ATTACHMENT #5h

Performance Area 2 - Pharmacology and Toxicology Studies

Non-Human Primate (NHP) Dose Range Finding Study
% effort or # of hoursTotal
Labor Costs - (List individuals by name / labor category. DO NOT indicate/provide hourly rate for each.)
$
$
$

Subtotal Direct Labor $

Fringe Benefits $

Subtotal Labor & Fringe $

Other Direct Costs (List and Itemize as Necessary)
$
$
$

Subtotal Other Direct Costs $

Total Estimated Direct Cost $

IND Toxicology Package Technical Proposal Budget Template - ATTACHMENT #5i

Performance Area 2 - Pharmacology and Toxicology Studies

Investigational New Drug (IND) Toxicology Package
% effort or # of hoursTotal
Labor Costs - (List individuals by name / labor category. DO NOT indicate/provide hourly rate for each.)
$
$
$

Subtotal Direct Labor $

Fringe Benefits $

Subtotal Labor & Fringe $

Other Direct Costs (List and Itemize as Necessary)
$
$
$

Subtotal Other Direct Costs $

Total Estimated Direct Cost $

In-Vitro ADMET Panel Technical Proposal Budget Template - ATTACHMENT #5j

Performance Area 2 - Pharmacology and Toxicology Studies

In-Vitro ADMET Panel
% effort or # of hoursTotal
Labor Costs - (List individuals by name / labor category. DO NOT indicate/provide hourly rate for each.)
$
$
$

Subtotal Direct Labor $

Fringe Benefits $

Subtotal Labor & Fringe $

Other Direct Costs (List and Itemize as Necessary)
$
$
$

Subtotal Other Direct Costs $

Total Estimated Direct Cost $

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