Attachment No. 5 Technical Proposal Budget Templates.xlsx
XLSX spreadsheet 39 KB Posted
- Solicitation number
- 75N95022R00003
About this file
This document provides budget templates and cost estimates for a Pharmacology and Toxicology for Therapeutics Program contract opportunity. Key details include:
The National Institute of Neurological Disorders and Stroke is pursuing multiple IDIQ contracts to conduct preclinical pharmacology and toxicology testing to support drug development. Services include single dose and multi-dose PK studies in rodents and non-rodents, dose range finding, IND package toxicology and safety assessments, and in vitro ADMET panels. Templates provide labor categories without rates and estimate costs for study types typically required for lead optimization and GLP stage projects. The estimated annual costs for lead optimization projects are provided based on anticipated numbers and study mixes. The solicitation number is 75N95022R00003 and was issued by the National Institutes of Health National Institute on Drug Abuse for the Pharmacology and Toxicology for Therapeutics Program. Responses are due based on the standard solicitation schedule and resultant contracts will support regulatory filings with the FDA.
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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 Item | Unit | Period of Performance | Price/Unit | Units | Total Price |
| Performance Area 1, "Management and Operations Support" | Month | Date of Award - 09/12/2021 | $ | 2 | $ |
Performance Area 1, "Management and Operations Support" Month 09/13/2021 - 09/12/2022 $ 12 $
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 hours | Total | |
| Labor Costs - (List individuals by name / labor category. DO NOT Indicate/provide hourly rate ) | ||
| Project Director/Principal Investigator | 0.83% or 17.5 hours | |
| Senior Professional Information Technology | 0.42% or 8.75 hours | |
| Administrative Operations Coordinator | 0.17% 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 YEAR | YEARLY ESTIMATE |
| Single Dose Rodent Pharmacokinetic Study – 5 | $ | 5 | 10 | $ |
| Single Dose Non-Rodent Pharmacokinetic Study – 2 | $ | 2 | 10 | $ |
| Multi-Dose Rodent Pharmacokinetic Study – 2 | $ | 2 | 10 | $ |
| Rodent Dose Range Finding Study – 1 | $ | 1 | 10 | $ |
| Non-Human Primate Dose Range Finding Study | $ | 1 | 10 | $ |
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 hours | Total | |
| 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 hours | Total | |
| 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 hours | Total | |
| 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 hours | Total | |
| 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 hours | Total | |
| 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 hours | Total | |
| 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 hours | Total | |
| 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 $
File details come from the government source that posted it. Updated .