Attachment No. 10 Business Proposal Budget Templates.xlsx

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Pharmacology and Toxicology for Therapeutics Program (PTTP)
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75N95022R00003
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This document package includes budget templates and cost estimates to support the Pharmacology and Toxicology for Therapeutics Program (PTTP) federal contract opportunity. The templates provide cost breakdowns for various preclinical study types required over the 10-year period of performance, including single dose rodent and dog pharmacokinetic studies, multi-dose rodent pharmacokinetic studies, rodent and non-human primate dose range findings, an investigational new drug toxicology package, and an in vitro absorption, distribution, metabolism, excretion and toxicity panel. The cost estimates are based on assumptions of the estimated number and mix of study types needed for 10 lead optimization projects and 5 development/GLP projects annually. The National Institute of Neurological Disorders and Stroke (NINDS) seeks to award multiple indefinite delivery/indefinite quantity contracts to conduct the necessary preclinical pharmacology and toxicology testing to support assessment of promising compounds and selection of clinical candidates for the PTTP, as well as studies required for investigational new drug applications.

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Attachment No. 8 Propos Summary NIH-2043_revised.pdf PDF
Attachment No. 5 Technical Proposal Budget Templates_revised.xlsx XLSX spreadsheet
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. 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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Contract Kick-Off Meeting Business Proposal Budget Template - Attachment #10a

Sample Task Order 1(a): Contract Kick-Off Meeting

Contract Type: Firm-Fixed-Price

Base Month
% effort or # of hoursRateTotal
Labor Costs - (List individuals by name / labor category. Indicate hourly rate or rate equivalent for each.)
Project Director/Principal Investigator$$
Senior Professional Information Technology$$
Administrative Operations Coordinator$$

Subtotal $

Fringe Benefits *% $

Subtotal Labor & Fringe $

Labor Overhead *% $

Other Direct Costs (List as Necessary)

Materials & Supplies$
Consultants$
Travel$

Subtotal Other Direct Costs $

Subtotal Labor/Fringe, Labor Overhead & Direct Costs $

General & Administrative Cost *% $

Subtotal: Labor, Direct Costs, Overhead, G&A $

Fee $

Total Firm-Fixed-Price$
*Include and cite % rates for fringe benefits, labor overhead, and G&A as appropriate to your organization.
Also, provide a copy of your organization's most recent Negotiated Indirect Cost Rate Agreement with cognizant Government Agency

PA 1 Summary Business Proposal Budget Template - Attachment #10b

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 - 09/12/2021$2$

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 Business Proposal Budget Template - Attachment #10c

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

Contract Type: Fixed-Price

Breakdown by Month (Base Year)
^Est. Monthly % effort or # of hoursMonthly RateTotal
Labor Costs - (List individuals by name / labor category. Indicate hourly rate or rate equivalent for each.)
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 $

Fringe Benefits *% $

Subtotal Labor & Fringe $

Labor Overhead *% $

Other Direct Costs (List as Necessary)

Materials & Supplies$
Consultants$
Travel: 1 Trip by PI to NIH/BethesdaEst. 1/12 of 1 trip per year or option term$

Subtotal Other Direct Costs $

Subtotal Labor/Fringe, Labor Overhead & Direct Costs $

General & Administrative Cost *% $

Subtotal: Labor, Direct Costs, Overhead, G&A $

Fee $

Fixed Price per Month$
^Estimated Annual % Effort or # Hours is: Principal Investigator/Project Director 10% or 210 hours; Senior Professional Information Technology 5% or 105 hours; Administrative Operation Coordinator 2% or 42 hours
*Include and cite % rates for fringe benefits, labor overhead, and G&A as appropriate to your organization.
Also, provide a copy of your organization's most recent Negotiated Indirect Cost Rate Agreement with cognizant Government Agency

PA 2 Summary

COST SUMMARY FOR PERFORMANCE AREA 2 - PHARMACOLOGY AND TOXICOLOGY STUDIESATTACHMENT #10d
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 (Rat) Pharmacokinetic Study – 5$510$
Single Dose Dog Pharmacokinetic Study – 2$210$
Multi-Dose Rodent (Rat) Pharmacokinetic Study – 2$210$
Rodent (Rat) Dose Range Finding Study – 1$110$
Non-Human Primate Dose Range Finding Study - 1$110$

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 Performance Area 2 - Pharmacology and Toxicology Studies ATTACHMENT #10e

Single Dose Rodent (Rat) Pharmacokinetic Study Budget Template
% effort or # of hoursRate / QuantityTotal
Labor Costs - (List individuals by name / labor category. Indicate hourly rate or rate equivalent for each.)
$
$
$

Subtotal $

Fringe Benefits *% $

Subtotal Labor & Fringe $

Labor Overhead *% $

Other Direct Costs (List and Itemize as Necessary)

Subtotal Other Direct Costs $

Subtotal Labor/Fringe, Labor Overhead & Direct Costs $

General & Administrative Cost *% $

Subtotal: Labor, Direct Costs, Overhead, G&A $

Fee $

Total Estimated Cost Plus Fee$
*Include and cite % rates for fringe benefits, labor overhead, and G&A as appropriate to your organization.
Also, provide a copy of your organization's most recent Negotiated Indirect Cost Rate Agreement with cognizant Government Agency

Single Dose Dog PK Performance Area 2 - Pharmacology and Toxicology Studies ATTACHMENT #10f

Single Dose Dog Pharmacokinetic Study Budget Template
% effort or # of hoursRate / QuantityTotal
Labor Costs - (List individuals by name / labor category. Indicate hourly rate or rate equivalent for each.)
$
$
$

Subtotal $

Fringe Benefits *% $

Subtotal Labor & Fringe $

Labor Overhead *% $

Other Direct Costs (List and Itemize as Necessary)

Subtotal Other Direct Costs $

Subtotal Labor/Fringe, Labor Overhead & Direct Costs $

General & Administrative Cost *% $

Subtotal: Labor, Direct Costs, Overhead, G&A $

Fee $

Total Estimated Cost Plus Fee$
*Include and cite % rates for fringe benefits, labor overhead, and G&A as appropriate to your organization.
Also, provide a copy of your organization's most recent Negotiated Indirect Cost Rate Agreement with cognizant Government Agency

Multi-Dose Rodent (Rat) PK Performance Area 2 - Pharmacology and Toxicology Studies ATTACHMENT #10g

Multi-Dose Rodent (Rat) Pharmacokinetic Study Budget Template
% effort or # of hoursRate / QuantityTotal
Labor Costs - (List individuals by name / labor category. Indicate hourly rate or rate equivalent for each.)
$
$
$

Subtotal $

Fringe Benefits *% $

Subtotal Labor & Fringe $

Labor Overhead *% $

Other Direct Costs (List and Itemize as Necessary)

Subtotal Other Direct Costs $

Subtotal Labor/Fringe, Labor Overhead & Direct Costs $

General & Administrative Cost *% $

Subtotal: Labor, Direct Costs, Overhead, G&A $

Fee $

Total Estimated Cost Plus Fee$
*Include and cite % rates for fringe benefits, labor overhead, and G&A as appropriate to your organization.
Also, provide a copy of your organization's most recent Negotiated Indirect Cost Rate Agreement with cognizant Government Agency

Rodent (Rat) Dose Range Finding Performance Area 2 - Pharmacology and Toxicology Studies ATTACHMENT #10h

Rodent (Rat) Dose Range Finding Study Budget Template
% effort or # of hoursRate / QuantityTotal
Labor Costs - (List individuals by name / labor category. Indicate hourly rate or rate equivalent for each.)
$
$
$

Subtotal $

Fringe Benefits *% $

Subtotal Labor & Fringe $

Labor Overhead *% $

Other Direct Costs (List and Itemize as Necessary)

Subtotal Other Direct Costs $

Subtotal Labor/Fringe, Labor Overhead & Direct Costs $

General & Administrative Cost *% $

Subtotal: Labor, Direct Costs, Overhead, G&A $

Fee $

Total Estimated Cost Plus Fee$
*Include and cite % rates for fringe benefits, labor overhead, and G&A as appropriate to your organization.
Also, provide a copy of your organization's most recent Negotiated Indirect Cost Rate Agreement with cognizant Government Agency

Non-Human Primate Dose Range Performance Area 2 - Pharmacology and Toxicology Studies ATTACHMENT #10i

Non-Human Primate (NHP) Dose Range Finding Study Budget Template
% effort or # of hoursRate / QuantityTotal
Labor Costs - (List individuals by name / labor category. Indicate hourly rate or rate equivalent for each.)
$
$
$

Subtotal $

Fringe Benefits *% $

Subtotal Labor & Fringe $

Labor Overhead *% $

Other Direct Costs (List and Itemize as Necessary)

Subtotal Other Direct Costs $

Subtotal Labor/Fringe, Labor Overhead & Direct Costs $

General & Administrative Cost *% $

Subtotal: Labor, Direct Costs, Overhead, G&A $

Fee $

Total Estimated Cost Plus Fee$
*Include and cite % rates for fringe benefits, labor overhead, and G&A as appropriate to your organization.
Also, provide a copy of your organization's most recent Negotiated Indirect Cost Rate Agreement with cognizant Government Agency

IND Toxicology Package Performance Area 2 - Pharmacology and Toxicology Studies ATTACHMENT #10j

Investigational New Drug (IND) Toxicology Package Budget Template
% effort or # of hoursRate / QuantityTotal
Labor Costs - (List individuals by name / labor category. Indicate hourly rate or rate equivalent for each.)
$
$
$

Subtotal $

Fringe Benefits *% $

Subtotal Labor & Fringe $

Labor Overhead *% $

Other Direct Costs (List and Itemize as Necessary)

Subtotal Other Direct Costs $

Subtotal Labor/Fringe, Labor Overhead & Direct Costs $

General & Administrative Cost *% $

Subtotal: Labor, Direct Costs, Overhead, G&A $

Fee $

Total Estimated Cost Plus Fee$
*Include and cite % rates for fringe benefits, labor overhead, and G&A as appropriate to your organization.
Also, provide a copy of your organization's most recent Negotiated Indirect Cost Rate Agreement with cognizant Government Agency

In-Vitro ADMET Panel Performance Area 2 - Pharmacology and Toxicology Studies ATTACHMENT #10k

In-Vitro ADMET Panel Budget Template
% effort or # of hoursRate / QuantityTotal
Labor Costs - (List individuals by name / labor category. Indicate hourly rate or rate equivalent for each.)
$
$
$

Subtotal $

Fringe Benefits *% $

Subtotal Labor & Fringe $

Labor Overhead *% $

Other Direct Costs (List and Itemize as Necessary)

Subtotal Other Direct Costs $

Subtotal Labor/Fringe, Labor Overhead & Direct Costs $

General & Administrative Cost *% $

Subtotal: Labor, Direct Costs, Overhead, G&A $

Fee $

Total Estimated Cost Plus Fee$
*Include and cite % rates for fringe benefits, labor overhead, and G&A as appropriate to your organization.
Also, provide a copy of your organization's most recent Negotiated Indirect Cost Rate Agreement with cognizant Government Agency

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