Sol_Doc - RFP_Attachment_1 Studies to Price.xlsx

XLSX spreadsheet 38 KB Posted Jul 18, 2024

Attached to: Food and Drug Administration (FDA) Office of Clinical Pharmacology (OCP) – Multi-phase/Multi- site Clinical Studies and Laboratory Support Indefinite Delivery-Indefinite Quantity (IDIQ) Type Contract
Solicitation number: 75F40124R00064
Issued by: Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services

About this file

Written by GovTribe AI · Jul 18, 2024

This document is a Request for Proposal (RFP) for an Indefinite Delivery Indefinite Quantity (IDIQ) contract for multi-phase/multi-site clinical studies and laboratory support services for the Food and Drug Administration (FDA) Office of Clinical Pharmacology. The contract is set aside for 100% small business, under NAICS codes 541714 and 541715 with a 1,000-employee size standard. The IDIQ has a $2,500 minimum guarantee and a $50,000,000 maximum ceiling over a 5-year ordering period.

The contractor must have in-house capabilities to conduct multiple Phase I clinical trials per year, provide a full range of clinical trial services, and comply with FDA/ICH regulations. The contractor must also provide bioanalytical, biomarker, and omics laboratory support services. Proposals must include a completed pricing worksheet template, and the contract will be awarded on a Firm-Fixed-Price basis for individual task orders.

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File	Type	Posted
Sol_Doc - Amend 0001 - RFP_Attachment_2 Wage Det_No. 2015_4269_Rev 26_dated 07_22_24.pdf	PDF	Aug 15, 2024
Sol_Doc - Amend 0001 - RFP - BODY (Pages 3-145) - CDER IDIQ - 75F4012R00064.pdf	PDF	Aug 15, 2024
Sol_Doc - Amend 0001 - RFP_Attachment_4 RFP QUESTIONS_RESPONSES.xlsx	XLSX spreadsheet	Aug 15, 2024
Sol_Doc - Amend 0001 - RFP - BODY - (Pages 1-2) - CDER IDIQ - 75F40124R00064.pdf	PDF	Aug 15, 2024
Sol_Doc - RFP - BODY (Pages 3-145) - CDER IDIQ - 75F4012R00064 - FINAL.pdf	PDF	Jul 18, 2024
Sol_Doc - RFP SF1449 (Pages 1-2) - CDER IDIQ - 75F40124R00064 - FINAL.pdf	PDF	Jul 18, 2024
Sol_Doc - RFP_Attachment_2 Wage Determination_No. 2015_4269_Rev1_dated 12_27_2022.pdf	PDF	Jul 18, 2024
Sol_Doc - RFP_Appendix_A_PIV Card Forms of Identification Table.docx	DOCX document	Jul 18, 2024
Sol_Doc - RFP_Attachment_3 - Past Performance Questionnaire (PPQ).docx	DOCX document	Jul 18, 2024

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Typical Sample Study 1 Provide cost for a study with 24 healthy subjects undergoing the following drug metabolism/food effect study. Include cost for pharmacokinetic (PK) sample collection for multiple small molecules and bioanalytical costs including method development and validation for 3 drugs.

Screening

Check-in / Baseline

Washout

Treatment Period 1

Wash-out

Treatment Period 2

Wash-out

Treatment Period 3

Wash-out

Treatment Period 4

Study Day

-21 to -3

-2

-1

Hour

0.5

1.5

4.5

8.5

13.5

0.5

1.5

4.5

8.5

13.5

0.5

1.5

4.5

8.5

13.5

0.5

1.5

Visit

Recruitment/Screening - healthy

Screening Stipend

In House Residency

Meals

Informed Consent

Medical History

Comprehensive Physical exam

Vital Signs

Height, weight

12-Lead ECG 1

Clinical Chemistry and Hematology 1

Urinalysis

HIV Test

Hepatitis Test

Urine Drug and Alcohol Screen

Pregnancy Test (females only) 2

FSH

Study agent preparation & application - oral

PK Sample (plasma)

Urine Sample Collection

Concomitant Medications

Adverse Events

eSource Management

1 clinically notable results are repeated

2 serum test

Performance Area A: Task 2
Protocol No: Clinical Pharmacology Study 1
Population: Healthy Volunteers	# of Subjects:	24

	Unit
	Charge	Frequency		Multiplier	Total per Subject
Recruiting & Screening
Informed Consent		1	x	1	0.00
Complete History		1	x	1	0.00
Prior/Concomitant Meds Assessment		1	x	1	0.00
Adverse Event Assessment		1	x	1	0.00
Physical Exam		1	x	1	0.00
ECG - 12 Lead		1	x	1	0.00
Chemistry and Hematology		1	x	1	0.00
Urinalysis		1	x	1	0.00
Cotinine		1	x	1	0.00
Pregnancy Test		1	x	0.5	0.00
FSH		1	x	0.25	0.00
Drug & Alcohol Screen		1	x	1	0.00
Vital Signs		1	x	1	0.00
Height, Weight & BMI		1	x	1	0.00
Hepatitis B & C		1	x	1	0.00
HIV		1	x	1	0.00
Advertising/Recruitment Fee		1	x	1	0.00
Screening Stipend		1	x	1	0.00
Sub-Total					0.00
Confinement 9 total nights
Physical Exam		2	x	1	0.00
Height, Weight & BMI		2	x	1	0.00
Medical History		1	x	1	0.00
Drug & Alcohol Screen		2	x	1	0.00
Prior/Concomitant Meds Assessment		2	x	1	0.00
Adverse Event Assessment		6	x	1	0.00
Pregnancy Test		2	x	0.5	0.00
Vital Signs		2	x	1	0.00
COVID-19 antigen test		1	x	1	0.00
ECG - single		2	x	1	0.00
Clinic Bed		9	x	1	0.00
Meals		9	x	1	0.00
PK Draws		48	x	1	0.00
Urine collection		24	x	1	0.00
Study Agent Preparation and Administration - Oral Dose		4	x	1	0.00
Chemistry and Hematology		2	x	1	0.00
Urinalysis		2	x	1	0.00
Electronic Source Management		1	x	1	0.00
Sub-Total					0.00
Other Subject Charges
Volunteer Stipend & Travel Reimbursement
Sub-Total					0.00
Cost Per Completed Subject					0.00
Total Cost for Completed Subjects					0.00
Screening Failures (2:1 ratio)	0.00	24	x	2.00	0.00
Total Cost (task 2 subtotal)					0.00

Performance Area A: Task 1 & 2
Other Study Charges
	Unit Charge	Units/Hours		Months/ Occurrences	Total Cost
Data Manager			x		0.00
Project Manager			x		0.00
Alternate Stipends and Check-in Procedures (# of subjects x # of cohorts)		25	x	1	0.00
Clerical		1	x	1	0.00
Pharmacy Manual		1	x	1	0.00
Dry Ice and Shipment Costs		1	x	10	0.00
Purchase of Primary Drug & Packaging Supplies for the Whole Study		1	x	1	0.00
Verified Clinical Trials (Subject Registry System)		1	x	1	0.00
Investigator			x		0.00
Pharmacist			x		0.00
Clinical Technician			x		0.00
Lab Technician			x		0.00
Analyst			x		0.00
Study Data Transfers		2	x	1	0.00
Report preparation		1	x	1	0.00
Total Other Study Charges					0.00

Performance Area B: Task 3
Bioanalytical Costs
Item	Number	Cost Per Item	Total
Method Development/Validation with Single Analyte	3		0
Sample analysis for single analyte	1728		0
Incurred Sample Reanalysis (~10%)	180		0
Bioanalytical report with single analyte	3		0
Interim Data Transfer with QC	1		0
Materials Costs	1		0
Shipping Samples to FDA	1		0
		Total	0	0

Total Study Cost 0.00

Typical Sample Study 2

Provide cost for a study with 32 healthy subjects undergoing the following drug interaction study. Include cost for pharmacokinetic (PK) sample collection for a small molecule drug and bioanalytical costs including method development and validation for 5 drugs and 2 metabolites.

Screening

Check-In and Baseline

Treatment Period

Check-out

Units

Cost

Total per subject

Study Day

-28 to -2

-1

Hour

Visit

Recruitment/Screening

Screening Stipend

In House Residency

Meals

Informed Consent

Medical History

Comprehensive Physical Exam

Vital signs (including pulse oximetry)

Height/Weight

ECG - single1

Telemetry

Chemistry/hematology1

Urinalysis

Urine drug screen + alcohol screen

Pregnancy test2

FSH (females only)

HIV test

Hepatitis test

Covid-19 Antigen Test

Study Agent preparation & administration - oral

Plasma PK draw

(See protocol for time points)

Buffy Coat Collection3

Con Med/AE Assessment

eSource Management

Dosing Day

Washout Days

Dosing Day

Washout Days

Dosing Day

Washout Days

Dosing Day

Washout Days

Dosing Day

1 Clinically notable results are repeated

Cost per subject

$0.00

2 Serum test

3 Buffy coat samples are processed as part of a PK sample and is not a separate sample

Performance Area A: Task 2
Protocol No: Clinical Pharmacology Study 2
Population: Healthy Volunteers	# of Subjects:	32

	Unit
	Charge	Frequency		Multiplier	Total per Subject
Recruiting & Screening
Informed Consent		1	x	1	0.00
Complete History		1	x	1	0.00
Prior/Concomitant Meds Assessment		1	x	1	0.00
Adverse Event Assessment		1	x	1	0.00
Physical Exam		1	x	1	0.00
ECG - 12 Lead		1	x	1	0.00
Chemistry and Hematology		1	x	1	0.00
Urinalysis		1	x	1	0.00
Cotinine		1	x	1	0.00
Pregnancy Test		1	x	0.5	0.00
FSH		1	x	0.25	0.00
Drug & Alcohol Screen		1	x	1	0.00
Vital Signs (including pulse oximetry)		1	x	1	0.00
Height, Weight & BMI		1	x	1	0.00
Hepatitis B & C		1	x	1	0.00
HIV		1	x	1	0.00
Advertising/Recruitment Fee		1	x	1	0.00
Screening Stipend		1	x	1	0.00
Sub-Total					0.00
Confinement 18 total nights
Physical Exam		2	x	1	0.00
Height, Weight & BMI		2	x	1	0.00
Targeted Physical Exam		2	x	1	0.00
Medical History		1	x	1	0.00
Drug & Alcohol Screen		2	x	1	0.00
Prior/Concomitant Meds Assessment		18	x	1	0.00
Adverse Event Assessment		18	x	1	0.00
Pregnancy Test		2	x	0.5	0.00
Vital Signs		19	x	1	0.00
COVID-19 antigen test		1	x	1	0.00
ECG - triplicate		5	x	1	0.00
ECG - single		7	x	1	0.00
Clinic Bed		18	x	1	0.00
Meals		18	x	1	0.00
PK Draws		70	x	1	0.00
Buffy coat		1	x	1	0.00
Study Agent Preparation and Administration - Oral Dose		5	x	1	0.00
Chemistry and Hematology		2	x	1	0.00
Urinalysis		2	x	1	0.00
Electronic Source Management		1	x	1	0.00
Sub-Total					0.00
Other Subject Charges
Volunteer Stipend & Travel Reimbursement
Sub-Total					0.00
Cost Per Completed Subject					0.00
Total Cost for Completed Subjects					0.00
Screening Failures (2:1 ratio)	0.00	32	x	2.00	0.00
Total Cost (task 2 subtotal)					0.00

Performance Area A: Task 1 & 2
Other Study Charges
	Unit Charge	Units/Hours		Months/ Occurrences	Total Cost
Data Manager (2 FTE for 3 months)			x		0.00
Project Manager (1 FTE for 3 months)			x		0.00
Alternate Stipends and Check-in Procedures (# of subjects x # of cohorts)		40	x	1	0.00
Clerical		1	x	1	0.00
Pharmacy Manual		1	x	1	0.00
Dry Ice and Shipment Costs		1	x	10	0.00
Purchase of Primary Drug & Packaging Supplies for the Whole Study		1	x	1	0.00
Verified Clinical Trials (Subject Registry System)		1	x	1	0.00
Investigator (.5 FTE per week for 3 months)			x		0.00
Pharmacist (.25 FTE per week for 3 months)			x		0.00
Clinical Technician (2 FTEs per week for 3 months)			x		0.00
Lab Technician (2 FTEs per week for 3 months)			x		0.00
Analyst (.5 FTE for 3 months)			x		0.00
Study Data Transfers		2	x	1	0.00
Report preparation		1	x	1	0.00
Total Other Study Charges					0.00

Performance Area B: Task 3
Bioanalytical Costs
Item	Number	Cost Per Item		Total
Method Development/Validation small molecule	7			0
Sample analysis for single analyte	2200			0
Sample analysis for additional analytes added on	880			0
Incurred Sample Reanalysis (~10%)	220			0
Incurred Sample Reanalysis additional analytes (~10%)	88			0
Bioanalytical report preparation	7			0
Interim Data Transfer with QC	1			0
Materials Costs	1			0
Shipping Samples to FDA	1			0
			Total	0

Total Study Cost 0.00

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