Sol_Doc_FDA-22-RFP-1249967_Attachment 4 - Pricing Sheet.xlsx

XLSX spreadsheet 27 KB Posted Jul 12, 2022

Attached to: Clinical Study and Laboratory Support Services for FDA Office of Clinical Pharmacology (OCP).
Solicitation number: FDA-22-SOL-1249967
Issued by: Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services

View the file

Other files

File	Type	Posted
Sol_Doc_FDA-22-RFP-1249967_Questions 7-29-22.pdf	PDF	Aug 1, 2022
Sol_Doc_FDA-22-RFP-1249967_Questions.pdf	PDF	Jul 28, 2022
Sol_Doc_FDA-22-RFP-1249967_Attachment 1 - Questions Template.docx	DOCX document	Jul 12, 2022
Sol_Doc_FDA-22-RFP-1249967 Final.pdf	PDF	Jul 12, 2022
Sol_Doc_FDA-22-RFP-1249967_Attachment 5 - Sample Studies_.xlsx	XLSX spreadsheet	Jul 12, 2022
Sol_Doc_FDA-22-RFP-1249967_Attachment 3 - Contractors Commitment to Protect Non-Public Information (NPI) Agreement.docx	DOCX document	Jul 12, 2022
Sol_Doc_FDA-22-RFP-1249967_Attachment 6 - Past Performance Questionnaire.doc	DOC document	Jul 12, 2022
Sol_Doc_FDA-22-RFP-1249967_Attachment 2 - FAR Class Deviation 2018-01.pdf	PDF	Jul 12, 2022

On GovTribe

Work with this file

Download the original file
Contacts named in this file
Similar government files
Ask GovTribe AI about this file

Try for free Login

Text version

The file's text, extracted by GovTribe without its formatting.

FDA - Attachment 1 CDER-OTS-22-C-2730 Office of Clinical Pharmacology - Multiphase Clinical Studies and Laboratory Support IDIQ

Procedure & Labor Rates
ATTACHMENT 1
Estimated Overall Price Categories - menu items are all inclusive (labor, materials, etc.)
Item	Unit	Year 1 ($)	Year 2 ($)	Year 3 ($)	Year 4 ($)	Year 5 ($)
PERFORMANCE AREA A							Description
Administrative and Per Study Price ($)
Administrative Overhead (including set-up, standard project management/meetings)	hourly
Clerical fees	hourly		$ - 0	$ - 0	$ - 0	$ - 0
Study document preparation (protocol/informed consent form/case report form)	document		$ - 0	$ - 0	$ - 0	$ - 0
Institutional Review Board (IRB) fees and other fees (e.g. verified clinical trials)	IRB		$ - 0	$ - 0	$ - 0	$ - 0
Study data transfer	transfer		$ - 0	$ - 0	$ - 0	$ - 0
Report preparation	hourly		$ - 0	$ - 0	$ - 0	$ - 0
Per Subject Price ($)
Overhead (overhead can be a percentage of per subject price)
Recruitment/Screening - healthy			$ - 0	$ - 0	$ - 0	$ - 0
Recruitment/Screening - patient			$ - 0	$ - 0	$ - 0	$ - 0
Informed consent process			$ - 0	$ - 0	$ - 0	$ - 0
Medical history - healthy			$ - 0	$ - 0	$ - 0	$ - 0
Medical history - patient			$ - 0	$ - 0	$ - 0	$ - 0
Prior/concomitant meds assessment			$ - 0	$ - 0	$ - 0	$ - 0
Comprehensive physical exam	exam		$ - 0	$ - 0	$ - 0	$ - 0
Targeted physical exam	exam		$ - 0	$ - 0	$ - 0	$ - 0
Vital signs	exam		$ - 0	$ - 0	$ - 0	$ - 0
Electrocardiogram - triplicate	test		$ - 0	$ - 0	$ - 0	$ - 0
Electrocardiogram - single	test		$ - 0	$ - 0	$ - 0	$ - 0
Telemetry Medical Monitoring/Day	day		$ - 0	$ - 0	$ - 0	$ - 0
Chemistry/hematology	test		$ - 0	$ - 0	$ - 0	$ - 0
Urinalysis	test		$ - 0	$ - 0	$ - 0	$ - 0
Coagulation tests	test		$ - 0	$ - 0	$ - 0	$ - 0
Urine drug screen + alchohol screen	screen		$ - 0	$ - 0	$ - 0	$ - 0
Pregnancy test	test		$ - 0	$ - 0	$ - 0	$ - 0
Human immunodeficiency virus test	test		$ - 0	$ - 0	$ - 0	$ - 0
Hepatitis test (hepatitis B surface antigen, hepatitis C virus)	test		$ - 0	$ - 0	$ - 0	$ - 0
SARS-CoV-2 PCR test	test		$ - 0	$ - 0	$ - 0	$ - 0
SARS-CovV-2 serology test (IgG/IgM antibody test)	test		$ - 0	$ - 0	$ - 0	$ - 0
In-house day/overnight stay - healthy	lab		$ - 0	$ - 0	$ - 0	$ - 0
In-house day/overnight stay - patient	lab		$ - 0	$ - 0	$ - 0	$ - 0
Meals (1 day)	subject		$ - 0	$ - 0	$ - 0	$ - 0
Outpatient visit	subject		$ - 0	$ - 0	$ - 0	$ - 0
Study agent preparation & application - oral	subject		$ - 0	$ - 0	$ - 0	$ - 0
Study agent preparation & application - Injection	subject		$ - 0	$ - 0	$ - 0	$ - 0
Study agent preparation & application - IV	subject		$ - 0	$ - 0	$ - 0	$ - 0
Study agent preparation & application - topical	subject		$ - 0	$ - 0	$ - 0	$ - 0
Study agent preparation & application - intranasal	subject		$ - 0	$ - 0	$ - 0	$ - 0
Urine pharmacokinetic collection	subject		$ - 0	$ - 0	$ - 0	$ - 0
Cheek swab (e.g. genomic sample)	subject		$ - 0	$ - 0	$ - 0	$ - 0
Pharmacokinetic blood draw	subject		$ - 0	$ - 0	$ - 0	$ - 0
Pharmacodynamic blood draw	subject		$ - 0	$ - 0	$ - 0	$ - 0
Adverse event assessment			$ - 0	$ - 0	$ - 0	$ - 0
Questionnaire administration			$ - 0	$ - 0	$ - 0	$ - 0
EXAMPLE PASS THROUGH PRICES (DEPENDENT ON STUDY DETAILS, INCLUDE IN SAMPLE STUDY PRICING SHEET) ($)
Advertising fees			$ - 0	$ - 0	$ - 0	$ - 0
Sample shipment with dry ice			$ - 0	$ - 0	$ - 0	$ - 0
Sample shipment with dry ice (facility-to-facility)			$ - 0	$ - 0	$ - 0	$ - 0
Stipend per visit - Screening			$ - 0	$ - 0	$ - 0	$ - 0
Stipend per visit - Baseline			$ - 0	$ - 0	$ - 0	$ - 0
Alternate Stipend			$ - 0	$ - 0	$ - 0	$ - 0
Stipend per visit randomized			$ - 0	$ - 0	$ - 0	$ - 0
Lab Fees			$ - 0	$ - 0	$ - 0	$ - 0
Drug Fees			$ - 0	$ - 0	$ - 0	$ - 0
Travel (per subject)			$ - 0	$ - 0	$ - 0	$ - 0
PERFORMANCE AREA B
Administrative ($)
Data transfer			$ - 0	$ - 0	$ - 0	$ - 0
Report preparation			$ - 0	$ - 0	$ - 0	$ - 0
Analysis Price ($)
Bioanalytical assay method development & validation - small molecule			$ - 0	$ - 0	$ - 0	$ - 0
Bioanalytical assay method development & validation - large molecule			$ - 0	$ - 0	$ - 0	$ - 0
Bioanalytical per sample - small molecule			$ - 0	$ - 0	$ - 0	$ - 0
Bioanalytical per sample - large molecule			$ - 0	$ - 0	$ - 0	$ - 0
Bioanalytical per sample - small molecule - incurred sample reanalysis			$ - 0	$ - 0	$ - 0	$ - 0
Bioanalytical per sample - large molecule - incurred sample reanalysis			$ - 0	$ - 0	$ - 0	$ - 0
Flow cytometry assay validation (for either stored or same-day analysis)			$ - 0	$ - 0	$ - 0	$ - 0
Flow cytometry per sample analysis			$ - 0	$ - 0	$ - 0	$ - 0

Anticipated Labor Categories Year 1 ($/hr) Year 2 ($/hr) Year 3 ($/hr) Year 4 ($/hr) Year 5 ($/hr)

PERFORMANCE AREA A AND B
Labor Rates ($/hr) - only items not on above menu can be billed as labor hours (Time & Materials)					Description
Principal Investigator	$ - 0	$ - 0	$ - 0	$ - 0	Supervises clinical research trials by effectively managing investigational sites, developing study protocols, preparing CRFs and IRB submissions, and ensuring compliance with study protocols, FDA regulations, IRB requirements and clinical strategy. Supervises research team, providing direction and guidance to clinical research associate.
Investigator	$ - 0	$ - 0	$ - 0	$ - 0	Assist in the design, planning and execution of clinical research trials by effectively managing investigational sites, assisting with development of study protocols, preparing CRFs and IRB submissions, and ensuring compliance with study protocols, FDA regulations, IRB requirements and company clinical strategy. Control drugs under investigation.
Pharmacist	$ - 0	$ - 0	$ - 0	$ - 0	Compounds and dispenses prescribed drugs.
Clinical Technician	$ - 0	$ - 0	$ - 0	$ - 0	Performs research activities and other tasks. Has knowledge of commonly-used concepts, practices, and procedures within a particular field. Relies on instructions and pre-established guidelines to perform the functions of the job. Works under immediate supervision.
Lab Technician	$ - 0	$ - 0	$ - 0	$ - 0	Performs research activities and other tasks. Has knowledge of commonly-used concepts, practices, and procedures within a particular field. Relies on instructions and pre-established guidelines to perform the functions of the job
Project Manager	$ - 0	$ - 0	$ - 0	$ - 0	Leads and performs program area work. Proposes and implements creative methods to complete work effectively and efficiently. Meets with client regularly, if not daily, to ensure work meets/exceeds client objectives.
Statistician	$ - 0	$ - 0	$ - 0	$ - 0	Identifies methodologies and measures for assessment and summarization of findings. Selects appropriate statistical and epidemiologic techniques and databases. Assists in developing and managing databases for analysis. Ensure reliability and consistency of the data. Provide technical assistance on the use of complex statistical and epidemologic techniques. Serves as technical expert in all phases of statistical interpretation. Disseminate results of research projects in a wide
Technical Writer	$ - 0	$ - 0	$ - 0	$ - 0	Writes a variety of technical articles, reports, brochures, and/or manuals for documentation for a wide range of uses. May be responsible for coordinating the display of graphics and the production of the document.
Data Manager	$ - 0	$ - 0	$ - 0	$ - 0	Assist with the design and produce tools and materials to support data collections and surveys, including survey instruments and data entry tools. Develop, clean, and maintain databases.
Analyst	$ - 0	$ - 0	$ - 0	$ - 0	Participates in research and development activities.

File details come from the government source that posted it. Updated Jul 12, 2022.