MOD 2 FDA SCIENTIFIC SUPPORT IDIQ RFP 9 5 2023.docx 10 12 2023.pdf 2 55 pm.pdf
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- Solicitation number
- 75F40123R00132
About this file
This is a request for proposal for an indefinite delivery/indefinite quantity scientific support services contract issued by the Food and Drug Administration. The contractor shall provide a wide range of scientific professional services including research and technical guidance, scientific consultation regarding IT systems, investigations and data analysis, publishing assistance, laboratory support, and task and program management. Services will be ordered through subsequent task orders which can be firm-fixed price or labor hour, for periods up to five years. The small business set-aside contract has a maximum value of $99.9 million over four base years and includes fully burdened hourly rates for over 100 labor categories. Offerors must register in SAM.gov and proposals are due within 10 business days of task order requests.
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Text version
FDA: SCIENTIFIC SUPPORT SERVICES IN THE HEALTH SECTOR IDIQ
REQUEST FOR PROPOSAL
Solicitation 75F40123R00132
TABLE OF CONTENTS:
1. SOLICITATION INFORMATION
1.1 NOTICE OF COMBINED SYNPOSIS/SOLICITATION
1.2 NOTICE OF FAC
1.3 NOTICE OF NAICS/SET ASIDE
2. PRICING AND ORDERING SERVICES
2.1 OVERVIEW OF PRICING SCHEDULE
2.2 PRICING TERMS
2.3 CONTRACT TYPE
2.4 MINIMUM AND MAXIMUM CONTRACT VALUE
2.5 ORDERING
2.6 TASK ORDER PROCESSING
3. DESCRIPTION OF REQUIREMENTS/STATEMENT OF WORK
3.1 BACKGROUND
3.2 OBJECTIVE
3.3 SCOPE OF WORK
4. TASK AREAS
4.1 RESEARCH AND TECHNICAL GUIDANCE
4.2 SCIENTIFIC CONSULTATION (IT AND INFORMATION MANAGEMENT SYSTEMS)
4.3 SCIENTIFIC INVESTIGATIONS, PROCEDURES AND ANALYSIS
4.4 PUBLISHING
4.5 LABORATORY TECHNICAL AND ADMINISTRATIVE SUPPORT…
4.6 TASK MANAGEMENT
4.7 TRANSITION SERVICES
5. DELIVERABLES
5.1 CRITERIA FOR ACCEPTANCE OF DELIVERABLES
6. PERSONNEL
6.1 TRAINING
6.2 PERSONNEL REPLACEMENTS
6.3 KEY PERSONNEL
6.4 NON-PERSONAL SERVICES AND INHERANT GOVERNMENT FUNCTIONS
7. PERIOD OF PERFORMANCE
8. PLACE OF PERFORMANCE
9. TRAVEL
10. OTHER DIRECT COSTS
11. GOVERNMENT FURNISHED EQUIPMENT/MATERIALS/INFORMATION
12. 508 STANDARD REQUIREMENTS
13. CONTRACTOR CONFORMANCE WITH APPLICABLE LAWS, REGULATIONS, POLICIES AND
STANDARDS
14. POST-AWARD EVALUATION OF CONTRACTOR PERFORMANCE
15. GOVERNMENT POINTS OF CONTACT, AUTHORITY, DIRECTION
15.1 CONTRACT SPECIALIST
15.2 CONTRACTING OFFICER
15.3 IDIQ CONTRACTING OFFICER’S REPRESENTATIVE
15.4 TASK ORDER CONTRACTING OFFICER’S REPRESENTATIVE
15.5 TECHNICAL DIRECTION
16. PAYMENT AND INVOICING PROCEDURE
17. PROVISION AND CLAUSES
17.1 FEDERAL ACQUISTION REGULATION (FAR) PROVISIONS INCORPORATED BY
REFERENCE
17.2 FEDERAL ACQUISITION REGULATION (FAR) PROVISIONS INCORPORATED BY
FULL TEXT
17.3 FEDERAL ACQUISITION REGULATION (FAR) CLAUSES INCORPORATED BY REFERENCE…72
17.4 FEDERAL ACQUISITION REGULATION (FAR) CLAUSES INCORPORATED BY FULL TEXT
17.5 HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) PROVISIONS
INCORPRATED BY REFERENCE
17.6 HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) CLAUSES
INCORPORATED BY REFERENCE
17.7 HEALTH AND HUMAN SERVICES ACQUISTION REGULATION (HHSAR) CLAUSES
INCORPORATED IN FULL TEXT
17.8 HEALTH AND HUMAN SERVICES (HHS) FEDERAL ACQUISTION REGULATION (FAR) CLASS
DEVIATIONS
18. SECURITY LANGUAGE
19. PRIVACY LANGUAGE
20. OCCUPATIONAL SAFETY AND HEALTH TERMS AND CONDITIONS
21. CONTRACTOR PERSONNEL SECURITY CLEARANCE STANDARDS AND RESIDENCY
REQUIREMENTS
(OCTOBER
2017)…………………………………………………………………………………………………………………………………..113
22. INSTRUCTIONS TO OFFERORS
LIST OF ATTACHMENTS
1. SOLICITATION INFORMATION
1.1 Notice of Combined Synopsis/Solicitation
This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with the format in FAR 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation;
proposals are being requested and a written solicitation will not be issued. This is a request for proposal (RFP) for commercial items IAW the procedures of FAR part 12 – Acquisition of Commercial Items, in conjunction with FAR part 15 – Contracting by Negotiations.
1.2 Notice of FAC
This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2023-04, effective June 2, 2023.
1.3 Notice of NAICS/Set Aside
This requirement is being solicited as a competitive 8(a) small business set-aside. The associated North American Classification System (NAICS) code is 541990, All Other Professional, Scientific and Technical Services, 19.5 million dollars size standard. Offerors must have an active registration in SAM.gov (www.sam.gov) with completed representations and certifications by the close date of the solicitation. Proposals submitted by offerors without an active registration in SAM.gov will not be considered.
2. PRICING AND ORDERING SERVICES
2.1 Overview of Pricing Schedule
The Contractor’s price schedule s for labor categories shall contain fully burden hourly rates.
The fully burden hourly rates for each labor category shall include wages, indirect costs, fringe benefits, overhead, general and administrative, and profit. Hourly rates shall apply to services at both Government and non-Government sites.
By mutual agreement of the parties, additional labor categories may be added to this IDIQ contract to support the tasks of this contract.
Definition: Visa Assistance: Contractor assistance with work visas, etc.
http://www.sam.gov/
ORDERING PERIOD 1: PERIOD OF PERFORMANCE: 12 MONTHS
LABOR CATEGORY Non-Visa Assistance
Labor Hour Rate Visa Assistance Labor Hour Rate
Analyst I
Analyst II
Analyst III
Analyst IV
Analyst V
Application Developer/Programmer -I (a)
Application Developer/Programmer – II (a)
III (Application Engineer III)
IV (Application Engineer IV)
V (Application Engineer V)
Biomedical Informatics Specialist I
Biomedical Informatics Specialist II
Biomedical Informatics Specialist III
Biomedical Informatics Specialist IV
Biomedical Informatics Specialist V
Bioinformatician I
Bioinformatician II
Bioinformatician III
Bioinformatician IV
Bioinformatician V
Bioinformatics Analyst I
Bioinformatics Analyst II
Bioinformatics Analyst III
Bioinformatics Analyst IV
Bioinformatics Analyst V
Business Process Analyst I
Business Process Analyst II
Business Process Analyst III
Business Process Analyst IV
Business Process Analyst V
Clinical Information/Data Analyst - Senior
Clinical Trials Coordinator I
Clinical Trials Coordinator II
Clinical Trials Coordinator III
Clinical Trials Coordinator IV
Clinical Trials Coordinator V
Data Analyst I
Data Analyst II
Data Analyst III
Data Analyst IV
Data Analyst V
Data Architect I
Data Architect II
Data Architect III
Data Architect IV
Data Architect V
Data Entry Specialist I (a)
Data Entry Specialist II (a)
Data Entry Specialist III (a)
Data Entry Specialist IV (a)
Data Entry Specialist V (a)
Data Manager I
Data Manager II
Data Manager III
Data Manager IV
Data Manager V
Data Scientist I
Data Scientist II
Data Scientist III
Data Scientist IV
Data Scientist V
Data Administrator I
Data Administrator II
Data Administrator III
Data Administrator IV
Data Administrator V
Engineer, General (Chemical, Mechanical, Electrical, Environmental, Biosystems, Food) I
Engineer, General (Chemical, Biosystems, Food) II
Biosystems, Food) III
Biosystems, Food) IV
Biosystems, Food) V
Evaluation Specialist I
Evaluation Specialist II
Evaluation Specialist III
Evaluation Specialist IV
Evaluation Specialist V
Functional Expert Consultant I
Functional Expert Consultant II
Functional Expert Consultant III
Functional Expert Consultant IV
Functional Expert Consultant V
Health IT Computational Biologist I
Health IT Computational Biologist II
Health IT Computational Biologist III
Health IT Computational Biologist IV
Health IT Computational Biologist V
High Performance Health IT Computing Specialist I
Computing Specialist II
Computing Specialist III
Computing Specialist IV
Computing Specialist V
Informatics I
Informatics II
Informatics III
Informatics IV
Informatics V
IT Engineer I
IT Engineer II
IT Engineer III
IT Engineer IV
IT Engineer V
Instructional Systems Designer I
Instructional Systems Designer II
Instructional Systems Designer III
Instructional Systems Designer IV
Instructional Systems Designer V
Investigator I
Investigator II
Investigator III
Investigator IV – Principal Investigator I
Investigator IV – Principal II Investigator
Lab Technician I (a)
Lab Technician II (a)
Lab Technician III (a)
Lab Technician IV (a)
Lab Technician V (a)
Lab Technical Support I (a)
Lab Technical Support II (a)
Lab Technical Support III (a)
Lab Technical Support IV (a)
Lab Technical Support V (a)
Microbiologist I
Microbiologist II
Microbiologist III
Microbiologist IV
Microbiologist V
Pharmacist I
Pharmacist II
Pharmacist III
Pharmacist IV
Pharmacist V
Pharmacy Technician I (a)
Pharmacy Technician II (a)
Pharmacy Technician III (a)
Pharmacy Technician IV (a)
Pharmacy Technician V (a)
Principle I
Principle II
Programmer I (a)
Programmer II (a)
Programmer III (a)
Programmer IV (a)
Programmer V (a)
Program Manager I
Program Manager II
Program Manager III
Program Manager IV
Program Manager V
Project Coordinator I
Project Coordinator II
Project Coordinator III
Project Coordinator IV
Project Coordinator V
Project Manager I
Project Manager II
Project Manager III
Project Manager IV
Project Manager V
Protocol Data Analyst I
Protocol Data Analyst II
Protocol Data Analyst III
Protocol Data Analyst IV
Protocol Data Analyst V
Lead Quality Assurance Specialist
Quality Assurance Specialist I
Quality Assurance Specialist II
Quality Assurance Specialist III
Quality Assurance Specialist IV
Quality Assurance Specialist V
Researcher I
Researcher II
Researcher III
Researcher IV
Researcher V
Research Analyst I
Research Analyst II
Research Analyst III
Research Analyst IV
Research Analyst V
Research Assistant I
Research Assistant II
Research Assistant III
Research Assistant IV
Research Assistant V
Scientist I
Scientist II
Scientist III
Scientist IV
Senior Scientist - PhD
Subject Matter Expert I
Subject Matter Expert II
Subject Matter Expert III
Subject Matter Expert IV
Subject Matter Expert V
Statistician I
Statistician II
Statistician III
Statistician IV
Statistician V
Scientific Administration Support I
Scientific Administration Support II
Scientific Administration Support III
Scientific Administration Support IV
Scientific Administration Support V
Scientific Data Analyst I
Scientific Data Analyst II
Scientific Data Analyst III
Scientific Data Analyst IV
Scientific Data Analyst V
Specialist Regulatory Documentation I
Specialist Regulatory Documentation
II
III
IV
V
Technical Writer I (a)
Technical Writer II (a)
Technical Writer III (a)
Technical Writer IV (a)
Technical Writer V (a)
Training Specialist I (a)
Training Specialist II (a)
Training Specialist III (a)
Training Specialist IV (a)
Training Specialist V (a)
Validation Engineer I
Validation Engineer II
Validation Engineer III
Validation Engineer IV
Validation Engineer V - Manager
ORDERING PERIOD 2: PERIOD OF PERFORMANCE: 12 MONTHS
Labor Hour Rate
Visa Assistance Labor Hour Rate
Analyst I
Analyst II
Analyst III
Analyst IV
Analyst V
Application Developer/Programmer -I (a)
II (a)
Biomedical Informatics Specialist III
Biomedical Informatics Specialist IV
Biomedical Informatics Specialist V
Bioinformatician I
Bioinformatician II
Bioinformatician III
Bioinformatician IV
Bioinformatician V
Bioinformatics Analyst I
Bioinformatics Analyst II
Bioinformatics Analyst III
Bioinformatics Analyst IV
Bioinformatics Analyst V
Business Process Analyst I
Business Process Analyst II
Business Process Analyst III
Business Process Analyst IV
Business Process Analyst V
Clinical Trials Coordinator III
Clinical Trials Coordinator IV
Clinical Trials Coordinator V
Data Analyst I
Data Analyst II
Data Analyst III
Data Analyst IV
Data Analyst V
Data Architect I
Data Architect II
Data Architect III
Data Architect IV
Data Architect V
Data Entry Specialist I (a)
Data Entry Specialist II (a)
Data Entry Specialist III (a)
Data Entry Specialist IV (a)
Data Entry Specialist V (a)
Data Manager I
Data Manager II
Data Manager III
Data Manager IV
Data Manager V
Data Scientist I
Data Scientist II
Data Scientist III
Data Scientist IV
Data Scientist V
Data Administrator I
Data Administrator II
Data Administrator III
Data Administrator IV
Data Administrator V
Engineer, General (Chemical, Evaluation Specialist II
Evaluation Specialist III
Evaluation Specialist IV
Evaluation Specialist V
Functional Expert Consultant I
Functional Expert Consultant II
Functional Expert Consultant III
Functional Expert Consultant IV
Functional Expert Consultant V
Health IT Computational Biologist I
Health IT Computational Biologist II
Health IT Computational Biologist III
Health IT Computational Biologist IV
Health IT Computational Biologist V
Informatics III
Informatics IV
Informatics V
IT Engineer I
IT Engineer II
IT Engineer III
IT Engineer IV
IT Engineer V
Instructional Systems Designer I
Instructional Systems Designer II
Instructional Systems Designer III
Instructional Systems Designer IV
Instructional Systems Designer V
Investigator I
Investigator II
Investigator III
Lab Technician III (a)
Lab Technician IV (a)
Lab Technician V (a)
Lab Technical Support I
Lab Technical Support II
Lab Technical Support III
Lab Technical Support IV
Lab Technical Support V
Microbiologist I
Microbiologist II
Microbiologist III
Microbiologist IV
Microbiologist V
Pharmacist I
Pharmacist II
Pharmacist III
Pharmacist IV
Pharmacist V
Pharmacy Technician I (a)
Pharmacy Technician II (a)
Pharmacy Technician III (a)
Pharmacy Technician IV (a)
Pharmacy Technician V (a)
Principle I
Principle II
Programmer I
Programmer II
Programmer III
Programmer IV
Programmer V
Program Manager I
Program Manager II
Program Manager III
Program Manager IV
Program Manager V
Project Coordinator I
Project Coordinator II
Project Coordinator III
Project Coordinator IV
Project Coordinator V
Project Manager I
Project Manager II
Project Manager III
Project Manager IV
Project Manager V
Protocol Data Analyst I
Protocol Data Analyst II
Protocol Data Analyst III
Protocol Data Analyst IV
Protocol Data Analyst V
Lead Quality Assurance Specialist
Quality Assurance Specialist I
Quality Assurance Specialist II
Quality Assurance Specialist III
Quality Assurance Specialist IV
Quality Assurance Specialist V
Researcher I
Researcher II
Researcher III
Researcher IV
Researcher V
Research Analyst I
Research Analyst II
Research Analyst III
Research Analyst IV
Research Analyst V
Research Assistant I
Research Assistant II
Research Assistant III
Research Assistant IV
Research Assistant V
Scientist I
Scientist II
Scientist III
Scientist IV
Senior Scientist - PhD
Subject Matter Expert I
Subject Matter Expert II
Subject Matter Expert III
Subject Matter Expert IV
Subject Matter Expert V
Statistician I
Statistician II
Statistician III
Statistician IV
Statistician V
Scientific Administration Support I
Scientific Administration Support II
Scientific Administration Support III
Scientific Administration Support IV
Scientific Administration Support V
Scientific Data Analyst I
Scientific Data Analyst II
Scientific Data Analyst III
Scientific Data Analyst IV
Scientific Data Analyst V
Specialist Regulatory Documentation I
Technical Writer III (a)
Technical Writer IV (a)
Technical Writer V (a)
Training Specialist I (a)
Training Specialist II (a)
Training Specialist III (a)
Training Specialist IV (a)
Training Specialist V (a)
Validation Engineer I
Validation Engineer II
Validation Engineer III
ORDERING PERIOD 3: PERIOD OF PERFORMANCE: 12 MONTHS
Labor Hour Rate Visa Assistance Labor Hour Rate
Analyst I
Analyst II
Analyst III
Analyst IV
Analyst V
Application Developer/Programmer -I
Application Developer/Programmer -
Biomedical Informatics Specialist III
Biomedical Informatics Specialist IV
Biomedical Informatics Specialist V
Bioinformatician I
Bioinformatician II
Bioinformatician III
Bioinformatician IV
Bioinformatician V
Bioinformatics Analyst I
Bioinformatics Analyst II
Bioinformatics Analyst III
Bioinformatics Analyst IV
Bioinformatics Analyst V
Business Process Analyst I
Business Process Analyst II
Business Process Analyst III
Business Process Analyst IV
Business Process Analyst V
Clinical Trials Coordinator III
Clinical Trials Coordinator IV
Clinical Trials Coordinator V
Data Analyst I
Data Analyst II
Data Analyst III
Data Analyst IV
Data Analyst V
Data Architect I
Data Architect II
Data Architect III
Data Architect IV
Data Architect V
Data Entry Specialist I (a)
Data Entry Specialist II (a)
Data Entry Specialist III (a)
Data Entry Specialist IV (a)
Data Entry Specialist V (a)
Data Manager I
Data Manager II
Data Manager III
Data Manager IV
Data Manager V
Data Scientist I
Data Scientist II
Data Scientist III
Data Scientist IV
Data Scientist V
Data Administrator I
Data Administrator II
Data Administrator III
Data Administrator IV
Data Administrator V
Engineer, General (Chemical, Evaluation Specialist III
Evaluation Specialist IV
Evaluation Specialist V
Functional Expert Consultant I
Functional Expert Consultant II
Functional Expert Consultant III
Functional Expert Consultant IV
Functional Expert Consultant V
Health IT Computational Biologist I
Health IT Computational Biologist II
Health IT Computational Biologist III
Health IT Computational Biologist IV
Health IT Computational Biologist V
Informatics III
Informatics IV
Informatics V
IT Engineer I
IT Engineer II
IT Engineer III
IT Engineer IV
IT Engineer V
Instructional Systems Designer I
Instructional Systems Designer II
Instructional Systems Designer III
Instructional Systems Designer IV
Instructional Systems Designer V
Investigator I
Investigator II
Investigator III
Lab Technician III (a)
Lab Technician IV (a)
Lab Technician V (a)
Lab Technical Support I
Lab Technical Support II
Lab Technical Support III
Lab Technical Support IV
Lab Technical Support V
Microbiologist I
Microbiologist II
Microbiologist III
Microbiologist IV
Microbiologist V
Pharmacist I
Pharmacist II
Pharmacist III
Pharmacist IV
Pharmacist V
Pharmacy Technician I (a)
Pharmacy Technician II (a)
Pharmacy Technician III (a)
Pharmacy Technician IV (a)
Pharmacy Technician V (a)
Principle I
Principle II
Programmer I
Programmer II
Programmer III
Programmer IV
Programmer V
Program Manager I
Program Manager II
Program Manager III
Program Manager IV
Program Manager V
Project Coordinator I
Project Coordinator II
Project Coordinator III
Project Coordinator IV
Project Coordinator V
Project Manager I
Project Manager II
Project Manager III
Project Manager IV
Project Manager V
Protocol Data Analyst I
Protocol Data Analyst II
Protocol Data Analyst III
Protocol Data Analyst IV
Protocol Data Analyst V
Lead Quality Assurance Specialist
Quality Assurance Specialist I
Quality Assurance Specialist II
Quality Assurance Specialist III
Quality Assurance Specialist IV
Quality Assurance Specialist V
Researcher I
Researcher II
Researcher III
Researcher IV
Researcher V
Research Analyst I
Research Analyst II
Research Analyst III
Research Analyst IV
Research Analyst V
Research Assistant I
Research Assistant II
Research Assistant III
Research Assistant IV
Research Assistant V
Scientist I
Scientist II
Scientist III
Scientist IV
Senior Scientist - PhD
Subject Matter Expert I
Subject Matter Expert II
Subject Matter Expert III
Subject Matter Expert IV
Subject Matter Expert V
Statistician I
Statistician II
Statistician III
Statistician IV
Statistician V
Scientific Administration Support I
Scientific Administration Support II
Scientific Administration Support III
Scientific Administration Support IV
Scientific Administration Support V
Scientific Data Analyst I
Scientific Data Analyst II
Scientific Data Analyst III
Scientific Data Analyst IV
Scientific Data Analyst V
Specialist Regulatory Documentation I
Technical Writer II (a)
Technical Writer III (a)
Technical Writer IV (a)
Technical Writer V (a)
Training Specialist I (a)
Training Specialist II (a)
Training Specialist III (a)
Training Specialist IV (a)
Training Specialist V (a)
Validation Engineer I
Validation Engineer II
Validation Engineer III
ORDERING PERIOD 4: PERIOD OF PERFORMANCE: 12 MONTHS
Labor Hour Rate Visa Assistance Labor Hour Rate
Analyst I
Analyst II
Analyst III
Analyst IV
Analyst V
Application Developer/Programmer -I
Biomedical Informatics Specialist III
Biomedical Informatics Specialist IV
Biomedical Informatics Specialist V
Bioinformatician I
Bioinformatician II
Bioinformatician III
Bioinformatician IV
Bioinformatician V
Bioinformatics Analyst I
Bioinformatics Analyst II
Bioinformatics Analyst III
Bioinformatics Analyst IV
Bioinformatics Analyst V
Business Process Analyst I
Business Process Analyst II
Business Process Analyst III
Business Process Analyst IV
Business Process Analyst V
Clinical Trials Coordinator III
Clinical Trials Coordinator IV
Clinical Trials Coordinator V
Data Analyst I
Data Analyst II
Data Analyst III
Data Analyst IV
Data Analyst V
Data Architect I
Data Architect II
Data Architect III
Data Architect IV
Data Architect V
Data Entry Specialist I (a)
Data Entry Specialist II (a)
Data Entry Specialist III (a)
Data Entry Specialist IV (a)
Data Entry Specialist V (a)
Data Manager I
Data Manager II
Data Manager III
Data Manager IV
Data Manager V
Data Scientist I
Data Scientist II
Data Scientist III
Data Scientist IV
Data Scientist V
Data Administrator I
Data Administrator II
Data Administrator III
Data Administrator IV
Data Administrator V
Engineer, General (Chemical, Evaluation Specialist III
Evaluation Specialist IV
Evaluation Specialist V
Functional Expert Consultant I
Functional Expert Consultant II
Functional Expert Consultant III
Functional Expert Consultant IV
Functional Expert Consultant V
Health IT Computational Biologist I
Health IT Computational Biologist II
Health IT Computational Biologist III
Health IT Computational Biologist IV
Health IT Computational Biologist V
Informatics III
Informatics IV
Informatics V
IT Engineer I
IT Engineer II
IT Engineer III
IT Engineer IV
IT Engineer V
Instructional Systems Designer I
Instructional Systems Designer II
Instructional Systems Designer III
Instructional Systems Designer IV
Instructional Systems Designer V
Investigator I
Investigator II
Investigator III
Lab Technician III (a)
Lab Technician IV (a)
Lab Technician V (a)
Lab Technical Support I
Lab Technical Support II
Lab Technical Support III
Lab Technical Support IV
Lab Technical Support V
Microbiologist I
Microbiologist II
Microbiologist III
Microbiologist IV
Microbiologist V
Pharmacist I
Pharmacist II
Pharmacist III
Pharmacist IV
Pharmacist V
Pharmacy Technician I (a)
Pharmacy Technician II (a)
Pharmacy Technician III (a)
Pharmacy Technician IV (a)
Pharmacy Technician V (a)
Principle I
Principle II
Programmer I
Programmer II
Programmer III
Programmer IV
Programmer V
Program Manager I
Program Manager II
Program Manager III
Program Manager IV
Program Manager V
Project Coordinator I
Project Coordinator II
Project Coordinator III
Project Coordinator IV
Project Coordinator V
Project Manager I
Project Manager II
Project Manager III
Project Manager IV
Project Manager V
Protocol Data Analyst I
Protocol Data Analyst II
Protocol Data Analyst III
Protocol Data Analyst IV
Protocol Data Analyst V
Lead Quality Assurance Specialist
Quality Assurance Specialist I
Quality Assurance Specialist II
Quality Assurance Specialist III
Quality Assurance Specialist IV
Quality Assurance Specialist V
Researcher I
Researcher II
Researcher III
Researcher IV
Researcher V
Research Analyst I
Research Analyst II
Research Analyst III
Research Analyst IV
Research Analyst V
Research Assistant I
Research Assistant II
Research Assistant III
Research Assistant IV
Research Assistant V
Scientist I
Scientist II
Scientist III
Scientist IV
Senior Scientist – PhD
Subject Matter Expert I
Subject Matter Expert II
Subject Matter Expert III
Subject Matter Expert IV
Subject Matter Expert V
Statistician I
Statistician II
Statistician III
Statistician IV
Statistician V
Scientific Administration Support I
Scientific Administration Support II
Scientific Administration Support III
Scientific Administration Support IV
Scientific Administration Support V
Scientific Data Analyst I
Scientific Data Analyst II
Scientific Data Analyst III
Scientific Data Analyst IV
Scientific Data Analyst V
Specialist Regulatory Documentation I
Technical Writer III (a)
Technical Writer IV (a)
Technical Writer V (a)
Training Specialist I (a)
Training Specialist II (a)
Training Specialist III (a)
Training Specialist IV (a)
Training Specialist V (a)
Validation Engineer I
Validation Engineer II
Validation Engineer III
Validation Engineer V – Manager
6 MONTH EXTENSION: PERIOD OF PERFORMANCE: 6 MONTHS
Labor Hour Rate Visa Assistance Labor Hour Rate
Analyst I
Analyst II
Analyst III
Analyst IV
Analyst V
Application Developer/Programmer -I
Biomedical Informatics Specialist III
Biomedical Informatics Specialist IV
Biomedical Informatics Specialist V
Bioinformatician I
Bioinformatician II
Bioinformatician III
Bioinformatician IV
Bioinformatician V
Bioinformatics Analyst I
Bioinformatics Analyst II
Bioinformatics Analyst III
Bioinformatics Analyst IV
Bioinformatics Analyst V
Business Process Analyst I
Business Process Analyst II
Business Process Analyst III
Business Process Analyst IV
Business Process Analyst V
Clinical Trials Coordinator III
Clinical Trials Coordinator IV
Clinical Trials Coordinator V
Data Analyst I
Data Analyst II
Data Analyst III
Data Analyst IV
Data Analyst V
Data Architect I
Data Architect II
Data Architect III
Data Architect IV
Data Architect V
Data Entry Specialist I (a)
Data Entry Specialist II (a)
Data Entry Specialist III (a)
Data Entry Specialist IV (a)
Data Entry Specialist V (a)
Data Manager I
Data Manager II
Data Manager III
Data Manager IV
Data Manager V
Data Scientist I
Data Scientist II
Data Scientist III
Data Scientist IV
Data Scientist V
Data Administrator I
Data Administrator II
Data Administrator III
Data Administrator IV
Data Administrator V
Engineer, General (Chemical, Evaluation Specialist III
Evaluation Specialist IV
Evaluation Specialist V
Functional Expert Consultant I
Functional Expert Consultant II
Functional Expert Consultant III
Functional Expert Consultant IV
Functional Expert Consultant V
Health IT Computational Biologist I
Health IT Computational Biologist II
Health IT Computational Biologist III
Health IT Computational Biologist IV
Health IT Computational Biologist V
Informatics III
Informatics IV
Informatics V
IT Engineer I
IT Engineer II
IT Engineer III
IT Engineer IV
IT Engineer V
Instructional Systems Designer I
Instructional Systems Designer II
Instructional Systems Designer III
Instructional Systems Designer IV
Instructional Systems Designer V
Investigator I
Investigator II
Investigator III
Lab Technician III (a)
Lab Technician IV (a)
Lab Technician V (a)
Lab Technical Support I
Lab Technical Support II
Lab Technical Support III
Lab Technical Support IV
Lab Technical Support V
Microbiologist I
Microbiologist II
Microbiologist III
Microbiologist IV
Microbiologist V
Pharmacist I
Pharmacist II
Pharmacist III
Pharmacist IV
Pharmacist V
Pharmacy Technician I (a)
Pharmacy Technician II (a)
Pharmacy Technician III (a)
Pharmacy Technician IV (a)
Pharmacy Technician V (a)
Principle I
Principle II
Programmer I
Programmer II
Programmer III
Programmer IV
Programmer V
Program Manager I
Program Manager II
Program Manager III
Program Manager IV
Program Manager V
Project Coordinator I
Project Coordinator II
Project Coordinator III
Project Coordinator IV
Project Coordinator V
Project Manager I
Project Manager II
Project Manager III
Project Manager IV
Project Manager V
Protocol Data Analyst I
Protocol Data Analyst II
Protocol Data Analyst III
Protocol Data Analyst IV
Protocol Data Analyst V
Lead Quality Assurance Specialist
Quality Assurance Specialist I
Quality Assurance Specialist II
Quality Assurance Specialist III
Quality Assurance Specialist IV
Quality Assurance Specialist V
Researcher I
Researcher II
Researcher III
Researcher IV
Researcher V
Research Analyst I
Research Analyst II
Research Analyst III
Research Analyst IV
Research Analyst V
Research Assistant I
Research Assistant II
Research Assistant III
Research Assistant IV
Research Assistant V
Scientist I
Scientist II
Scientist III
Scientist IV
Senior Scientist – PhD
Subject Matter Expert I
Subject Matter Expert II
Subject Matter Expert III
Subject Matter Expert IV
Subject Matter Expert V
Statistician I
Statistician II
Statistician III
Statistician IV
Statistician V
Scientific Administration Support I
Scientific Administration Support II
Scientific Administration Support III
Scientific Administration Support IV
Scientific Administration Support V
Scientific Data Analyst I
Scientific Data Analyst II
Scientific Data Analyst III
Scientific Data Analyst IV
Scientific Data Analyst V
Specialist Regulatory Documentation I
Technical Writer III (a)
Technical Writer IV (a)
Technical Writer V (a)
Training Specialist I (a)
Training Specialist II (a)
Training Specialist III (a)
Training Specialist IV (a)
Training Specialist V (a)
Validation Engineer I
Validation Engineer II
Validation Engineer III
Validation Engineer V – Manager
(a) Covered by the Service Contract Labor Standards
TOTAL IDIQ CEILING AMOUNT: $99,900,200.00
2.2 Pricing Terms
The Contractor shall comply with FAR Clause 52.212-4, Contract Terms and Conditions – Commercial Items (Dec 2022) in regard to fixed prices for individual task orders. The total amount specified In Firm Fixed Price (FFP) task orders shall be fixed for the task order period of performance and shall not be subject to adjustment; except, as a result of a direct action or inaction by the Government which delays the Contractor from completing the task order within the time specified in the order.
The Contractor shall comply with FAR Clause 52.212-4, Alt 1 Contract Terms and Conditions (Dec 2022) with regard to the ceiling price for each labor-hour type task order.
2.3 Contract Type
This is a single award Indefinite Delivery-Indefinite Quantity (IDIQ) type contract, per FAR
16.5. Authorized contract types under this IDIQ contract are: Firm-Fixed-Price (FFP) and Labor-Hour (LH) or a combination thereof. There can be ODC’s such as travel allowances for task orders.
2.4 Minimum and Maximum Contract Value
IDIQ MINIMUM: The minimum guarantee for this IDIQ contract is $3,000.00 which will be obligated at the time of the IDIQ award.
IDIQ MAXIMUM: The maximum aggregate dollar value of all the task orders awarded over the 4 year period of this IDIQ shall not exceed the IDIQ ceiling amount of $99,900,200.00.
See FAR Clause 52.216-19 (Oct 1995) for individual task order limitations.
2.5 Ordering
A request for task order proposal (RFTOP) will be issued via email for individual task orders.
Task orders against the IDIQ contract will be in accordance with FAR 16.505 and FAR Clause 52.216-18 (Aug 2020).
Ordering Procedures Any contracting officer of the Food and Drug Administration (FDA) is authorized and may place orders under this IDIQ contract. Each individual task order will describe the specific performance requirements. The process for issuing task orders is as follows:
1. The FDA CO will issue a RFTOP via email. The RFTOP will include the following information:
a. SOW
b. Period of Performance
c. Anticipated Contract Type
d. Reporting Requirements and Deliverables
e. Key Personnel (if applicable)
f. Any special terms and conditions specifically applicable to the task order.
2. The Contractor will typically have a minimum of ten (10) business days, unless otherwise specified, to provide a proposal in response to the RFTOP. The proposal shall include:
a. Description of the technical approach to the task order requirements
b. Price Buildup (including labor categories, hours for each labor category, extended pricing, other direct costs, and concurrence with the anticipated contract type)
c. Resumes of any key personnel identified in the RFTOP
d. Other Direct Costs: Other direct costs shall be clearly identified, explained and substantiated.
e. Travel Expenses: Travel rates will be limited to those costs authorized by the
Federal Travel Regulations in effect at the time of the task order award. Trips in excess of the approved dollars set forth in each task order will be at the Contractor’s expense. The Contractor shall identify the estimated travel requirements by number, purpose, and duration (inclusive of travel days in/out) with the submission of each proposed TO. The government reserves the right to insert anticipated travel by utilizing Other Direct Costs (ODC).
3. The FDA will evaluate the task order proposal for technic acceptability and price reasonableness. If the FDA has questions and concerns, the Contracting Officer will contact the Contractor and may request a revised proposal.
4. If the task order proposal is determined to be acceptable, the Contracting Officer will issue a task order. All task orders will, at a minimum, include the following:
a. Task Order Number
b. Date of Task Order
c. Funding for the Task Order
d. Task Order SOW and specific deliverables and due dates
e. Task Order Pricing
f. Period of Performance of the task order
g. Any terms, condition, and instructions specific to the task order
Any work that the Contractor undertakes prior to receiving a fully executed task order that has been signed by the Contracting Officer (or the Contractor has received prior authorization to proceed from the Contracting Officer) shall be at the Contractor’s risk.
No separate payment will be made to the Contractor for the cost to prepare, submit and/or negotiate a Task Order proposal.
Pricing of Orders
1. Proposals submitted in response to the RFTOP must be in accordance with the Ordering Period rates in the IDIQ Price Schedule based on the performance start date of the task order, and that rate must be used for the duration of the task order; however, if a task order’s period of performance is longer than twelve
(12) months, the Contractor may propose the applicable ordering period rate for that portion of the performance after the 12 month period. The Contractor may propose lower rates in response to a RFTOP.
2. RFTOPs may include option periods in accordance with FAR 52.217-9 (Mar 2000).
However, option periods must utilize the Ordering Period rates listed in the IDIQ Price Schedule, based on the performance start date of the option period. The performance period end date of the last option cannot exceed twelve (12) months past the performance end date of the IDIQ contract.
3. Labor-Hour (LH) type task orders will include a ceiling price
4. If a task order’s stated period of performance must be extended as a result of
Government delay, the Contractor may request that the most current labor rates be used to price the work effort during the extended period for LH task orders.
These Ordering Pricing terms and conditions apply to all task orders issued under this IDIQ contract.
2.6 Task Order Processing
All task orders issued hereunder are subject to the terms and conditions of the contract.
The IDIQ contract takes precedence over the task order in the event of conflict with requirements and/or deliveries. Task orders shall be “issued” for purpose of this contract upon the effective date of the order. The IDIQ Contract COR must be notified when task orders are issued against the IDIQ, detailing task order number, scope, awarded amount and pricing modifications.
It is the Government’s intention to perform closeout procedures on a Task Order basis as well as for the IDIQ Contract. The Contractor shall perform those internal functions necessary to support this process in a timely manner. The Task Order closeout will occur as soon as possible after required audit and establishment of final rates, as applicable.
3. DESCRIPTION OF REQUIREMENT/STATEMENT OF WORK
3.1 Background
The Food and Drug Administration (FDA) is a science-based regulatory agency critically important to the stability of the nation’s public health and health care systems. FDA protects and promotes the health and safety of all Americans by enhancing the availability of safe medical products and foods and promoting innovation that addresses unmet medical and public health needs. FDA also protects and promotes the health and safety of animals by assuring the availability of safe animal drug products and food. FDA decisions must be based on the best available scientific data and use the best tools and methods available to ensure products meet the highest quality standards for consumers, while fostering and advancing innovation in the products it regulates.
In support of its regulatory mission, FDA conducts scientific research concerning vaccines, blood products, drug safety, food and food safety, food and color additive review, micro-analytical evaluations, cosmetics, colors certification, veterinary medicine, tobacco products, toxicology, medical devices, and radiological products as well as method development and method validation for regulatory laboratories and other scientific research. It also supports new technologies (such as genomics and proteomics) with traditional toxicological data, and it analyzes and visualizes these data to formulate new regulatory standards. Individual FDA Centers often leverage their resources by conducting integrated research programs with other FDA Centers and Offices and through collaborative agreements with government agencies, academia, and industry.
More so than ever before, FDA’s science is data-centric, complex, and collaborative, involving multidisciplinary groups. FDA researchers and other scientists must have access to the latest documented advancements across the medical disciplines, as well as leverage IT and information managements systems to knowledge-share policies, procedures, and data in their fields of expertise. The purpose of this Scientific Services IDIQ contract is to enable all FDA Centers to have access to an experienced set of scientific professionals who will apply best practices and innovative processes and solutions effectively across centers and offices.
3.2 Objectives
The scientific services will support each Center’s mission with increased accuracy on findings, supported data analysis and timely reporting. The scientific services will represent industry best practices shared across all offices, divisions and branches located within the structure of the FDA to achieve improvement and advancement in scientific processes and procedures.
3.3 Scope
The following scientific-related professional services will be available across all FDA Centers:
Research and technical guidance related to policy across medical disciplines;
Consulting regarding improvements to IT and information management systems in support of scientific processes and activities;
Scientific investigations, procedures, plans, clinical data analysis and reporting;
Drafting of scientific documentation suitable for public dissemination;
Laboratory technical and administrative support; and
Task management directly and specifically focused on the scientific requirements at the Task Order level.
The scope does not include procurement of IT hardware.
Specific details for the work will be defined and provided in each Task Order issued under this
IDIQ.
4. 0 Task Areas Independently, and not as an agent of the Government, the Contractor shall perform tasks that provide scientific-related professional services for the FDA. The task areas to be performed under this IDIQ are listed directly below. The labor categories to be applied to the task areas are detailed in Appendix 1.
4.1 Research and Technical Guidance
The Contractor shall provide scientific research support that will inform or result in technical guidance and expertise related to regulatory, pharmaceutical, public health and manufacturing functions across the FDA Centers. Examples include, but are not limited to, research areas that address emerging technologies (e.g. continuous manufacturing, 3D printing, nanotechnology, biosimilars, and biologics).
4.2 Scientific Consultation (IT and Information Management Systems)
The Contractor shall provide research information, consultation, technical and functional analysis that will assist the FDA with decisions on procurements of hardware and software that can be used to advance scientific-related processes, procedures and workflows. The Contractor shall provide technical support to successfully transfer operational databases, models, methods, or tools developed on Contractor platforms to FDA internal platforms, including full documentation and code.
The Contractor shall identify functional gaps and efficiencies and participate and coordinate with the Office of Information Management and Technology (OIMT) on design plans for hardware (such as networking, data storage and computing resources) and software solutions to meet the needs of laboratory and other science activities. The Contractor shall maintain the general scientific IT knowledge management infrastructure (e.g., SharePoint scientific content) and manage the inventory of scientific software licenses for designated offices.
4.3 Scientific Investigations, Procedures and Analysis
The Contractor shall provide support for scientific investigations on evaluating the feasibility and capability for various regulatory policies and actions including Standard Operating Procedures (SOPs), Manuals of Policy and Procedures (MAPPs), and Guidance for FDA-agency level, and Center/Office products. Contractor investigations shall include data collection, database development and management, analysis (e.g., computational experiments/research, meta-analysis), method development, critical reviews, technical surveys of industry capability and technology gaps that are not currently addressed by policies and actions (e.g., emerging technology guidance). Scientific investigations may also involve the surveillance and testing of pre- and post-market drugs and drug products as it relates to current world events.
The Contractor shall review and edit clinical data plans, conduct data collections, perform data analysis, and write assessment reports that may address data quality, sufficiency, and integrity.
4.4 Publishing
The Contractor shall submit material to the Government for consideration to publish or present health research/consultation related to drug shortages and access due to quality and manufacturing, and public health emergencies due to drug quality, surveillance and manufacturing processes that may have negative impacts on public health.
4.5 Laboratory Technical and Administrative Support
The Contractor shall provide support to assist, operate, maintain, calibrate, and repair various laboratory systems, instrumentation, and equipment. Examples include but are not limited to benchtop bioreactor systems, cell and biochemical analyzer systems, bio-layer interferometer, and protein purification systems. Additionally, the Contractor shall assist with the upkeep of inventory of lab supplies, sample-collection, -management and -analysis, data analysis and other laboratory project specific support tasks.
4.6 Task Management
The Contractor shall provide both Indefinite Delivery, Indefinite Quantity (IDIQ) Contract-Level Program Management support and Task Order-level Project Management support to establish control, staffing management, monitoring, and notification mechanisms and shall work with the Government Contracting Officer (CO), Contracting Officer’s Representative (COR) and subject matter experts (SMEs) to ensure that all tasks stay on track and important milestones are met.
The Contactor shall ensure management resources are in place to effectively plan and manage multiple Task Orders, and transition-on and -off activities, when required. The Contractor shall conduct transition activities, as needed, as Task Orders begin/end and as staff changes on an effort.
Staffing management activities shall include administrative and programmatic responsibilities to assist its applicable proposed Contractor personnel with completion of VISA documentation and H1B sponsorship and processing fees.
Specific task management and reporting activities will be detailed at the Task Order level.
The Contractor shall provide both Indefinite Delivery, Indefinite Quantity (IDIQ) Contract-Level Program Management support and Task Order-level Project Management support to establish control, management, monitoring, and notification mechanisms and shall work with the Government Contracting Officer (CO), Contracting Officer’s Representative (COR) and subject matter experts (SMEs) to ensure that all tasks stay on track and important milestones are met.
Representative activities include but are not limited to:
Meetings
The Contractor shall participate in various meetings for the IDIQ contract and as required, for each Task Order. If Task Order requires meetings, the Contractor shall prepare the following: meeting agenda, minutes or notes, issues and action items. Additionally, the Contractor may be required to distribute the related documentation (generally by email), and actively contribute to the meetings.
At a minimum, the Contractor shall convene and participate in the following meetings relating to the overall IDIQ contract:
• Contract Kickoff Meeting – Contractor will coordinate this meeting within 15 working days of contract award. Purpose of this meeting is to introduce Contractor staff to the government staff that will be managing the contract. Additionally, Contractor will begin work with the COR (and, if necessary, the CO) to determine the course of future status update meetings and the government’s expectations for reporting.
• Annual Update Meetings – Contractor shall coordinate quarterly meetings with responsible government staff (COR, and if necessary, CO) for the purpose of reporting the status of the overall contract and the individual Task Orders. During these meetings, Contractor shall report on costs and burn rates, schedule, demonstrations, presentations, transitions activities, site visits and any other factors which may impact Task Orders or the overall contract.
Staff Training and Management
• The Contractor shall support and verify that all personnel including new hires havethe education, experience, andtraining necessary to perform their duties and successful performance of contract requirements in terms of protocols for data-entry, quality control and various standardized coding technology
• The Contractor shall schedule, participate in and track required mandatory FDA training
• As appropriate to the size and scope of each Task Order, the Contractor shall develop, implement, and update a Management Plan to include communication plan, quality control plan, quality assurance plan, training plan, contingency plan, IT security plan and staffing plan o The Contractor shall provide management personnel for the administration and oversight of all phases of TOs and IDIQ contract o The Contractor shall provide a Management Plan to be developed in terms of technical approach, organizational resources and management control o The Contractor shall plan, organize, secure and manage resources with appropriate knowledge and skills o The Contractor shall manage Contractor staff and provide subcontractor management
• The Contractor shall safeguard all FDA confidential information
The Contractor shall NOT:
• Discuss with unauthorized persons any information obtained in the performance of work under this contract
• Conduct business not directly related to this contract on Government premises
• Use computer systems and/or other Government facilities for company or personal business other than work related to this contract
• Recruit on Government premises or otherwise act to disrupt official Government business
Process and Procedure Improvement
As required at each Task Order level, the Contractor shall provide ongoing reviews of existing processes and procedures to identify areas where improvements can be made as well as recommend changes that will benefit the quality, efficiency and/or effectiveness of the FDA’s standard operating procedures and business rules The Contractor shall research, plan, collect, analyze, recommend and implement changes to FDA processes and procedures, which may include for example: create and document processes and procedures according to organizational format templates, document as-is and to-be performance baselines, support the development and implementation of performance measures and surveillance methods.
4.7 Transition
The Contractor shall provide all management, administrative, clerical, and supervisory functions required for the effective and efficient performance of this contract. A smooth and orderly transition between the Contractor and the successor Contractor is necessary to ensure minimum disruption to vital Government business. The Contractor shall cooperate fully in the transition. At the IDIQ level, the Contractor will provide 30 days of transition to allocate this time to transition in activities and transition out activities. Such activities shall include meeting with the incoming vendor. The Contractor shall adhere to the same professional and ethical standards of conduct required of Government personnel. Specific transition-in and/or transition-out requirements may be provided in individual Task Orders. The Contractor shall provide transition activities as directed in each Task Order for beginning and ending efforts, as well as when staff transition on/off Task Orders in progress.
5. 0 Deliverables All deliverables will be specified and detailed by the FDA in specific task orders. All deliverables required under this contract shall be packaged, marked and shipped in accordance with FDA specifications. At a minimum, all deliverables shall be marked with the contract number and contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.
Be advised that FDA does not accept documents which contain the use of macros. When submitting documents via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). Document submissions required throughout the award period(s) shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.
5.1 Criteria for Acceptance of Deliverables
The Contractor shall submit all preliminary, intermediate, and final deliverables in electronic formats (i.e., Microsoft Office and Adobe) to the COR. The contractor shall submit final deliverables in electronic format to the CO. Requirements for inspection and acceptance are as follows:
• The COR or Government POC designated in each task order, will inspect and accept the services or deliverables provided to ensure they meet the requirements detailed in the relevant individual order.
• The Government will accept products and services only if they conform to all terms and conditions of the IDIQ and each individual order.
• The Government will provide written notification of acceptance or rejection within ten (10) calendar days of receiving the service.
• The Government will reject non-conforming products and services. The Contractor shall correct any deficiencies within thirty (30) calendar days of when the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this timeframe, the Contractor shall immediately notify the Task Order COR of the reason for the delay and provide a proposed corrective action plan within ten (10) calendar days.
• The Contractor shall provide all data, notes and/or backups that have been stored on any system or other media to the government prior to the completion of each task order.
Each individual task order will provide for the frequency of reporting and/or meeting requirements.
This contract incorporates the following…
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