RFI.pdf

Reference No. FDA-21-RFI-1238783

Document Type Request for Information Title Non-Clinical Studies and Laboratory Support Response Due Date 1pm EST on April 02, 2021 NAICS Code 541380-Testing Laboratories

541714- Research and Technology in Biotechnology (except Nanobiotechnology) 541715-Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) 541940- Veterinary Services 541990-All Other Professional, Scientific and Technical Services

This is a Request for Information (RFI) Notice only. This is not a request for proposal, but a survey to locate potential sources in furtherance and support of market research efforts. This RFI does not constitute an Invitation for Bids, Request for Proposals or a Request for Quotations, and is not to be construed as a commitment by the Government to issue an order or otherwise pay for the information solicited, nor is it a guarantee of a forthcoming solicitation or contract. It is for market research purposes only. Respondents will not be notified of the results of the evaluation.

The purpose of this RFI is to gain knowledge of interest, capabilities, and qualifications of the Small Business Community: Small Business, Section 8(a), Academia, Historically Underutilized Business Zones (HUB-Zone), Service-Disabled Veteran-Owned Small Business (SDVOSB), Women-Owned Small Business (WOSB), and Economically Disadvantaged Women-Owned Small Business (EDWOSB). The Government must ensure there is adequate competition among the potential pool of responsible contractors. Small business, Section 8(a), HUBZone, SDVOSB, WOSB, & EDWOSB businesses are highly encouraged to participate. Only small business sources shall respond to this RFI.

BACKGROUND

The FDA has the need for animal research as well as bioanalytical and other in vitro and ex vivo laboratory assay support. Depending on the project, the services required under this contract may include assessment of different drug and metabolite concentrations, biomarkers levels, in vitro assays or include novel experimental methodologies. These assessments may be needed for samples collected from animal or laboratory research per formed within the contract or could be required as a standalone option to mission-critical research performed at FDA facilities. The results of studies and other performed work under this contract will be used to advance regulatory science. In most cases, the animal and laboratory work will not require Good Laboratory Practice (GLP) and/or GMP controls but the provider should have those capabilities.

Overall, the efforts would support a full range of services from animal study protocol development and execution, conducting supportive laboratory studies, and bioanalytical/biomarker/omics services, where required, as well as independent in vitro laboratory studies and ex vivo laboratory studies including but not limited to drug metabolism, transport and binding and drug-drug interaction studies.

OBJECTIVE

The scope of activities FDA may require of the contractor shall include provision of animal and laboratory research sites and the provision of a full range of services to support contracted non-clinical studies as well as non-clinical in vivo and in vitro studies conducted at FDA sites and reporting of the results. All work shall be carried out in a timely fashion and in compliance with all FDA regulations and GLP, GMP and GCP guidelines, as applicable. The contractor should be able to provide laboratory studies including bioanalytical/biomarker/omics support that includes determination of drug concentration, anti-drug antibodies, and multiple pharmacodynamic biomarkers through various standard and potentially emerging technologies.

Work under the anticipated IDIQ Contract is divided into four performance areas: (1) Overall Animal Research Operations Support and Execution in appropriate animal species; (2) Bioanalytical/Biomarker/’Omics’ Analysis and Laboratory Support resulting from performance area 1 or from independent work conducted at FDA facilities or through other FDA contracts; (3) In vitro and ex vivo laboratory assay support for drug metabolism, drug transport, drug binding etc. from performance area 1 or from independent work conducted at FDA facilities or through other FDA contracts; and (4) GMP manufacturing of API and Production final dosage form.

Organizations must have in-house capabilities in performance areas 1 and in-house or sub-contracting capability for Performance Area 2, and Performance Area 3. Ability to provide access in-house or through subcontracts to specialized materials, assays or technologies is desired but not required. All work shall be carried out in a timely fashion. Unless otherwise specified, bioanalytical method validation shall be performed in compliance with FDA’s Bioanalytical Method Validation Guidance. Sample analysis does not need to be performed under complete GLP guidelines.

REQUIREMENTS

Performance Area 1: Overall Animal Study Operations and Support

The contractor shall perform activities related to overall administration and implementation of animal study services including but not limited to the setup for project management, technical preparedness and support, communications and submission of deliverables and the ongoing archive of completed study data and reports.

A. Protocol Development and Finalization

Finalize a full protocol based on protocol synopsis provided by the FDA study team and submit to FDA for scientific review and approval in compliance to the timelines specified within individual Task Orders. Submit the final protocol and other required documents to the Institutional Animal Care and Use Committee (IACUC) for review and approval.

B. Study Execution

All animal studies to be conducted under this contract must be completed as per finalized protocol requirement. The time duration for a study from protocol writing to study completion can be variable based on specific needs and will be specified in respective Task Orders. The Government will be responsible for providing a detailed protocol outline or synopsis for each study.

C. Protocol Implementation: Compliance and Oversight

1. Activities required prior to study initiation

• Obtain local IACUC approval and approval of any other authority prescribe by the

IACUC (e.g., Institutional Biosafety Committee)

• Obtain any necessary Material Transfer Agreement (MTA) from contributor if required

• Prepare and deliver a study management plan

• Conduct a study initiation meeting

2. Regulatory Compliance

• Throughout the studies essential regulatory documents should be generated and stored in files/folders and be available for monitors and at the end of the studies all essential regulatory documents at the study unit should be placed in the master regulatory file for archiving. Regulatory documents may include but are not limited to: IACUC approved protocol, IACUC approval letter; IACUC membership list; PI and sub-investigators curriculum vitae, indemnification/insurance documents, shipment receipts, etc. During the conduct of the study, all new relevant information/data must be appended to the essential documents as it becomes available.

• Ensure that the conduct of the clinical trials performed complies with all FDA and OLAW regulations and guidelines.

• Ensure the confidentiality of all study records and information.

3. Study Initiation

The contractor’s study team and support staff shall participate in a study initiation meeting at the Contractor’s clinical research facility or through teleconference, as appropriate. Prepare and deliver a summary report of the initiation meeting to include but not be limited to the agenda and the list of participants.

4. Protocol Amendments

Prepare all protocol amendments and modifications, as needed.

• Upon COR, CO or FDA study team approval, the contractor will submit the amended protocol to the IACUC for review and approval.

• Upon IACUC approval, the amended protocol shall be archived in the master regulatory file.

• The study management plan and other supporting documents will be modified to reflect the protocol amendments.

• If necessary, the PI or designee will conduct a training session describing the protocol amendment and its impact on study procedures and assessments.

5. Protocol Oversight

Oversee all study activities conducted at the animal facility and all collaborating sites including research pharmacy, clinical laboratory, data management center, imaging center and subcontracting sites.

6. Data Management and Quality Control

• Modify the database to support any protocol amendments that are implemented during the conduct of the study, as required.

• Provide quality control to ensure initial data entry within 24 hours and to correct or issue a data query within 48 hours and inform promptly the study staff of any missing, incomplete and erroneous data.

7. Audit Compliance

The FDA at their discretion may undertake an audit of the contractor’s facility including all collaborating sites. The contractor shall make available all facilities, records and files as related to the contract. The contractor will submit a report describing the implementation of any corrective actions.

D. Study Agents and Clinical Specimens

1. Study Agents

• Maintain inventory records of study agent(s) in accordance to the pharmacy SOPs.

• Maintain documentation that the study agent(s) will be stored and quarantined under appropriate conditions in the research pharmacy per the sponsor and regulatory requirements.

• Mechanism for the return and/or destruction of study material.

2. Study Specimens

• Ensure collection, processing, labeling, temporary storage under appropriate conditions and management of all collected biological specimens.

• Ensure shipping of biological specimens for testing and/or repository deposition, as specified in the protocol, in compliance with current domestic laws and regulations.

E. Study Analysis, Close-Out and Final Reporting

1. Close-Out and Analysis

Following completion of study procedures, the contractor shall (in discussion with the FDA study team):

• Complete data editing/cleanup

• Finalize and lock the database

• Deliver the locked database in agreed upon format (e.g., R, SAS, SPSS, ASCII) and schedule as requested by the COR, CO, or FDA study team

2. Completion

In discussion with the FDA study team:

• Prepare for archiving the final dataset and all associated study records. Study records are considered necessary to assess the final dataset with specific codes for all variables including all transformation that have been created (i.e., data dictionary), as needed.

• Prepare and deliver draft and final study report, if needed and as specified in a Task Order.

F. Facilities, Equipment and Other Resources

The Contractor shall be responsible for the adequacy and availability of all facilities, equipment, and other resources necessary for the conduct of a clinical trial which may include, but is not limited to, the following.

Animal Research Facility:

• The Office of Laboratory Animal Welfare (OLAW) Assurance

• Adequate and secure computing resources for communication and data management

(e.g., entry editing, quality control).

• Adequate and secure electronic access to the data management center.

• Emergency care and a definitive plan for management of life- threatening adverse events

• Adequate equipment, staff and services for performing routine health evaluations, precisely timed phlebotomy, collection of urine and other bodily fluids for PK/PD trials and processing of PK and PD samples, as needed.

• Staff with expertise in the conduct and support of animal studies.

Provide Laboratory Facility:

• Adequate space for the processing and temporary storage of biological specimens.

• On-site sample storage facilities at room temperature, 4, -20 and -70 degrees Celsius.

• Laboratory support services with provisions of 24 hours/day processing/testing if required by the protocol.

• Adequate and secure electronic access to the data management center.

Provide Pharmacy Facility

• Study staff with expertise in the preparation, distribution and storage of study agents for animal studies.

• Adequate space for processing, storing and dispensing study agents under appropriate conditions.

• Adequate and secure electronic access to the data management center.

Provide Data Management Center

• Adequate computing resources to support data collection activities.

• Personnel knowledgeable about data management activities and operations including but not limited to data management planning and reporting, performance reporting, quality assurance and administrative support.

• Data management capabilities necessary to support the conduct of the study.

Provide other facilities and equipment, as may be specified by the Task Order protocols.

G. Insurance

The Government will not provide third party liability insurance.

NOTE: The Government will not provide financial compensation to contractors for work-related injuries.

Performance Area 2: Bioanalytical/Biomarker/’Omics’ Analysis and Laboratory Support

Under this performance area, the contractor shall perform activities related to development of laboratory work that may include sensitive bioanalytical methods and validation per current FDA guidance followed by quantitative analyses of drug and/or metabolite concentrations, biomarkers in plasma/serum, urine, tissue homogenates, and other biological fluids found in animal species and humans, as applicable for small and large molecules for study samples. These analyses can include but are not limited to flow cytometry and cell-based assays, ligand binding assays, immunohistochemistry, liquid chromatography-tandem mass spectrometry and molecular assays and genomics. Contractor will be responsible for final bioanalytical reports and for shipping samples to designated facility if needed.

The general requirements for the different components under performance area 2 are as described below.

A. Administrative

• Prepare responses to Task Order Request for Proposals (TORFPs) issued solely under performance area 2 (or, if applicable, in combination with performance area 1 and/or 3)

• Provide a Principal Investigator (PI) or other managerial designate and appropriate support staff who will be responsible for overall project management including the development, implementation and maintenance of a project management plan to ensure effective management of the contract infrastructure including support services, the tracking of progress, communication and preparation of deliverables and the archival activities.

• Prepare and deliver a Project Management Plan (PMP) within 30 days after the base/initial Task Order award. The PMP shall address and include, at a minimum, the following (if needed, alterations to this requirement will be made in specific Task Orders):

o Standard operating procedures (SOPs) for the conduct of bioanalytical/biomarker or laboratory support work as specified in the Task Order and for all other integrated and collaborating services;

o Data management procedures and systems planning that complies as specified with the contract terms and conditions including but not limited to development of databases using specified common data element where applicable, data collection and data monitoring;

o Laboratory quality monitoring procedures, as appropriate;

o Procedures for preventing, identifying, handling, reporting and resolving protocol deviations;

o Quality control plans and procedures;

o Establishment and demonstration for independence of oversight including quality assurance procedures;

o Archival plans for securing completed data per regulatory requirements;

o Contingency planning; and o Close-out plan

• Conduct teleconferences and meetings for:

o Pre-TORFP meetings if needed: to review the task order requirements, timelines, milestones and deliverables; discuss task order plans and approaches and identify any anticipated difficulties in completing the task order requirements;

o Standing and/or ad hoc teleconferences/webinars: as requested by the Contracting Officer Representative (COR), Contracting Officer (CO) or study team, participate in teleconferences or webinars to review progress and performance, discuss modifications to procedures, and/or discuss other issues related to project management or infrastructure of the overall contract or Task Order work;

o Site Visits: Host site visits for the COR, CO and other FDA staff, as needed;

o Prepare minutes of all site visits and teleconferences/webinars and submit to the

COR, CO, or FDA study team for review and approval within 2 business days of the meetings.

• Archive the final locked dataset conducted under each task order in Performance Area 2 in an agreed upon format (e.g., R, SAS, SPSS, ASCII) that is readily usable by FDA or FDA designee.

• Within 45 days of Task Order expiration, the contractor shall provide the COR, CO, or FDA study team with a proposed Transition Plan for an orderly and complete transition/relocation of the task order resources to a successor Contractor or to the Government. The plan shall include details on the relocation/disposition of: unused materials and supplies; manuals and directories developed by the contractor; and all other government property not listed. Upon written direction by the Government, the contractor shall transfer all Government property as directed, and fully cooperate with any successor contractor and the Government to ensure an efficient transfer.

• Audit(s): The FDA at their discretion may undertake an audit of the contractor’s facility including all collaborating sites. The contractor shall make available all facilities, records and files as related to any activity under performance area 2. The contractor will submit a report describing the implementation of any corrective actions.

B. Study Agents and Biological Specimens

Study Agents

• Maintain inventory records of study agent(s) in accordance to the SOPs.

• Maintain documentation that the study agent(s) will be stored and quarantined under appropriate conditions per the sponsor and regulatory requirements.

Biological Specimens and management of all collected biological specimens.

• Ensure shipping of biological specimens for testing and/or repository deposition, as specified in the protocol, in compliance with current Good Laboratory Practice (cGLP), cGCP and domestic laws and regulations as applicable.

• Each agent will be considered potentially hazardous. Therefore, all necessary precautions must be taken to protect personnel and the environment against possible exposure to the agents being tested. The contractor shall perform all work associated with this contract in accordance with all applicable Federal, State and local regulations including transportation and disposal of hazardous waste.

C. Analysis, Close-Out and Final Reporting

Close-Out and Analysis

Following completion of Task Order work, the contractor shall (in discussion with the FDA study team):

• Complete data editing/cleanup

• Finalize and lock the database

• Deliver the locked database in agreed upon format (e.g., R, SAS, SPSS, ASCII) and schedule as requested by the COR, CO, or FDA study team

Completion

In discussion with the FDA study team:

• Prepare for archiving the final dataset and all associated records. Records are considered detailed documentation necessary to assess the final dataset with specific codes for all variables including all transformation that have been created (i.e., data dictionary), as needed.

• Prepare and deliver draft and final report, as appropriate and as needed.

Facilities, Equipment and Other Resources and other resources necessary for the conduct of bioanalytical work, which may include, but is not limited to, the following.

Provide Laboratory Facility

• Adequate space for the processing and storage of biological specimens.

• Adequate facilities and equipment for conducting protocol-required tests and assays such as PK and specialty PD assays on blood, plasma, other body fluids and tissues found in both animal species and humans, as applicable and as needed.

• On-site sample storage facilities at room temperature, 4, -20 and -70 degrees Celsius.

• Clinical laboratory support services with provisions of 24 hours/day testing if required by the protocol.

Provide Information Technology System

• Securely submitting, compiling, storing, collating, analyzing, tracking and retrieving data, structures, results, specimens, reagents, biological agents, drug product produced and released, documents generated in product development, and data received from other compound screening activities performed by third parties. This database will contain confidential/ proprietary information that shall not be used for data-mining purposes by the contractor or any potential subcontractors.

• Ensuring secure electronic communications, including email, word processing and transmission of data files, between the contractor, FDA staff, subcontractors and consultants.

• Organizing, maintaining, and transferring information on protocols and test results and provide electronic copies of all reports to the COR, CO, or FDA study team. All electronic deliverables shall comply with Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d).

• Maintaining the confidentiality of data received from FDA or third parties and data generated within the scope of the contract. [Note: The Government reserves the right to have complete access to those files relevant to FDA studies in databases, provide access to third parties, and to transfer all rights and custody to a successor contractor.]

Provide other facilities and equipment, as may be specified by the Task Order protocols.

Performance Area 3: In vitro and ex vivo laboratory assay support for drug metabolism, drug transport, drug binding etc.

Under this performance area, the contractor shall perform activities related to development of laboratory work that may include sensitive bioanalytical methods and validation per current FDA guidance followed by quantitative analyses of drug and/or metabolite concentrations, biomarkers in plasma/serum, urine, tissue homogenates, and other biological fluids found in animal species and humans, as applicable for small and large molecules for study samples. Contractor will be responsible for final bioanalytical reports and for shipping samples to designated facility if needed. Assay and analysis of in vitro and in vivo samples may also include but not be limited to FDA standard measurements for drug-drug interaction and receptor binding. Contractor will be responsible for final reports for all assays and for shipping sampled to subcontracted or alternate site.

The general requirements for the different components under performance Area 3 are as

• Prepare responses to TORFPs issued solely under performance Area 3 (or, if applicable, in combination with performance area 1 and/or 2)

• Provide a Principal Investigator (PI) or other managerial designate and appropriate development, implementation and maintenance of a project management plan to ensure effective management of the contract infrastructure including support services, the tracking of progress, communication and preparation of deliverables and the archival activities.

• Prepare and deliver a Project Management Plan (PMP) within 30 days after the base/initial Task Order award. The PMP shall address and include, at a minimum, the following (if needed, alterations to this requirement will be made in specific Task Orders):

o Standard operating procedures (SOPs) for the conduct of bioanalytical/biomarker or laboratory work as specified in the Task Order and for all other integrated and collaborating services;

o Data management procedures and systems planning that complies as specified with the contract terms and conditions including but not limited to development of databases using specified common data elements where applicable, data collection and data monitoring;

o Laboratory quality monitoring procedures, as appropriate;

o Procedures for preventing, identifying, handling, reporting and resolving protocol deviations;

o Quality control plans and procedures;

o Establishment and demonstration for independence of oversight including quality assurance procedures;

o Archival plans for securing completed data per regulatory requirements;

o Contingency planning for operational delays and interruptions; and milestones and deliverables; discuss task order plans and approaches and identify any anticipated difficulties in completing the task order requirements;

o Standing and/or ad hoc teleconferences/webinars: as requested by the Contracting Officer Representative (COR), Contracting Officer (CO) or study team, participate in teleconferences or webinars to review progress and performance, discuss modifications to procedures, and/or discuss other issues related to project management or infrastructure of the overall contract or Task Order work;

o Site Visits: Host site visits for the COR, CO and other FDA staff, as needed;

o Prepare minutes of all site visits and teleconferences/webinars and submit to the

• Archive the final locked dataset conducted under each task order in Performance Area 2 in an agreed upon format (e.g., R, SAS, SPSS, ASCII) that is readily usable by FDA or FDA designee.

transition/relocation of the task order resources to a successor Contractor or to the Government. The plan shall include details on the relocation/disposition of: unused materials and supplies; manuals and directories developed by the contractor; and all other government property not listed. Upon written direction by the Government, the contractor and files as related to any activity under performance area 2. The contractor will submit a

B. Study Agents and Biological Specimens

Study Agents

• Maintain inventory records of study agent(s) in accordance to the SOPs.

• Maintain documentation that the study agent(s) will be stored and quarantined under appropriate conditions per the sponsor and regulatory requirements.

Biological Specimens and management of all collected biological specimens.

• Ensure shipping of biological specimens for testing and/or repository deposition, as specified in the protocol, in compliance with current Good Laboratory Practice (GLP), and domestic laws and regulations as applicable.

• Each agent will be considered potentially hazardous. Therefore, all necessary precautions must be taken to protect personnel and the environment against possible exposure to the agents being tested. The contractor shall perform all work associated with this contract in accordance with all applicable Federal, State and local regulations including transportation and disposal of hazardous waste.

C. Sample Analysis, Close-Out and Final Reporting

Close-Out and Analysis

Following the completion of Task Order work, the contractor shall (in discussion with the FDA study team):

• Prepare for archiving the final dataset and all associated records. Records are considered detailed documentation necessary to assess the final dataset with specific codes for all variables including all transformation that have been created (i.e., data dictionary), as needed.

• Complete data editing/cleanup

• Finalize and lock the database

• Deliver the locked database in agreed upon format (e.g., R, SAS, SPSS, ASCII) and schedule as requested by the COR, CO, or FDA study team

Completion - In discussion with the FDA study team

• Prepare for archiving the final dataset and all associated records. Records are considered detailed documentation necessary to assess the final dataset with specific codes for all variables including all transformation that have been created (i.e., data dictionary), as needed.

• Within 45 days of Task Order expiration, the contractor shall provide the COR, CO, or FDA study team with a proposed Transition Plan for an orderly and complete transition/relocation of the task order resources to a successor Contractor or to the Government. The plan shall include details on the relocation/disposition of: unused materials and supplies; manuals and directories developed by the contractor; and all other government property not listed. Upon written direction by the Government, the contractor

• Prepare and deliver draft and final report, as appropriate and as needed.

• Audit(s): The FDA at their discretion may undertake an audit of the contractor’s facility including all collaborating sites. The contractor shall make available all facilities, records and files as related to any activity under performance Area 3. The contractor will submit a report describing the implementation of any corrective actions.

D. Facilities, Equipment and Other Resources and other resources necessary for the conduct of bioanalytical work, which may include, but is not limited to, the following.

Provide Research Laboratory Facility

• Adequate space for the processing and storage of chemicals, drugs and biological specimens.

• Adequate facilities and equipment for conducting protocol-required tests and assays.

• On-site sample storage facilities at room temperature, 4, -20 and down to -80 degrees

Celsius.

• Laboratory support services with provisions of 24 hours/day testing if required by the protocol.

• Licenses and capabilities to work with scheduled compounds

Provide Information Technology System

• Securely submitting, compiling, storing, collating, analyzing, tracking and retrieving data, structures, results, specimens, reagents, biological agents, drug product produced and released, documents generated in product development, and data received from other compound screening activities performed by third parties. This database will contain confidential/ proprietary information that shall not be used for data-mining purposes by the contractor or any potential subcontractors.

• Ensuring secure electronic communications, including email, word processing and transmission of data files, between the contractor, FDA staff, subcontractors and consultants.

• Organizing, maintaining, and transferring information on protocols and test results and provide electronic copies of all reports to the COR, CO, or FDA study team. All electronic deliverables shall comply with Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d).

• Maintaining the confidentiality of data received from FDA or third parties and data generated within the scope of the contract. [Note: The Government reserves the right to have complete access to those files relevant to FDA studies in databases, provide access to third parties, and to transfer all rights and custody to a successor contractor.]

• Provide other facilities and equipment, as may be specified by the Task Order protocols.

Performance Area 4: GMP manufacturing of API and Production final dosage form.

Under this performance area, the contractor shall perform activities under GMP conditions to manufacture API requested by FDA. Contractor would be responsible for characterization and final release of the API under FDA directions. Contractor should have ability and GMP facility for production of the final dosage form. Contractor will follow FDA guidelines in the manufacture, certification and release of the final dosage form. Contractor would also be responsible for all development of analytical, testing, release and stability testing methods needed for the production and release of the API and the dosage form.

The general requirements for the different components under performance Area 4 are as

• Prepare responses to TORFPs issued solely under performance Area 4

• Provide a manufacturing supervisor (MS) or other managerial designate and appropriate development, implementation and maintenance of a project management plan to ensure effective management of the contract infrastructure including support services, the tracking of progress, communication and preparation of deliverables and the archival activities.

• Prepare and deliver a Project Management Plan (PMP) within 30 days after the base/initial Task Order award. The PMP shall address and include, at a minimum, the following (if needed, alterations to this requirement will be made in specific Task Orders):

o All SOPs and GMP will followed;

o API and product management procedures and systems planning that complies as specified with the contract terms and conditions;

o Laboratory quality monitoring procedures, as appropriate;

o Procedures for preventing, identifying, handling, reporting and resolving manufacturing issues;

o Quality control plans and procedures;

o Establishment and demonstration for independence of oversight including quality assurance procedures;

o Archival plans for securing completed data per regulatory requirements;

o Contingency planning for operational delays and interruptions; and milestones and deliverables; discuss task order plans and approaches and identify any anticipated difficulties in completing the task order requirements;

o Standing and/or ad hoc teleconferences/webinars: as requested by the Contracting Officer Representative (COR), Contracting Officer (CO) or study team, participate in teleconferences or webinars to review progress and performance, discuss modifications to procedures, and/or discuss other issues related to project management or infrastructure of the overall contract or Task Order work;

o Site Visits: Host site visits for the COR, CO and other FDA staff, as needed;

o Prepare minutes of all site visits and teleconferences/webinars and submit to the transition/relocation of the task order resources to a successor Contractor or to the Government. The plan shall include details on the relocation/disposition of: unused materials and supplies; manuals; batch records and directories developed by the contractor; and all other government property not listed. Upon written direction by the Government, the contractor shall transfer all Government property as directed, and fully cooperate with any successor contractor and the Government to ensure an efficient transfer.

and files as related to any activity under performance area 4. The contractor will submit a

B. API and Dosage forms

• Maintain inventory records of API and manufactured dosage forms in accordance to the SOPs and GMP regulations.

• Maintain documentation that the study agent(s) will be stored and quarantined under appropriate conditions per the sponsor and regulatory requirements.

• Mechanism for the return and/or destruction of study material.

• Precautions must be taken to protect personnel and the environment against possible exposure to the agents being tested. The contractor shall perform all work associated with this contract in accordance with all applicable Federal, State and local regulations including transportation and disposal of hazardous waste.

C. Sample Analysis, Close-Out and Final Reporting

Following completion of Task Order work, the contractor shall (in discussion with the FDA study team):

• Prepare for delivery and archiving all manufacturing, analysis, stability and release related records.

DELIVERABLES/REPORTS

Technical Performance Reports

Performance Area 1

The Contractor shall be required to prepare and deliver the following reports during the base year (and subsequent option years) of the initial Task Order award for Performance Area 1:

• Progress Report-Progress report requirements will be outlined in specific Task Orders, as needed and appropriate.

Project Management Plan (PMP)

• The PMP report shall address and include all elements as listed in the SOW requirements for this report as set forth under Performance Area A or according to the PMP requirements in specific Task Orders.

• Reporting requirements may be amended or updated with each Task Order award.

SOW Deliverable Delivery Schedule Program/Project Management

Copies of all relevant contractor SOPs and/or manuals for studies in the Task Order; relevant documents for study personnel including CVs and signed non-disclosure agreements

Within 3 months after or award or before any study initiation dates (whichever is earliest)

Project Management Plan 2 business days after meeting

Protocol Development and Finalization

Final protocol and any related amendments/modifications, to include all required regulatory forms

3 weeks after receiving protocol synopsis from the Government unless otherwise specified in Task Order

Approval from local IACUC 3 months after award Study Execution Summary Report for each study meeting 2 business days after meeting

Locked database to be specified by the terms of each study protocol

Will be determined by terms of each trial Task Order

Study Analysis, Close-Out and Final Reporting

Will be determined by terms of each trial Task Order

Shipment of study biological specimens to FDA for storage or disposal as outlined in the Task Order

Will be determined by terms of each trial Task Order

Performance Area 2

The Contractor shall prepare and deliver the following reports for each Task Order awarded under Performance Area 2:

• Progress Report-Progress report requirements will be outlined in specific Task Orders, as needed and appropriate.

Project Management Plan (PMP)

• The PMP report shall address and include all elements as listed in the SOW requirements for this report as set forth under Performance Area 2 or according to the PMP

Management

Copies of all relevant contractor SOPs and/or manuals for studies in the Task Order; relevant documents for study personnel including CVs and signed non-disclosure agreements

Within 3 months after or award or before any study initiation dates (whichever is earliest)

Project Management Plan 2 business days after meeting

Protocol Development and Finalization

Final protocol and any related amendments/modifications

Draft documents 3 weeks after receiving protocol synopsis from the FDA unless otherwise specified in Task Order

Study Execution Summary Report and adverse event reports for each study meeting frequency designated in TORFP

2 business days after meeting

Study Analysis, Close- Out and Final Reporting

Locked database to be specified by the terms of each study protocol

Will be determined by

Shipment of study biological specimens to FDA for storage or disposal as outlined in the Task Order

Will be determined by

Performance Area 3 under Performance Area 3:

for this report as set forth under Performance Area C or according to the PMP

Management

Copies of all relevant contractor SOPs and/or manuals for studies in the Task Order; relevant documents for study personnel including CVs and signed non-disclosure agreements

Within 3 months after or award or before any study initiation dates (whichever is earliest)

Project Management Plan 2 business days after meeting

Protocol Development and Finalization

Final protocol and any related amendments/modifications

Draft documents 3 weeks after receiving protocol synopsis from the FDA unless otherwise specified in Task Order

Study Execution Summary Report and adverse event reports for each study meeting frequency designated in TORFP

2 business days after meeting

Study Analysis, Close- Out and Final

Will be determined by terms of each trial Task Order

Shipment of study biological specimens to FDA for storage or disposal as outlined in the Task Order

Will be determined by

Performance Area 4 under Performance Area 4:

for this report as set forth under Performance Area 4 or according to the PMP

Management

Copies of all relevant contractor SOPs and/or manuals for studies in the Task Order; relevant documents for study personnel including CVs and signed non-disclosure agreements

Within 3 months after or award or before any study initiation dates (whichever is earliest)

Project Management Plan 2 business days after meeting

Protocol Development and Finalization

Final protocol and any related amendments/modifications

Draft documents 3 weeks after receiving protocol synopsis from the FDA unless otherwise specified in Task Order

Study Execution Summary Report and adverse event reports for each study meeting frequency designated in TORFP

2 business days after meeting

Study Analysis, Close- Out and Final

Will be determined by

INSTRUCTIONS FOR RESPONSE

Your responses to the questions provided below will assist the Government in selecting the appropriate acquisition method. Page limit: Maximum 10 pages (font size Times New Roman 11 or larger). A copy of the company capability statement will also be accepted (but not in place of the responses to the below questions). The anticipated period of performance for the anticipated IDIQ Contract is 5 years from date of award with an estimated value well-exceeding $10M. After review of the responses received, a formal solicitation may be published on Beta.SAM.

Responses to this RFI must include company name, address, point of contact, size of business pursuant to the NAICS code.

Responses shall address each of the following:

1. Describe your present work volume capacity to provide the types of services required under the project description to the best of your abilities with a brief statement addressing current staffing and resources, clearly addressing the limiting factor of pre-existing demands place upon you from existing customers.

*Please include a very brief synopsis of existing contracts/projects awarded – to include complexity and value, along with customer contact information.

2. Describe your proven capability to provide the services described herein.

3. Describe your experience providing services described herein, with an emphasis on the magnitude and complexity of the contracts/projects for same/similar services.

4. Is your business a small business under the NAICS code?

5. Does your firm qualify as a small disadvantaged business?

6. If disadvantaged, specify if your firm is certified under Section 8(a) of the Small

Business Act?

7. Are you considered a certified HUBZone firm?

8. Are you considered woman-owned or operated business?

9. Are you a certified Service-Disabled Veteran-Owned or Veteran-Owned business?

10. Current GSA Schedules appropriate for this requirement, if applicable.

11. Indicate if your organization/entity has provided the expertise needed to fulfill requirements in all 4 performance areas identified above and provide a description of the completed projects.

12. Identify any existing or anticipated joint venture or teaming arrangements that would provide full coverage of all activities indicating whether this coverage could be provided via one or more of the Government Contract vehicle(s) (GSA Schedules, GWAC, etc.).

Responses to this RFI are due no later than 1:00 PM Eastern time April 02, 2021.

Questions and Responses are to be e-mailed to Telisha Wilson, Contract Specialist, at Telisha.Wilson@fda.hhs.gov. Please include Reference No. FDA-21-RFI-1238783 in the subject line when responding to this notice.

Please be advised that .zip and .exe files cannot be accepted, nor any documents with embedded Macros.

The contact information for the Contract Specialist is the following:

Telisha Wilson U.S. Food and Drug Administration Office of Acquisitions and Grants Services 4041 Powder Mill Road Beltsville, MD 20705 Telisha.Wilson@fda.hhs.gov mailto:Telisha.Wilson@fda.hhs.gov