Attachment_5_-_Sample_Task_Orders.pdf

ATTACHMENT 5: TASK ORDER A

ADMINISTRATIVE AND MANAGEMENT SUPPORT ACTIVITIES

[ASSOCIATED WITH TASK AREA A: ADMINISTRATIVE AND MANAGEMENT

SUPPORT AND ACTVITIES]

EVALUATION AND TESTING SERVICES (ETS) FOR VACCINES AND OTHER

BIOLOGICS FOR INFECTIOUS DISEASES

75N93024R00019

NOTE: All Offerors must submit to this Task Area. NIAID anticipates issuing Task Order A on the effective date of the contract. Offerors are to include in their proposals a response that specifies the methods by which this Task Order will be accomplished with associated costs. Offerors should refer to the Additional Technical Proposal Instructions and Additional Business Proposal Instructions for guidance regarding preparation of their proposals.

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

I. SCOPE

The scope of this Task Order includes administrative and contract management functions performed by the Contractor in support of NIAID’s contract entitled “EVALUATION AND

TESTING SERVICES (ETS) FOR VACCINES AND OTHER BIOLOGICS FOR

INFECTIOUS DISEASES” which occurs independently of other specific Task Orders to be awarded under the contract.

II. TECHNICAL REQUIREMENTS

Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below.

For the purpose of the Task Order, the Contractor shall perform the tasks identified in the Project Management, Section III below.

III. PROJECT MANAGEMENT

Overall Project Management and Administration

A. Initiation Master Project Meeting (Occurs in the Base for Year 1)

Plan and participate in the one-day Initiation Master Project Meeting to be held in Rockville, Maryland, in the Contractor’s vicinity, or virtually within two months following the effective date of this Task Order. The meeting is to be attended by the Contractor Principal Investigator and other relevant key Contractor technical and business staff, the COR and his/her designees, and the Contracting Officer and/or his/her designees. The purpose of the Initiation Master Project Meeting shall be to:

1. Introduce Contractor and NIAID staff.

2. Discuss the terms and conditions of the Task Order including reporting structure.

3. Review transition plans and activities and materials to be prepared and submitted within the first three months of the task order period of performance.

4. Establish priorities and timelines and associated task-linked budgets for specific activities and Task Orders.

B. Site Visits/ Audits

1. Conduct a site visit or audit for the purpose of assessing capabilities, quality systems, processes, training, equipment, facilities, and standard operating procedures. This includes travel associated with the site visit.

2. An Informational Report for site visits will be provided as the deliverable by Contractor to NIAID. For audits, an Audit Report with responses from audited site will be provided as a deliverable.

C. General Requirements For All Meetings Under This Task Order

1. Prepare and distribute agenda and background materials no later than two business days in advance to all meeting attendees.

2. Organize, coordinate, and record minutes for the above meetings. Provide meeting minutes to the COR for review within three business days post-meeting.

3. Provide travel and per diem funds for all meetings, as necessary and as directed and approved by NIAID for participants, including the Contractor Principal Investigator, Project Managers, key personnel, and selected subcontractors.

D. Monthly and Final Progress Reports

Reports shall include the following information:

a. Scope;

b. Progress on Milestones and Deliverables (actions taken to achieve the task);

c. Schedule analyses of estimated completion date with actual;

d. Discussion of schedule variance;

e. Financial Summary: a task-linked budget report to include any modifications in cost that were incurred during the reporting period;

a. High Level Financial Summary of Task Orders to date and period of performance.

E. OPTIONS

In order to implement the continuation of the services to be provided as outlined above, Options for the extension of this Task Order’s Base Period of performance may be exercised at the discretion of the Government and are defined as follows:

The Government may extend the Task Order’s period of performance (task order term) by yearly increments (not to exceed 12 months each) to be commensurate with the IDIQ contract term. The Government may exercise this Option up to nine times during the life of the Task Order. The total period of performance resulting from the Base Period plus all Options is 10 years. Upon each exercise of this Option, the services will consist of the same scope and technical requirements as described above.

IV. REPORTING REQUIREMENTS AND DELIVERABLES

Required Reports and Deliverables for each section of the Statement of Work can be found in Attachment 6: Reporting Requirements and Deliverables.

[END OF TASK AREA A STATEMENT OF WORK]

ATTACHMENT 5: SAMPLE TASK AREA B

ASSAY DEVELOPMENT, CLINICAL AND NON-CLINICAL SAMPLE TESTING

[SAMPLE ASSOCIATED WITH TASK AREA B]

NOTE: Submission of this Task Order is at the discretion of the Offeror. Only Offerors that submit to this Task Area will be evaluated for inclusion in the Task Area pool. The following Sample Task Order indicated in this Attachment is provided to assess the Offeror’s capabilities to conduct and fulfill the requirements of the Statement of Work for projects of similar scope and size to be issued under contracts awarded in response to this solicitation. Although the Task Order will NOT be executed, nor will awards be made for the Task Order, Offerors are to include in their proposals a response that specifies the methods by which the Task Order will be accomplished and the project management plan, with associated costs. Offerors should refer to the Additional Technical Proposal Instructions and Additional Business Proposal Instructions for guidance regarding preparation of their proposals.

The scope of the activity to be supported under this Sample Task Order is to develop immunoassays for a vaccine in accordance with FDA and ICH guidelines and to perform immunoassays on clinical and non-clinical samples. For the purposes of this Sample Task Order the Offeror shall choose a viral pathogen that causes human disease and develop assays against an antigen relevant to the pathogen..

provided by the Government under the terms of the contract, as needed to undertake targeted research essential to translating basic research concepts into a candidate vaccine product.

The scope of activities to be performed under this Sample Task Order is to develop cellular and humoral immunogenicity assays against the viral protein antigen.

Assume the following:

• Some reagents and other materials needed for assay development and optimization can be obtained from BEI Repository (BEI Resources Repository, https://www.niaid.nih.gov/research/bei-resources-repository) and/or COR-designated site(s). Others will have to be procured or generated by the Contractor.

• Individual Contractors may provide a subset of the activities described within the scope.

Specifically, the Contractor shall:

A. Develop, Qualify and Validate Humoral Assays

1. Explore assay format options for immunoassays to quantitate antigen specific serum IgG and mucosal IgA humoral responses in non-human primates andhumans against the viral protein antigen.

2. Develop a functional assay for the antigen specific response.

3. Prepare and provide an Assay Development /Reagent Procurement Plan.

4. Prepare and provide a Study Plan / Protocols.

5. Develop product specific control reagents and methods.

6. Prepare and provide an Assay Development Report.

7. Prepare and provide assay qualification protocol(s).

8. Prepare and provide Draft Validation Protocols for human serum IgG and mucosal IgA assays, including a statistical analysis plan for COR review and approval.

9. Provide COR-approved Final Validation Protocols.

10. Perform validation of the IgG and IgA assays.

11. Prepare and provide a Draft Validation Report for the assays for COR review and approval.

12. Provide a COR-approved Final Validation Report.

B. Develop Cellular Based Immune Assays

1. Explore assay format options for assays to evaluate cellular immune responses in non-human primates and/or humans against the viral protein antigen evaluating T cell and B cell responses to the antigen.

2. Prepare and provide an Assay Development /Reagent Procurement plan.

3. Prepare and provide a Study Plan / Protocols.

4. Develop all methods necessary to support the work for this SOW. Supply all animals and animal derived reagents required for this SOW and develop product specific control reagents.

5. Prepare and provide assay development report(s).

C. Sample Testing

1. Prepare and provide Draft Protocols as required for assays, including a statistical analysis plan for COR review and approval.

2. Provide COR-approved Final Protocols.

3. Receive and store serum samples from pre-clinical and/or clinical subjects and determine the immune response.

https://www.niaid.nih.gov/research/bei-resources-repository

4. Perform assays as required on samples from 18 NHP at 5 timepoints for serum and nasal samples and for 60 human participants at 5 timepoints for serum and nasal samples.

5. Perform cellular assays on frozen Peripheral blood mononuclear cells (PBMC) for 50 human subjects at 2 timepoints.

6. Perform assays on clinical specimens in accordance with FDA guidelines.

7. Perform control assays and trend analysis to monitor assay performance over time.

8. Submit results from human samples electronically into an electronic clinical specimen tracking and data management web site as directed by COR.

9. Prepare and provide Draft Study Report summarizing the pre-clinical and/or clinical sample testing for review by the COR, including a description of clinical sample testing; activities and procedures performed, control assays and trend analysis to monitor assay performance over time, salient accomplishments or issues and their resolution, high level recommendations for improving the process, and other information as required by the COR.

10. Provide a COR-approved Final Study Report.

III. QUALITY MANAGEMENT

The Contractor shall develop and /or qualify immunoassays for a vaccine candidate in accordance with FDA and ICH guidelines.

Required Reports and Deliverables for each section of the Statement of Work can be found in Attachment 6: Reporting Requirements and Deliverables.

[END OF SAMPLE TASK AREA B STATEMENT OF WORK]

ATTACHMENT 5: SAMPLE TASK AREA C

NON-CLINICAL IMMUNOGENICITY AND EFFICACY TESTING

[SAMPLE ASSOCIATED WITH TASK AREA C]

following Sample Task Order indicated in this Attachment is provided to assess the Offeror’s capabilities to conduct and fulfill the requirements of the Statement of Work for projects of similar scope and size to be issued under contracts awarded in response to this solicitation. Although the Sample Task Order will NOT be executed nor will awards be made for the Sample Task Order, Offerors are to include in their proposals a response that specifies the methods by which each Sample Task Order will be accomplished and the project management plan, with associated costs. Offerors should refer to the Additional Technical Proposal Instructions and Additional Business Proposal Instructions for guidance regarding preparation of their proposals.

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

The scope of the activities to be supported under this Sample Task Order is the design and conduct of immunogenicity and efficacy testing in NHPs for a vaccine against a human pathogen of the Offeror’s choice in accordance with FDA and ICH guidelines.

provided by the Government under the terms of the contract, as needed to undertake targeted research essential to translating basic research concepts into a candidate vaccine product.

The scope of the activities to be supported under this Sample Task Order is the conduct of immunogenicity and efficacy testing of the vaccine to provide proof-of-concept data for submission for a regulatory filing with the FDA.

Assume the following:

A. The sponsor has a relevant animal model of infection sufficiently developed to allow testing of vaccine candidates.

B. The planned clinical dosing regimen is 2 vaccinations at days 0 and 30.

C. NIAID will provide vaccine product, vehicle control, and access to an appropriate challenge strain.

D. The product is formulated in individual use vials such that a 0.2 mL volume contains the target clinical dose.

E. The Contractor shall specify if they will use only in house animals or animals furnished by the government.

F. NIAID will provide Animal Case Report Forms (CRFs) to capture data from the study quarantine period.

Specifically, the Contractor shall:

1. Propose a Study Plan to transfer the sponsor developed nonhuman primate study to the Contractor’s or Subcontractor’s site.

2. Design a nonpivotal vaccination and challenge study that would provide proof of concept data to support vaccine studies in humans, including a description of:

a. Doses, dosing regimen, route of administration of the vaccine, and study duration.

b. The experimental groups, and number of animals per group.

c. The testing schedule and assays used to determine immunogenicity and efficacy endpoints.

d. Schedule and performance of challenge.

e. All subsequent testing, including clinical chemistry, gross pathology and histopathology.

f. Any other relevant endpoints.

3. Prepare and provide Draft Study Protocols for COR review.

4. Provide a COR-approved Final Study Protocol.

5. Perform the proposed immunogenicity and efficacy study and supporting assays.

6. Prepare and provide a Draft Study Report for COR review.

7. Provide a COR-approved Final Study Report.

8. Provide the COR-approved Final Study Report in support of an FDA application.

9. Provide an e-data set associated for this animal study using FDA guidelines for

Providing Regulatory Submissions.

10. Provide Animal Case Report Forms (CRFs) and scanned raw data.

The Contractor shall comply with all applicable sections of the Final Rules of the Animal Welfare Act regulations (9 CFR Parts 1, 2, and 3) and Guide for the Care and Use of Laboratory Animals – National Academy Press, Washington D.C. 1996 (the Guide) and conduct studies in an AAALAC (Association for the Assessment and Accreditation of Laboratory Animal Care)-accredited facilities. While strict compliance to 21 CFR 58, GLP is not a requirement of the Task Order, the Contractor shall execute and document all study activities/tasks sufficiently to facilitate reproducibility, to demonstrate adherence to study documents, including all relevant SOPs and protocols, to show that study performance aligns with the executed Final Study Protocol and that there is sufficient quality oversight of the study. In addition, the Contractor shall assure the quality and integrity of the data generated at their facility and/or Subcontractor facility by performing an audit of the study data file and the study report.

The Contractor shall submit to the NIAID COR for review and approval a Plan for monitoring the quality of the studies (Quality Agreement Plan) executed by a Subcontractor. This Plan must meet pharmaceutical industry standards for critical phase monitoring of studies. The Contractor shall propose which critical phases of the study will be carried out by the Subcontractor that the Contractor plans to inspect and/or audit.

Written summaries from these critical phase inspections as well as audit reports shall be deliverables under this task order. These are in addition to the audit of the study data and study report prior to finalization.

Required Reports and Deliverables for each section of the Statement of Work can be found in Attachment 6: Reporting Requirements and Deliverables.

[END OF SAMPLE TASK AREA C STATEMENT OF WORK]

ATTACHMENT 5: SAMPLE TASK AREA D

SAFETY AND TOXICITY TESTING INCLUDING SPECIALTY TOXICOLOGY

ASSOCIATED WITH TASK AREA D

following Sample Task Order indicated in this Attachment is provided to assess the Offeror’s capabilities to conduct and fulfill the requirements of the Statement of Work for projects of similar scope and size to be issued under contracts awarded in response to this solicitation. Although the Sample Task Order will NOT be executed nor will awards be made for the Sample Task Order, Offerors are to include in their proposals a response that specifies the methods by which each Sample Task Order will be accomplished and the project management plan, with associated costs. Offerors should refer to the Additional Technical Proposal Instructions and Additional Business Proposal Instructions for guidance regarding preparation of their proposals.

The scope of the activity to be supported under this Sample Task Order is to assess, design, and conduct safety and toxicity testing of a vaccine in accordance with FDA and ICH guidelines and in compliance with Good Laboratory Practices regulations.

provided by the Government under the terms of the contract, as needed to undertake targeted research essential to translating basic research concepts into a candidate vaccine product.

The scope of the activity to be supported under the Sample Task Order (TO) is to assess, design, and conduct safety and toxicity testing of NIAID vaccine candidates in accordance with FDA and International Conference on Harmonization (ICH) guidelines and in compliance with Good Laboratory Practices (GLP) regulations (21 CFR 58).

These guidelines prescribe, in a specific and consistent manner, how safety and toxicity testing of vaccines is to be conducted. This guidance facilitates development of a

Statement of Work (SOW) that is specific with regard to required activities but also general enough that it is applicable to all vaccines.

For the purpose of this Sample Task Order, the vaccine candidate will consist of a virally vectored vaccine that express a heterologous viral glycoprotein from a human pathogen.

The intended clinical use of this vaccine will consist of prime- boost vaccinations to be administered on days 0 and 28.

Assume the following:

NIAID will provide sufficient vaccine material in single use vials. The prime and boost vaccines each contain a viral vector that expresses the glycoprotein in a formulation appropriate to achieve the highest clinical dose. NIAID will also provide a control article, Immunogenicity readouts will be performed by the vaccine manufacturer or a third party and provided to be appended to the toxicity report. NIAID will audit the draft final safety and toxicity report.

Specifically, the Contractor shall:

A. Design and provide a draft Safety and Toxicology Protocol for COR review and submission in a pre-IND, including a description of:

a. Doses, dosing regimen, route of administration, and study duration.

b. The animal model(s), group descriptions, and number of animals per group.

c. The testing schedule for immune response and safety/toxicity endpoints.

d. The safety and toxicity endpoints throughout the study and at study termination.

e. Any other relevant endpoints to be assessed.

B. Provide a draft Study Protocol for approval prior to initiation of study.

C. Provide a COR-approved Final Study Protocol.

D. Perform the safety and toxicity studies.

E. Supply all animals and animal derived reagents required for this SOW.

F. Provide a draft Final Safety and Toxicity Report for NIAID review and approval.

G. Provide a Final Safety and Toxicology Study Report.

H. Provide an e-data set associated for this animal study using FDA guidelines for

Providing Regulatory Submissions.

This Sample Task Order requires typical industry practice quality/regulatory compliance appropriate for the conduct safety and toxicity testing in accordance with FDA and International Conference on Harmonization (ICH) guidelines and in compliance with Good Laboratory Practices (GLP) regulations (21 CFR 58).

I. REPORTING REQUIREMENTS AND DELIVERABLES

Required Reports and Deliverables for each section of the Statement of Work can be found in Attachment 6: Reporting Requirements and Deliverables.

[END OF SAMPLE TASK AREA D STATEMENT OF WORK]