Attachment_7_-_Technical_Proposal_Instructions.pdf

ATTACHMENT 7: ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS,

FORMAT FOR TECHNICAL PROPOSAL, and TABLE OF CONTENTS

EVALUATION AND TESTING SERVICES (ETS) FOR VACCINES AND OTHER

BIOLOGICS FOR INFECTIOUS DISEASES

75N93024R00019

It is strongly recommended that Offerors use the following template as the Table of Contents for the Technical Proposal. All information presented in the Technical Proposal should be presented in the order specified below.

These additional Technical Proposal instructions reflect the requirements of the solicitation and provide specific instructions and formatting for the Technical Proposal. While Section L of the solicitation provides a generic set of Technical Proposal instructions applicable to all NIH R&D solicitations, these instructions are tailored to the specific requirements of the RFP. The information requested in these instructions should be used to format and prepare the Technical Proposal, and should be used as a Table of Contents for your Technical Proposal. Offerors should follow the instructions in Section L of the solicitation, and include the information requested here.

Offerors are advised to give careful consideration to the Statement of Work, all reference materials, and attachments, the Technical Evaluation Criteria in Section M, and the solicitation as a whole in the development of their Technical Proposals.

Offerors proposing subcontracts to perform portions of the Statement of Work should clearly identify the specific tasks for which they plan to utilize subcontractors, as well as the method and level of integration/coordination between the prime Contractor and all proposed subcontractors, and the expected advantages of such an approach.

Offerors must refer to the solicitation Attachment entitled “Packaging and Delivery of the Proposal,” which details strict guidelines, including page limitations, formatting and layout of proposals, and prohibits the Offerors use of links to internet web site addresses (URLs) to direct readers to alternate sources of information.

TECHNICAL PROPOSAL – TABLE OF CONTENTS

Note: The Government has requirements in all Task Areas, however, Offerors are not required to submit proposals in response to all Task Areas. All Offerors must submit separate proposals to Task Area A and at least one other Task Area (from Task Areas B, and/or C, and/or D). Offerors must submit one proposal per Task Area proposed. If submitting to all four Task Areas, you are required to submit four separate proposals.

Offerors should submit to Task Areas where they are capable to best meet the overall qualifications needed to fulfill the technical requirements of that Task Area. Each Technical Proposal must address all elements of the proposed Task Area and provide detailed plans in response to the Sample Task Order matching the proposed Task Area; as well as all General Task Order Requirements described in the statement of work. All proposals will be evaluated independently for the Task Area proposed.

If an Offeror submits a proposal to Task Areas A, as well as proposals for any combination of Task Areas B, and/or C, and/or D, award may occur for Task Area A as well as:

• any combination of Task Area B, and/or Task Area C, and/or D

• in addition to the possibility of no award.

SECTION 1:

1) PROPOSAL TITLE PAGE. Include RFP title, number and Task Area, name of organization, DUNS number, and identify if the proposal is an original or a copy. Offerors that include in their proposals data that they do not want disclosed to the public for any purpose, or used by the Government except for evaluation purposes, shall also include the legend regarding Restriction on Disclosure and Use of Data prescribed by FAR 52.215-1 (e)]

2) TABLE OF CONTENTS

SECTION 2: TECHNICAL PROPOSAL OVERVIEW (suggested 3-page maximum)

Provide a brief overview of the Technical Proposal, including:

1) A brief description of the activities proposed by the offeror and all proposed subcontractors, including identification of all proposed subcontractors and a list of key personnel for the offeror and the proposed subcontractors with degrees, titles and role in the project.

2) By area of expertise, provide the total number of staff, the number available to be assigned to the contract for the offeror and all proposed subcontractors, and total number of additional staff to be hired and trained.

3) A brief description of the facilities and equipment to be made available by the offeror and all proposed subcontractors.

SECTION 3: TECHNICAL PLAN/APPROACH FOR EACH TASK AREA

The Offeror’s ability to fulfill the requirements of the SOW will be assessed based on their responses to the Task Order and Sample Task Orders for each Task Area. Specific information for each Task Area are described in this section. In addition, the Offeror should follow these general approaches when responding to the Sample Task Orders for each of the Task Areas A-D:

https://www.acquisition.gov/sites/default/files/current/far/html/52_215.html

1. Describe any acquisition processes, procedures and anticipated timelines for obtaining any of the technical capabilities required to fulfill the SOW.

2. Describe in detail the proposed approaches, methodologies, plans and procedures to specifically complete the activities in the SOW.

3. Describe all capabilities that will be provided by external sources and identify the specific subcontractor, external vendor, or consortia partner for these resources if currently known.

4. Describe plans to maintain critical reagents and materials, including a change control program for critical reagents.

5. Describe capacity or throughput for performing these tasks.

6. Provide a timeline to complete the activities described in the Sample Task Order and include a Work Breakdown Structure (WBS) along with a Gantt chart.

7. Describe systems and plans to perform work with biohazardous (BSL-2, BSL-3, and BSL-

4) material and previous experience.

8. Discuss relevant organizational experience, problems, or obstacles encountered and approaches implemented to resolve or correct potential or identified problems.

9. Describe previous experience, i.e., similar technical capabilities for other vaccines, vaccine components, and other biologics not specified in each Sample Task Order. Use a tabular format to provide the following information:

a. With other product classes (vaccines and biologics).

b. Range of products within class.

c. Range of assays or platforms available.

d. Description of qualification or validation of assays (i.e., developed for non-GLP, qualified for GLP, qualified/validated for clinical samples).

e. Description of animal models previously used.

f. Description of whether work was performed in-house, outsourced, or a combination.

1. Administration and Contract Management Activities (Sample Task Order A)

a. Describe capabilities, processes, procedures to:

i. Organize and convene meetings of the principal investigators, key personnel of Contractor worksites and organize teleconferences and meetings.

ii. Organize, coordinate, and record meeting minutes.

iii. Prepare and submit Plans AND reports.

iv. Conduct site visits and/or audits for the purpose of assessing of capabilities, quality systems, processes and standard operating procedures.

v. Establish and maintain reliable electronic communication links for sharing word processing, data files, and product timelines in a format that is compatible with software used by NIAID.

2. Assay Development and Clinical and Non-Clinical Sample Testing (Sample Task

Order B)

a. Describe technical capabilities, processes, procedures, and timelines to develop, qualify, and validate test assays as defined below:

i. Humoral assays, including ELISA, neutralization, inhibition, immunoproteomics, and functional (cell based) assays.

ii. Cell-mediated immune (CMI) assays, including lymphoproliferation, intracellular cytokine determination, genetic expression arrays, ELISPOT, Luminex, and immunophenotyping. Describe the platforms (such as flow cytometry instrumentation and analysis software) that are available.

iii. Statistical analysis related to assay development, qualification and validation. Development of data reduction algorithms and system suitability criteria. Analysis of quality control data, including trending and tracking assay performance.

b. Describe plans to develop, qualify, and validate assays as required to achieve compliance with non-GLP, GLP, and CGMP regulations.

c. Describe plans to perform assay testing and monitor assay performance over time.

d. Describe plans to document and track sample receipt and management of inventory, reagent control, assay control, assay monitoring, and statistical review to support the conduct of the analysis.

3. Non-Clinical Immunogenicity and Efficacy Testing (Sample Task Order C)

a. Describe technical capabilities, processes, procedures, and timelines to:

i. Assess, develop, qualify and use the appropriate in vitro test assays.

ii. Obtain, quarantine, and house animals following appropriate regulatory guidelines and animal welfare guidelines.

iii. Perform animal models of disease and efficacy of interventions.

4. Safety and Toxicity Testing (Sample Task Order D)

a. Describe technical capabilities, processes, procedures, and timelines to:

i. Assess, propose, and finalize toxicology protocols.

ii. Obtain, quarantine, and house animals following appropriate regulatory guidelines and animal welfare guidelines.

b. Describe the conduct of the required safety and toxicology testing.

SECTION 4: PROJECT MANAGEMENT PLAN

Provide a Project Management Plan for the overall organization that addresses the planning, initiation, implementation, conduct, monitoring and completion of tasks identified in the Statement of Work. If consultants and/or subcontractors are proposed, include a plan to manage, coordinate, and oversee the work performed by consultants and/or subcontractor(s).

1. Provide a Staffing Plan that describes roles, responsibilities, and level of effort for all scientific and technical personnel, including all proposed subcontractors and consultants. Provide an administrative and technical framework indicating clear lines of authority and responsibility for all proposed personnel. Include a chart of the proposed organizational/management structure for the project.

2. Describe the project management systems that will be used to track activities and to keep multiple activities on time and budget. The plan must include a description of the quality control methods that will be used to ensure the effective and efficient initiation, implementation, management, and oversight of contract requirements.

3. Outline how the Contractor Principal Investigator (PI) (or Project Manager) will communicate with the COR and Contracting Officer and how the PI (or Project Manager) will communicate, monitor, and manage the project both internally and externally (at subcontractor facilities).

SECTION 5: QUALITY MANAGEMENT SYSTEM

Describe your current model and operating procedures for implementing a Quality Management System for completion of the proposed Task Area and Sample Task Order requirements. As appropriate, include the following:

1) Description of the personnel, resources and lines of authority and responsibilities of the

Quality Assurance Unit (QAU) and the Quality Control (QC); governing policies and procedures of the QAU

2) Description of process to ensure the commitment of the Contractor’s senior management support for the Quality Systems;

3) Quality System management of activities at subcontractor’s site that is appropriate for the phase of product development and within all applicable regulatory regulations;

4) Relevant organizational experience, problems or obstacles encountered and approaches implemented to resolve or correct identified problems;

5) Experience with GLP compliance and interactions with regulatory agencies;

6) Experience with, and plans for, conduct of GLP and Animal Rule studies;

7) Experience with the clinical sample testing to support human clinical trials; and

8) Describe plans and procedures to be utilized for compliance with all GLP regulations and guidelines, including a personnel training program.

SECTION 6: SCIENTIFIC AND TECHNICAL PERSONNEL (20 page maximum)

Provide information relevant to document individual training, experience, qualifications and expertise necessary for the successful completion of all Task Order requirements. Limit CVs to 2-3 pages and provide selected references for publications relevant to the scope of the Task Order.

1) Principal Investigator (PI): Describe the experience, training, expertise, and qualifications, and level of effort of the proposed Principal Investigator to lead and direct the activities to be carried out under this Task Order.

2) Other Key Scientific and Technical Personnel: Describe the experience, training, expertise and qualifications, as well as the level of effort, for all proposed key scientific and technical personnel. Include the following: Project Manager, and leads in Quality Assurance, Quality Control, Safety, Assay Development, Animal Model Studies, Safety and Toxicology and Sample Testing.

SECTION 7: FACILITIES, EQUIPMENT, AND OTHER RESOURCES

The Technical Proposal should document availability and adequacy of facilities, equipment, space and other resources necessary to carry out the Statement of Work, including:

A. Infrastructure

1. Features of facilities including a description of CGMP, QC, quarantine, non-GLP animal, and GLP animal suites; and lists of equipment and resources (lease or ownership information should be provided) for the Contractor, partners, and subcontractors, as applicable.

2. Information on facility and equipment validation.

3. The history and details of facility audits and/or inspections, and any relevant Master File information.

4. Information on non-GLP assay development and animal testing.

5. Identification and description of all support resources (including Information Technology systems) that will be required to effectively complete the SOW.

6. Plans and procedures to be utilized for compliance with all safety regulations and guidelines, including training and monitoring of personnel for exposure to infectious and other hazardous materials.

7. A description of biocontainment facilities

B. Storage and Shipping

Describe the proposed plans and procedures for the receipt, storage, retrieval, packaging, and shipping of products, materials, and specimens from domestic and international locations.

C. Transition Plan

Describe experience, current operating procedures, and plans to ensure a smooth and timely transition including of all material, reagents, data, documentation, stored specimens, and Government-owned equipment. The plan shall also provide for transition of all software files, databases and data storage and retrieval equipment.

SECTION 8: TASK ORDER/SAMPLE TASK ORDER OPTIONS - [Associated with Task Area A only]

OPTIONS 1-9 for Extension for Period of Performance (Task Order Term)

Discuss plans and procedures for continuing and providing the same services indicated in the Statement of Work beyond the contract base year for Task Area A (Task Order 1). Options should be presented as a separate part of the Technical Proposal for each Task Order and clearly identified as such.

SECTION 9: OTHER CONSIDERATIONS

This section of the Technical Proposal should document other resources not covered in Sections 1 through 8 above necessary to carry out the Task Order Statement of Work, including:

1. Biological Agents or Toxins - The Technical Proposal should include a plan for biohazard safety and security requirements.

2. Care of Live Vertebrate Animals.

3. Obtaining and Disseminating Biomedical Research Resources.

4. Data Management and Sharing Plan.

5. Information Technology (IT) Systems Security.