75N95023R00004_Att. 7_Additional Technical Proposal Instructions.pdf
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- Pharmacology Studies and Animal Model Development and Related Services for Drug Development
- Solicitation number
- 75N95023R00004
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This document provides instructions for submitting technical proposals in response to solicitation number 75N95023R00004 from the Department of Health and Human Services National Institutes of Health for Pharmacology Studies and Animal Model Development and Related Services for Drug Development. Offerors may propose on one, two, or all three of the technical areas, which include preclinical pharmacology and toxicology studies, animal model development, and related services. The technical proposal must not exceed 150 pages and follow the provided formatting requirements. It must include a statement of work, personnel qualifications, facilities and resources, quality plans, organizational experience, and a response to a sample task order for each proposed technical area. Up to 50 pages of attachments may be included to support each technical area, for a total of 150 pages of attachments if all three areas are proposed. The technical proposal and attachments will be evaluated based on the criteria in Section M of the solicitation.
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ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS
These Technical Proposal instructions reflect the requirements of the RFP and provide specific instructions and formatting for the Technical Proposal. Offerors are not required to propose on all Technical Areas but may submit proposals that include one, two, or all three Technical Areas. Proposals will be evaluated for each Technical Area the Offeror proposes. Offerors are advised to give careful consideration to the Statement of Work, all attachments, the Technical Evaluation Criteria in SECTION M, and the RFP as a whole in the development of their Technical Proposals.
Offerors shall use the following format for preparing and presenting your Technical Proposal. Subsections 3.A., 3.B., and 3.C. must be complete on their own and include all requested information for that subsection. Subsections may not refer to other subsections for information. For example, if Personnel information is the same for Subsections 3.A., 3.B., and 3.C., each subsection must include all of the information; Subsections 3.B. or 3.C. may not refer the reader back to Subsection 3.A. for the information.
Section headings should be bolded and in a larger font. It is desired but not required that section headings be bookmarked and linked to from the Table of Contents. The Technical Discussion of the technical proposal shall not exceed 150 pages. This page limitation does not include the Title Page, Table of Contents, or Technical Proposal Introduction. Attachments shall not exceed a total of 50 pages per technical area; 150 pages total if all three technical areas are proposed on. Resumes must be no more than two pages each. Pages in excess of these limitations will be deleted and will be neither read nor evaluated. Each page of the technical proposal must be numbered sequentially.
Type density and size must be 10 to 12 points. If constant spacing is used, 15 cpi (characters per inch) or fewer shall be used, whereas proportional spacing should provide an average of no more than 15 cpi. There must be no more than six lines of text within a vertical inch. Margins must be no less than ½ inch around, exclusive of headers and footers.
SECTION 1: TITLE PAGE AND TABLE OF CONTENTS
1. Proposal Title Page
Include RFP title and number, name of your organization, UEI number, indicate that this is the Technical Proposal, and identify if the proposal is an original or a copy.
2. Project Objectives, NIH-1688-1
Insert a completed NIH Form 1688-1, Project Objectives, as provided in SECTION J, ATTACHMENT No. 19, behind the Title Page of each copy of the proposal, along with the "Government Notice for Handling Proposals." The NIH Form 1688-1 is to be completed as follows: For an Institution of Higher Education: The form MUST be completed in its entirety; For OTHER than an Institution of Higher Education: The starred items (Department, Service, Laboratory or Equivalent, and Major Subdivision) should be left blank.
3. Table of Contents
RFP No. 75N95023R00004 Attachment 7
SECTION 2: TECHNICAL PROPOSAL INTRODUCTION
1. A statement of the overall objectives of this acquisition as understood by the Offeror;
2. An overview of the Offeror’s organization and any proposed subcontractors;
3. Information which documents and/or supports that the Offeror meets the “Mandatory Qualification Criteria” set forth in SECTION M;
4. A plan for sharing of model organisms; and
5. A data management and sharing plan. The plan should address the following:
a. Will material transfers be made with no more restrictive terms than in a Simple Letter Agreement (SLA) at:
https://www.ott.nih.gov/sites/default/files/documents/pdfs/slaform.pdf ; for the transfer of materials or the Uniform Biological Material Transfer Agreement (UBMTA) (https://autm.net/surveys-and-tools/agreements/material-transfer-agreements/mtatoolkit/uniform-biological-material-transfer-agreement)
b. How will inappropriate "reach-through" requirements (as discussed in the NIH Research Tools Policy) on materials transferred be discussed?
c. How will technologies remain widely available and accessible to the research community, for example, if any intellectual property rights arise for which a patent application may be filed?
SECTION 3: TECHNICAL DISCUSSIONS (maximum of 150 pages)
I. SUBSECTION 3.A. – TECHNICAL AREA 1 (maximum of 50 pages)
This subsection must be complete on its own and must not refer to Subsections 3.B. or 3.C. for information.
If you are not proposing on Technical Area 1, include Subsection 3.A. in your proposal and include a statement that you are not proposing on this technical area instead of providing the information requested below.
1. TECHNICAL DISCUSSIONS: The technical discussion included in the Technical Proposal should respond to the items set forth below:
a. Statement of Work
1. Objectives
State the overall objectives and the specific accomplishments you hope to achieve. Indicate the rationale for your plan, and relation to comparable work in progress elsewhere. Review pertinent work already published which is relevant to this project and your proposed approach. This should support the scope of the project as you perceive it.
2. Approach
RFP No. 75N95023R00004 Attachment 7 https://autm.net/surveys-and-tools/agreements/material-transfer-agreements/mtatoolkit/uniform-biological-material-transfer-agreement https://autm.net/surveys-and-tools/agreements/material-transfer-agreements/mtatoolkit/uniform-biological-material-transfer-agreement
The Offeror must submit an explanation of the proposed technical approach in conjunction with the tasks to be performed in achieving the project objectives. Proposals which merely restate the requirements of the Government's scope of work will not be eligible for award.
Use as many subparagraphs, appropriately titled, as needed to clearly outline the general plan of work. Discuss phasing of research and, if appropriate, include experimental design and possible or probable outcome of approaches proposed.
3. Methods
Describe in detail the methodologies you will use for the project, indicating your level of experience with each, areas of anticipated difficulties, and any unusual expenses you anticipate.
b. Personnel
Describe the experience and qualifications of personnel who will be assigned for direct work on this program.
Information is required which will show the composition of the task or work group, its general qualifications, and recent experience with similar equipment or programs. Special mention shall be made of direct technical supervisors and key technical personnel, and the approximate percentage of the total time each will be available for this program.
OFFERORS SHOULD ASSURE THAT THE PRINCIPAL INVESTIGATOR, AND ALL OTHER PERSONNEL PROPOSED, SHALL NOT BE COMMITTED ON FEDERAL GRANTS AND CONTRACTS FOR MORE THAN A TOTAL OF 100% OF THEIR TIME. IF THE SITUATION ARISES WHERE IT IS DETERMINED THAT A PROPOSED EMPLOYEE IS COMMITTED FOR MORE THAN 100% OF HIS OR HER TIME, THE GOVERNMENT WILL REQUIRE ACTION ON THE PART OF THE
OFFEROR TO CORRECT THE TIME COMMITMENT.
1. Single Principal Investigator/Project Director
List the name of the Principal Investigator/Project Director responsible for overall implementation of the contract and key contact for technical aspects of the project. Even though there may be co-investigators, identify the Principal Investigator/Project Director who will be responsible for the overall implementation of any awarded contract. Discuss the qualifications, experience, and accomplishments of the Principal Investigator/Project Director. State the estimated time to be spent on the project, his/her proposed duties, and the areas or phases for which he/she will be responsible.
2. Other Investigators
List all other investigators/professional personnel who will be participating in the project. Discuss the qualifications, experience, and accomplishments. State the estimated time each will spend on the project, proposed duties on the project, and the areas or phases for which each will be responsible.
3. Additional Personnel
List names, titles, and proposed duties of additional personnel, if any, who will be required for full-time employment, or on a subcontract or consultant basis. The technical areas, character, and extent of subcontract or consultant activity will be indicated and the anticipated sources will be specified and qualified. For all proposed personnel who are not currently members of the Offeror's staff, proposed consultants, and proposed subcontractors, a letter of commitment or other evidence of availability is required. A resume does not meet this requirement. Commitment letters must include, at a minimum, the below information:
A. The specific expertise and resources/facilities they will provide.
B. Their availability to the project and the amount of time anticipated.
C. Willingness to become an employee, consultant, or subcontractor.
D. How rights to publications and patents will be handled.
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.
4. Resumes
Resumes of all key personnel are required. Each must indicate educational background, recent experience, specific or technical accomplishments, and a listing of relevant publications. Resumes must be no longer than two pages each and should be provided in Section 4: Attachments.
c. Facilities, Equipment, and Other Resources. The Technical Proposal should document availability and adequacy of facilities, equipment, space, and other resources necessary to perform the work in the IDIQ Statement of Work. The proposal should include whether the equipment/resource is possessed by the Offeror or a proposed subcontractor, and whether it is owned or leased. Offerors should describe their plans to ensure the availability of necessary resources, and to identify and mitigate supply chain issues or other delays. The proposal should include a description of the Offeror’s institutional biosafety program, a description of the contingency and catastrophic event procedures, and a floor plan.
d. Quality Assurance and Quality Control. The Technical Proposal should discuss the processes and procedures in place to provide quality assurance / quality control oversight. Offerors should discuss how they manage the quality, integrity, and reproducibility of data. Offerors should discuss their established infrastructure and standard operating procedures (SOPs) for quality assurance and quality control, and their quality management plan. The proposal should discuss the results of any audits conducted and the resolution of any noted deficiencies.
e. Organizational Experience, Operations, and Project Management.
1. Organizational Experience: The accomplishment of work, either past or on-going, which is comparable or related to the effort required by this RFP. This includes overall Offeror or corporate experience, but not the individual experience and/or past performance of individuals who are proposed as scientific and technical personnel. Include the following information for work in the past five (5) years, being clear whether the experience is from the Offeror or a subcontractor (and which subcontractor):
A. A description of the Offeror’s experience that is similar to the requirements of the technical area including the (1) services provided; (2) scope of work performed; (3) scale of project; and (4) complexity of project.
B. A description of the diversity of projects on which the Offeror has worked; including the types of target molecules and the diseases with which the target molecules are associated.
C. For subcontractors proposed to individually perform 20% or more of the work:
i. A description of the subcontractor’s experience that is similar to the requirements of the technical area(s) including the (1) services provided; (2) scope of work performed; (3) scale of project; and (4) complexity of project.
ii. A description of the diversity of projects on which the subcontractor has worked; including the types of target molecules and the diseases with which the target molecules are associated.
D. For subcontractors proposed to perform activities that are essential to the success of the project, regardless of size or percentage:
i. A description of the subcontractor’s experience that is similar to the requirements of the technical area(s) including the (1) services provided; (2) scope of work performed; (3) scale of project; and (4) complexity of project.
ii. A description of the diversity of projects on which the subcontractor has worked; including the types of target molecules and the diseases with which the target molecules are associated.
2. Organizational Operations and Project Management. Describe the overall organizational operations and project management approach. Include the following:
A. A Project Management Plan for the overall organization that addresses the planning, initiation, implementation, conduct, monitoring and completion of tasks. If consultants and/or subcontractors are proposed, include a plan to manage, coordinate, and oversee the work performed by consultants and/or subcontractor(s).
B. 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.
C. A description of 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.
D. An outline of how the PI (or Project Manager) will communicate with the Contracting Officer’s Representative and Contracting Officer and how the PI (or Project Manager) will communicate, monitor, and manage the project both internally and externally (at subcontractor facilities).
E. A description of the quality systems that are in place to provide quality control and assurance, maintain data quality, and manage and report issues pertinent to data quality.
F. A description of the range and types of clients (e.g. government, industry, academia, nonprofits, etc.) the Offeror has worked with in the prior five (5) years.
f. Response to Sample Task Order. The response to the Sample Task Order should be provided in a format consistent with Parts a-e above and supplemented as outlined below. Where information in this Response to Sample Task Order would be identical to information provided in Parts a-e above, appropriate reference may be made to prior information in lieu of repeating identical information here. However, this Response to Sample Task Order must be clear and easy to follow. The Technical Proposal Cost Summary (See Section J-List of Attachments) for the Sample Task Order response shall be included as an attachment.
1. Statement of Work
A. Objectives
B. Approach
C. Methods
D. Schedule
2. Personnel
3. Facilities, Equipment, and Other Resources
4. Quality Assurance and Quality Control
5. Organizational Experience, Operations, and Project Management
2. OTHER CONSIDERATIONS
Record and discuss specific factors not included elsewhere which support your proposal. Using specifically titled subparagraphs, items may include:
a. Any agreements and/or arrangements with subcontractor(s). Provide as much detail as necessary to explain how the statement of work will be accomplished within this working relationship.
b. Unique arrangements, equipment, etc., which none or very few organizations are likely to have which is advantageous for effective implementation of this project.
c. Equipment and unusual operating procedures established to protect personnel from hazards associated with this project.
d. Other factors you feel are important and support your proposed research.
e. Recommendations for changing reporting requirements if such changes would be more compatible with the Offeror's proposed schedules.
II. SUBSECTION 3.B. – TECHNICAL AREA 2 (maximum of 50 pages)
This subsection must be complete on its own and must not refer to Subsections 3.A. or 3.C. for information.
If you are not proposing on Technical Area 2, include Subsection 3.B. in your proposal and include a statement that you
1. TECHNICAL DISCUSSIONS: The technical discussion included in the Technical Proposal should respond to the items set
a. Statement of Work
1. Objectives
State the overall objectives and the specific accomplishments you hope to achieve. Indicate the rationale for your plan, and relation to comparable work in progress elsewhere. Review pertinent work already published which is relevant to this project and your proposed approach. This should support the scope of the project as you perceive it.
2. Approach
The Offeror must submit an explanation of the proposed technical approach in conjunction with the tasks to be performed in achieving the project objectives. Proposals which merely restate the requirements of the Government's scope of work will not be eligible for award.
Use as many subparagraphs, appropriately titled, as needed to clearly outline the general plan of work. Discuss phasing of research and, if appropriate, include experimental design and possible or probable outcome of approaches proposed.
3. Methods
Describe in detail the methodologies you will use for the project, indicating your level of experience with each, areas of anticipated difficulties, and any unusual expenses you anticipate.
b. Personnel
Describe the experience and qualifications of personnel who will be assigned for direct work on this program.
Information is required which will show the composition of the task or work group, its general qualifications, and recent experience with similar equipment or programs. Special mention shall be made of direct technical supervisors and key technical personnel, and the approximate percentage of the total time each will be available for this program.
OFFERORS SHOULD ASSURE THAT THE PRINCIPAL INVESTIGATOR, AND ALL OTHER PERSONNEL PROPOSED, SHALL NOT BE COMMITTED ON FEDERAL GRANTS AND CONTRACTS FOR MORE THAN A TOTAL OF 100% OF THEIR TIME. IF THE SITUATION ARISES WHERE IT IS DETERMINED THAT A PROPOSED EMPLOYEE IS COMMITTED FOR MORE THAN 100% OF HIS OR HER TIME, THE GOVERNMENT WILL REQUIRE ACTION ON THE PART OF THE
OFFEROR TO CORRECT THE TIME COMMITMENT.
1. Single Principal Investigator/Project Director
List the name of the Principal Investigator/Project Director responsible for overall implementation of the contract and key contact for technical aspects of the project. Even though there may be co-investigators, identify the Principal Investigator/Project Director who will be responsible for the overall implementation of any awarded contract. Discuss the qualifications, experience, and accomplishments of the Principal Investigator/Project Director. State the estimated time to be spent on the project, his/her proposed duties, and the areas or phases for which he/she will be responsible.
2. Other Investigators
List all other investigators/professional personnel who will be participating in the project. Discuss the qualifications, experience, and accomplishments. State the estimated time each will spend on the project, proposed duties on the project, and the areas or phases for which each will be responsible.
3. Additional Personnel
List names, titles, and proposed duties of additional personnel, if any, who will be required for full-time employment, or on a subcontract or consultant basis. The technical areas, character, and extent of subcontract or consultant activity will be indicated and the anticipated sources will be specified and qualified. For all proposed personnel who are not currently members of the Offeror's staff, a letter of commitment or other evidence of availability is required. A resume does not meet this requirement. Commitment letters for use of consultants and other personnel to be hired must include:
A. The specific items or expertise they will provide.
B. Their availability to the project and the amount of time anticipated.
C. Willingness to act as a consultant.
D. How rights to publications and patents will be handled.
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.
4. Resumes
Resumes of all key personnel are required. Each must indicate educational background, recent experience, specific or technical accomplishments, and a listing of relevant publications. Resumes must be no longer than two pages each and should be provided in Section 4: Attachments.
c. Facilities, Equipment, and Other Resources. The Technical Proposal should document availability and adequacy of facilities, equipment, space, and other resources necessary to perform the work in the IDIQ Statement of Work. The proposal should include whether the equipment/resource is possessed by the Offeror or a proposed subcontractor, and whether it is owned or leased. Offerors should describe their plans to ensure the availability of necessary resources, and to identify and mitigate supply chain issues or other delays. The proposal should include a description of the Offeror’s institutional biosafety program, a description of the contingency and catastrophic event procedures, and a floor plan.
d. Quality Assurance and Quality Control. The Technical Proposal should discuss the processes and procedures in place to provide quality assurance / quality control oversight. Offerors should discuss how they manage the quality, integrity, and reproducibility of data. Offerors should discuss their established infrastructure and standard operating procedures (SOPs) for quality assurance and quality control, and their quality management plan. The proposal should discuss the results of any audits conducted and the resolution of any noted deficiencies.
e. Organizational Experience, Operations, and Project Management.
1. Organizational Experience: The accomplishment of work, either past or on-going, which is comparable or related to the effort required by this RFP. This includes overall Offeror or corporate experience, but not the individual experience and/or past performance of individuals who are proposed as scientific and technical personnel. Include the following information for work in the past five (5) years, being clear whether the experience is from the Offeror or a subcontractor (and which subcontractor):
A. A description of the Offeror’s experience that is similar to the requirements of the technical area including the (1) services provided; (2) scope of work performed; (3) scale of project; and (4) complexity of project.
B. A description of the diversity of projects on which the Offeror has worked; including the types of target molecules and the diseases with which the target molecules are associated.
C. For subcontractors proposed to individually perform 20% or more of the work:
i. A description of the subcontractor’s experience that is similar to the requirements of the technical area(s) including the (1) services provided; (2) scope of work performed; (3) scale of project; and (4) complexity of project.
ii. A description of the diversity of projects on which the subcontractor has worked; including the types of target molecules and the diseases with which the target molecules are associated.
D. For subcontractors proposed to perform activities that are essential to the success of the project, regardless of size or percentage:
i. A description of the subcontractor’s experience that is similar to the requirements of the technical area(s) including the (1) services provided; (2) scope of work performed; (3) scale of project; and (4) complexity of project.
ii. A description of the diversity of projects on which the subcontractor has worked; including the types of target molecules and the diseases with which the target molecules are associated.
2. Organizational Operations and Project Management. Describe the overall organizational operations and project management approach. Include the following:
A. A Project Management Plan for the overall organization that addresses the planning, initiation, implementation, conduct, monitoring and completion of tasks. If consultants and/or subcontractors are proposed, include a plan to manage, coordinate, and oversee the work performed by consultants and/or subcontractor(s).
B. 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.
C. A description of 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.
D. An outline of how the PI (or Project Manager) will communicate with the Contracting Officer’s Representative and Contracting Officer and how the PI (or Project Manager) will communicate, monitor, and manage the project both internally and externally (at subcontractor facilities).
E. A description of the quality systems that are in place to provide quality control and assurance, maintain data quality, and manage and report issues pertinent to data quality.
F. A description of the range and types of clients (e.g. government, industry, academia, nonprofits, etc.) the Offeror has worked with in the prior five (5) years.
f. Response to Sample Task Order. The response to the Sample Task Order should be provided in a format consistent with Parts a-e above and supplemented as outlined below. Where information in this Response to Sample Task Order would be identical to information provided in Parts a-e above, appropriate reference may be made to prior information in lieu of repeating identical information here. However, this Response to Sample Task Order must be clear and easy to follow. The Technical Proposal Cost Summary (See Section J-List of Attachments) for the Sample Task Order response shall be included as an attachment.
1. Statement of Work
A. Objectives
B. Approach
C. Methods
D. Schedule
2. Personnel
3. Facilities, Equipment, and Other Resources
4. Quality Assurance and Quality Control
5. Organizational Experience, Operations, and Project Management
2. OTHER CONSIDERATIONS
Record and discuss specific factors not included elsewhere which support your proposal. Using specifically titled subparagraphs, items may include:
a. Any agreements and/or arrangements with subcontractor(s). Provide as much detail as necessary to explain how the statement of work will be accomplished within this working relationship.
b. Unique arrangements, equipment, etc., which none or very few organizations are likely to have which is advantageous for effective implementation of this project.
c. Equipment and unusual operating procedures established to protect personnel from hazards associated with this project.
d. Other factors you feel are important and support your proposed research.
e. Recommendations for changing reporting requirements if such changes would be more compatible with the
III. SUBSECTION 3.C. – TECHNICAL AREA 3 (maximum of 50 pages)
This subsection must be complete on its own and must not refer to Subsections 3.A. or 3.B. for information.
If you are not proposing on Technical Area 3, include Subsection 3.C. in your proposal and include a statement that you
1. TECHNICAL DISCUSSIONS: The technical discussion included in the Technical Proposal should respond to the items set
a. Statement of Work
1. Objectives
State the overall objectives and the specific accomplishments you hope to achieve. Indicate the rationale for your plan, and relation to comparable work in progress elsewhere. Review pertinent work already published which is relevant to this project and your proposed approach. This should support the scope of the project as you perceive it.
2. Approach
The Offeror must submit an explanation of the proposed technical approach in conjunction with the tasks to be performed in achieving the project objectives. Proposals which merely restate the requirements of the Government's scope of work will not be eligible for award.
Use as many subparagraphs, appropriately titled, as needed to clearly outline the general plan of work. Discuss phasing of research and, if appropriate, include experimental design and possible or probable outcome of approaches proposed.
3. Methods
Describe in detail the methodologies you will use for the project, indicating your level of experience with each, areas of anticipated difficulties, and any unusual expenses you anticipate.
b. Personnel
Describe the experience and qualifications of personnel who will be assigned for direct work on this program.
Information is required which will show the composition of the task or work group, its general qualifications, and recent experience with similar equipment or programs. Special mention shall be made of direct technical supervisors and key technical personnel, and the approximate percentage of the total time each will be available for this program.
OFFERORS SHOULD ASSURE THAT THE PRINCIPAL INVESTIGATOR, AND ALL OTHER PERSONNEL PROPOSED, SHALL NOT BE COMMITTED ON FEDERAL GRANTS AND CONTRACTS FOR MORE THAN A TOTAL OF 100% OF THEIR TIME. IF THE SITUATION ARISES WHERE IT IS DETERMINED THAT A PROPOSED EMPLOYEE IS COMMITTED FOR MORE THAN 100% OF HIS OR HER TIME, THE GOVERNMENT WILL REQUIRE ACTION ON THE PART OF THE
OFFEROR TO CORRECT THE TIME COMMITMENT.
1. Single Principal Investigator/Project Director
List the name of the Principal Investigator/Project Director responsible for overall implementation of the contract and key contact for technical aspects of the project. Even though there may be co-investigators, identify the Principal Investigator/Project Director who will be responsible for the overall implementation of any awarded contract. Discuss the qualifications, experience, and accomplishments of the Principal Investigator/Project Director. State the estimated time to be spent on the project, his/her proposed duties, and the areas or phases for which he/she will be responsible.
2. Other Investigators
List all other investigators/professional personnel who will be participating in the project. Discuss the qualifications, experience, and accomplishments. State the estimated time each will spend on the project, proposed duties on the project, and the areas or phases for which each will be responsible.
3. Additional Personnel
List names, titles, and proposed duties of additional personnel, if any, who will be required for full-time employment, or on a subcontract or consultant basis. The technical areas, character, and extent of subcontract or consultant activity will be indicated and the anticipated sources will be specified and qualified. For all proposed personnel who are not currently members of the Offeror's staff, a letter of commitment or other evidence of availability is required. A resume does not meet this requirement. Commitment letters for use of consultants and other personnel to be hired must include:
A. The specific items or expertise they will provide.
B. Their availability to the project and the amount of time anticipated.
C. Willingness to act as a consultant.
D. How rights to publications and patents will be handled.
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.
4. Resumes
Resumes of all key personnel are required. Each must indicate educational background, recent experience, specific or technical accomplishments, and a listing of relevant publications. Resumes must be no longer than two pages each and should be provided in Section 4: Attachments.
c. Facilities, Equipment, and Other Resources. The Technical Proposal should document availability and adequacy of facilities, equipment, space, and other resources necessary to perform the work in the IDIQ Statement of Work. The proposal should include whether the equipment/resource is possessed by the Offeror or a proposed subcontractor, and whether it is owned or leased. Offerors should describe their plans to ensure the availability of necessary resources, and to identify and mitigate supply chain issues or other delays. The proposal should include a description of the Offeror’s institutional biosafety program, a description of the contingency and catastrophic event procedures, and a floor plan.
d. Quality Assurance and Quality Control. The Technical Proposal should discuss the processes and procedures in place to provide quality assurance / quality control oversight. Offerors should discuss how they manage the quality, integrity, and reproducibility of data. Offerors should discuss their established infrastructure and standard operating procedures (SOPs) for quality assurance and quality control, and their quality management plan. The proposal should discuss the results of any audits conducted and the resolution of any noted deficiencies.
e. Organizational Experience, Operations, and Project Management.
1. Organizational Experience: The accomplishment of work, either past or on-going, which is comparable or related to the effort required by this RFP. This includes overall Offeror or corporate experience, but not the individual experience and/or past performance of individuals who are proposed as scientific and technical personnel. Include the following information for work in the past five (5) years, being clear whether the experience is from the Offeror or a subcontractor (and which subcontractor):
A. A description of the Offeror’s experience that is similar to the requirements of the technical area including the (1) services provided; (2) scope of work performed; (3) scale of project; and (4) complexity of project.
B. A description of the diversity of projects on which the Offeror has worked; including the types of target molecules and the diseases with which the target molecules are associated.
C. For subcontractors proposed to individually perform 20% or more of the work:
i. A description of the subcontractor’s experience that is similar to the requirements of the technical area(s) including the (1) services provided; (2) scope of work performed; (3) scale of project; and (4) complexity of project.
ii. A description of the diversity of projects on which the subcontractor has worked; including the types of target molecules and the diseases with which the target molecules are associated.
D. For subcontractors proposed to perform activities that are essential to the success of the project, regardless of size or percentage:
i. A description of the subcontractor’s experience that is similar to the requirements of the technical area(s) including the (1) services provided; (2) scope of work performed; (3) scale of project; and (4) complexity of project.
ii. A description of the diversity of projects on which the subcontractor has worked; including the types of target molecules and the diseases with which the target molecules are associated.
2. Organizational Operations and Project Management. Describe the overall organizational operations and project management approach. Include the following:
A. A Project Management Plan for the overall organization that addresses the planning, initiation, implementation, conduct, monitoring and completion of tasks. If consultants and/or subcontractors are proposed, include a plan to manage, coordinate, and oversee the work performed by consultants and/or subcontractor(s).
B. 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.
C. A description of 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.
D. An outline of how the PI (or Project Manager) will communicate with the Contracting Officer’s Representative and Contracting Officer and how the PI (or Project Manager) will communicate, monitor, and manage the project both internally and externally (at subcontractor facilities).
E. A description of the quality systems that are in place to provide quality control and assurance, maintain data quality, and manage and report issues pertinent to data quality.
F. A description of the range and types of clients (e.g. government, industry, academia, nonprofits, etc.) the Offeror has worked with in the prior five (5) years.
f. Response to Sample Task Order. The response to the Sample Task Order should be provided in a format consistent with Parts a-e above and supplemented as outlined below. Where information in this Response to Sample Task Order would be identical to information provided in Parts a-e above, appropriate reference may be made to prior information in lieu of repeating identical information here. However, this Response to Sample Task Order must be clear and easy to follow. The Technical Proposal Cost Summary (See Section J-List of Attachments) for the Sample Task Order response shall be included as an attachment.
1. Statement of Work
A. Objectives
B. Approach
C. Methods
D. Schedule
2. Personnel
3. Facilities, Equipment, and Other Resources
4. Quality Assurance and Quality Control
5. Organizational Experience, Operations, and Project Management
2. OTHER CONSIDERATIONS
Record and discuss specific factors not included elsewhere which support your proposal. Using specifically titled subparagraphs, items may include:
a. Any agreements and/or arrangements with subcontractor(s). Provide as much detail as necessary to explain how the statement of work will be accomplished within this working relationship.
b. Unique arrangements, equipment, etc., which none or very few organizations are likely to have which is advantageous for effective implementation of this project.
c. Equipment and unusual operating procedures established to protect personnel from hazards associated with this project.
d. Other factors you feel are important and support your proposed research.
e. Recommendations for changing reporting requirements if such changes would be more compatible with the
SECTION 4: ATTACHMENTS (maximum of 50 pages per technical area (up to 150 pages total))
Attachments should be used to document and support the information provided in Section 3. Attachments should not be used in place of the information requested. A detailed discussion of the requested content should be provided in Section 3 and be supported by attachments as applicable.
Such attachments should include resumes, letters of commitment, SOPs, a technical proposal cost summary, and any other documents requested above or in the RFP or as needed to support the information provided above.
The attachments in Section 4 should be grouped together by technical area. All attachments for Technical Area 1 should be first, followed by attachments for Technical Areas 2 and 3 (if all technical areas are proposed on).
The attachments in Section 4 should be sequentially numbered and labeled with a header. The header should include the 1) technical area, 2) attachment number, and 3) a brief description of the document. For example: “TA 2_Att. 1_CV- Smith”, or “TA 3_Att. 4_SOP-QC”. The header should make it easy for reviewers to quickly identify which technical area(s) the document pertains to and what the document is. Where the same attachment is needed for multiple technical areas, one attachment may be used. The header should identify all technical areas, such as: TA 1,2,3_Att.
2_CV-Johnson.
References to attachments should include at least the technical area and attachment number. For example: “Dr. Smith’s resume is provided as Attachment 1 in Technical Area 2”, or “See Dr. Smith’s resume (TA 2_Att. 1_CV-Smith)”.
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