Attachment 12 - Additional Technical Proposal Instructions.pdf

ATTACHMENT 12: ADDITIONAL TECHNICAL PROPOSAL

INSTRUCTIONS, FORMAT FOR TECHNICAL PROPOSAL, and TABLE OF

CONTENTS

IN VITRO ASSESSMENTS OF ANTIMICROBIAL ACTIVITY

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: Offerors are not required to propose to all Task Areas but may submit proposals for one, two, three or all four Task Areas. Offerors proposing to multiple Task Areas are required to submit separate technical and business proposals to each proposed Task Area. Offerors should not include information in one Task Area proposal that pertains to any other Task Area. Each Technical Proposal shall address all elements of the proposed Task

Area and provide detailed plans in response to the Sample Task Order matching the proposed Task Area. Proposals will be evaluated separately for each Task Area the offeror proposes.

The choice to submit proposals for more than one Task Area will not weigh in favor of or against an Offeror’s proposal, however, the Government may limit the number of proposals in the competitive range to the greatest number that will permit an efficient competition among the most highly rated proposals. For this reason, Offerors are encouraged to respond only to the Task Areas in which they have demonstrable qualifications.

SECTION 1: (suggested 3-page maximum)

1) PROPOSAL TITLE PAGE. Include RFP title, number, Task Area proposed, name of organization, Unique Entity Identifier (UEI), 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 7-page maximum)

Provide an overview of the Technical Proposal, including:

1) A description of the capabilities proposed by the offeror and all proposed subcontractors.

2) Identification of proposed key personnel for the Offeror and all proposed subcontractors with degrees, titles and role in the contract.

3) By area of expertise, 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.

4) A brief description of the facilities and equipment to be made available by the offeror and all proposed subcontractors. If work with infectious agents requiring high containment is proposed, also include descriptions of containment areas, in particular BSL-3 and BSL-4 capacity.

SECTION 3: TECHNICAL PLAN/APPROACH – Sample Task Order (suggested 20-page maximum)

GENERAL INSTRUCTIONS FOR ALL SAMPLE TASK ORDERS

https://www.acquisition.gov/far/part-52#FAR_52_215_1

In response to the Sample Task Order(s) provide background and justification for in vitro approach taken to achieving the goal of the SOW. Describe in detail the proposed approaches, methodologies, plans, and procedures for completion of activities in the proposed Sample Task Order SOW. Offerors should clearly specify their planned source for described technical capabilities. If technical capabilities are to be obtained from a subcontractor, identify the subcontractor, if already known.

Propose a timeline to complete the activities described in the Sample Task Order, including any issues with availability of staff, facilities, or resources to fulfill the requirements of the SOW, and include a Gantt chart, if possible. Include past relevant organizational experience, technical and scientific problems or obstacles encountered, and approaches implemented to resolve or correct potential or identified problems.

Describe the methods used to collect and manage data. Describe the methods to be used to evaluate and communicate the data, including planned statistical analysis. Describe the planned approach to ensuring data quality, integrity, and reproducibility.

Describe any reference or quality control stocks of cell lines, pathogenic agents, and/or vectors employed for quality control and quality assurance of reference articles.

Describe plans to maintain quality-controlled, viable, preserved (e.g., frozen or lyophilized) stocks (including master and working agent or cell banks) of all cell lines, pathogenic agents and/or vectors under appropriate conditions.

For the different Task Areas, the following additional instructions apply:

a. Task Area A: Bacteria, Fungi and Toxins:

Sample Task Order A01:

Provide information demonstrating current capability in determining Minimum Inhibitory Concentration values for candidate anti-bacterial or anti-fungal compounds.

The technical proposal should clearly identify the chosen bacterial or fungal strain and provide a short overview of the Offeror’s experience and knowledge of the assays to be performed, including experience in the effectiveness of the assay.

Sample Task Order A02:

Provide information demonstrating current capability in determining toxin neutralization of candidate products.

The technical proposal should clearly identify the chosen toxin and provide a short overview of the Offeror’s experience and knowledge of the assays to be performed, including experience in the effectiveness of the assay.

b. Task Area B: Viruses:

Sample Task Order B01

Provide information demonstrating the Offeror’s current capability in assessing the inhibitory effect and cytotoxicity of candidate antiviral test articles.

The technical proposal should clearly identify the chosen viral pathogen panel and provide a short overview of the Offeror’s experience and knowledge of the assays to be performed, including experience in the effectiveness of the assay.

a. Task Area C: Parasites and Vectors:

Sample Task Order C01

Provide information demonstrating the Offeror’s current capability in determining in vitro Parasite Growth Inhibition or Vector Repellency of candidate anti-parasitic or anti-vector test articles.

The technical proposal should clearly identify the chosen parasite or vector and provide a short overview of the Offeror’s experience and knowledge of the assays to be performed, including experience in the effectiveness of the assay.

d. Task Area D: Development of New Techniques to Culture Difficult to

Grow Pathogens:

Provide information demonstrating the Offeror’s currently capability in the development of new in vitro culture conditions that support growth of currently difficult to grow pathogens. This capability can be demonstrated by previous experience growing hard to culture pathogens or related non-pathogenic species.

The technical proposal should clearly identify the chosen subject for cultivation (bacteria/fungi/virus/parasite) and provide a short overview of the Offeror’s experience and knowledge of the subject selected. Included in this overview should be information about the current state of the art for culturing the subject (bacteria/fungi/virus/parasite) and information about how it is thought to replicate in vivo. It is expected that the above information will be used to propose a rational approach to growing the subject in vitro. Include an overview of the experience growing similar difficult to grow subjects (bacteria/fungi/virus/parasite).

SECTION 4: SCIENTIFIC AND TECHNICAL PERSONNEL (suggested 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 3 pages and provide selected references relevant to the scope of the Sample 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 the Sample Task Order. In particular, address scientific and technical expertise developing, performing, and analyzing data from in vitro assays to assess the effectiveness of candidate countermeasures targeting pathogenic agents and vectors. If responding to Task Area D requirements, describe the experience and qualifications of the PI pertaining to method development for difficult to grow pathogens. As relevant, provide documentation of training related to select agent use, including training in BSL-3 or BSL-4 laboratory procedures.

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. Address scientific and technical expertise developing, performing, and analyzing data from in vitro assays to assess the effectiveness of candidate countermeasures targeting pathogenic agents and vectors. If responding to Task Area D requirements, describe the experience and qualifications of the proposed personnel with method development for difficult to grow pathogens. As relevant, provide documentation of training related to select agent use, including training in BSL- 3 or BSL-4 laboratory procedures.

SECTION 5: FACILITIES, EQUIPMENT, AND OTHER RESOURCES (suggested 10-page maximum)

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

1) Location and features of facilities including a floor plan and a list of equipment, and resources dedicated to the project for the prime contractor and any proposed subcontractors (lease or ownership information should be provided).

2) Relevant documentation of recent inspection of BSL-3 or BSL-4 biocontainment facilities. Relevant certifications for use of select agents; please refer to Article H of the solicitation, “POSSESSION, USE AND TRANSFER OF SELECT BIOLOGICAL AGENTS OR

TOXINS”.

3) Identification and description of ALL support resources (including Information

Technology systems) that will be required to effectively complete the SOW.

SECTION 6: PROJECT MANAGEMENT (suggested 15-page maximum)

1) 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).

2) 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.

3) 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.

4) Outline 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 proposed subcontractor facilities).