A07-W81XWH-18-R-0058-01-Solicitation-Amendment.docx

W81XWH18R0058

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION M - EVALUATION FACTORS FOR AWARD

The following have been modified:

BASIS FOR AWARD

General Information.

Process: Evaluations will be conducted by a Source Selection Team after the deadline for receipt of proposals. The Source Selection Team will evaluate all proposals based on the evaluation criteria set forth below and will only be conducted on the information provided, with the exception of Past Performance which may utilize information obtained from Government sources in addition to what is proposed. It is the Government’s intent to award up to 3 contracts from this solicitation. Based on the number and quality of proposals received, the Government reserves the right to award fewer than five contracts.

Discussions: The Government intends to award without discussions. Offerors shall provide their best, complete proposal upon initial submission. If discussions are required they will be conducted with Offerors in the competitive range to the extent deemed necessary by the Contracting Officer in accordance with FAR 15.306. Discussions will be conducted on the content of the proposal and, if discussions have been conducted, a Final Revised Proposal (FRP) will be solicited from those Offerors within the competitive range. A common cut-off date will be established for receipt of all FRPs.

Basis for Award:

Award of this contract will be made on a competitive best value basis, using “best value tradeoff” among cost and non-cost factors. A best value tradeoff process will be used, thus the Government may award to other than the lowest priced Offeror, or other than the Offeror with the highest rated non-cost proposal. Past Performance will be evaluated independently from the other non-cost evaluation factors utilizing different standards. For other than U.S. Small Business offerors, the Small Business Subcontracting Plan will be reviewed for acceptability IAW FAR 19.704 but is not evaluated as a non-cost factor.

The non-cost evaluation factors are numbered in descending order of importance are as follows:

Government evaluators will not assume that the Offeror possesses any capability or knowledge unless it is specified in the proposal.

After each of the above non-cost factors is rated individually, an overall rating will be assigned collectively to these factors. If any of the above non-cost evaluation factors receives an individual rating of “Unacceptable”, the collective overall rating will also be “Unacceptable”. Only proposals receiving an overall rating of “Acceptable” or higher will be considered for award.

Of the non-cost factors, the non-past performance factors are more important than past performance.

The non-cost factors are significantly more important than cost. As the collective non-cost/price factors begin to reach equality in the evaluation, cost/price becomes a more important factor in the tradeoff analysis.

Non-Cost Evaluation Criteria:

The following criteria will be used to evaluate the non-cost aspects of the proposal.

1. Technical Approach:

The Offeror’s technical approach will be evaluated to the degree that it describes the ability to accomplish the requirements of the SOO. The SOW will be evaluated as part of the technical approach. The Offeror’s SOW will be evaluated to the degree that it details tasks to be performed to accomplish the government’s Objective to meet all phases, on schedule, and within budget.

The Offeror’s SOW will be evaluated to the degree that it demonstrates:

i. A series of concise statements which demonstrate a fundamental understanding of the problem(s) and comprise the approach to each of the major goals or objectives of the proposed work. The statements should outline the specific tasks, systems and materials that are reasonable estimates for accomplishing work described in the SOO. An outline should be included which shows the work statements to be accomplished over the PoP.

2. Regulatory Approach:

The Offeror’s regulatory approach will be evaluated for the degree to which it addresses elements of DI-TCSP-82040 described below and degree that it details the ability to accomplish the requirements of the SOO.

The Offeror's regulatory approach will be evaluated for the degree that it addresses the following elements:

i. A proposed Regulatory Strategy that describes the regulatory pathway for FDA regulatory approval/licensure and includes any possible post-marketing commitments that include, but are not limited to, the following:

a. Product Nomenclature and Classification,

b. Device Description,

c. Intended use/indications for use statement,

d. Regulatory Pathway,

e. Current development status and regulatory status of the product and previous FDA interactions or submissions,

f. For those devices that will potentially require a 510(k), provide information about the proposed predicate and approach to substantial equivalence, and

g. Life Cycle Considerations

Please reference attached Data Item Description (DI-TCSP-82040) for additional details and definitions.

ii. A proposed RDP that describes specific steps, elements, and project deliverables to meet the objectives defined in the regulatory strategy. The Offeror’s proposal should describe regulatory-specific deliverables that include, but are not limited to, the following:

a. Regulatory timeline,

b. Regulatory communication plan,

c. Previous regulatory communication information,

d. Analysis of testing requirements based on established standards and guidance, and

e. Specific facility or pre-Inspection requirements such as PAIs

iii. A proposed Pre-Clinical Development Plan (Pre-CDP) that describe the goals and objectives of the pre-clinical program for the product. This plan should include, but is not limited to: animal study data; pre-clinical tests for safety; efficacy or performance in in vitro and animal systems; animal model rationale; animal study protocols, methods, data; and reports. Provide description of how pre-clinical testing will be performed in compliance with 21 CFR Part §58, GLPs.

iv. A proposed FDA Interactions Plan that will ensure the government has visibility and the opportunity to comment on all communications and documents submitted to the FDA regarding the medical device. The Government recognizes that the Offeror will be the FDA sponsor and ultimately is responsible for communication with the FDA. The plan will be evaluated for the following, but not limited to:

a. Interactions,

b. Meetings,

c. Communications,

d. Submissions packets,

e. Inspections and enforcement documentation

f. Registration and Listing

g. Post-Marketing Commitments

h. Clinical Laboratory Improvement Amendments waivers and supporting documentation

v. If available, Pre-Clinical Testing and Trials documentation that includes information and testing required to market the device that is determined by product classification, mechanisms of cooperation, technological characteristics, and labeling. Describe how pre-clinical testing performed in support of a premarket submission of a product will comply with 21 CFR Part 58, GLPs, and provide evidence of GLP compliance. Documentation can include, but is not limited to:

a. Results and reports of preclinical tests for safety, efficacy, or performance in in vitro and animal systems including biocompatibility tests designed to ensure biological safety of the materials and animal efficacy tests designed to evaluate effectiveness of the design in nonhuman systems;

b. Animal model rationale;

c. Animal study protocols, methods, data;

d. Final report versions provided in regulatory submissions to demonstrate safety and performance of the device under study

3. Management Approach:

The Offeror’s proposal will be evaluated for the degree to which the Offeror’s Quality Control Plan (QCP) documents how the Contractor will meet and comply with the quality standards established in the proposal. The proposal will be evaluated for the degree to which the Offeror’s Quality Control Plan (QCP) documents a description of adequate and appropriate procedures that the Contractor will use to maintain quality, timeliness, and responsiveness.

The Offeror’s proposal will be evaluated to the degree that the following elements are addressed:

i. The completion of the Quality Questionnaire Checklist (QQC) and Quality Management Plan. If the Contractor is not currently compliant, a brief explanation should be provided and anticipated event driven date of compliance (e.g. prior to IDE submission). The Contractor should provide a Quality Management Plan. The Quality Management Plan should include, but is not limited to the quality policy and objectives, management review, competencies and training, process document control, feedback, evaluation, corrective action and preventive action, process improvement, measurement, and data analysis processes. The framework should provide a description of the infrastructure, senior management responsibility, resource management, lifecycle management, and quality management system evaluation.

ii. The Offeror shall submit a written Project Management Plan (PMP) and a Project Management Approach for accomplishing the requirements of the SOO and be organized in SOW format using the same common numbering system as the Contract Work Breakdown Structure (CWBS) and Integrated Master Schedule (IMS).

The Offeror’s PMP will be evaluated for the degree to which the Offeror’s proposal documents:

· A CWBS with elements that meet the capabilities outlined in the SOO. The CWBS should outline in detail to accurately describe the Offeror’s proposed effort and sufficiently correlate with the proposed SOW, IMS, and CLINs.

· An IMS that documents the critical path, major milestones, tasks/activities, duration, lead/lag/slack time, and schedule relationships and be directly traceable to the SOW, CLINs and the CWBS. The tasks/activities in the IMS should link together showing predecessor/successor relationships and be sufficient to account for the entire program/project under contract.

The Offeror’s Project Management Approach will be evaluated for the degree to which the Offeror’s proposal documents:

A project management approach in sufficient detail, including managing and integrating various aspects of the proposed effort according to milestones, decision points, risk mitigation plans, and related processes. The proposal should include the Offeror’s approach to managing and interfacings with key subcontractors, to include the approach for assuring subcontractors meet cost, schedule, and performance requirements. The Offeror should present, in detail, their management strategies and fully describe their management structure, key personnel, and lines of authority to include the team balance including mechanical, electrical, and software design and engineering, interface and human factors design, and clinical expertise.

4. Experience:

The Offeror‘s proposal will be evaluated to the degree to which it effectively demonstrates the Offeror’s (and any subcontractors, consultants, or business partners) relevant experience identical to, similar to or related to performing services contained within the proposed SOW. The proposal should provide documented evidence of the Offeror’s (and any subcontractors, consultants, or business partners) experience (for this purpose, experience refers to what an Offeror has done, not how well it was accomplished) in performing proposed processes and procedures.

For all individuals proposed to fill Key Personnel positions, you are to submit resumes. Resumes of Key Personnel do not count against the page totals. These resumes should include a list of relevant training, education, and certifications. Proof of such may be requested prior to beginning work. For those individuals proposed as Key Personnel who are not current employees of your company, include a signed a letter of intent. Key Personnel are:

The Key Personnel’s experience will be evaluated to the degree to which it demonstrates: Team experience and expertise in similar projects, including resumes for key personnel describing knowledge, training, and education; to include both individual and team experience identical to, similar to, or related to performing services sought to complete the proposed research and development.

5. Past Performance:

a. The Government will conduct a Past Performance evaluation of the Offerors Past Performance as well as that of its subcontractors. Past Performance consists of two aspects for evaluation, past performance relevancy and performance confidence; thus, the Offeror will be assigned two ratings for past performance. First, the Government will evaluate the Offeror’s past performance references to determine how relevant a recent effort accomplished by the Offeror is to the requirement to be acquired through this procurement. Common aspects of relevance include similarity of service/support, complexity, magnitude of effort, dollar value, and contract type. Second, the Government will evaluate the Offeror’s past performance references to determine the quality of work performed and assess the level of expectation that the Offeror can successfully perform the required effort.

Cost Evaluation Criteria:

Cost will be evaluated separately from past performance and other non-cost factors, and will be evaluated for fairness and reasonableness. The total evaluated cost will be evaluated for reasonableness and for the degree to which it addresses:

1. Consistency with labor categories proposed as they relate to the carrying out of tasking outlined in the proposed statement of work

1. Level of effort, in that the proposed labor mix and labor hours are based on reasonable assumptions.

1. Consistency with the technical approach, in that the prices are consistent with and reflect the proposed staffing requirement for all years.

1. The Government will also conduct an appropriate analysis to determine whether the proposed cost is realistic in that the level of effort, labor mix and other direct costs (ODCs) are realistic given the nature of the work to be performed.

1. The evaluated price will be the total of all the priced line items, including fee, for the base year and all options.

1. Unsubstantiated costs that are considered unreasonable, not fully supported, or both, may cause the overall technical evaluation to be adjusted in one or more of the non cost evaluation factors.

1. The Government will evaluate offers by establishing a Total Evaluated Cost which will consist of the total cost proposed for all base contract line items, option contract line items, and the amount associated with FAR 52.217-8. The amount evaluated under FAR 52.217-8 will be calculated using the rates proposed for the last option period, prorated six months.

Cost Attachments

i. Completed Cost/Pricing Template: The proposal will be evaluated for evidence that the Offeror included a completed version of the Cost Proposal Form (Solicitation Attachment 3). The Cost Template will be evaluated for evidence that the Offeror followed the instructions on the first tab of the Cost Proposal Form and ensured all mathematical computations were correct. If the Offeror proposed Contractor Manpower Reporting (CMR) as “Not Separately Priced” the template will be evaluated for evidence that the Offeror left the CMR tab of the template to reflect a $0.00 balance.

ii. Completed Contract Data Requirements List (CDRL) Form: The proposal will be evaluated for evidence that the Offeror provided the CDRL attachment (DD Form 1423-1) with Blocks 17 & 18 completed as part of the Cost Proposal Section. If there is a cost associated with providing the CDRL, the form will be evaluated for evidence that the Offeror specified in the appropriate tab of the Cost/Pricing Template and in Block 18 of the CDRL Attachment Form (Solicitation Exhibit 1). If the Offeror proposed the CDRL as “Not Separately Priced” the proposal will be evaluated for evidence that the Offeror inserted “NSP” into the field in the CDRL tab of the Cost Template and Block 18 of the CDRL.

iv. Supporting Cost Information:

Supplemental Information. The Offeror’s proposal will be evaluated for evidence that it included supplemental pricing information that provided a detailed breakdown of its proposed pricing including but not limited to: labor, Overhead, G&A, profit or fee, other direct costs, and any sub elements of each. The proposal will be evaluated for evidence that the supplemental information included all other direct and indirect costs including materials, equipment, travel, shipping, and any other costs associated with the performance of the resulting contract. The proposal will be evaluated for evidence that the Offeror has an approved accounting system that the Defense Contract Audit Agency (DCAA), the Defense Contract Management Agency (DCMA), or any federal civilian audit agency, has deemed adequate for determining costs applicable to this contract in accordance with FAR 16.301-3(a)(1).

Subcontractor Cost. The proposal will be evaluated for evidence that the Offeror provided an analysis of how it determined subcontractor cost to be fair and reasonable and the basis for their determination. Reference FAR Part 15.404. The proposal will be evaluated for evidence that the Offeror provided sufficient information regarding the subcontractor cost analysis that the Government could recreate the analysis and come to the same conclusion.

Rating Standards:

Rating Standards for the Non-Cost Proposal excluding past performance are as follows:

Combined Technical/Risk Ratings

Rating Standards for Past Performance are as follows:

Past Performance Relevancy Ratings

Past Performance Confidence Assessments

Best Value Tradeoff Evaluation Standard Definitions

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