Instructions to Offeror and Evaluation - Updated 27AUG2024.pdf

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INSTRUCTIONS TO OFFEROR AND EVALUATION/AWARD CRITERIA

Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Surveillance and Epidemiology (OSE)

SENTINEL SYSTEM 3.0: PROGRAM MANAGEMENT ORGANIZATION (PMO)

RFP 75F40124R00181

Table of Contents Instructions to Offerors…………………………………………………………………………1

Proposal Instructions…………………………………………………………………………….. 5 Evaluation Factors……………………………………………………………………………………………………………………………… 6

Award Criteria…………………………………………………………………………………12

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1. INSTRUCTIONS TO OFFERORS AND EVALUATION/AWARD CRITERIA

1.1 Solicitation Information

Notice of Combined Synopsis/Solicitation This is a combined synopsis/solicitation for commercial products/services prepared in accordance with the format in FAR12.6, as supplemented with additional information included in this notice.

This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This is a request for proposal (RFP) for commercial items IAW the procedures of FAR Part 12-Acquisition of Commercial Items, in conjunction with FAR Part 15- Contracting by Negotiations.

Notice of FAC: This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2024-05, effective 5/22/2024.

Notice of NAICS/Set aside: This requirement is being solicited as a women owned small business set aside. The associated North American Classification System (NAICS) code is 541990, All Other Professional, Scientific, and Technical Services, 16.5 million dollars size standard. Offerors must have an active registration in SAM.gov (www.sam.gov) with completed representations and certifications by the close date of the solicitation. Proposals submitted by offerors without an active registration in SAM.gov will not be considered.

PRICING AND ORDERING SERVICES

Overview of Pricing Schedule The contractor’s price schedule for labor categories shall contain fully burdened hourly rates. The fully burden hourly rates for each labor category shall include wages, indirect costs, fringe benefits, overhead, general and administrative, and profit. Hourly rates shall apply to services at non- Governmental sites.

By mutual agreement of the parties, additional labor categories may be added to this IDIQ contract to support the tasks of this contract.

For Pricing Schedule See Attachment B For Labor Category Descriptions, See Attachment C Total IDIQ Ceiling amount is $ 9,500,000.000.

Pricing Terms The Contractor shall comply with FAR Clause 52.212-4, Contract Terms and Conditions (Nov 2023) in regard to fixed prices. The total amount specified in Firm Fixed Price (FFP) task orders shall be fixed for the task order period of performance and shall not be subject to adjustment;

except, as a result of a direct action of inaction of the Government which delays the Contractor from completing the task order within the time specified in the order.

http://www.sam.gov/

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The Contractor shall comply with FAR Clause 52.212-4 Contract Terms and Conditions Alt 1 (Nov 2022) with regard to the ceiling price for each labor-hour type task order and time and materials order task order.

Contract Type:

This is a single award Indefinite Delivery-Indefinite Quantity (IDIQ) type contract, per FAR

16.5. Authorized contract types under this IDIQ are: Firm Fixed Price (FFP), Labor Hour (LH) and Time and Materials (T & M) an/or a combination thereof.

Minimum and Maximum Contract Value:

IDIQ Minimum: The minimum guarantee for this IDIQ contract is $3,000.00 which will be obligated at the time of the IDIQ award.

IDIQ Maximum: The maximum aggregate dollar value of all task orders awarded over a 5-year period of this IDIQ shall not exceed the IDIQ ceiling amount of $9,500,000.00. See FAR Clause 52.216-19 (Oct 1995) for individual task order limitation.

Ordering:

A request for task order proposal (RFTOP) will be issued via email for individual task orders. Task orders against the IDIQ contract will be in accordance with FAR 16.505 and FAR Clause 52.216- 18 (Aug 2020).

Ordering Procedures Any contracting officer of the Food and Drug Administration (FDA) is authorized and may place orders under this IDIQ contract. Each individual task order will describe the specific requirements.

The process of issuing task orders as follows:

1. The FDA CO will issue a RFTOP via email. The RFTOP will include the following information:

a. SOW

b. Period of Performance

c. Anticipated Contract Type

d. Reporting Requirements and Deliverables

e. Key Personnel (if applicable)

f. Any special terms and conditions specifically applicable to the task order

2. The Contractor will typically have a minimum of ten (10) business days, unless otherwise specified, to provide a proposal in response to the RFTOP.

The proposal shall include:

a. Description of the technical approach to the task order requirements

b. Price Buildup (including labor categories, hours for each labor category, extended pricing, other direct costs and concurrence with the anticipated contract type)

c. Resumes of any key personnel identified in the RFTOP

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d. Other Direct Costs: Other Direct Costs shall be clearly identified, explained and substantiated

3. The FDA will evaluate the task order proposal for technically acceptability and price reasonableness. If the FDA has questions or concerns, the Contracting Officer will contact the Contractor and may request a revised proposal.

4. If the task order proposal is determined to be acceptable, the Contracting Officer will issue a task order. All task orders will, at a minimum, include the following:

a. Task Order Number

b. Date of Task Order

c. Funding for the Task Order

d. Task Order SOW and specific deliverables and due dates

e. Task Order Pricing

f. Period of Performance of the task order

g. Any terms, condition and instructions specific to the task order

Any work that the Contractor undertakes prior to receiving a fully executed task order signed by the Contracting Officer (or the Contractor has received prior authorization to proceed from the Contracting Officer) shall be at the Contractor’s risk.

No separate payment will be made to the Contractor for the cost to prepare, submit and/or negotiate a task order proposal.

Pricing of Orders:

1. Proposals submitted in response to the RFTOP must be in accordance with the Ordering Period rates in the IDIQ Price Schedule based on performance start date of the task order, and the rate must be used for the duration of the task order;

however, if a task order’s period of performance is longer than twelve (12) months, the Contractor may propose the applicable ordering period rate for that portion of the performance after the twelve (12) month period. The Contractor may propose lower rates in response to a RFTOP.

2. RFTOPS may include option periods in accordance with FAR 52.217-9 (Mar 2000). However, option periods must utilize the Ordering Period rates listed in the IDIQ Price Schedule, based upon performance start date of the option period.

The performance period end date of the last option period cannot exceed twelve

(12) months past the performance end date of the IDIQ contract.

3. Labor-Hour (LH) type task orders and Time and Materials (T & M) type task orders will include a ceiling price.

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4. If a task order’s stated period of performance must be extended as a result of Government delay, the Contractor may request that the most current labor rates be used to price the work effort during the extended period for LH task orders.

These Ordering Pricing terms and conditions apply to all task orders issued under this IDIQ contract.

Task Order Processing All task orders issued hereunder are subject to the terms and conditions of the contract. The IDIQ contract takes precedence over the task order in the event of conflict with requirements and/or deliveries. Task orders shall be “issued” for purpose of this contract upon the effective date of the order. The IDIQ contract COR must be notified when task orders are issued against the IDIQ, detailing task order number, scope, awarded amount and pricing modifications.

It is the Government’s intention to perform close-out procedures on a Task Order basis as well as for the IDIQ contract. The Contractor shall perform those internal functions necessary to support this process in a timely manner. The Task Order closeout will occur as soon as possible after required audit and establishment of final rates, as applicable.

STATEMENT OF WORK: See Attachment A PRICING SCHEDULE: See Attachment B LABOR CATEGORY DESCRIPTIONS: See Attachment C

2. PROPOSAL INSTRUCTIONS

The Government intends to establish a single-award IDIQ. This RFP is open only to woman owned small businesses. Teaming arrangements are encouraged to apply.

Questions/Clarifications regarding this requirement shall be submitted via email to the Contract Specialist Howard S. Yablon, howard.yablon@fda.hhs.gov and the Contracting Officer Ian Weiss, ian.weiss@fda.hhs.gov by 3:00 PM (Eastern) on August 23, 2024. The subject line shall read:75F40124R00181: Sentinel System 3.0: Program Management Organization (PMO) IDIQ Contractor Questions. FDA may not answer questions received after this date and time and will not answer questions submitted by individuals other than named contacts. Questions submitted by another means will not be answered, including phone calls. It is the Offeror’s responsibility to confirm receipt of all proposals and/or questions by the closing date of this announcement by contacting the above Contract Specialist/Contracting Officer.

The Offeror shall submit electronic documents using Microsoft Office suite products without the use of “macros”. If the offeror or applicant submits documents that contain macros the Government will not be able to view or open such documents and the submission will be mailto:howard.yablon@fda.hhs.gov mailto:ian.weiss@fda.hhs.gov

6 | P a g e considered non- responsive to the solicitation. No additional time will be given to an offeror or applicant to correct the document submission and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award. It is the offeror’s responsibility to ensure all electronic documents are submitted without the use of macros.

The FDA is not responsible for any costs incurred in preparing the documents described in this RFP. Offeror employees responsible for preparing materials that may be proprietary information must mark each page that the Offeror believes contains proprietary information with the legend “Proprietary Information.”

The Government reserves the right to evaluate only the information provided by the Offeror within each Phase/section response in formulating the Government evaluation for the corresponding factor. The Government reserves the right to make an award decision without conducting post- proposal communications with Offerors.

Responses to all evaluation criteria are essential to this evaluation. Omissions will result in a poor rating for that technical criterion.

Note: The Government reserves the right to evaluate proposals and make awards without discussions. Therefore, the Offeror’s initial proposal shall contain the Offeror’s best terms from a cost/price and technical standpoint. However, the Government may conduct discussions if the Contracting Officer determines they are necessary. (See Attachment D for Contractor Questions Template.)

3. EVALUATION

Description Evaluation Factors Method of

Response

IDIQ and Task Order Contract

Volume 1 Factor No. 1 – Demonstrated Relevant Experience

Written Response

Volume 1 Factor No. 2 – Technical Approach Written Response

Volume 1 Factor No. 3 – Past Performance FDA review of contractor’s past performance ratings and reviews.

Volume 2 Factor No. 4 – Contract Pricing Written Response

All responses shall be submitted electronically via email to the Contract Specialist Howard S. Yablon, howard.yablon@fda.hhs.gov and to the Contracting Officer Ian Weiss, 7 | P a g e ian.weiss@fda.hhs.gov by 2:00 PM (Eastern) on August 30, 2024 and the subject line shall read “ 75F40124R00181, Sentinel System 3.0: Program Management Organization (PMO) Proposal. Late submissions will not be evaluated. Fax submissions are not authorized.

A complete response to the solicitation shall consist of two sets of separate volumes for both the IDIQ and Task Order 1 identified as:

• Sentinel System 3.0: Program Management Organization (PMO) Proposal:

IDIQ Volume I -Technical and Volume II Business/Price Proposal

• Sentinel System 3.0: Program Management Organization (PMO) Proposal:

Task Order 1 - Volume I-Technical and Volume II Business/Price Proposal

For both the IDIQ and Task Order 1 submission for the Technical Proposal and Business/Price Proposal each must be kept separate from each other. Kept separate is defined as not including any cost/price information in the Technical Proposal. Technical Proposal must not make any reference to pricing data in order that the technical evaluation may be made strictly on the basis of technical merit. For submission purposes, it is acceptable for the Technical and Business/Price Proposal be submitted on the same email; however, each attachment must be clearly marked to which Volume it belongs to.

The Government reserves the right to not evaluate Business/Price proposals for any Offeror determined to be technically unsatisfactory. All text of the body in Volume I response shall be black. The Offeror may choose to use color in graphics, charts or tables for greater clarity.

Text in graphics and charts shall be no smaller than 9-point Arial Narrow, and text in tables shall be no smaller than 9-point Arial. No fonts may be condensed.

The IDIQ submission for Volume I is limited to 30 pages and the Task Order 1 submission for Volume 1 is limited to 20 pages. Offerors shall use only 8.5 inch by 11 inch (210 mm by 297

mm) paper, single-spaced pages with margins no less than one inch on each border and shall number the pages consecutively. FDA prefers the Offerors use Arial 11 font, but the Offeror may use any legible font that is equal in size to or larger than Arial 11 font.

An individual authorized to contractually bind the Offeror shall sign the cover page of the Volume I response.

Note: In both the IDIQ and the Task Order 1 Volume I response, a page that contains a table, chart, graph etc. not otherwise excluded below, is subject to the page limitation.

The following items are not included in the 30-page limit for the IDIQ and the 20 page limit for the Task Order 1 Volume I responses: Cover Sheet, Table of Contents, Dividers, and Resumes.

All critical information from appendices should be summarized in the Volume I response.

Note: Information submitted over the page limit will not be evaluated.

Additionally, a PPQ shall be submitted for each of the past examples cited. The Offeror shall send Attachment C Past Performance Questionnaire to each of the examples cited. Each mailto:ian.weiss@fda.hhs.govby

8 | P a g e reference must complete the PPQ and email an electronic copy to the Contract Specialist Howard S. Yablon, howard.yablon@fda.hhs.gov and cc the Contracting Officer Ian Weiss, ian.weiss@fda.hhs.gov by the proposal due date (See Attachment E for PPQ Questionnaire).

Note: The Offeror shall provide an IDIQ and Task Order 1 response to include a cover page, table of contents, introduction and technical discussion for each of the technical areas in Volume I in the order of evaluation factors.

SECTION DESCRIPTION

Cover Page • The name of the proposing organization, author(s) of the technical proposal, the Solicitation number and the title should appear on the cover.

Table of Contents • Provide sufficient detail so that all important elements of the proposal can be located readily.

Introduction • The introduction shall be a one- or two-page summary outlining the proposed work, the Offeror’s interest in submitting a proposal, and the importance of this effort in relation to Offeror’s overall operation.

Technical discussion • The Offeror shall address each of the technical areas in Volume 1 in the order of factors listed below.

RELEVANT PAST EXPERIENCE, TECHNICAL APPROACH, PAST

PERFORMANCE (VOLUME 1) AND CONTRACT PRICING (VOLUMES 2)

Note: Factor Nos. 1, 2, 3, and 4 are listed in “descending” order of importance.

FACTOR NO. 1 – DEMONSTRATED RELEVANT PAST EXPERIENCE

Detailed Information: The offeror shall provide detailed information for the government to evaluate its level of confidence by addressing each of the four (4) elements in the table below.

Prior Relevant Experience Examples: The evaluation of this technical factor is based on the demonstrated prior experience presented by the offeror, and how well it aligns with the requirements and standards in the PWS. Offerors may provide up to three (3) relevant recent examples of demonstrated prior experience in their submission. At least one (1) prior experience shall come from the offeror who will be the prime contractor for this requirement.

Recent is defined as within the last five (5) years, and relevant is defined as being of a similar scope and complexity with the requirements in the PWS.

Prime/Sub/Teaming Arrangements: The offeror may use prior experiences in which they serve as a prime, subcontractor, and other team organizations. The offeror must identify the offeror’s role in all the prior experience submitted. If the offeror plays no role in any submitted prior experience, the offeror must state that fact. Offerors are encouraged to submit experience performed as a prime, through teaming agreements, or as the sole sub-contractor mailto:ian.weiss@fda.hhs.gov

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Summary of Data: For any work cited, the contractor must provide a summary of the contract/task order/reference no. to include the following data:

• Name of the Customer Agency/Organization

• Point of Contact Information

• Contract/Task Order Type

• Prime/Subcontractor Percentage

• Period of Performance

• Total Contract Dollar Value

1 Collaboration Platform

(Reference PWS Task Area 1)

Sentinel System 3.0 Collaboration Platform:

Development, management, and maintenance of a secure collaboration environment, referred to as the “Sentinel Collaboration Platform”, that will allow Sentinel System 3.0 contractors, FDA staff, and Federal Partners to communicate and collaborate in projects and tasks including information and data exchange. The Collaboration Platform will provide access to tools to support Sentinel operations including but not limited to the following: (1) team collaboration tools (e.g., communication and document management tools),

(2) workflow management and performance metrics collection and tracking tools, (3) data visualization tools and dashboards (including the ARIA System Dashboard), and (4) medical code sets management tool. The dashboard will also track communication for applicant notification per

MAPP 6701.4.

Please explain your prior relevant experience in developing, implementing, and maintaining a multi-user authentication, secure collaboration environment that hosts program and project management and communication tools.

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2 Sentinel Initiative Website (Reference PWS Task Area 2)

The Sentinel Initiative Website (https://www.sentinelinitiative.org/) is a communication tool to inform industry and the public about the work performed under the Sentinel Initiative. This website is one of the primary vehicles used to meet transparency mandates associated with FDA policy objectives and user fee commitments. The Sentinel Initiative Website has a vast amount of information that promotes scientific collaborations.

Please explain your prior relevant experience in managing a website requiring frequent updates of scientific information.

3 Scientific and Regulatory Operations Support (Reference PWS Task Area 7)

The PMO will support the SCC in managing all scientific and regulatory operations including: (1) the management of all requests for Sentinel System

3.0 consults and services, workflows, and individual scientific projects, tasks and data calls;

(2) collection, tracking, and reporting of program

Please explain your prior relevant experience in managing multiple, concurrent scientific projects involving a government agency and multiple collaborators in a fast-paced operation that requires careful documentation of all work workload and performance metrics; and (3) development and management of standard operating procedures (SOPs) related to the operation of the PMO (4) Facilitate communication between the stakeholders.

Regulatory Operations support activities include but are not limited to generating responses to Congressional inquiries, user-fee commitments related activities, and activities directly associated to regulatory requirements such as Sponsor Notification Letters, Sentinel 3.0 performance metrics tracking, PDUFA mandated Sentinel Assessment Reports, ARIA sufficiency documentation, public posting of Sentinel study results and public presentations.

products including tracking, reporting, and archiving project deliverables in compliance with federal records management requirements.

http://www.sentinelinitiative.org/)

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4 Program Management: Program Management Plans (Reference PWS Task Area 7)

The Contractor shall provide Program Management support services for Sentinel 3.0 PMO requirements. These Program Management responsibilities shall include what is necessary to plan, structure, coordinate, schedule, manage, communicate, report, and steward all respective task orders and activities throughout the period of performance. The Contractor shall provide end-to-end program management services to support all programmatic activities in support of the FDA Sentinel System 3.0.

The PMP shall provide written processes and procedures describing the PMO operations and interactions with FDA SCC, other FDA Sentinel

3.0 stakeholders (e.g., reviewers in other CDER offices), Federal Partners (e.g., CMS IAA points of contact), and other contractors supporting Sentinel 3.0.

Please explain your prior relevant experience in providing program management support to a complex, multidisciplinary organization with a high-profile scientific mission that requires detailed plans to maintain overall management and insight of all tasks and deliverables.

FACTOR NO. 2 - TECHNICAL APPROACH

The Offeror’s proposals shall present sufficient information to reflect a thorough understanding of the work requirements and a detailed plan for achieving the objectives as detailed in Section C. Technical proposals shall not merely paraphrase the requirements of the Agency’s scope of work or parts thereof or use of phrases such as “will comply” or “standard techniques will be employed.”

The technical proposals must include a detailed description of the techniques and procedures to be used in achieving the proposed end results in compliance with the Agency’s requirements as detailed in Section C. A successful technical proposal shall have all of the following sections.

Technical Approach • Section 1 – The Offeror shall provide a comprehensive narrative demonstrating that it understands of all aspects of the requirements and standards.

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• Section 2 – The Offeror shall provide a detailed written narrative demonstrating that its technical approach meets or exceeds all requirements and standards for all PWS Task Areas 1-10 specifically Task Area 1 - Collaboration Platform, 2 – Sentinel Initiative Website, 3 – Sentinel Source Code Repository, 4 – Medical Code Look-Up Tool; 5 – O&M for Collaboration Platform, Website and Source Code Repository, 6 – DME of the Collaboration Platform, Website and Source Code Repository , 7

– Regulatory Operation Support, 8 – Program Management Plans, 9 – Transition-In Services, 10 – Transition-Out Services.

FACTOR NO. 3 – PAST PERFORMANCE

The FDA will evaluate past performance as risk assessment, not as a weighted technical evaluation factor.

The Government will assess the relative performance risks associated with each offer.

Performance risk are those associated with an offeror’s likelihood of success in performing the acquisition requirements as indicated by that offeror’s record of past performance.

The assessment of performance risk is not intended to be a product of a mechanical or mathematical analysis of an offeror’s performance on a list of contracts but rather the product of subjective judgement by the Government after it considers relevant information.

When assessing performance risk, the Government will focus on the past performance of the offeror as it relates to all acquisition requirements, such as the offeror’s record of performing according to specifications, including standards of good workmanship; the offeror’s record of controlling and forecasting costs; the offeror’s adherence to contract schedules, including the administrative aspects of performance; the offeror’s reputation for reasonable and cooperative behavior and commitment to customer satisfaction; and generally, the offeror’s business-like concern for the interest of the customer.

The lack of a past performance record may result in an unknown performance risk assessment, which will neither be used to the advantage nor disadvantage of the offeror.

Ratings of Good, Neutral or Poor will be given. A rating of Good past performance will take precedence over Neutral or Poor performance. Neutral past performance takes precedence over Poor past performance.

The Government will evaluate the extent to which the Offeror’s proposal demonstrates (within the last five (5) years) and successful performance of work similar in scope and size (dollar amount) to the requirements set forth in the statement of work.

Offerors are cautioned that the Government may use data in addition to that provided be each offeror, to include data obtained from possible other sources such as Government past performance data bases (e.g., Contractor Performance Assessment Reporting System (CPARS) in evaluation of past performance.

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FACTOR NO. 4 – CONTRACT PRICING (Volume 4)

Page Limitation - None The Offeror shall submit a business quote fully supported by underlying cost information (i.e., price breakdown) adequate for the Government to determine the reasonableness of the unit pricing proposed, and to evaluate whether the proposed costs are consistent with the technical quote and the Offeror’s effort to perform the requirement. The Offeror shall provide proposed contract pricing for both the IDIQ (Attachment B – Copy of Pricing Table – Sentinel PMO IDIQ) and Task Order 1 (Attachment I – Copy of Pricing Table – Sentinel PMO Task Order 1) for the period of performance.

The pricing data shall be submitted in both PDF and MS Excel format for verification and evaluation purposes. In addition, all pricing formula, linkages between cells, as well as basis of estimate shall be shown to support the Offeror’s derivation of their proposed pricing.

Pasted pricing data shall not be accepted. The FDA is not responsible for any costs incurred in preparing the documents described in this solicitation.

The hourly rates for each labor category shall be fully burdened to include wages, fringe benefits, overhead, general, and administrative expenses, and/or profit.

4. EVALUATION FACTOR FOR AWARD CRITERIA

General: All proposals will be evaluated by the government in accordance with the factors and criteria established above. The factors will measure the government’s confidence that the Offeror understands the requirement, proposes a sound technical approach, and will be successful in performing the contract.

Award Criteria: The award criteria to be evaluated consists of: Demonstrated Prior Experience, Technical Factors and all associated elements, Past Performance, and Price.

Order of Importance: The technical factors will be evaluated in descending order of importance.

Award Without Discussions: The government reserves the right to make award without discussions based on the initial proposals received. A limited exchange, between the government and Offerors for the purpose of clarification may occur when award without discussions is contemplated. Offerors may be given the opportunity to clarify certain aspects of proposals (e.g., the relevance of an Offeror’s demonstrated experience) to which the Offeror has not previously had an opportunity to respond) or to resolve minor or clerical errors. In the event that discussions become necessary, the Contracting Officer may determine that the number of proposals that would otherwise remain in the competitive range exceeds the number at which an efficient competition can be conducted and 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.

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BASIS FOR AWARD / BEST VALUE PROCUREMENT:

This is a “best value” procurement using the tradeoff process as described at FAR 15.101-1.

The government will make an award to the responsible Offeror whose proposal is most advantageous to the government, price and other factors considered.

Accordingly, the government may or may not award to the lowest price Offeror. The government reserves the right to make award to a higher priced Offeror to achieve a superior approach in meeting the requirements of the PWS. Offerors should, therefore, propose their best approach to meeting the requirements of the PWS.

Ratings: The evaluation of Volume 1 will be done holistically with a rating scale of "high confidence," "some confidence," and "low confidence," representing the government’s confidence that the Offeror understands the requirement and will be successful in performing the work. All non-price factors are more important than price. The definition of these ratings are as follows:

Rating Description High Confidence The Government has high confidence that the Offeror will be successful in performing the contract with little or no Government intervention given the Offeror’s proposed sound and superior technical approach with no significant weaknesses and it’s understanding of the requirements.

Some Confidence The Government has some confidence that the Offeror will be successful in performing the contract with some Government intervention given the Offeror’s proposed technical approach having some weaknesses and it’s understanding of the requirements.

Low Confidence The Government has low confidence that the Offeror will be successful in performing the contract even with Government intervention due to the Offeror’s proposed technical approach having significant weaknesses and it’s lack of understanding of the requirements.

FACTOR 1: RELAVENT PAST EXPERIENCE

The Government will evaluate the Offeror’s relevant experience examples to assess the level of confidence that the Offeror will be able to successfully perform the requirements similar to those outlined in the Statement of Work based on the Offeror’s past relevant experience. Past relevant experience will be given a rating of High Confidence, Some Confidence or Low Confidence. The confidence rating is not intended to be a product of a mathematical analysis of the Offeror’s performance on a list of contracts but rather a product of subjective judgements by the Government after it considers relevant information.

The Government reserves the right to select which references to contact. The Government reserves the right to contact references for verification or request additional information, and the right to consider other past performance information such as Contractor

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Performance Assessment Reporting System (CPARS) in assessing relevant past performance. The Government may contact customers, whether or not listed on the provided list, to inquire about the Offeror’s relevant past performance.

The Government does not assume the duty to search for data to cure the problems it finds with the information provided by the Offeror. The burden of providing thorough and/or complete relevant past performance information remains with the Offeror.

FACTOR NO. 2 - TECHNICAL APPROACH

The Government will assess its level of confidence that the Offeror has the technical experience and a sound technical approach to each of the evaluation factors to successfully perform the contract requirements.

• The Government will evaluate the depth to which the Offeror demonstrates an understanding of the requirement and has proposed an approach to meet all the task areas (1-10) for the Sentinel 3.0 PMO requirements and standards and all related support services that satisfy or exceed the requirements of the PWS.

• FDA will evaluate whether the Offeror meets the technical requirements and the depth to which the Offeror has proposed an adequate Program Management Plan (PMP) inclusive of a Quality Management Plan, Risk Management Plan, Communication Management Plan, and Staffing Plan that demonstrates the capabilities to satisfy or exceed the requirements and standards of the PWS; and that the Key Personnel meet minimum requirements.

Proposals that merely offer to perform in accordance with the requirements of the PWS (i.e., merely paraphrase the requirements of the Agency’s scope of work or parts thereof, or use of phrases such as “will comply” or “standard techniques will be employed”) without providing a description of their approach will not be considered for award.

FACTOR NO. 3 – PAST PERFORMANCE

The Government will assess its level of confidence that the Offeror possesses past performance experience from at least two (2) contracts and/or projects that demonstrate the Offeror’s past performance with the same or similar services performed within the last five

(5) years; and has successfully performed the past experiences in these areas:

1. Business Relations

2. Quality of Service

3. Cost Control

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4. Timeliness of Performance

5. Customer Satisfaction

The Government may use the past performance ratings below:

Rating Description

High Confidence The Government has high confidence that the Offeror will be successful in performing the contract with little or no Government intervention given the Offeror’s proposed sound and superior technical approach with no significant weaknesses and it’s understanding of the requirements.

Some Confidence The Government has some confidence that the Offeror will be successful in performing the contract with some Government intervention given the Offeror’s proposed technical approach having some weaknesses and it’s understanding of the requirements.

Low Confidence The Government has low confidence that the Offeror will be successful in performing the contract even with Government intervention due to the Offeror’s proposed technical approach having significant weaknesses and it’s lack of understanding of the requirements.

Neutral An Offeror without relevant past performance, or for whom information on past performance is not available, will be given a neutral rating.

FACTOR NO. 4 – CONTRACT PRICING

Contract pricing will be evaluated after conclusion of the non-price factors evaluation. The government will conduct a price analysis of the Offeror’s proposed pricing to determine if the underlying cost information (i.e., price breakdown) is fair and reasonable and in compliance with the DOL Wage Determination rates. This factor will not receive a confidence rating but will be evaluated to ensure that the price is reasonable based on, for example, the current market rates, GSA schedule rates, etc.

ATTACHMENTS:

Attachment A: Statement of Work

Attachment B: Pricing Table

Attachment C: Key Personnel Labor Category Descriptions

Attachment D: Contractor Questions Template

Attachment E: Past Performance Questionnaire

Attachment F: Commitment to Protect NPI Form 3398

First Task Order: The first task order will be issued in conjunction with

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First Task Order Statement of Work: See Attachment G.

First Task Order Pricing Schedule: See Attachment H.