att_24_Additional_Proposal_Instructions_Eval_Criteria_and_Sub_Attachments.pdf

Chemistry Research for The Division of Translational Toxicology (DTT) Attachment 24- Additional Proposal Instructions and Evaluation Criteria

EVALUATION

A. BASIS FOR AWARD

1. The Government reserves the right to eliminate from consideration for award any or all offers at any time prior to award of the contract; to negotiate with offerors in the competitive range; and to award the contract to the offeror submitting the proposal determined to represent the best value— the proposal most advantageous to the Government, price and other factors considered.

2. As stated in the solicitation, the Government intends to evaluate proposals and award a contract without discussions with offerors (except clarifications as described in FAR 15.306(a)). The Government reserves the right to conduct discussions if the CO later determines them to be necessary. In addition, if the CO determines that the number of proposals that would otherwise be in the competitive range exceeds the number at which an efficient competition can be conducted, the CO 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.

3. The tradeoff process is selected as appropriate for this acquisition. The Government considers it to be in its best interest to allow consideration of award to other than the lowest priced offeror or other than the highest technically rated offeror.

4. As stated in the solicitation, all technical factors when combined are of equal importance to the performance confidence assessment (past performance) rating; and all technical factors and the performance confidence assessment (past performance) rating, when combined are significantly more important than cost.

5. Any proposal found to have a deficiency in meeting the stated solicitation requirements or performance objectives will be considered ineligible for award, unless the deficiency is corrected through discussions. An Unacceptable rating in any of the non-cost/price factors and/or sub-factors will result in an overall rating of “Unacceptable” for the non-cost/price factors, unless corrected through discussions. Proposals may be found to have either a significant weakness or multiple weaknesses that impact either the individual factor rating or the overall rating for the proposal. The evaluation report must document the evaluation board’s assessment of the identified weakness(s) and the associated risk to successful contract performance resulting from the weakness(s). This assessment must provide the rationale for proceeding to award without discussions.

B. ADJECTIVAL RATINGS/DESCRIPTIONS

1. TECHNICAL EVALUATION:

The technical rating reflects the degree to which the proposed approach meets or does not meet the minimum performance or capability requirements through an assessment of the strengths, weaknesses, significant weaknesses, deficiencies, and risks of a proposal.

a. A combined technical/risk evaluation includes consideration of risk in conjunction with the significant strengths, strengths, weaknesses, significant weaknesses, uncertainties, and deficiencies in determining technical ratings shall be used. The technical risk evaluation shall utilize the combined technical/risk ratings listed in the following table. Adjectival ratings and rating descriptions will be used to assign an overall rating to each technical proposal and to assign a rating for each technical factor. Use upper case letter ratings for major technical factors as well as the overall rating. The addition of plus (+) or minus (-) to an adjective rating is not allowed.

Table 1. Combined Technical/Risk Rating Method

Adjectival Rating Description

Outstanding (O)

Proposal demonstrates an exceptional approach and understanding of the requirements and contains multiple strengths and/or at least one significant strength, and risk of unsuccessful performance is low.

Good (G)

Proposal indicates a thorough approach and understanding of the requirements and contains at least one strength or significant strength, and risk of unsuccessful performance is low to moderate.

Acceptable (A)

Proposal meets requirements and indicates an adequate approach and understanding of the requirements, and risk of unsuccessful performance is no worse than moderate.

Marginal (M)

Proposal has not demonstrated an adequate approach and understanding of the requirements, and/or risk of unsuccessful performance is high.

Unacceptable (U)

Proposal does not meet requirements of the solicitation and, thus, contains one or more deficiencies and is unawardable unless corrected through discussions, and/or risk of performance is unacceptably high.

b. Definitions: The following definitions are provided to assist evaluators in the evaluation of each non-cost/price factor.

(i) Significant Strength: An aspect of an offeror’s proposal with appreciable merit or will exceed specified performance or capability requirements to the considerable advantage of the Government during contract performance.

(ii) Strength: An aspect of an offeror's proposal with merit or will exceed specified performance or capability requirements to the advantage of the Government during contract performance.

(iii) Weakness: A flaw in the proposal that increases the risk of unsuccessful contract performance.

(iv) Significant Weakness: A flaw that appreciably increases the risk of unsuccessful contract performance.

(v) Uncertainty: Any aspect of a non-cost/price factor proposal for which the intent of the offer is unclear (e.g., more than one way to interpret the offer or inconsistencies in the proposal indicating that there may have been an error, omission, or mistake).

(vi) Deficiency: A material failure of a proposal to meet a Government requirement or a combination of significant weaknesses in a proposal that increases the risk of unsuccessful contract performance to an unacceptable level.

2. PAST PERFORMANCE EVALUATION

a. The past performance evaluation results in an assessment of the offeror’s ability of meeting the solicitation requirements. The past performance evaluation considers each offeror’s demonstrated recent and relevant record of performance in supplying products and services that meet the contract’s requirements. The currency and relevance of the information, source of the information, context of the data, and general trends in contractor’s performance shall be considered. These are combined to establish one performance confidence assessment rating for each offeror.

b. There are three aspects to the past performance evaluation: recency, relevancy (including context of data), and quality (including general trends in contractor performance and source of information).

The first is to evaluate the recency of the offeror’s past performance. The second is to determine how relevant a recent effort accomplished by the offeror is to the effort to be acquired through the source selection. The third is to establish the overall quality of the offeror’s past performance. Recency is generally expressed as a time period during which past performance references are considered relevant and is critical to establishing the relevancy of past performance information. In establishing what is relevant for the acquisition, consideration should be given to those aspects of an offeror’s contract history that would give the greatest ability to measure whether the offeror will satisfy the current procurement. Common aspects of relevancy include, but are not limited to, the following: similarity of service/support, complexity, dollar value, contract type, use of key personnel (for services) and extent of subcontract/teaming. The third aspect of the past performance evaluation is to establish the overall quality of the offeror’s past performance (see FAR 15.304[c][2]). The past performance evaluation conducted in support of a current source selection does not establish, create, or change the existing record and history of the offeror’s past performance on past contracts;

rather, the past performance evaluation process gathers information from customers on how well the offeror performed those past contracts. A separate quality assessment rating is not required; rather, the past performance rating using the confidence assessment rating, is based on the offeror’s overall record of recency, relevancy, and quality of performance.

c. This source selection will evaluate past performance relevancy in accordance with the ratings in

Table 3 below:

Table 3. Past Performance Relevancy Rating Method

Very Relevant Present/past performance effort involved essentially the same scope and magnitude of effort and complexities this solicitation requires.

Relevant Present/past performance effort involved similar scope and magnitude of effort and complexities this solicitation requires.

Somewhat Relevant

Present/past performance effort involved some of the scope and magnitude of effort and complexities this solicitation requires.

Not Relevant Present/past performance effort involved little or none of the scope and magnitude of effort and complexities this solicitation requires.

d. The SSEB will review all past performance information collected and determine the quality of the offeror’s performance, general trends, and usefulness of the information and incorporate these into the performance confidence assessment. A separate quality assessment rating is not required; rather, the past performance confidence assessment rating is based on the offeror’s overall record of recency, relevancy and quality of performance.

In the case of offerors for which there is no information on past contract performance or where past contract performance is not available, the offeror may not be evaluated favorably or unfavorably on the factor of past contract performance. In this case, the offeror’s past performance is unknown and assigned a confidence rating of “neutral.” Although the SSEB may not rate an offeror that lacks recent, relevant past performance favorably or unfavorably with regard to past performance, the SSA may determine, that a “Substantial Confidence” or “Satisfactory Confidence” past performance rating is worth more than a “Neutral Confidence” past performance rating in a best value tradeoff as long as the determination is consistent with stated selection criteria.

e. Performance Confidence Assessment. This source selection requires a greater level of discrimination within the past performance evaluation, therefore, the SSEB shall use all confidence ratings identified in Table 4 below.

Table 4. Performance Confidence Assessments

Substantial Confidence Based on the offeror’s recent/relevant performance record, the Government has a high expectation that the offeror will successfully perform the required effort.

Satisfactory Confidence Based on the offeror’s recent/relevant performance record, the Government has a reasonable expectation that the offeror will successfully perform the required effort.

Neutral Confidence

No recent/relevant performance record is available or the offeror’s performance record is so sparse that no meaningful confidence assessment rating can be reasonably assigned. The offeror may not be evaluated favorably or unfavorably on the factor of past performance.

Limited Confidence Based on the offeror’s recent/relevant performance record, the Government has a low expectation that the offeror will successfully perform the required effort.

No Confidence Based on the offeror’s recent/relevant performance record, the Government has no expectation that the offeror will be able to successfully perform the required effort.

C. EVALUATION FACTORS FOR AWARD

1. The solicitation requires the evaluation of cost and the following non-cost/price factors:

• Factor 1 – Experience

• Factor 2 – Program and Project Management and Coordination

• Factor 3 – Technical Approach and Sample Research Outlines

• Factor 4 – Personnel

• Factor 5 – Environment – Facilities, Equipment, and Security

• Factor 6 – Small Business Utilization

• Factor 7 – Past Performance

The distinction between experience and past performance is that experience pertains to the volume of work completed by a contractor that is comparable to the types of work described under the definition of recent, relevant projects, in terms of size, scope, and complexity. Past performance pertains to both the relevance of recent efforts and how well a contractor has performed on the contracts.

In order to be considered for award, offerors must clearly demonstrate that the following mandatory requirements can be met by the time of contract award. Offerors shall include all information that documents and/or supports the qualification criterion in one clearly marked section of the Technical Proposal.

MANDATORY QUALIFICATION CRITERIA

Listed below are mandatory qualification criteria. THE OFFEROR SHALL INCLUDE ALL

INFORMATION WHICH DOCUMENTS AND/OR SUPPORTS THE QUALIFICATION CRITERIA IN

ONE CLEARLY MARKED SECTION OF ITS TECHNICAL PROPOSAL.

The qualification criteria establishes conditions that must be met at the time of receipt of Technical Proposals by the Contracting Officer in order for your proposal to be considered any further for award.

1. Mandatory Requirement: Good Laboratory Practices (GLP) Compliance

All work performed under this contract for any assignment that directly supports a GLP Toxicology study shall comply with Food and Drug Administration Good Laboratory Practices for Nonclinical Laboratory Studies (FDA GLP Regulations; 21 CFR 58 Link: CFR Code of Federal Regulations Title 21 unless specifically authorized by the COR.

Organizations supporting proposals shall include information and documentation that demonstrates evidence of the testing laboratory’s current compliance with the provisions of 21 CFR 58. Such documentation may include (but is not limited to):

FDA 482-Notice of Inspection forms, as evidence that general surveillance inspections and/or directed inspections have occurred.

Establishment Inspection Report (EIR) forms issued to document the results of any inspections.

Any adverse findings or Form 483 reports issued.

History (number, time-frame, and evidence) of GLP studies conducted if documentation from a regulatory agency such as the above a, b, or c, cannot be provided.

2. Mandatory Requirement: Animal Welfare

The work conducted must be in compliance with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, the AWRs, the current edition of the Guide for the Care and Use of Laboratory Animals (the Guide), and all local, state, or federal regulations. The contractor must be accredited by AAALAC International. Organizations supporting proposals must have an approved Animal Welfare Assurance on file with the Office of Laboratory Animal Welfare (OLAW) at the time of contract award. (Note: an offeror that does not have a PHS Assurance may be selected but the CO will have to initiate the process of obtaining an assurance from OLAW, and contract funds may not be expended for animal work, until the assurance has been approved).

The Offeror and any proposed subcontractors shall be accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC).

Further information may be obtained from the following source:

Office of Laboratory Animal Welfare Office of Extramural Research National Institutes of Health Rockledge Center I, Suite 360, MSC 7982 6705 Rockledge Drive Bethesda, MD 20817 Phone: (301) 496-7163, ext. 234

Copies of the PHS policy are available by fax at 301-402-2803 and on the internet at URL:

http://grants.nih.gov/grants/olaw/olaw.htm

3. Mandatory Requirement: EVALUATION OF DATA MANAGEMENT AND SHARING PLAN

An Offeror's plan for the management and sharing of final research data (Data Management and Sharing Plan) shall be assessed for appropriateness, adequacy, and reasonableness.

If an Offeror's proposal does not include a Data Management and Sharing Plan (Plan) or if the Plan in an Offeror's proposal is considered "unacceptable," and the Government includes Offeror's proposal in the competitive range (for competitive proposals), or if the Government holds discussions with the selected source (for sole source acquisitions), the Offeror will be afforded the opportunity to further discuss, clarify, and/or modify its Plan during discussions and in its Final Proposal Revision (FPR).

However, if the Plan is still considered "unacceptable" by the Government after discussions, the Offeror may not be further considered for award.

2. The relative order of importance of the non-cost/price evaluation factors is the technical factors (Factors 1-

6) are of equal importance to each other and, when combined are equal in importance to the past performance evaluation/performance confidence assessment factor (Factor 7). When the proposal is evaluated as a whole, the technical factors and past performance/performance confidence assessment factor combined (i.e., the non-cost/price evaluation factors) are significantly more important than cost.

The importance of price will increase if the offerors’ non-cost/price proposals are considered essentially equal in terms of overall quality, or if price is so high as to significantly diminish the value of a non-cost/price proposal’s superiority to the Government. Award will be made to the responsible offeror(s) whose offer conforms to the solicitation and represents the best value to the Government, price and non-price factors considered.

3. Basis of Evaluation and Submittal Requirements for Each Factor.

a. Cost:

(1) Solicitation Submittal Requirements: Five sample Research Outlines (RO 1,2,3,4, and 5) are included in the Source Selection Plan (Attachment B) to provide offerors example research activities that might be conducted under the contract. When the actual contract award is made, the type and number of research activities may vary from the sample ROs, and options may be unilaterally exercised by the Government at any time during the contract.

Table 5 lists the activities that the offeror shall assume will be conducted during the base and optional periods (assumes an Option Year to extend the period of performance is exercised each year of the contract) and during the option to add labor hours (Option 1).

Option 1 can be exercised at any time for level of effort (LOE) up to a ceiling defined by cost assumptions listed in Table 5 and the Independent Government Cost Estimate (IGCE). Option1 to perform additional work in eight Functional Areas, may be exercised up to 1 time per year with costs capped at 30% of the base contract proposal. Offerors shall prepare a cost proposal for Option 1 based on a maximum of 30% of the level of effort, and the prorated assignment mix anticipated in the base optional periods during the year the assignment is exercised. To estimate the total effort and cost over the 10-year period of the contract, Offerors are to utilize sample ROs to estimate cost for each Functional Activity listed in Table 5 and those activities in full will be conducted in the contract year listed (assume a starting date of January 18, 2027). Activities associated with overall contract management and coordination, such as preparing monthly status reports, monthly budget summary reports, invoices, and annual reports; maintaining contract and research records etc. shall be captured under an administrative category.

An optional 6-month extension of the period of performance may be exercised after Option Year 9. Offerors shall prepare a separate cost proposal for the optional 6-month extension based on the level of effort anticipated in Option Year 9 of the base contract.

Table 5. Anticipated Research Activities per Year

Research Activity

Anticipated Number per Year for Base Year and

Option Years (Option Years 1-9)1

Anticipated Number per Year for Option 1

Contract management and administration Ongoing Ongoing

Activities Captured in Sample ROs

Logistics and Handling – Chapter 6.2 DTT Chemistry Specifications2

Chemical Handling (CH) 3 1 Chemical Procurement (CP) 3 1

Chemical Storage (CS) 2 1 Shipment (SHIP) 10 3

Research Activity

Anticipated Number per Year for Base Year and

Option Years (Option Years 1-9)1

Anticipated Number per Year for Option 1

Protocols Development (PD) 1 0 Multiple Chemical Handling (MCH) 3 1 Multiple Chemical Procurement (MCP) 3 1

Characterization – Chapter 6.3 DTT Chemistry Specifications

Comprehensive Chemical Analysis (CCA) 3 1 Chemical Identity and Purity Screen (CIPS) 3 1

Chemical Reanalysis (CRA) 2 1 Multiple Chemical Identity and Purity (MIPS) 3 1 Formulation – Chapter 6.4 DTT Chemistry

Preliminary Formulation Studies (PFS) 1 0 Formulation Analysis (FA) 2 1 Formulation Development (FD) 3 1 Formulation Preparation, Analysis, and Shipment

(FPAS) 3

Vehicle Analysis (VA) 3 1 Biosample Analysis – Chapter 6.5 DTT Chemistry Specifications

Biosample Method Development (BMD) 3 1 Biosample Analysis (BSA) 5 1 Special Studies – Chapter 6.6 DTT Chemistry

Annual Water Analysis (AWA) 1 0 Special Chemical Activity (SCA) 8 2 Animal Studies – Chapter 6.7 DTT Chemistry

Toxicokinetic Study (TKS) 2 1 Absorption, Distribution, Metabolism, and Distribution Study (ADMES) 1 0

Omics – Chapter 6.8 DTT Chemistry Specifications

Omics Studies (OMICS) 23 1 In Vitro Assays – Chapter 6.9 DTT Chemistry Specifications

In Vitro Assays (IVA) 24 1 1Assume 30% of base contract for Option 1 to perform additional work.

2Refer to DTT Chemistry Specifications https://ntp.niehs.nih.gov/data/research/chemistry/rfp for detail descriptions of each Functional Area and Functional Activity.

3Assume that one assignment includes all activities found in Sample Research Outline 3 (OMICS) for costing purposes.

4Assume that one assignment includes all activities found in Sample Research Outline 4 (In Vitro Assays) for costing purposes.

Description of Cost and Effort Summaries: Offerors must provide detailed effort and cost breakdowns to include the following. Refer to the NIH Breakdown of Proposed Estimated Cost (Plus Fee) and Labor Hours (https://oamp.od.nih.gov/content/breakdown-proposed-estimated-cost-plus-fee-and-labor-hours) (Section J - Attachment 13: NIH Breakdown of Proposed Estimated Costs- Business Proposal) for guidance and for the required Business Proposal Spreadsheet submission:

• Direct labor hours, including labor classification (professional/technical), labor category, individual, and hourly rate

• Other direct costs, including subcontracts, consulting, travel, etc.

• Material and supply costs

• Indirect rates

• Fee

Offerors shall provide detailed effort and cost breakdowns by filling out NIEHS Level of Effort Worksheet (Section J - Attachment 24: Sub Attachment E) according to the provided instructions. A complete NIEHS Level of Effort Worksheet (Attachment E) shall include effort and cost information for overall summary cost estimate (base year + 9 option years + Option 1 to add labor hours) for all research activities per Table 5 and sample ROs and associated administrative costs.

The following Business Proposal Spreadsheets are required with Proposal submission:

1. Section J - Attachment 13: NIH Breakdown of Proposed Estimated Costs- Business

Proposal) for guidance and for the required Business Proposal Spreadsheet submission.

2. NIEHS Level of Effort Worksheet (Section J - Attachment 24: Sub Attachment E) Additional Costing Assumptions

(a) Chemical Procurement (CP) Cost Assumption

1. For costing purposes, Offerors shall assume that Chemical Procurement (CP) chemicals will be procured in quantities of < 200 kg. For purposes of cost estimation only, Offerors shall assume that an average procurement under the Base contract costs $11,000.

2. For costing purposes, Offerors shall assume that Multiple Chemical Procurement (MCP) of 90 chemicals will be procured in quantities of 10 g. For purposes of cost estimation only, Offerors shall assume an average procurement cost of $500 per chemical.

(b) Multiple Chemical Handling (MCH) Cost Assumption For costing purposes Offerors shall assume that a MCH assignment will involve handling 90 chemicals.

(c) Chemical Shipment (SHIP) Cost Assumptions

For costing purposes, Offerors shall assume an average cost of $3,500 per shipment.

(d) Multiple Chemical Identity and Purity Screen (MIPS)

For costing purposes Offerors shall assume that a MIPS assignment will involve identity and purity determination for 90 chemicals. Chemical and biosample inventory transfer.

(e)Chemical and biological Sample inventory Receipt and Storage For costing purposes Offerors shall assume that quantities given in Attachment G will need to be stored. Offerors will need to plan for shipping and other required costs.

(2) Basis of Evaluation: The Government will evaluate price based on the total price. Total price consists of the basic requirements and all option items (see Section B of the solicitation). The Government intends to evaluate all options and has included the provision FAR 52.217-5, Evaluation of Options (JUL 1990) in Section M of the solicitation.

In accordance with FAR 52.217-5, evaluation of options will not obligate the Government to exercise the option(s). Analysis will be performed by one or more of the following techniques to ensure a fair and reasonable price:

(a) Comparison of proposed prices received in response to the RFP.

(b) Comparison of proposed prices with the IGCE.

(c) Comparison of proposed prices with available historical information.

(d) Comparison of market survey results.

b. Non-cost/price Factors:

(1) Factor 1, Experience:

(a) Solicitation Submittal Requirements: The offeror shall provide a minimum of one (1) and a maximum of three (3) examples of recent and relevant contract actions to be documented through use of the Corporate Experience Project Data Form (Attachment A). The offeror shall clearly demonstrate past experience to perform the services described in the Statement of Work (SOW). Examples submitted shall be recent and relevant contract actions that were similar in size, scope, and complexity to the requirements described in the SOW completed within the last five (5) years preceding the release date of the solicitation. To meet the minimum standard acceptable for this evaluation, offerors shall demonstrate through their examples experience in items one

(i) through seven (vii) either separately or combined to demonstrate relevancy per requirements in DTT Chemistry Specifications:

(i) Logistics and Handling

(ii) Characterization

(iii) Formulation

(iv) Biosample Analysis

(v) Animal Studies (Absorption, Distribution, Metabolism, Excretion, and

Toxicokinetics, ADME/TK)

(vi) OMICS

(vii) In Vitro Assays

Offerors that demonstrate through their experience an understanding and proficiency in ADME/TK study design and conduct may be viewed more favorably than offerors without such experience. Relevant experience performed by the offeror as a prime contractor may be considered more favorably than experience performed by the offeror as a subcontractor.

For each contract action the offeror shall complete the Corporate Experience Project Data Form included as Attachment A. All information shall be provided as requested on the form.

If the offeror uses affiliates/subsidiaries/parent/LLC/LTD member companies or subcontractors to demonstrate corporate experience, the offeror shall clearly demonstrate that the affiliates/subsidiaries/parent/LLC/LTD member companies or subcontractors will have meaningful involvement in the performance of this contract.

IMPORTANT: It is the offeror’s responsibility to clearly explain and demonstrate to the Government how its work experience, and the experience of each teaming partner (if applicable) in each submitted contract action is relevant to the contract requirements in this solicitation. If the offeror does not clearly explain how its experience(s) are relevant to the contract requirements in this specification, the Government may determine that the submitted contract experience is not relevant.

(b) Basis of Evaluation: Offeror demonstrates experience in performing work of similar size, scope, and complexity to this requirement. The assessment of the offeror’s recent and relevant experience will be used as a means of evaluating the capability of the offeror to successfully meet the requirements of the RFP. At a minimum, the offeror must submit contract actions demonstrating experience in:

(i) Logistics and Handling

(ii) Characterization

(iii) Formulation

(iv) Biosample Analysis

(v) Animal Studies (Absorption, Distribution, Metabolism, Excretion, and

Toxicokinetics, ADME/TK)

(vi) OMICS

(vii) In Vitro Assays

The Government will review only the first three (3) contract actions submitted. Any contract actions submitted in excess of the three (3) contract action limit will not be considered in the evaluation.

Offerors that demonstrate through their experience an understanding and proficiency conducting literature-based evaluations may be viewed more favorably than offerors without such experience.

Offerors that submit contract actions demonstrating experience performing the other requirements outlined in the SOW that are above and beyond those required to meet the minimum standard may be rated more favorably than offerors who only meet the minimum standard.

(2) Factor 2, Program and Project Management and Coordination:

(a) Solicitation Submittal Requirements: The contract requires a Principal Investigator (PI) and Deputy PI both as key personnel. The offerors shall propose a delineation of the day-to-day roles and responsibilities of the PI and Deputy PI. Collectively, the PI and Deputy PI are expected to be knowledgeable and involved in all aspects of the contract, including project status, record keeping, reporting, and detailed analysis of budget for all contract functions. The offeror shall submit a detailed plan, not to exceed 100 pages (excluding QMP, see below), addressing all areas below. Any information exceeding the 100-page limit for this factor will not be considered in the evaluation.

(i) Management Plan and Approach

• Proposed approach to program and project management and coordination.

• A functional organization chart, including lines of reporting.

• Details on the scope of the program, how work will be scheduled, how progress will be monitored, and how project status will be communicated to the Government.

• Management of staff responsibilities and interactions, including provision of a functional organization chart, showing lines of reporting.

• Proposed project staff working together as a team. The daily interaction and constant coordination of efforts needed amongst these discipline areas throughout the performance of work makes it critical that they be physically and organizationally together.

• Documentation of procedures applied to the allocation of facilities and equipment required to achieve timely completion of assigned laboratory work, including health and safety aspects.

• Documentation of offeror’s flexibility to perform a large number (>50) of multidisciplinary Functional Activity assignments. Note that these assignments will often occur simultaneously. Describe how staffing will be handled during periods of peak activity (e.g., close to deadlines) to ensure continued progress on all ongoing assignments.

• A Quality Management Plan (QMP; submit as an appendix to this factor, not to exceed 60 pages). A QMP identifies the organizational structure, policy and procedures, functional responsibilities of management and staff, lines of authority, and its processes for planning, implementing, documenting, and assessing all activities conducted under the organization's quality system.

Discuss within the QMP a process for assessing possible conflicts of interest.

For additional information on QMPs, see https://www.epa.gov/irmpoli8/quality-management-plan-qmp-standard.

• Summary of corporate experience in the conduct and management of programs and projects of similar size, scope, and complexity, including those of any proposed subcontractors, to those described in the SOW.

• Summary of the approach for avoiding real and perceived conflict of interest for all staff.

• Documentation of procedures for acquisition and oversight of any proposed subcontractors/consultants. If any subcontractors/consultants are proposed, the offeror must clearly define how any proposed subcontract/consultant arrangements would meet program needs. A letter of commitment from each subcontractor/consultant must be provided. If subcontracting is proposed, details must be given as to how this would be structured, organized, managed, and monitored.

(ii) Principal Investigator (PI) and Deputy PI

• The PI and Deputy PI shall both be employees of the contractor and designated as key personnel, considered essential to the contract.

• Provide a description (limited to 2 pages for each personnel) to be included in the proposal body.

• Provide a biographical sketch for both the PI and the Deputy PI (in an appendix) using the form in Attachment D. Include information to document relevant training, experience, scientific expertise, accomplishments, and competency including selected references for publications relevant to the scope of the SOW and sample ROs (limited to 5 pages; see RFP), necessary for the successful completion of all contract requirements.

• Provide details on the experience in the management and coordination of multidisciplinary projects similar to those described in the sample ROS and

SOW.

• Provide details on specific duties on the SOW and sample ROs, and availability to the contract.

• The PI must be responsible for the daily management of the contract, point of contact for communication with the Government officials and serves as an on-staff expert and technical resource for chemistry and chemistry-related issues, which may from time-to-time arise during the contract. The PI must be knowledgeable in all aspects of the Program/Contract, including the status of all active assignments, record keeping, reporting, and detailed analysis of cost for any or all functions which make up the total operation

• General qualifications expected of a PI and Deputy PI include: a Doctorate, or the equivalent relevant experience in a key scientific discipline applicable to the Program/Contract (e.g., chemistry, biochemistry, ADME and TK); significant experience in managing large-scale programs in multiple disciplines;

demonstrated capability for effective written and oral communication

(b) Basis of Evaluation: Each offeror will be evaluated on the extent to which the offeror demonstrates an understanding of the three (3) below areas.

(i) Management Plan and Approach: Appropriateness of the proposed approach to program and quality management strategy, including: functional organization chart;

Quality Management Plan; management of staff, experience of staff working together as a team, and communication between the project staff and Government staff; details of project scope; scheduling and monitoring of progress; relevancy of corporate experience in projects of similar size, scope and complexity; evaluation of the Offeror’s flexibility to perform various multidisciplinary assignments;

adequacy of details for arrangement and oversight for any proposed subcontractors/consultants.

(ii) PI and Deputy PI: Appropriateness of the education, training, experience, scientific expertise, competency, and accomplishments of the proposed PI and Deputy PI (as demonstrated in the biographical sketch) familiar with in the management and coordination of multidisciplinary projects covering the activities under the Functional Areas given in DTT Chemistry specifications; proposed specific duties, effort on, and availability to the program. Appropriateness of the education, training, experience, scientific expertise, competency, and accomplishments of the proposed deputy PI (as demonstrated in the biographical sketch) familiar with the organization, management and coordination of multidisciplinary projects; proposed specific duties, effort on, and availability to the program.

(iii) Quality Control and Quality Assurance: Appropriateness of the proposed approach and procedures for quality control and quality assurance, including details of the organization and operating procedures of the Quality Assurance Unit and evaluation of the Offeror's schedule for quality assurance audits and inspections.

Appropriateness of the training, experience, and competency of the proposed Quality Assurance Officer (as demonstrated in the biographical sketch- Attachment D) and support staff, including proposed specific duties and effort on the program;

include those of any proposed subcontractors/consultants.

(3) Factor 3, Technical Approach and Sample Research Outlines:

(a) Solicitation Submittal Requirements: The criteria described here apply to both the overall technical approach as demonstrated in response to the RFP and the required capabilities, in addition to proposals for the specific requirements in each of the sample ROs. The responses to all sample ROs should be very detailed and describe how all aspects of the work would be conducted. The offeror shall submit a detailed plan, not to exceed 200 pages, addressing all areas below. Any information exceeding the 200-page limit for this factor will not be considered in the evaluation.

(i) Project Approach

• Describe the overall strategy to accomplish the goals of the SOW and for each of the sample ROs. Throughout the sample ROs, there are additional specific outputs that offerors shall include in their Technical Proposal.

• Identify potential problems that may be encountered during performance of work under the SOW and for each of the sample ROs, and solutions to these problems.

• Identify alternative strategies to accomplish the goals of the SOW and sample ROs; identify benchmarks for success.

(ii) Overall Technical Approach

• Demonstrate technical approach, including demonstrated understanding of the scope of the contract and overall strategy, procedures and approaches, and services, including those that are novel or innovative; technical capability in the conduct of chemistry activities under Functional Areas in the DTT Chemistry Specifications.

• Include detail and provide documentation to demonstrate how all aspects of the SOW and sample ROs will be implemented, including methodologies, analyses, technologies, and services to meet the goals of the program, including those that are novel or innovative.

• The offeror must clearly define how subcontractor and/or consultant arrangements would contribute to the success of the offeror's technical approach.

• Include copies of the Standard Operating Procedures to be used in the management and technical activities

(iii) Organizational Details

• Include organizational details for how projects will be staffed, managed, and organized, and details for submission of all reports/deliverables.

• Describe how work will be coordinated between functional areas (e.g., Animal study conduct).

• Describe how work will be coordinated between the contractor and proposed subcontractors.

(i) Project Approach: Appropriateness of the demonstrated understanding of how all aspects of the SOW and sample ROs per DTT Chemistry Specifications will be achieved, including identification of problems, solutions, alternative strategies, and benchmarks for success.

(ii) Overall Technical Approach: Appropriateness and feasibility of the demonstrated technical approach, including overall strategy, methodologies, analyses, technologies, and services, including those that are novel or innovative; technical capability in the conduct of scientific information management and literature-based evaluations; including all aspects of the work performed by contractor staff and any proposed subcontractors or consultants. Appropriateness of the demonstrated understanding of the information provided in the Sample Research Outlines (Attachment B).

(iii) Organizational Details: Appropriateness of organizational details, including how projects are staffed, managed, and organized, and details for the submission of deliverables, including all aspects of the work to be performed by contractor staff and any proposed subcontractors/consultants. Appropriateness of the proposed approach to coordinate work between functional areas and provide independence for peer reviews.

(4) Factor 4, Personnel:

(a) Solicitation Submittal Requirements: The offeror shall address the areas below. Tables summarizing personnel and years of experience are not limited.

(i) Professional/Key personnel

• For professional staff, provide a table of proposed staff that will work on the contract, including major roles/disciplines and qualifying criteria (e.g., years of experience, skill sets appropriate for the contract). All key personnel and shall be employees of the offeror.

• Provide a description (limited to 1 page for professional/key personnel; ½ page for other professional personnel) to be included in the proposal body. If professional/critical staff are committed to other Government-supported projects, include their time commitment to these projects.

• Provide a biographical sketch for all personnel (submit using Attachment D) with a Master’s or Doctorate degree, or the equivalent in experience and/or responsibility. Include information to document relevant training, experience, scientific expertise, and competency including selected references for publications relevant to the scope of the SOW and Sample Research Outlines (limited to 5 pages; see RFP), necessary for the successful completion of all contract requirements.

• Document specific duties on, and availability to the program.

(ii) Technical Personnel: Technical personnel job functions include all activities under Functional Areas in the DTT Chemistry Specifications. All job functions proposed by the offeror to support the SOW and sample ROs shall be described as outlined below.

• Provide a table of technical personnel that will work on the contract. Include major roles/discipline on the contract, highest degree, years of experience, proposed effort of (percent effort), and availability to the contract,

• Include information to document relevant training, experience, and competency necessary for the successful completion of all contract requirements; these should be separated by Functional Areas per DTT Chemistry Specifications.

• List additional technical personnel and total effort to the project by job function (e.g., analysts, animal care technicians, lab staff). Subcontractors/consultants shall be included and designated as such.

• Subcontractors/consultants shall be described similarly to contractor staff and designated as such.

demonstrates an understanding of the two (2) below areas.

(i) Professional/Key Personnel: Appropriateness of the demonstrated understanding of how all aspects of the SOW and sample ROs will be achieved, including identification of problems.

• Logistics and Handling Functional Area Discipline Lead; appropriateness of the education, training, and experience in the conduct and reporting of all Functional Activities under the Logistics and Handling Functional Area.

Detailed requirements for chemistry Functional Activities are given in the DTT Chemistry Specifications Chapter 6.2. The Materials and Handling Discipline Lead shall also have experience managing a sample-handling program or facility and performing sample handling, including sample shipments of biological materials and biohazards, sample tracking, and handling of hazardous chemicals. This individual shall have a Master’s or Bachelor’s degree and any combination of graduate work and equivalent relevant experience, in a key scientific discipline applicable to the Program/Contract (e.g., chemistry, biology, and/or materials science)

• Characterization Functional Area Discipline Lead; appropriateness of the education, training, and experience in the design, conduct, data analysis and interpretation, and reporting of all Functional Activities under the Characterization Functional Area. Detailed requirements for chemistry Functional Activities are given in the DTT Chemistry Specifications Chapter

6.3. This individual shall have a Bachelor of Science degree in chemistry or a related science or any combination of years of experience in chemistry and full-time college-level study in the field totaling 4 years. This individual shall also have analytical chemistry experience, which includes trace analysis.

• Formulation Functional Area Discipline Lead; appropriateness of the education, training, and experience in the design, conduct, data analysis and interpretation, and reporting of all Functional Activities under the Formulation Functional Area. Detailed requirements for chemistry Functional Activities are given in the DTT Chemistry Specifications Chapter 6.4. This individual shall have a Bachelor of Science degree in chemistry or a related science or any combination of years of experience in chemistry and full-time college-level study in the field totaling 4 years. This individual shall also have analytical experience related to formulation analysis and experience formulating test articles for toxicology studies.

• Biosample Analysis Functional Area Discipline Lead; appropriateness of the education, training, and experience in the design, conduct, data analysis and interpretation, and reporting of all Functional Activities under the Biosample Analysis Functional Area. Detailed requirements for chemistry Functional Activities are given in the DTT Chemistry Specifications Chapter 6.5. This individual shall have a Doctoral or a Master’s degree with 5 year’s of experience in bioanalytical chemistry especially with trace analysis of biological samples using state-of-the art analytical instrumentation.

• Animal Studies Functional Area Discipline Lead; appropriateness of the education, training, and experience in the design, conduct, data analysis and interpretation, and reporting of all Functional Activities under the Animal Studies Functional Area. Detailed requirements for chemistry Functional Activities are given in the DTT Chemistry Specifications Chapter 6.7. This individual shall have a Doctoral or a Master’s degree experience in ADME and toxicokinetics or a related science totaling 5 years. The ADME/TK Discipline Lead shall also have experience designing, conducting time course (toxicokinetic or pharmacokinetic) studies, including analyzing and modeling and interpreting ADME and TK data.

• OMICS Functional Area Discipline Lead; appropriateness of the education, training, and experience in the design, conduct, data analysis and interpretation, and reporting of all Functional Activities under the OMICS Functional Area. Detailed requirements for chemistry Functional Activities are given in the DTT Chemistry Specifications Chapter 6.8. The individual shall have a Master’s or any combination of graduate experience totaling 5 years of experience in a key scientific discipline (e.g., chemistry (environmental, analytical, or bioanalytical); significant experience in managing programs of comparable scope and size; experience performing metabolomics, proteomics, and/or exposomics analyses; and demonstrated ability to provide effective written and oral communication.

• In Vitro Assays Functional Area Discipline Lead; appropriateness of the education, training, and experience in the design, conduct, data analysis and interpretation, and reporting of all Functional Activities under the In Vitro Assays Functional Area. Detailed requirements for chemistry Functional

Activities are given in the DTT Chemistry Specifications Chapter 6.9. The In Vitro Project Manager shall have a Master’s or any combination of graduate experience in a key scientific discipline applicable to the conduct of assignments (e.g., chemistry, biochemistry, toxicology); significant experience in managing programs of comparable scope and size; experience conducting in vitro assays; and demonstrated ability to provide effective written and oral communication. Document the training and experience of the proposed Discipline Lead to conduct in vitro cell-based studies to determine in vitro intestinal and dermal absorption, hepatic metabolism and clearance, and bioaccumulation following repeated exposure.

All subcontracted work (e.g., DNA barcoding of botanical materials for authentication; imaging mass spectrometry to determine xenobiotic distribution in tissues) must have a responsible staff member employed by the prime contractor who will oversee activities at the subcontractor.

(ii) Technical Personnel: Appropriateness of the education, training, experience, and competency of the proposed technical personnel with the knowledge and ability to conduct chemistry activities under the Functional Areas given in DTT Chemistry specifications; effort on, and availability to projects; include those of any proposed subcontractors/consultants.

(5) Factor 5, Environment – Facilities, Equipment, and Security:

(a) Solicitation Submittal Requirements: The offeror shall address the areas below. The offeror shall submit a detailed plan (no page limit), addressing all areas below.

(i) Facilities

• Provide detailed facility floor plans and a description of all facilities relevant to technical conduct of work on the project. Include all disciplines relevant to the project (e.g., materials handling; chemical characterization, formulation, bioanalysis, ADME/TK) with clear labels as to the location of equipment and function/use of all rooms.

• Animal facility floor plans shall include airflow direction and corridor system/traffic flow for personnel as well as animals, equipment and supplies through all facilities proposed for use. Information on the air handling system and back-up generator and other pertinent features shall be included. Describe available space for the performance of work. Document compliance with all applicable Federal and state regulations and guidelines for all aspects of the project. Include the above for any proposed subcontractors/consultants.

• Describe the hazard containment facility(ies) (HCF) proposed…