CSS_75N95020Q00197_Remuneration.pdf

RFQ No. 75N95020Q00197

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COMBINED SYNOPSIS / SOLICITATION-COMPETITIVE

Title: NIDA IRP Clinical Program Support for Participant Remuneration, Travel and Subsistence.

1. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; Quotes are being requested and a separate written solicitation will not be issued.

2. The solicitation number is 75N95020Q00197 and the solicitation is issued as request for quotation (RFQ).

This acquisition is for a commercial item or service and is conducted under the authority of the FAR Part 13.5—Simplified Acquisition Procedures for Certain Commercial Items; and FAR Part 12—Acquisition of Commercial Items.

The mission of the National Institute on Drug Abuse (NIDA) Intramural Research Program (IRP) is to conduct state-of-the-art research on basic mechanisms that underlie substance use disorders (SUDs), and to develop new methods for the treatment of SUDs. Research is supported at the molecular, genetic, cellular, animal, and human clinical levels and conceptually integrates highly innovative strategies and techniques. The long-term goal of the research is to better understand the biological and behavioral factors contributing to initiation, maintenance, and elimination of SUDs (and associated diseases), and to translate this knowledge into improved strategies for prevention, treatment, and reduction of negative consequences for the individual and for society caused by substance use disorders.

Using volunteer human participants, the IRP clinical program conducts residential and nonresidential research studies that interrelate with pre-clinical laboratory work. In general, these studies include assessment of drug-use patterns, investigation of underlying brain mechanisms, and testing of a variety of SUD behavioral or biomedical treatments. The NIDA IRP provides IT support and services for data to be stored in an electronic clinical records system, the Human Research Information System (HuRIS). HuRIS is on a secure private network. Medical information, recruiting, screening, remuneration and research data, including remuneration and travel for all participants is recorded in HuRIS.

NIDA requires the contracted support services to provide remuneration, travel and subsistence support to eligible research participants for inclusion in human research studies conducted by the NIDA IRP as part of their ongoing mission. NIDA IRP enrolls a highly targeted and representative study population of research participants including those with active SUDs (e.g. nicotine, alcohol, cocaine, marijuana, opioids) who are not seeking treatment, those who are seeking treatment, people who use these substances occasionally and healthy controls who match the other populations with respect to characteristics such as age, gender, socio-economic status (SES), IQ, etc. The NIDA IRP is also conducting studies requiring HIV-positive populations. Special attention and consideration need to be made to the sensitive nature of the data collected when working with these populations.

3. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2020-07, dated 07-02-2020.

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4. NAICS Code: The North American Industry Classification System (NAICS) code is 541611 - Administrative Management and General Management Consulting Services, and the small business size standard $16,500,000. This requirement is not a total small business set-aside.

5. Line Items: Through this procurement the NIDA requires the contracted support services for the remuneration, travel and subsistence of eligible research participants for inclusion in human research studies conducted by the NIDA IRP as part of their ongoing mission as described in Attachment 1 – Statement of Work.

NIDA anticipates the use of a Time and Materials / Labor Hour (T&M/LH) type contract as a result of this solicitation. If an award is made as a result of this solicitation, NIDA shall establish a ceiling price for the contract that the Contractor shall not exceed.

NIDA also anticipates the use of Options and Options Quantities in accordance with the Federal Acquisition Regulation (FAR) 52.217-7 Option for Increased Quantity – Separately Priced Line Items (Mar 1989); 52.217-8 Option to Extend Services (Nov 1999); and 52.217- 9 Option to Extend the Term of the Contract (Mar 2000).

It is anticipated that this contract will consist of a 12-month Base Period, with two (2) additional 12-month Option Periods. The contract will also include additional option quantities. This period of performance will allow for the greatest flexibility given the program needs and funding availability. It is estimated that the Base Period will begin on November 1, 2020 and run through October 31, 2021.

Below is a table that contains the line item number and description of the requirement for the anticipated award of the Base Period.

Line No. Description 1 FY21. Base Period. 11/1/20 – 10/31/21. NIDA IRP Clinical Program Support for Participant Remuneration, Travel and Subsistence. N02DA-20-9004.

6. Project Requirement: Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment not otherwise provided by the Government, as needed to perform the following tasks for the remuneration, travel and subsistence of NIDA research participants.

a. Remuneration, Travel and Subsistence, and other research-related Supply Management

Services. The Contractor shall:

i. Provide, distribute and track all participant remuneration based on each protocol’s requirements and consistent with the IRB-approved protocol version;

ii. Provide transportation and subsistence for all research participants as defined in each protocol and in compliance with all NIH policies and standard operating procedures.

iii. Provide other research-related supplies and consumables.

b. Contract Administration. The Contractor shall:

i. Provide staffing support as directed and required by the Government in support of all tasks defined in this Statement of Work. Some tasks may occur outside of normal business hours.

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ii. Monitor staffing requirements and work collaboratively with the Government to develop specific staffing plans to accommodate the various aspects of tracking expenses related to the remuneration, travel and subsistence of research participants in the most efficient and cost-effective manner.

The Offeror shall protect all sensitive protected health information (PHI) or personally identifiable information (PII) collected while performing the required services. Sensitive PHI/PII shall not be transferred to nor shared with NIDA. Any data collected must be deidentified or coded so that the code cannot be linked to participants by NIDA.

As part of the Technical Quote, the Offeror shall include the following:

a. Statement of Understanding – The Offeror shall provide a Statement of Understanding that describes its experience and understanding of the project goals and objectives as described in the SOW. The Statement of Understanding should also demonstrate the Offeror’s understanding and experience in providing remuneration, travel and subsistence services, and other research-related supply management services for research participants and clinical patients, in the Greater Baltimore-Washington Area.

The Offeror should describe the unique challenges in dispersing, tracking and accounting for all participant remuneration, travel, and subsistence coordinating and providing transportation services. The Offeror shall also describe its experience in creating multiple remuneration and support programs which comply with a variety of study protocols. For example, some studies pay participants in cash, daily, for remuneration earned, while other studies allow participants to earn credits that are paid out to them at various intervals after participation (e.g. weekly, monthly or at the end of the study). Participants will receive remuneration based on the approved research study methods such as cash, check, gift card or electronic payments). Furthermore, responses must describe how the Offeror shall protect health information (PHI) or personally identifiable information (PII). PHI/PII cannot leave NIH systems. Any data needed to conduct contract requirements must be deidentified or coded so that the code cannot be linked to participants by anyone outside of NIH. Any proposed use of cloud systems, or outside Information Technology (IT) systems must describe the impact on existing NIH systems and must comply with all HHS and NIH privacy and IT related policies and must undergo all associated approvals prior to implementation.

b. Sample Remuneration Plan (SRP) – As part of its technical approach, the Offeror shall develop and describe its SRP detailing its approach and methodology to provide remuneration, travel and subsistence, and other research-related supply management support services. A complete SRP shall describe the administrative and management oversight of providing real-time payments, flexibility with methods of participant payments as well as tracking and accounting for payments made to individual participants. The SRP should also include a description of contingency planning efforts, a detailed chain of custody plan to manage all payments and the cash needed onsite to make daily cash payments, and alternative strategies to overcome potential challenges associated with provide remuneration, travel and subsistence, and other research-related supply management support services for participants. The sample SRP should be designed to support the following sample protocol:

i. Sample Protocol – For Quote purposes, the SRP shall be based on a study that will last 2-years and will research how stress and craving influence alcohol, tobacco, cocaine and/or opioid use. Offerors should assume the following

4 | P a g e criteria: NIDA IRP is recruiting right-handed adults; 18-60 years old; living in the Greater Baltimore-Washington Area; who have a substance use disorder (opiate, alcohol, cocaine, or nicotine use disorders); but are otherwise healthy (e.g. no chronic health conditions and not taking prescription medications). Participants will be asked to travel to NIDA for up to 12 visits over 24 months. Each visit will consist of filling out various questionnaires and completing various thinking tasks.

On 6 of the visits, Magnetic Resonance Imaging (MRI) brain scans will be done.

MRI scans will be about 2 hours long and participants will complete various thinking tasks while inside the MRI. Participants must be able to abstain from caffeine and alcohol for 24 hours before the MRI sessions. On non-MRI visits, participants will have to select foods and drinks while in NIDA’s virtual reality food-mart and bar-lab, while wearing smart devices to measure responses.

Participants who have an opiate or nicotine use disorder will be offered medications. Participants who use cocaine will be asked to participate in a brain stimulation study. The Brain Simulation Study uses a type of brain stimulation called “intermittent theta-burst stimulation” (iTBS) as an experimental treatment for cocaine that will be given to everyone who participates. iTBS stimulates a part of the brain that is thought to play a role in addiction. iTBS uses a magnet to stimulate parts of the brain and is not an invasive procedure. iTBS visits will be approximately 2 hours per day for two weeks (5 sessions per week, for a total of 10 sessions).

While not in the clinic, participants will be asked to respond daily to surveys sent to their smartphone (or to the study smartphone provided by NIDA). Some participants may be invited to enroll in a social media sub-study. Thus, some of the participants will be required to have social media accounts.

Offerors will be responsible to have enough cash to pay participants in real-time as they complete their study procedures. Furthermore, the Offeror shall be responsible for maintaining the accounting accuracy, managing the security of funds, and maintaining the chain of custody for payments dispersed. Participants may be paid for their time at the end of each visit, which will last for about 2-4 hours. Payment to participants may be in the form of cash (most common), some participants will choose check, gift cards or online payments (e.g. PayPal).

Remuneration is based on the following pay rates:

i. Time spent at NIDA (assume 100 total participants): $20/hour;

ii. Survey responses - $25/complete set (6 sets total; assume 100 total participants)

iii. Travel (assume 100 total participants – 50 of whom will need transportation and 50 who will have their own transportation): $15 per roundtrip to NIDA (12 visits max) for those who have their own transportation and travel must be provided to and from NIDA for those without transportation (e.g. using 3rd party vendor who will protect privacy and identities and utilize car or taxi service or Uber/Lyft services);

iv. MRI group (assume 50 total participants): $50 per MRI (6 scans max per participant);

v. Transcranial Magnetic Stimulation (TMS) group (assume 20 total participants): $25 per TMS session (10 sessions max per participant);

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vi. Meals: each participant will be provided at least one meal per visit (breakfast, lunch or dinner and snacks and drinks as needed). Meals must be delivered to NIDA on the day of the study. For proposal purposes, provide a plan to maintain a supply of readily available shelf stable drinks, snacks in addition to how meals will be purchased, stored, prepared, and/or provided to participants.

For Quote purposes, Offerors should assume that the enrollment goals are an average of 10-15 qualified participants per month to obtain a total of 20 enrolled participants who complete the protocol, per each of the 5 groups: alcohol, tobacco, cocaine and/or opioid use disorder participants and matched controls (total completed goal is 100 participants over 2 years).

c. Key Personnel – The Offeror shall identify the proposed key personnel to be assigned to this project and describe their experience in providing remuneration, travel and subsistence, and contract administration support, primarily in the Greater Baltimore- Washington area.

d. Communication and Management Plan – The Offeror shall prepare a management plan to effectively conduct, manage, and coordinate the resources necessary to successfully perform the SOW. The Management Plan should include the Offeror’s personnel loading chart, milestone chart, and organizational chart delineating lines of authority and reporting responsibilities for staff and any consultants as well as a backup plan to ensure personnel coverage and completion of work in the event of the unexpected personnel challenges.

e. Draft Transition Plans – The Offeror shall prepare a Draft Transition-In and Transition-

Out Plan. Each draft submitted should describe the Offeror’s approach to enable a seamless transition of services from the incumbent to an incoming Contractor/ Government personnel (as required). The Draft Transition Plans shall identify points-of-contact (POC) for liaison between the Government, the prime Contractor, and other contracted industry partners to ensure a proper and orderly transition and transfer of services and assets between the parties cited.

f. Option Quantities – The Offeror shall describe its approach to provide additional remuneration support to NIDA IRP Principal Investigators (PIs). The NIDA IRP has multiple primary PIs who may require additional remuneration, travel and subsistence support individually or jointly as necessary based on current protocol needs. The NIDA IRP Principal Investigators (PIs) may require additional financial support separately from the tasks defined in the SOW.

g. Past Performance Information – The Offeror shall provide a list of at least three (3) contracts completed during the past four years, similar in size and scope to the requirements outlined in the SOW. Include the following information for each contract or subcontract listed:

i. Name of Contracting Organization

ii. Contract Number (for subcontracts, provide the prime contract number and the subcontract number)

iii. Contract type

iv. Total contract value

v. Description of requirement and results

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vi. Contract period of performance

vii. Contracting Officer’s name and telephone number

viii. Program Manager’s name and telephone number

ix. The offeror may provide information on problems encountered on the identified contracts and the offeror’s corrective actions.

h. Section 508 Compliance – As applicable the Offeror must demonstrate compliance with the "Electronic and Information Technology Accessibility Provisions" set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the "Access Board") in 36 CFR part 1194 for all electronic and information technology (EIT) products and services developed, acquired, maintained, or used under this contract/order, including EIT deliverables such as electronic documents and reports.

i. Approach to and Compliance with HHS Security and Privacy Language for Information and Information Technology – The Offeror shall describe its approach and ability to comply with the with the Security and Information Technology requirements defined in Attachment 2 - HHS Security and Privacy Language for Information and IT Procurements.

j. Small Business Subcontracting Plan – If the Offeror is an “Other Than Small Business”, and if the proposed contract exceeds a total estimated cost of $700,000 for the entire period of performance, the offeror shall be required to submit an acceptable subcontracting plan in accordance with the terms of the clause entitled "Small Business Subcontracting Plan," FAR Clause No. 52.219-9, incorporated herein by reference in the Solicitation as Attachment 3 – Small Business Subcontracting Plan Template.

PLEASE NOTE THIS PROVISION DOES NOT APPLY TO SMALL BUSINESS

CONCERNS.

The term "subcontract" means any agreement (other than one involving an employer-employee relationship) entered into by a Federal Government prime Contractor or subcontractor calling for supplies or services required for the performance of the original contract or subcontract. This includes, but is not limited to, agreements/purchase orders for supplies and services such as equipment purchase, copying services, and travel services.

The offeror understands that:

i. No contract will be awarded unless and until an acceptable plan is negotiated with the Contracting Officer which plan will be incorporated into the contract, as a material part thereof.

ii. An acceptable plan must, in the determination of the Contracting Officer, provide the maximum practicable opportunity for Small Businesses, Small Disadvantaged Businesses, Women-Owned Small businesses, HUBZone Small Businesses, Veteran-Owned Small Businesses, and Service Disabled Veteran-Owned Small Businesses to participate in the performance of the contract.

iii. If a subcontracting plan acceptable to the Contracting Officer is not negotiated within the time limits prescribed by the contracting activity and such failure arises out of causes within the control and with the fault or negligence of the offeror, the offeror shall be ineligible for an award. The Contracting Officer shall notify the Contractor in writing of the reasons for determining a subcontracting plan

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iv. Prior compliance of the offeror with other such subcontracting plans under previous contracts will be considered by the Contracting Officer in determining the responsibility of the offeror for award of the contract.

v. It is the offeror's responsibility to develop a satisfactory subcontracting plan with respect to Small Business Concerns, Small Disadvantaged Business Concerns, Women-Owned Small Business Concerns, HUBZone Small Business Concerns, Veteran-Owned Small Business Concerns, and Service Disabled Veteran-Owned Small Business Concerns that each such aspect of the offeror's plan will be judged independent of the other.

vi. The offeror will submit, as required by the Contracting Officer, subcontracting reports in accordance with the instructions thereon, and as further directed by the Contracting Officer. Subcontractors will also submit these reports to the Government's Contracting Officer or as otherwise directed, with a copy to the prime Contractor's designated small and disadvantaged business liaison.

Each plan must contain the following:

i. Goals, expressed in terms of percentages of total planned subcontracting dollars, for the use of Small, Small Disadvantaged, Women-Owned, HUBZone, Veteran- Owned, and Service Disabled Veteran-Owned Small Business Concerns as subcontractors.

ii. A statement of total dollars planned to be subcontracted. A statement of total dollars to be subcontracted to each of the following type of small business concerns: Small, Small Disadvantaged, Women-Owned, HUBZone, Veteran- Owned, and Service Disabled Veteran-Owned Small Businesses.

iii. A description of the principal types of supplies and services to be subcontracted with an identification of which supplies and services are expected to be subcontracted to Small, Small Disadvantaged, Women-Owned, HUBZone, Veteran-Owned and/or Service Disabled Veteran-Owned Small Business Concerns.

iv. A description of the method used to develop the subcontracting goals.

v. A description of the method used to identify potential sources for solicitation purposes.

vi. A statement as to whether or not indirect costs were included in establishing subcontracting goals. If they were, a description of the method used to determine the proportionate share of indirect costs to be incurred with Small, Small Disadvantaged, Women-Owned, HUBZone, Veteran-Owned, and Service Disabled Veteran-Owned Small Businesses.

vii. The name of the individual employed by the offeror who will administer the offeror's subcontracting program and a description of his/her duties.

viii. A description of the efforts the offeror will make to assure that Small, Small Disadvantaged, Women-Owned, HUBZone, Veteran-Owned, and Service Disabled Veteran-Owned Small Businesses have an equitable chance to compete for subcontracts.

ix. Assurances that the offeror will include in all subcontracts the contract clause "Utilization of Small Business Concerns." Assure that all subcontractors, other than small businesses, in excess of $700,000 adopt a plan similar to the plan agreed upon by the offeror.

x. Assurances that the offeror (and any required subcontractors) will cooperate in studies or surveys as required and submit required reports (Individual

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Subcontract Reports (ISRs) and Summary Subcontract Reports (SSRs) to the Government.

xi. List the types of records the offeror will maintain to demonstrate procedures that have been adopted to comply with the requirement and goals in the plan, including establishing source lists. Also, the offeror shall describe its efforts to locate Small, Small Disadvantaged, Women-Owned, HUBZone, Veteran-Owned, and Service Disabled Veteran-Owned Small Businesses and award subcontracts to them.

For additional information about each of the above elements required to be contained in the subcontracting plan, see FAR Clause 52.219-9, Small Business Subcontracting Plan, and the Sample Subcontracting Plan which is provided as an attachment to this RFP in Attachment 3 – Small Business Subcontracting Plan.

HHS expects each procuring activity to establish minimum subcontracting goals for all procurements. The anticipated minimum goals for this RFP are as follows:

33% for Small Business; 5% for Small Disadvantaged Business; 5% for Women- Owned Small Business; 3% for HUBZone Small Business; and 3% for Veteran- Owned Small Business and Service-Disabled Veteran-Owned Small Business.

7. The anticipated period of performance for the order shall be November 1, 2020 through October 31, 2021. All Program and Information Security deliverables are detailed in Attachment #1 – Statement of Work and Attachment 2 - HHS Security and Privacy Language for Information and IT Procurements.

8. The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items, applies to this acquisition.

9. The award resulting from this solicitation will be made to the responsible Offeror whose Quote is most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotations: Technical Criteria, Cost/Price, Options, Past Performance, and Section 508 compliance (if applicable).

A tradeoff process shall be used for this acquisition because it has been determined to be in the best interest of the Government to consider award to other than the lowest priced Offeror or other than the highest technically rated offeror. All evaluation factors and significant sub-factors are listed below in terms of their relative importance. Technical Factors and Past Performance when combined, are significantly more important than cost or price.

Evaluations will be based on the demonstrated capabilities of the prospective Offeror in relation to the needs of the project. The merits of each Quote will be evaluated carefully.

Each Quote must document the feasibility of successful implementation of the requirements of this solicitation. The Offeror must submit information sufficient to evaluate its Quote based on the detailed factors listed below.

The NIDA shall use the following methodology for evaluating each criterion:

Excellent (Risk level: Very low): The proposal has exceptional merit and reflects an excellent approach which will clearly result in the superior attainment of all requirements and

9 | P a g e objectives. This clearly achievable approach includes several advantageous characteristics of substance, and very few disadvantages, which can be expected to result in outstanding performance. The risk of unsuccessful performance is very low as the proposal provides solutions which are unquestionably feasible and practical. These solutions are further considered very low risk in that they are exceptionally clear and precise, fully supported, and demonstrate a clear understanding of the requirements.

Good (Risk level: Low): The proposal demonstrates a sound approach which is expected to meet all requirements and objectives. This sound approach includes advantageous characteristics of substance, and few relatively minor disadvantages, which collectively can be expected to result in satisfactory performance. The risk of unsuccessful performance is low as the proposal contains solutions which are considered feasible and practical. These solutions are further considered to reflect low risk in that they are clear and precise, supported, and demonstrate an understanding of the requirements.

Acceptable: The proposal demonstrates an approach which can meet all requirements and objectives. The approach includes both advantageous and disadvantageous characteristics of substance, where the advantages are not outweighed by the disadvantages. Collectively, the advantages and disadvantages are likely to result in acceptable performance. The risk of unsuccessful performance is moderate, as the proposal solutions are generally feasible and practical. These solutions may also be considered to reflect moderate risk in that they may be somewhat clear and precise, partially supported, and/or demonstrate a general understanding of the requirements.

Marginal (Risk level: High): The proposal demonstrates an approach which may not be capable of meeting all requirements and objectives. The approach has disadvantages of substance and advantages, which if they exist, are outweighed by the disadvantages.

Collectively, the advantages and disadvantages present a low or questionable likelihood of resulting in satisfactory performance. The risk of unsuccessful performance is high as the proposal contains solutions which may not be feasible and practical. These solutions may also be considered to reflect high risk in that they lack clarity and precision, are generally unsupported, and/or do not demonstrate a complete understanding of the requirements.

Unacceptable (Risk level: Very): The proposal demonstrates an approach which, based on a very high risk, will very likely not be capable of meeting all requirements and objectives. This approach has several disadvantages of substance, and advantages which, if they exist, are outweighed by disadvantages. Collectively, the advantages and disadvantages are unlikely to result in satisfactory performance. The risk of unsuccessful performance is very high as the proposal contains solutions which are not feasible and practical. The solutions may also be considered to reflect very high risk in that they lack any clarity or precision, are unsupported, and/or do not demonstrate an understanding of the requirement.

Neutral (Risk level: Neutral): Only applicable to the past performance factor. In the case of an offeror without a record of relevant past performance or for whom information on past performance is not available, the offeror may not be evaluated favorably or unfavorably on past performance

a. Technical Evaluation Criteria

i. Technical Factor 1: Project Understanding

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NIDA will evaluate each Offerors Quote on how well it demonstrates the Contractor’s comprehensive understanding of the project goals and objectives of the Statement of Work (SOW). This includes the Contractor’s description of its experience and understanding of issues and challenges associated with providing the necessary remuneration services, qualified personnel, materials, equipment not otherwise provided by the Government, as needed to perform the following tasks for the remuneration, travel and subsistence of NIDA research participants in the Greater Baltimore-Washington Area; understanding and describing the unique challenges in communicating and connecting with populations with active SUDs who are not seeking treatment, those who are seeking treatment, people who occasionally use these substances and healthy controls who match the other populations with respect to characteristics such as age, gender, SES, IQ, etc.

ii. Technical Factor 2: Technical Approach

NIDA will evaluate how clear, concise, feasible, and sound the Offeror’s technical approach and plan are for accomplishing all the tasks and requirements of the SOW. This includes discussion of the steps proposed for accomplishing each task, and alternatives to be considered should difficulties arise during performance of the project. NIDA also will evaluate each Offeror’s Description of the methodologies employed to provide the required objectives, requirements and deliverables. The SRP shall be evaluated in terms of its described approach and methodology to provide remuneration, travel and subsistence, and other research-related supply management support services. A complete SRP shall describe the administrative and management oversight of providing real-time payments, flexibility with methods of participant payments as well as tracking and accounting for payments made to individual participants. The SRP should also include a description of contingency planning efforts, a detailed chain of custody plan to manage all payments and the cash needed onsite to make daily cash payments, and alternative strategies to overcome potential challenges associated with provide remuneration, travel and subsistence, and other research-related supply management support services for participants..

iii. Technical Factor 3: Key personnel

NIDA will evaluate the résumés of proposed key personnel to be assigned to this project based on experiences relevant to providing remuneration, travel and subsistence, and TO administration support, primarily in the Greater Baltimore- Washington area (for some studies, specifically including Baltimore city) and related experience in working with the substance use disorder providing remuneration support. NIDA shall assess the credentials of any proposed staff given the work requirements defined in Attachment 1.

iv. Technical Factor 4: Communication and Management Plan

NIDA will evaluate the Offeror’s proposed management plan on its ability to effectively conduct, manage, and coordinate the resources necessary to successfully perform the project. NIDA will evaluate the feasibility and appropriateness of the Contractor’s personnel loading chart, milestone chart, and organizational chart delineating lines of authority and reporting responsibilities for

11 | P a g e staff and any consultants. NIDA shall also evaluate the Offeror’s proposed backup plan to ensure personnel coverage and completion of work in the event of the unexpected personnel challenges;

NIDA shall also evaluate the quality of the Offeror’s Draft Transition-In and Transition-Out Plan. Furthermore, NIDA will evaluate the Contractor’s plan and approach to track remaining funds and provide an accurate accounting of costs incurred to date but not invoiced, in addition to a monthly estimate funds require to accomplish the designated remuneration support tasks.

b. Cost / Price Evaluation

Offeror(s) cost/price Quote will be evaluated for reasonableness. For a price to be reasonable, it must represent a price to the government that a prudent person would pay when consideration is given to prices in the market. Normally, price reasonableness is established through adequate price competition, but may also be determined through cost and price analysis techniques as described in FAR 15.404.

Cost Realism: The specific elements of each offeror(s) proposed costs are realistic when the proposed cost elements are evaluated and found to: 1) be realistic for the work to be performed; 2) reflect a clear understanding of the requirements; and 3) be consistent with the unique methods of performance and materials described in the offeror(s) technical Quote.

Cost Realism will be evaluated only on the offeror(s) inputs which the Government will use to determine the most probable cost to perform the contract in a manner consistent with the offeror's Quote. Cost realism analysis will be conducted in accordance with FAR 15.404-1(d). The result of the cost realism analysis will be considered in the making the best value tradeoff decision. However, this evaluation will not be conducted on any offeror whose Quote is determined to be technically unacceptable.

c. Evaluation of Options

It is anticipated that any contract(s) awarded from this solicitation will contain option provision(s) and period(s).

In accordance with FAR Clause 52.217-5, Evaluation of Options, (July 1990), the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement, except when it is determined in accordance with FAR 17.206(b) not to be in the Government's best interests. Evaluation of options will not obligate the Government to exercise the option(s). However, this evaluation will not be conducted on any offeror whose Quote is determined to be technically unacceptable.

d. Past Performance

NIDA will evaluate the Offeror’s Quote based on recent experiences in providing remuneration, travel and subsistence, and contract/TO administration support. Offeror's past performance information will be evaluated after the technical evaluation. However, this evaluation will not be conducted on any offeror whose Quote is determined to be technically unacceptable.

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The evaluation will be based on information obtained from references provided by the offeror, other relevant past performance information obtained from other sources known to the Government, and any information supplied by the offeror concerning problems encountered on the identified contracts and corrective action taken.

The government will assess the relative risks associated with each offeror. Performance risks 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 judgment by the Government after it considers relevant information.

When assessing performance risks, 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 Government will consider the currency and relevance of the information, source of the information, context of the data, and general trends in the offeror's performance. The lack of a relevant performance record may result in an unknown performance risk assessment, which will neither be used to the advantage nor disadvantage of the offeror.

e. Evaluation of Electronic and Information Technology Accessibility - Section 508

If applicable the Offeror's Quote must demonstrate compliance with the "Electronic and Information Technology Accessibility Provisions" set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the "Access Board") in 36 CFR part 1194 for all electronic and information technology (EIT) products and services developed, acquired, maintained, or used under this contract/order, including EIT deliverables such as electronic documents and reports. However, this evaluation will not be conducted on any offeror whose Quote is determined to be technically unacceptable.

If your Quote does not include a completed HHS "Section 508 Product Assessment Template" (hereafter referred to as the "Template") which demonstrates that EIT products and services proposed support applicable Section 508 accessibility standards, or, if the completed "Template" included in your Quote is considered "noncompliant," and the Government includes your Quote in the competitive range (for competitive Quotes), or if the Government holds discussions with the selected source (for sole source acquisitions), you will be afforded the opportunity to further discuss, clarify or modify the "Template" during discussions and in your Final Quote Revision (FQR). If your "Template" is still considered "noncompliant" by the Government after discussions, your Quote may not be considered further for award.

10. The Offeror is to include a completed copy of the provision at FAR clause 52.212-3, Offeror

Representations and Certifications—Commercial Items, with its offer. Offerors must include the representation at 52.204-24 if it is not in in their completed FAR Representations and

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Certifications. A copy of that representation is attached as Attachment 4 - Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment.

11. The FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition and is supplemented by Attachment 5 - 52.212-4 Addendum and Supplemental Clauses.

12. The FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items, applies to this acquisition and is supplemented by Attachment 6 - 52.212-5 Addendum.

13. Additional contract requirement(s) or terms and conditions determined by the Contracting

Officer to be necessary for this acquisition are supplemented by:

Attachment 7 – Privacy Act Attachment 8 – Section 508 Evaluation Template Attachment 9 – Invoice Instructions.

Attachment 10 – Non-Disclosure Agreement Attachment 11 – Roster of Employees Requiring Suitability Investigations

14. This is not a rated order under the Defense Priorities and Allocations System (DPAS). The resultant purchase order will provide that HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A—Health Resources Priorities and Allocations System.

15. The response to the combined synopsis/solicitation is due no later than October 14, 2020 at 3:00 P.M. Eastern Standard Time (EST). Offers submitted after the deadline may not be considered. The response should be submitted in a searchable electronic format to the Contracting Officer, Josh Lazarus at Josh.Lazarus@nih.gov. Electronic submittals must include the combined synopsis/solicitation 75N95020Q00197 and the Title in the Subject Line.

In addition, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

The Offeror must submit with their Technical Quote the following information:

a. Transmittal and Quote Cover Page which includes the following information:

i. Solicitation / RFQ Number;

ii. Date of submission;

iii. Quote Due Date;

iv. Company Name mailing address, telephone number, and website address;

v. the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN);

vi. Company Point of Contact, telephone number, and email address (person to be contacted concerning any matter related to the Quote, e.g., Quote revisions, presentations, discussions, etc.).

b. Technical Quote must be clearly labeled and logically structured to identify the following components:

14 | P a g e

i. Technical Quote:

a. Project Understanding;

b. Technical Approach;

1. Sample Remuneration Plan.

c. Key Personnel;

d. Communication and Management Plan:

1. Resumes;

2. Organizational Chart;

3. Communication and Management Plan.

e. Draft Transition Plan

ii. Other Non-Cost/Price Factors:

a. Past performance references;

b. Approach to and Compliance with HHS Security and Privacy Language for

Information and Information Technology;

c. Completed and signed Representation Regarding Certain

Telecommunications and Video Surveillance Services or Equipment;

d. Section 508 Compliance (if applicable);

e. Small Business Subcontracting Plan (if applicable).

Technical Quotes shall be submitted in accordance with the General Requirement identified in Section 6 of this combined synopsis/solicitation.

The Offeror should submit a separate Business Quote in searchable PDF format and the backup excel documents with calculations. Offerors shall submit a complete price quotation using the format template provided below. Technical Quotes shall not exceed 25 pages.

However, Past performance references for same or similar work, Approach to and Compliance with HHS Security and Privacy Language for Information and Information Technology, Completed and signed Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment, Section 508 Compliance (if applicable), and Small Business Subcontracting Plan (if applicable) will not count towards the page limit.

Resumes and an organizational chart can be included as an attachment and will not count towards the page limit. Technical Quotes should be descriptive yet concise.

A time-&-material/labor-hour (T&M/LH) quote with ceiling prices is requested. The T&M/LH quote shall be based on the prices in the schedule contract and shall consider the mix of labor categories and level of effort required to perform the services described in the statement of work. The Business Quote is submitted separately from the Technical Quote for each task/sub-task as specified in the SOW and for each year / partial year of the base period of performance, and option periods, including a summary of the costs for the ultimate period of performance (base period plus all option periods). As stated above, NIDA anticipates the use of Options in accordance with the Federal Acquisition Regulation 52.217-9 Option to Extend the Term of the Contract (Mar 2000).

All services should identify labor category and position of the proposed personnel; the fully loaded (or burdened) labor rate / unit price for each personnel; the rate discount (if any); the total estimated hours for each personnel; and the total estimated annual cost based on the labor hours and rate identified. In accordance with FAR 16.601 (b), A time-and-materials contract provides for acquiring supplies or services on the basis of - (1) Direct labor hours at specified fixed hourly rates that include wages, overhead, general and administrative expenses, and profit; and (2) Actual cost for materials (except as provided for in 31.205- 26(e) and (f)). Therefore, all hourly rates proposed should be fully burdened and should

15 | P a g e include any costs associated with Indirect Costs, G&A, and Profit or Fees and should not be listed as a separate line item on the business proposal. Offerors should use the following format in calculating the cost proposal:

Proposed Staff Labor Category/Position Hourly Rate

Labor Rate

Discount

(Optional)

Discounted

Hourly Rate Total Labor Hours Total Labor Cost

Name Title ‐$ % ‐$ Hrs ‐$

Name Position ‐$ % ‐$ ‐$

0.00 ‐$

Cost Category Detailed Description Rate Quantity Unit Total

ODC, Materials, etc. Description of Cost ‐$ 0.00 ea., per, etc. ‐$

#DIV/0!

#DIV/0!

#DIV/0!

Rate Total

BASE PERIOD SUBTOTAL (Direct Labor and Total Other Direct Costs) ‐$

Total Cost/Price ‐$

Proposed Staff Labor Category/Position Hourly Rate

Labor Rate

Discount

(Optional)

Discounted

Hourly Rate Total Labor Hours Total Labor Cost

Name Title ‐$ % ‐$ 0.00 ‐$

0.00 ‐$

Cost Category Detailed Description Rate Quantity Unit Total

ODC, Materials, etc. Description of Cost ‐$ 0.00 ea., per, etc. ‐$

Rate Total

OPTION QUANTITY TASK A SUBTOTAL PER UNIT (Direct Labor and Total Other Direct Costs) ‐$

Proposed Staff Labor Category/Position Hourly Rate

Labor Rate

Discount

(Optional)

Discounted

Hourly Rate Total Labor Hours Total Labor Cost

Name Title ‐$ % ‐$ 0.00 ‐$

0.00 ‐$

Cost Category Detailed Description Rate Quantity Unit Total

ODC, Materials, etc. Description of Cost ‐$ 0.00 ea., per, etc. ‐$

Rate Total

OPTION QUANTITY TASK B SUBTOTAL (Direct Labor and Total Other Direct Costs) ‐$

Proposed Staff Labor Category/Position Hourly Rate

Labor Rate

Discount

(Optional)

Discounted

Hourly Rate Total Labor Hours Total Labor Cost

Name Title ‐$ % ‐$ 0.00 ‐$

0.00 ‐$

Cost Category Detailed Description Rate Quantity Unit Total

ODC, Materials, etc. Description of Cost ‐$ 0.00 ea., per, etc. ‐$

Rate Total

OPTION QUANTITY TASK C SUBTOTAL (Direct Labor and Total Other Direct Costs) ‐$

TOTAL COST IF ALL UNITS ARE EXERCISED

TOTAL COST IF ALL UNITS ARE EXERCISED

TOTAL COST IF ALL UNITS ARE EXERCISED

Base Period ‐ Option Quantity Task C ‐ Other Direct Costs (ODC) & Materials

Total Other Direct Costs & Materials

Total Direct Labor Hour Cost

Total Direct Labor Hour Cost

Total Direct Labor Hour Cost

Base Period ‐ Option Quantity Task A ‐ Other Direct Costs (ODC) & Materials

Total Other Direct Costs & Materials

Base Period ‐ Option Quantity Task B ‐ Other Direct Costs (ODC) & Materials

Total Other Direct Costs & Materials

Base Period ‐ Option Quantity Task A ‐ Direct Labor ‐ Time and Materials

Base Period ‐ Option Quantity Task B ‐ Direct Labor ‐ Time and Materials

Base Period ‐ Option Quantity Task C ‐ Direct Labor ‐ Time and Materials

Base Period ‐ Direct Labor ‐ Time and Materials

Total Direct Labor Hour Cost

Base Period Other Direct Costs (ODC) & Materials

Total Other Direct Costs & Materials

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In its Business Quote, the Offeror shall identify the total estimated labor hours, and calculate the average discounted rate per hour based on the fully loaded (burdened) rate. The Offeror should also provide a description for any proposed Other Direct Costs (i.e. remuneration payments, travel, meals, other research support supplies, direct IT expense, consultants, subcontracts, etc.) for each Other Direct Costs proposed, offerors should include a detailed description of the cost and identify how the cost was determined as well as a justification and supporting documentation for any anticipated Other Direct Cost.

The Offeror shall separate total cost for all Option Quantity Tasks, and the total cost for the basic requirements. The Offeror should complete a separate table for each period of performance proposed in the Business Quote using the format above.

As stated above, NIDA anticipates the use of Options and Options Quantities in accordance with the Federal Acquisition Regulation (FAR) 52.217-7 Option for Increased Quantity – Separately Priced Line Items (Mar 1989); 52.217-8 Option to Extend Services (Nov 1999).

Pursuant to FAR Clause 52.217-8 Option to Extend Services (Nov 1999) if exercised, Transition-Out Services shall occur at the final period of performance and shall last an estimated 30 days. The Offeror should also propose a separate cost and table for the Transition Out Option.

The NIDA IRP has multiple primary PIs who may require additional funding for participant remuneration support either individually or jointly as necessary based on current protocol needs. The Optional Quantities will be expended in additional remuneration compensation, travel and subsistence expenses, and other direct material support costs. In its business Quote the Offeror should differentiate between any additional labor costs and the actual funds that would be used for remuneration and funding support.