CSS RFQ 75N95020Q00126 and Attachments.pdf

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COMBINED SYNOPSIS / SOLICITATION-COMPETITIVE

Title: Grassroots Outreach and Community Partnership Services for Participant Recruitment at the NIDA IRP Clinical Program.

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 written solicitation will not be issued.

2. The solicitation number is 75N95020Q00126 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.

NIDA requires the services necessary to develop, implement, monitor and assess grassroots outreach and community partnership campaigns in order to recruit 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. The Contractor shall protect the sensitive nature of the information and data collected when working with these populations.

3. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2020-04, dated 01-15-2020.

4. NAICS Code: The associated NAICS code 541613, 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 Contractor support services for

2 | P a g e grassroots outreach and community partnership services in order to recruit eligible research participants for inclusion in human research studies conducted by the NIDA IRP. NIDA IRP seeks to enroll 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 occasionally use these substances 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 shall be made to protect the sensitive nature of the data collected when working with these populations. NIDA reserves the right to have the contracted services benefit NIDA and any other component of NIH.

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 9-month Base Period, with two (2) additional 12-month Option Periods and a final 3-month Option Period. 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 September 21, 2020 and run through June 20, 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 FY20. Base Period. Grassroots Outreach and Community Partnership Services for

Participant Recruitment at the NIDA IRP Clinical Program. 9/21/20 – 6/20/21. N02DA- 20-9005.

6. Project Requirement: Independently and not as an agent of the Government, the Offeror 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 Grassroots Outreach and Community Partnership with the goal of participant recruitment for research studies at the NIDA IRP Clinical Program.

In accordance with the General Requirements and the Statement of Work (SOW) attached to this combined synopsis/solicitation, labeled as Attachment 1 – Statement of Work; the Offeror shall:

a. Provide grassroots outreach marketing services and develop partnerships and referral networks with community-based organizations and businesses;

b. Monitor performance, analyze the efficacy, and continuously optimize its outreach recruitment strategies; and

c. Provide contract management and administrative services in support of the programmatic requirement.

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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.

In its response, the Offeror should clearly demonstrate its proposed approach and capability to successfully complete the following:

a. Develop and implement educational and awareness campaigns that will promote NIDA’s research opportunities and establish trust primarily within the Greater Baltimore- Washington Area, which will ultimately result in identifying and recruiting eligible research participants for inclusion in human research studies conducted by the NIDA

IRP.

b. Establish partnerships and referral networks primarily within the Greater Baltimore- Washington Area and surrounding community for the purposes of recruiting research participants for various NIDA studies;

c. Generate reportable data and utilize evidence-based statistics to create customizable, multi-tiered outreach marketing campaigns; based on each study’s approved protocol and Inclusion/Exclusion (I/E) criteria;

d. Develop flexible staffing plans, which include working with existing NIDA staffing to accommodate the various aspects of outreach initiatives to recruit participants in the most efficient and cost-effective manner.

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 working with, and establishing referral networks with community-based organizations, treatment centers, clinics, and non-profits, in the Greater Baltimore-Washington Area. The Offeror should describe the unique challenges in communicating and connecting with sensitive populations with active Substance Use Disorders (SUD)s (e.g. nicotine, alcohol, cocaine, marijuana, opioids) 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, socio-economic status (SES), IQ, etc.

b. Sample Community Engagement Plan (CEP) – The Offeror shall develop a sample CEP to engage the community in clinical research and promote public health, establishing community trust and ongoing grassroots community outreach that includes education and local awareness of NIDA research. In the CEP please describe how the proposed approach will utilize demographic data and an evidence-based approach to identify, develop and execute a community engagement strategy that includes key stakeholders such as community-based organizations, community gathering places, the media (including online platforms) and foundations providing support to the target populations NIDA seeks to enroll. The sample CEP should also identify a proposed approach to establishing local partnerships to obtain participant referrals from treatment centers, healthcare providers, etc. A complete CEP shall also include a description of contingency planning efforts and alternative strategies to overcome potential challenges associated with recruiting qualified participants. The sample CEP should be designed to

4 | P a g e support the following sample protocol:

i. Sample Protocol – For Quote purposes, the Sample Protocol shall last 2-years and will research how stress and craving influence alcohol, tobacco, cocaine and/or opioid use. Offerors should assume the following criteria: 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.

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.

Participants will be paid for their time and each visit will last for about 2-4 hours.

Payment to participants may be in the form of cash, check, gift cards or online payments (e.g. PayPal).

For Quote purposes, Offerors should assume that they will be working collaboratively with NIDA and its Advertising Contractor for digital and local ad placements to supplement and support its outreach efforts. Offerors should also assume that up to 4 NIDA Clinical Research Team members will be available to assist with attending local events and meetings.

c. Key Personnel – The Offeror shall identify the proposed key personnel to be assigned to this project and describe their experience in providing grassroots community outreach primarily in the Greater Baltimore-Washington area (for some studies, specifically including Baltimore city) and experience within the substance use disorder population.

d. 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

5 | P a g e 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/ overnment 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 programmatic support through the Option Quantities for additional Grassroots Outreach and Community Partnership support. The NIDA IRP Principal Investigators (PIs) may require additional financial support separately from the tasks defined in the SOW. The NIDA IRP has multiple primary PIs who may require additional outreach services individually or jointly as necessary based on current protocol needs. Through these Options for Increased Quantity, the Contractor may be required to provide additional support for community outreach support as described 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. In each example the Offeror shall include the scope of the work performed, the time period during which the work occurred, the dollar value of the work performed, the results of the project, the project title, client contact information, the specific responsibilities of the offeror, and any quality assurance initiatives. 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

vi. Contract period of performance

vii. Contracting Officer’s name and telephone number

viii. Program Manager’s name and telephone number

ix. North American Industry Classification System (NAICS) Code

x. Any quality assurance initiatives

xi. 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

6 | P a g e 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 unacceptable early enough in the negotiation process to allow the Contractor to modify the plan within the time limits prescribed.

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.

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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 like 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 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 RFQ in Attachment 3 – Small Business Subcontracting Plan Template.

HHS expects each procuring activity to establish minimum subcontracting goals

8 | P a g e for all procurements. The anticipated minimum goals for this RFQ 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 August 25, 2020 through April

24, 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.

a. Technical Evaluation Criteria

i. Technical Factor 1: Project Understanding

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 surrounding: working with and establishing connections with community based organizations, treatment centers and clinics in the Greater Baltimore-Washington Area; understanding and describing the unique challenges in communicating and connecting with sensitive 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

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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:

a) Description of the methodologies employed to provide the required deliverables.

b) Proposed approach to 1) develop a Community Engagement Plan (CEP) to engage the community in clinical research and promote public health, establishing community trust and ongoing grassroots community outreach that includes education and local awareness of NIDA research, 2) use demographic data and an evidence-based approach to identify, develop and execute a community engagement strategy that includes key stakeholders such as community-based organizations, community gathering places, the media (including online platforms) and foundations providing support to the target populations NIDA seeks to enroll and 3) establish local partnerships to obtain participant referrals from treatment centers, healthcare providers, etc.

c) Description of its proposed strategic outreach plan that includes contingency plans and alternative strategies to overcome potential challenges associated with recruiting qualified participants, some of whom may be reachable via social media or other online strategies, while many other participants may be reachable only through face-to-face contact.

d) The Sample CEP will be evaluated in terms of the proposed approach, the methodologies employed, the comprehensiveness of the plan, and its adherence and compliance with the sample protocol provided.

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 grassroots community outreach in the Greater Baltimore-Washington Area (for some studies, specifically including Baltimore city) and experience within the substance use disorder population. NIDA shall assess the credentials of any proposed staff given the work requirements defined in the SOW along with their demonstrated experience in community engagement and outreach in the Greater Baltimore- Washington Area (for some studies, specifically including Baltimore city).

iv. Technical Factor 4: 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 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

10 | P a g e 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 outreach and marketing 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.

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).

d. Past Performance

NIDA will evaluate the Offeror’s Quote based on recent and relevant experiences in providing grassroots community outreach, establishing partnerships with community stakeholders primarily within the Greater Baltimore-Washington Area (for some studies specifically including Baltimore city), and experience with people who currently use alcohol and/or drugs and/or have a current or remitted alcohol and/or substance use disorders. Offeror's past performance information will be evaluated subsequent to the technical evaluation. However, this evaluation will not be conducted on any offeror whose Quote is determined to be technically unacceptable.

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.

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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.

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 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.

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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 August 13, 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 75N95020Q00126 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 Quote the following information:

• Technical Quote in accordance with this combined synopsis/solicitation in a searchable

PDF format;

• Business Quote in an Searchable PDF or Word Document;

• Cost/Price Data and Tables in an Excel format;

• Dun and Bradstreet Number (DUNS); and

• Verification of System for Award Management (SAM) Registration www.sam.gov.

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.

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).

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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 its business Quote, the Offeror shall identify the total estimated labor hours, and calculate the average discounted rate per hour based on the proposed costs. The Offeror should also provide a breakdown and justification for any anticipated Other Direct Cost as well as a breakdown for any anticipated costs allocated for consultants and subcontractors.

Furthermore, the Offeror shall add the total price for all options to the total price for the basic requirements.

The offeror should complete a separate table for each period of performance proposed in the Business Quote using the following format:

Pursuant to FAR 52.217-7 Option for Increased Quantity – Separately Priced Line Items (Mar 1989); and 52.217-8 Option to Extend Services (Nov 1999) the Contractor may be required to provide additional Grassroots Outreach and Community Partnership support to NIDA IRP Principal Investigators (PIs) separately from the tasks above.

The NIDA IRP has multiple primary PIs who may require additional outreach services individually or jointly as necessary based on current protocol needs. The Optional Quantities

Proposed Staff Labor Category / Position Hourly Rate Labor Rate Discount

Discounted Hourly Rate

Total Labor Hours

Total Labor Cost

Name Title -$ % -$ 0.00 -$

Total Direct Labor Hour Cost 0.00 -$

Cost Category Detailed Description Rate Quantity Unit Total ODC, Materials, etc. Description of Cost -$ 0.00 ea., per, etc. -$

Total Other Direct Costs & Materials -$

Rate Total SUBTOTAL (Direct Labor and Total Other Direct Cost) -$ Indirect Costs / G&A / Fees % -$

Total Cost/Price -$

Direct Labor - Time and Materials

Other Direct Costs & Materials

14 | P a g e will be expended in additional marketing support and costs. In its business Quote the Offeror should differentiate between the administrative costs and the actual funds that would be used for marketing and outreach support. The Offeror should complete a separate table for each Option Quantity and each period of performance using the following format:

The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror. NIDA estimates that the total cost of this contract (inclusive of Options and Option Quantities) is between $450,000 and $500,000 for the Base Period, between $500,000 and $550,000 for Option Period 1, between $500,000 and $550,000 for Option Period 2, and between $360,000 and $410,000 for Option Period 3.

Note: The anticipated award shall include a not-to-exceed cost ceiling that the Contractor shall not exceed.

Any Quote, modification, or revision that is received at the designated Government office after the exact date and time specified for receipt of quotations is “late” and may not be considered. Quotes received “late” may not be evaluated or considered for award and may be returned to the Offeror.

If an emergency or unanticipated event interrupts normal Government processes so that Quotes cannot be received at the Government office designated for receipt of Quotes by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation closing date, the time specified for receipt of Quotes will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.

Proposed Staff Labor Category / Position Hourly Rate Labor Rate Discount

Discounted Hourly Rate

Total Labor Hours

Total Labor Cost

Name Title -$ % -$ 0.00 -$

Total Direct Labor Hour Cost 0.00 -$

Cost Category Detailed Description Rate Quantity Unit Total ODC, Materials, etc. Description of Cost -$ 0.00 ea., per, etc. -$

Total Other Direct Costs & Materials -$

Rate Total SUBTOTAL (Direct Labor and Total Other Direct Cost) -$ Indirect Costs / G&A / Fees % -$

Total Cost/Price -$

Direct Labor - Time and Materials

Other Direct Costs & Materials

15 | P a g e

The Government reserves the right to award without discussions if the Contracting Officer determines that the initial cost/prices are fair and reasonable and that discussions are not necessary.

16. Questions and requests for clarification should be submitted electronically to the Contracting Officer, Josh Lazarus at Josh.Lazarus@nih.gov on or before 3:00 pm July 30, 2020. Any questions or request for clarification must include the combined synopsis/solicitation 75N95020Q00126 and the Title in the Subject Line.

Attachment 1 – Statement of Work

Title:

Grassroots Outreach and Community Partnership Services for Participant Recruitment at the NIDA IRP Clinical Program

Description(s): Statement of Work Contracting Office Address:

Department of Health and Human Services, NIH, NIDA-IRP 11601 Landsdown Street Rockville, MD 20852 United States

Table of Contents

Title:

Description(s): Statement of Work

Section 1 - Background:

Section 2 - Definitions:

Section 3 - Purpose and Objectives:

Section 4 - Period of Performance:

Section 5 – General Requirement:

Requirements:

1. Grassroots Community Outreach and Partnerships (education, awareness, establishing trust)

2. Monitoring and continuous optimization of outreach recruitment strategies:

3. Contract Administrative Services

Section 6 – Option Quantities

A. Option Quantity Task A – Transition-Out Services

B. Option Quantity Task B – Optional Grassroots Outreach and Community Partnership Support

Section 7 - Deliverables

Section 8 - Government Furnished Equipment (GFE)/Government Furnished Property (GFP) . 13

Section 9 - Place of Performance

Section 10 - Contract Type

Section 11 - Key Personnel

Section 12 - Privacy and Security Requirements

Section 13 - Training Requirements

Section 14 - Section 508 Compliance – Electronic and Information Technology (EIT) Standards:

Section 1 - Background:

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.

For proposal purposes, NIDA typically has 10-15 research protocols actively recruiting for 2-4 specific study populations (e.g. a treatment-seeking SUD population, a non-treatment-seeking SUD population, and matched controls to each) at any given time. Each protocol has unique inclusion/exclusion criteria.

Section 2 - Definitions:

NIDA’s Targeted Populations: NIDA IRP seeks to enroll 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 are occasional users of these substances 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 needs to be made to the sensitive nature of the data collected when working with these populations.

Recruitment Success: NIDA researchers need to enroll eligible participants into studies at a reasonable rate. Therefore, success is considered meeting enrollment goals per study group within a given protocol.

Enrollment: Enrollment refers to a participant signing consent into a research protocol for which they meet all inclusion criteria to participate.

Principal Investigator (PI): The research scientist who is overall responsible for a given protocol.

Medical Advisory Investigator (MAI): The study physician who is responsible for the safety of individual study participants for a given protocol. The MAI is also responsible for assessing the screening data and is authorized to make a final determination of participant eligibility based on those data and the protocol’s Inclusion/Exclusion (I/E) criteria.

Contract Officer (CO) - authorized to obligate the Government to the expenditure of funds for contracts.

Contract Officer’s Representative (COR) - authorized on behalf of the Contract Office on matters related to monitoring and oversight of the technical and programmatic aspects of the contract.

Biomedical Research Center (BRC) – location of the NIDA IRP research facility situated on the Johns Hopkins Bayview Campus in Baltimore, MD.

Normal business hours - Monday through Friday, 8:30am – 5pm.

After hours note – Although our studies require accommodating participant schedules and can include evening and weekend hours, although we are not a 24/7 operation.

Custom recruitment campaign - each protocol may require the use of one or more mediums, specifically tailored to the target populations, based on protocol Inclusion/Exclusion (I/E) criteria.

Section 3 - Purpose and Objectives:

NIDA requires grassroots outreach and community partnership services in order to recruit eligible research participants for inclusion in human research studies conducted by the NIDA IRP. NIDA IRP requires the enrollment of 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 occasionally use these substances and healthy controls who match the other populations with respect to characteristics such as age, gender, socio-economic status (SES), IQ, etc. NIDA IRP also conducts studies requiring HIV-positive populations. The Contractor shall protect the sensitive nature of any information or data collected when working with these populations. NIDA reserves the right to have the contracted services benefit NIDA and any other component of

NIH.

Section 4 - Period of Performance:

NIDA anticipates that this requirement will include the use Options to Extend the Period of Performance as well Options…