Pre-Solicitation_Notice_of_Intent-NONCOMPETITIVE_4857465.pdf

PRE-SOLICITATION NOTICE OF INTENT

NON-COMPETITIVE

Solicitation: NIHDA201800047-NOI

Title: Mental Health Field Research in Amish and Mennonite Communities

INTRODUCTION

PURSUANT TO FAR Subpart 5.2—Synopses of Proposed Contract Actions, THIS IS A

PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT TO ACTION.

THIS IS A PRE-SOLICITATION NON-COMPETITIVE NOTICE OF INTENT TO AWARD

A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN

COMPETITION (INCLUDING BRAND-NAME).

The National Institute on Drug Abuse (NIDA), Station Support Contracts and Simplified Acquisitions Branch (SS/SA) on behalf of the National Institute on Aging (NIA) intends to negotiate and award a contract for contractor support services for Mental Health Field Research in the Amish and Mennonite Communities with Dr. Layla Kassem, 4801 Connecticut Avenue NW, APT 912, Washington, DC, 20008-2209.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541720 – Research and Development in the Social Sciences and Humanitites with a Size Standard of $20.5 Million.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses of the Federal acquisition Requlation (FAR) in effect through the Federal Acquisition Circular (FAC) 2005-97, January 24, 2018.

STATUTORY AUTHORITY

This acquisition is conducted as non-competitive under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302-1 – Only one response source and no other supplies or services will satisfy agency requirements.

DESCRIPTION OF REQUIREMENT

Purpose and Objectives The purpose of this acquisition is to procure contractor services to support recruitment of study volunteers from families with specific mental illnesses within Amish and Mennonite communities, perform structured diagnostic and other mental health assessments in the field, help to design and improve clinical assessment tools and establish their validity among individuals of Amish or Mennonite ancestry, and collect blood and other biological specimens in the field for use in molecular analyses. While most of the tasks will be performed by the contractor, qualified subcontractors may be engaged as needed.

The contractor will support clinical mental health genetics research work as directed by the Branch Chief. This will include (Task 1) continual improvement of the Branch’s ongoing family volunteer recruitment effort and ascertainment strategies within targeted special populations, (Task 2) performance of diagnostic assessments in the field, (Task 3) assisting the Branch in the refinement of diagnostic procedures, and

(4) assisting the branch with collection of blood specimens from research volunteers in the field. Because of their unique genetic and social circumstances, much of the work is done in the field with family volunteers of Amish or Mennonite ancestry. Thus, considerable travel, sensitivity to cultural differences, and independent professional judgement are required.

Project Description Task 1: Support Recruitment of Study Volunteers from Amish and Mennonite Communities The contractor shall provide the following services in support of the Branch’s ongoing family volunteer recruitment effort:

The contractor shall work with Branch staff to devise and refine procedures for ascertainment and recruiting of volunteers for ongoing family studies The contractor shall liaison with care providers and community representatives in the field to promote knowledge of studies and recruitment criteria and facilitate referral of potential volunteers The contractor shall employ specified eligibility criteria and carry out informed consent procedures with study volunteers, as directed by the Branch chief and in accordance with IRB regulations The contractor shall supervise the work of junior team members in the field

Task 2: Structured Diagnostic and Other Mental Health Assessments in the Field

The contractor shall provide the following services in support of the formulation of appropriate assessments:

The contractor shall perform structured diagnostic interviews with study participants in the field, using instruments as directed by the Branch chief The contractor shall elicit corroborative diagnostic information from family informants, using instruments selected by the Branch chief Encounters with study volunteers will be conducted in a private and professional manner, with appropriate consideration for the sensitive nature of the information collected, sensitivity to Amish and Mennonite cultural norms, Task 3: Diagnostic Procedure Refinement Support The contractor shall provide the following services in support of the refinement of mental health assessment procedures:

The contractor shall work with the Branch chief to modify existing assesment instruments to improve validity and utility with targeted special populations The contractor shall work with the Branch chief to adapt existing dimensional measures of mood and cognition to work with targeted special populations in the field The contractor shall participate in weekly best estimate diagnosis meetings where cases are reviewed by clinicians before diagnoses are assigned.

Task 4: Collection of Blood and Biological Specimens The contractor shall provide the following specimen collection services:

The contractor shall perform phlebotomy procedures in the field as directed by the Branch Chief The contractor shall maintain appropriate professional credentials for phlebotomy procedures, including licensing and liability coverage, where appropriate The contractor shall collect other biological specimens, such as saliva and skin, when appropriate as directed by the Branch Chief The contractor shall appropriately pack and ship specimens to a central repository as directed by the Branch Chief.

See attached Statement of Work (SOW) for further details.

Period of Performance The period of performance will be one 12-month base year (from date of award) plus two 12-month option years.

Delivery or Deliverables Contractor will provide hard-copies of completed consent forms, participant reimbursement requests, and all clinical assessments for review by the Branch Chief or his designees within 2 calendar days following each assessment visit. Biological specimens will be collected in appropriate containers, labeled, and shipped within 24 hr of collection to a biorepository as directed. Final deliverables will be submitted within 5 wrking days following receipt of government’s comments. The timely submission of deliverables is essential to successful completion of this requirement.

CLOSING STATEMENT

This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice.

Responses to this solicitation must include clear and convincing evidence of the offeror’s capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount.

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.”

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All responses must be received by Tuesday, March 27, 2018 at 11AM, Eastern Standard Time, and reference number NIHDA201800047-NOI. Responses may be submitted electronically to Danielle R. Brown, Contract Specialist, at Danielle.brown2@nih.gov.

Fax responses will not be accepted.

Extensions to the deadline will not be granted.

Please contact Danielle R. Brown, Contract Specialist, at Danielle.brown2@nih.gov or

(301) 594-1928 with any questions.

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SOW) – SERVICES

GENERAL INFORMATION

Title of Project:

Mental Health Field Research in Amish and Mennonite Communities

Statement of Need and Purpose:

The purpose of this acquisition is to procure contractor services to support recruitment of study volunteers from families with specific mental illnesses within Amish and Mennonite communities, perform structured diagnostic and other mental health assessments in the field, help to design and improve clinical assessment tools and establish their validity among individuals of Amish or Mennonite ancestry, and collect blood and other biological specimens in the field for use in molecular analyses. While most of the tasks will be performed by the contractor, qualified subcontractors may be engaged as needed.

Background Information and Objective:

The Genetic Basis of Mood and Anxiety Disorders Section, within the Human Genetics Branch, NIMH-IRP, is a clinical genetics research program with both human-subjects and laboratory components. Our leadership position depends critically on recruitment of family study volunteers, competent performance of structured diagnostic assessments in the field, refinement of diagnostic procedures, and the collection of research specimens. Ongoing research is focused on volunteers of Amish or Mennonite ancestry, who must usually be ascertained, enrolled, and assessed in the field.

Period of Performance:

The period of performance will be one 12-month base year (from date of award) plus two 12-month option years.

SCOPE OF WORK

General Requirements:

The contractor will support clinical mental health genetics research work as directed by the Branch Chief. This will include (Task 1) continual improvement of the Branch’s ongoing family volunteer recruitment effort and ascertainment strategies within targeted special populations, (Task 2) performance of diagnostic assessments in the field, (Task 3) assisting the Branch in the refinement of diagnostic procedures, and (4) assisting the branch with collection of blood specimens from research volunteers in the field. Because of their unique genetic and social circumstances, much of the work is done in the field with family volunteers of Amish or Mennonite ancestry. Thus, considerable travel, sensitivity to cultural differences, and independent professional judgement are required.

Specific Requirements:

Task 1: Support Recruitment of Study Volunteers from Amish and Mennonite Communities The contractor shall provide the following services in support of the Branch’s ongoing family volunteer recruitment effort:

The contractor shall work with Branch staff to devise and refine procedures for ascertainment and recruiting of volunteers for ongoing family studies The contractor shall liaison with care providers and community representatives in the field to promote knowledge of studies and recruitment criteria and facilitate referral of potential volunteers

The contractor shall employ specified eligibility criteria and carry out informed consent procedures with study volunteers, as directed by the Branch chief and in accordance with IRB regulations

The contractor shall supervise the work of junior team members in the field

Task 2: Structured Diagnostic and Other Mental Health Assessments in the Field The contractor shall provide the following services in support of the formulation of appropriate assessments:

The contractor shall perform structured diagnostic interviews with study participants in the field, using instruments as directed by the Branch chief

The contractor shall elicit corroborative diagnostic information from family informants, using instruments selected by the Branch chief

Encounters with study volunteers will be conducted in a private and professional manner, with appropriate consideration for the sensitive nature of the information collected, sensitivity to Amish and Mennonite cultural norms, Task 3: Diagnostic Procedure Refinement Support The contractor shall provide the following services in support of the refinement of mental health assessment procedures:

The contractor shall work with the Branch chief to modify existing assesment instruments to improve validity and utility with targeted special populations

The contractor shall work with the Branch chief to adapt existing dimensional measures of mood and cognition to work with targeted special populations in the field

The contractor shall participate in weekly best estimate diagnosis meetings where cases are reviewed by clinicians before diagnoses are assigned.

Task 4: Collection of Blood and Biological Specimens The contractor shall provide the following specimen collection services:

The contractor shall perform phlebotomy procedures in the field as directed by the Branch Chief

The contractor shall maintain appropriate professional credentials for phlebotomy procedures, including licensing and liability coverage, where appropriate

The contractor shall collect other biological specimens, such as saliva and skin, when appropriate as directed by the Branch Chief

The contractor shall appropriately pack and ship specimens to a central repository as directed by the Branch Chief.

LEVEL OF EFFORT:

The position requires a clinical psychologist at a full-time effort of 40 hr per week, 50 wks per year

GOVERNMENT RESPONSIBILITIES

The government will provide contact information on study volunteers, access to necessary laptop and desktop computers, necessary materials for collection of biological specimens, workspace in Building 10 on the main NIH campus in Bethesda, MD, with restricted access on Federal holidays, and a mobile telephone. The Branch Chief will review and approve all reports and data generated under the contract.

DELIVERY OR DELIVERABLES

Contractor will provide hard-copies of completed consent forms, participant reimbursement requests, and all clinical assessments for review by the Branch Chief or his designees within 2 calendar days following each assessment visit. Biological specimens will be collected in appropriate containers, labeled, and shipped within 24 hr of collection to a biorepository as directed. Final deliverables will be submitted within 5 wrking days following receipt of government’s comments. The timely submission of deliverables is essential to successful completion of this requirement.

REPORTING REQUIREMENTS

Written progress reports detailing recruitment efforts, volunteers enrolled, assessments completed, specimens submitted, and any problems encountered will be provided quarterly.

One copy each will be provided to the Branch Chief and the Clinical Coordinator.

OTHER CONSIDERATIONS

Travel:

Travel is required. The contractor will regularly be required to travel to other locations to recruit, screen, and evaluate study participants. Approximately 10 trips of 5 day duration will be required to points within the continental US.

Prior to incurring any travel expenses, contractor personnel must obtain authorization from the Project Officer that approves approximate travel, dates, expected duration, origin and destination, purpose, estimated costs and the number and names of personnel traveling.

Contractor is responsible for travel reimbursement.

Key Personnel:

The key personnel specified in this contract are considered to be essential to work performance.

At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the Contractor or Government.

The following individual(s) is/are considered to be essential to the work being performed hereunder:

Name Title .

To be Determined Clinical psychologist

Key personnel shall have extensive clinical training and experience, clinical experience with major mental illness, a good working knowledge of diagnostic definitions and procedures, and a solid grasp of fundamental statistical principles. Key personnel shall have knowledge and experience with cultural and societal norms typical of the targeted Amish and Mennonite populations and be able interact within these communities in a positive and professional manner that reflects well on the Branch and the NIH.

Key personnel must have the following minimum qualifications:

Doctoral degree in psychology or a related field;.

At least 6 years’ experience in clinical mental health, diagnosis, and neuropsychological assessement;

At least 6 years’ experience with Amish and Mennonite communities. Considerable judgment and sensitivity are required for navigating participant recruitment and assessment in the field within the targeted special populations.

Experience dealing with acute mental health issues that may require immediate assistance from medical, mental health, or law enforcement personnal

Physically able to travel independently by air and road

Trained in phlebotomy procedures, with at least 2 years experience in the field

The ideal contractor would also demonstrate extensive knowledge of family study methods as evidenced by recent course work and/or experience and a record of research publications in the field.

Information System Security Plan:

Work under this task order is UNCLASSIFIED. The contractor shall comply with all applicable NIH regulations and procedures during the performance of this task order. The contractor shall not disclose and must safeguard procurement of sensitive information, computer systems and data, privacy act data, and Government personnel work products that are obtained or generated in the performance of this task order. If necessary, the contractor will be required to provide clearances for personnel requiring access to Government computers and workstations.

Data Rights:

The National Institute of Mental Health shall have unlimited rights to and ownership of all deliverables provided under this contract, including reports, recommendations, briefings, work plans and all other deliverables. This includes the deliverables provided under the basic contract and any optional task deliverables exercised by the contracting officer. In addition, it includes any additional deliverables required by contract change. The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, “Definitions.”

FAR Clause 52.227-14, “Rights in Data-General” is hereby incorporated by reference and shall be a part of this contract.

Section 508—Electronic and Information Technology Standards:

The contractor shall comply with Section 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998.

Publications and Publicity:

Contractor may from time to time write and publish articles related to the data produced as a result of the SOW, but only under the direction and written agreement of the Branch Chief or his designees.

Confidentiality of Information:

Contractor will be provided with confidential information of a personal nature about individuals who have volunteered to participate in the study. Contractor will also generate confidential data concerning study participants. All information of a personal nature will be safegauarded in a secure form until submitted to the Branch Chief or his designees.

ATTACHMENTS

1. Independent Government’s Cost Estimate

2. Evaluation / Selection Criteria

STATEMENT OF WORK (SOW) SERVICES ATTACHMENT

Mental Health Field Research in Amish and Mennonite Communities ATTACHMENT 2: Technical Evaluation Criteria

The Government will award a contract or purchase order resulting from this requirement on the basis of best value, technical factors and price considered. Technical factors shall be considered more important than price and all technical evaluation factors are detailed below:

Factor 1: Technical Approach (70 Points)

The Contractor’s proposal shall address each area of the statement of work requirements in sufficient detail to demonstrate a clear understanding of the efforts to be performed and the skill level required to perform them. Approach shall be evaluated for their ability to adequately train laboratory personnel on diagnostic issues concerning autism spectrum disorders, and assist in the design of clinical studies.

Factor 2: Past Performance (20 Points)

The Contractor shall provide at least two (2) past performance references with knowledge of the contractor’s relevant skills and experience related to the requirements outlined in this Statement of Work.

References shall include the following information:

a. Name of Organization

b. Brief Description of Contractor’s Responsibilities

c. Contact Name and Title

Past Performance shall be evaluated for relevance to the current requirement.

Factor 3 – Cost/Price (10 Points)

Offeror(s) cost/price proposal 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 13.106. The Offeror shall submit firm fixed prices for all items listed in the Statement of Work.

Technical proposals will be evaluated using a summary adjectival rating in accordance with the following scale:

Excellent (90 – 100) Very Good (80 – 89) Good (70 – 79) Fair (60 – 69) Poor (0 – 59)

Excellent The proposal has exceptional merit and reflects an excellent approach which will clearly result in the superior attainment of all requirements and 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. Risk Level: Very Low

Very Good 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. Risk Level: Low

Good The proposal demonstrates an approach which is capable of meeting 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. Risk Level: Neutral.

Fair 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. Risk Level: High

Poor 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. Risk Level: Very High