Family Study of Comorbidity of Mood Spectrum Disorders

The chief goal of the contract is to facilitate development of a project on activity and mood disorders at the NIMH IRP at the Genetic Epidemiology Research Unit (Dr. Kathleen Merikangas, P.I.). The first phase involves development of methods for joint analysis of electronic diary and activity data, and the association between mood disorders and activity and mood regulation. The second phase involves joint analyses of NIMH data with those from other sites including Sydney, Australia (Professor Ian Hickie), Norway. The third phase involves establishment of these measures at new sites including Chengdu, China through a joint award of the National Chinese Research Council with the NIH Intramural Research Program, the CoLaus Project in Lausanne, Switzerland (Dr. Martin Preisig, PI). NON-COMPETITIVE COMBINED SYNOPSIS / SOLICITATION Title: Family Study of Comorbidity of Mood Spectrum Solicitation Number: HHS-NIH-NIDA-CSS-2018-77 (i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii) The solicitation number is HHS-NIH-NIDA-CSS-2018-77 and the solicitation is issued as an request for proposal (RFP). This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures; FAR Subpart 13.5-Simplified Procedures for Certain Commercial Items; and FAR Part 12-Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold. THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS SOLICITATION 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 of Mental Health intends to negotiate and award a purchase order without providing for full and open competition (Including brand-name) to Stichting VU-VUMC, Van der Boechorststraat 7 Amsterdam for Family Study of Comorbidity of Modd Spectrum Disorder. This acquisition is conducted as non-competitive for a commercial item or service and is conducted under the authority of the FAR Subpart 13.5-Simplified Procedures for Certain Commercial Items and 13.501 Special documentation requirements and the authority of 41 U.S.C. 1901 and the statutory authority of 6.302-1, only one responsible source and no other supplies or services will satisfy agency requirements. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-97, dated January 1, 2018. (iv) The associated NAICS code 611310 and the small business size standard $27.5 Million. (v) Statement of Need The chief goal of the contract is to facilitate development of a project on activity and mood disorders at the NIMH IRP at the Genetic Epidemiology Research Unit (Dr. Kathleen Merikangas, P.I.). The first phase involves development of methods for joint analysis of electronic diary and activity data, and the association between mood disorders and activity and mood regulation. The second phase involves joint analyses of NIMH data with those from other sites including Sydney, Australia (Professor Ian Hickie), Norway. The third phase involves establishment of these measures at new sites including Chengdu, China through a joint award of the National Chinese Research Council with the NIH Intramural Research Program, the CoLaus Project in Lausanne, Switzerland (Dr. Martin Preisig, PI). Background Information The major goal of the NIMH Family Study is to identify biologic markers for mood disorders. We have demonstrated that activity diagnostic thresholds, subtypes and boundaries with other disorders in order to identify the genetic and environmental risk factors for these conditions. The chief goal of the contract is to facilitate development of an international joint study of activity and mood disorders based on a project that was developed at the NIMH IRP at the Genetic Epidemiology Research Unit (Dr. Kathleen Merikangas, P.I.). The first phase of the study involves development of methods for joint analysis of electronic diary and activity data, and the association between mood disorders and activity and mood regulation. The second phase involves joint analyses of NIMH data with those from other sites including Sydney, Australia (Professor Ian Hickie), Norway (Ketil Odegaard, M.D.), and other sites now under discussion. The third phase involves establishment of these measures at new sites including Chengdu, China through a joint award of the National Chinese Research Council with the NIH Intramural Research Program, and the CoLaus Project in Lausanne, Switzerland (Dr. Martin Preisig, PI). General Scop of Work This contract specifies the agreement between the Genetic Epidemiology Research Branch and the contractor. The chief goal of the contract is to facilitate development and coordination of the March joint network that was set-up at the NIMH IRP at the Genetic Epidemiology Research Unit (Dr. Kathleen Merikangas, P.I.). This work involves contribution to the development of protocols, training modules, and March website + content, etc., and joint analyses of data. The contract primarily involves data analysis that will result in joint publications and coordination of international activities on activity and mood disorders and symptoms. Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below: The Contractor's major responsibilities will include the following broad areas: A. Statistical Analysis of NIMH Family Study Data and related data sets i. Conduct statistical analyses of NIMH family study data including: electronic diary data; actiwatch data; and clinical diagnostic data on subtypes of depression. ii. Coordinate joint analyses of the NIMH family study and the University of Lausanne family study data with Dr. Martin Preisig and Caroline Vandeleur. iii. Assist in error checking of biologic measures in NIMH Family Study in with the NIMH Data Manager and Statistical Analysts. B. Coordination of international joint efforts on activity and mood disorders and symptoms: i. Maintain overview of available data on activity with the NIMH GEB March initiative ii. Work with the analytic team from NIMH and Johns Hopkins Bloomberg School of Health to develop analytic plans and implement analyses, including development of training materials iii. Assist in coordination of core data collection and common analyses of activity data across sites iv. Assist in communication with new sites that may wish to join the workgroup. v. Assist in development of protocols for March vi. Assist in maintenance of the March website and other communication channels C. Procedures i. Written Documentation: The Contractor's analyses and activities will be documented through written agreements with Dr. Merikangas, the Principal Investigator of these studies. The Contractor shall provide written documentation of broad analytic plans; exchange results of computer programs used in the analyses, and prepare summaries of the findings of the above analyses in quarterly reports. Authorships on papers will be agreed upon in advance. ii. Conference calls: Communication will occur through regular email contact, and bi monthly conference calls with the PI and other group calls as needed. Monthly calls will be organized by NIMH and held for: the NIMH-JHU Activity Work Group; the NIMH- U Lausanne EMA Work Group; and the Mood Disorders Biomarker Work Groups. These calls will be held to facilitate communication of progress and analytic plans. LEVEL OF EFFORT: Assistant Professorship Senior Researcher level: 8 hours per week for 52 weeks (= 416 hours total). GOVERNMENT RESPONSIBILITIES There will be no Government Furnished Equipment as part of this Purchase Order. DELIVERY OR DELIVERABLES See Reporting Requirements below. REPORTING REQUIREMENTS Written Documentation: The Contractor's analyses and activities will be documented through written agreements with Dr. Merikangas, the Principal Investigator of these studies. The Contractor shall provide written documentation of broad analytic plans; exchange results of computer programs used in the analyses, and prepare summaries of the findings of the above analyses in quarterly reports. Authorships on papers will be agreed upon in advance and as in the past, the Contractor will be entitled to first authorship on papers on which they play the lead writing role, and co-authorship on publications in which they play a secondary role. Conference calls: Communication will occur through regular email contact, and bi monthly conference calls with the PI and other group calls as needed. Monthly calls will be organized by NIMH and held for: the NIMH-JHU Activity Work Group; the NIMH- U Lausanne EMA Work Group; and the Mood Disorders Biomarker Work Groups. These calls will be held to facilitate communication of progress and analytic plans. See attached SOW for further detail. Technical Evaluation Criteria FAR clause 52.212-2, Evaluation - Commercial Items applies to this acquisition and the specific evaluation criteria to be included in paragraph (a) of that provision are as follows: The Government will award a purchase order resulting from this solicitation on the basis of the factors below. These factors together shall be considered more important than price. Each factor will be evaluated on a scale of 1-5 - 5 (Excellent); 4 (Above Average); 3 (Average); 2 (Below Average); 1 (Very Poor). The evaluation factors are as follows: Factor 1: Subject Experience Review will be based upon: 1) demonstrated experience and ability to manage the project as outlined in the SOW; 2) appropriate expertise in evaluating the role of activity and emotional states in mood disorder subtypes; 3) ability to utilize mobile device data collection methods, electronic diary, and activity data. 4) Successful development of protocols and training modules for the March research project Factor 2: Level of training/expertise/certification of collaborating researcher. Review will be based upon: 1) Contractor's presentation of researcher's credentials: Ph.D., expertise with mood disorders (with emphasis in depression) and epidemiology. Factor 3: Delivery Review will be based upon: 1) The contractor shall describe their capability to adhere to the period of performance requirements listed under "Specific Requirements". Specifically, results and progress updates must be delivered regular e-mail contact, bimonthly conference calls. The period of performance will be for 12 months from the date of award. (vii) Period of Performance: One year from date of award. (xiii) The following additional contract requirement(s) or terms and conditions as determined by the contracting officer are necessary for this acquisition and consistent with customary commercial practices. FAR 52-213-4-Simplified Acquisitions (Other than Commercial Item) (xiv) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. 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." All responses must be received by 5:00PM EST on Sunday, February 4, 2018 and reference number HHS-NIH-NIDA-CSS-2018-77. Responses may be submitted electronically to Stephanie Dewitt, contact@example.gov. Fax responses will not be accepted. (xvi) The name and telephone number of the individual to contact for information regarding the solicitation Stephanie Dewitt, contact@example.gov. STATEMENT OF WORK (SERVICES) (SOW) GENERAL INFORMATION Title of Project: Family Study of Comorbidity of Mood Spectrum Disorders Statement of Need, Purpose, and/or Objective: The chief goal of the contract is to facilitate development of a project on activity and mood disorders at the NIMH IRP at the Genetic Epidemiology Research Unit (Dr. Kathleen Merikangas, P.I.). The first phase involves development of methods for joint analysis of electronic diary and activity data, and the association between mood disorders and activity and mood regulation. The second phase involves joint analyses of NIMH data with those from other sites including Sydney, Australia (Professor Ian Hickie), Norway. The third phase involves establishment of these measures at new sites including Chengdu, China through a joint award of the National Chinese Research Council with the NIH Intramural Research Program, the CoLaus Project in Lausanne, Switzerland (Dr. Martin Preisig, PI). Background Information: The major goal of the NIMH Family Study is to identify biologic markers for mood disorders. We have demonstrated that activity diagnostic thresholds, subtypes and boundaries with other disorders in order to identify the genetic and environmental risk factors for these conditions. The chief goal of the contract is to facilitate development of an international joint study of activity and mood disorders based on a project that was developed at the NIMH IRP at the Genetic Epidemiology Research Unit (Dr. Kathleen Merikangas, P.I.). The first phase of the study involves development of methods for joint analysis of electronic diary and activity data, and the association between mood disorders and activity and mood regulation. The second phase involves joint analyses of NIMH data with those from other sites including Sydney, Australia (Professor Ian Hickie), Norway (Ketil Odegaard, M.D.), and other sites now under discussion. The third phase involves establishment of these measures at new sites including Chengdu, China through a joint award of the National Chinese Research Council with the NIH Intramural Research Program, and the CoLaus Project in Lausanne, Switzerland (Dr. Martin Preisig, PI). Period of Performance: One year from date of award SCOPE OF WORK General Requirements: This contract specifies the agreement between the Genetic Epidemiology Research Branch and the contractor. The chief goal of the contract is to facilitate development and coordination of the March joint network that was set-up at the NIMH IRP at the Genetic Epidemiology Research Unit (Dr. Kathleen Merikangas, P.I.). This work involves contribution to the development of protocols, training modules, and March website + content, etc., and joint analyses of data. The contract primarily involves data analysis that will result in joint publications and coordination of international activities on activity and mood disorders and symptoms. Specific Requirements: Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below: The Contractor's major responsibilities will include the following broad areas: A.Statistical Analysis of NIMH Family Study Data and related data sets i.Conduct statistical analyses of NIMH family study data including: electronic diary data; actiwatch data; and clinical diagnostic data on subtypes of depression. ii.Coordinate joint analyses of the NIMH family study and the University of Lausanne family study data with Dr. Martin Preisig and Caroline Vandeleur. iii.Assist in error checking of biologic measures in NIMH Family Study in with the NIMH Data Manager and Statistical Analysts. B.Coordination of international joint efforts on activity and mood disorders and symptoms: i.Maintain overview of available data on activity with the NIMH GEB March initiative ii.Work with the analytic team from NIMH and Johns Hopkins Bloomberg School of Health to develop analytic plans and implement analyses, including development of training materials iii.Assist in coordination of core data collection and common analyses of activity data across sites iv.Assist in communication with new sites that may wish to join the workgroup. v.Assist in development of protocols for March vi.Assist in maintenance of the March website and other communication channels C.Procedures i.Written Documentation: The Contractor's analyses and activities will be documented through written agreements with Dr. Merikangas, the Principal Investigator of these studies. The Contractor shall provide written documentation of broad analytic plans; exchange results of computer programs used in the analyses, and prepare summaries of the findings of the above analyses in quarterly reports. Authorships on papers will be agreed upon in advance. ii.Conference calls: Communication will occur through regular email contact, and bi monthly conference calls with the PI and other group calls as needed. Monthly calls will be organized by NIMH and held for: the NIMH-JHU Activity Work Group; the NIMH- U Lausanne EMA Work Group; and the Mood Disorders Biomarker Work Groups. These calls will be held to facilitate communication of progress and analytic plans. LEVEL OF EFFORT: Assistant Professorship Senior Researcher level: 8 hours per week for 52 weeks (= 416 hours total). GOVERNMENT RESPONSIBILITIES There will be no Government Furnished Equipment as part of this Purchase Order. DELIVERY OR DELIVERABLES See Reporting Requirements below. REPORTING REQUIREMENTS Written Documentation: The Contractor's analyses and activities will be documented through written agreements with Dr. Merikangas, the Principal Investigator of these studies. The Contractor shall provide written documentation of broad analytic plans; exchange results of computer programs used in the analyses, and prepare summaries of the findings of the above analyses in quarterly reports. Authorships on papers will be agreed upon in advance and as in the past, the Contractor will be entitled to first authorship on papers on which they play the lead writing role, and co-authorship on publications in which they play a secondary role. Conference calls: Communication will occur through regular email contact, and bi monthly conference calls with the PI and other group calls as needed. Monthly calls will be organized by NIMH and held for: the NIMH-JHU Activity Work Group; the NIMH- U Lausanne EMA Work Group; and the Mood Disorders Biomarker Work Groups. These calls will be held to facilitate communication of progress and analytic plans. OTHER CONSIDERATIONS Travel: Travel and Professional Meetings: Travel across sites will also be used to facilitate implementation of contract goals. The travel of this requirement (e.g. type and number of trips) will be included and paid for. Key Personnel: The qualified candidate must have a Ph.D. in the behavioral, epidemiological, or public health fields, with at least 5 years of postgraduate experience. Extensive knowledge must be possessed in epidemiological methods, research protocol development, and data analysis in actigraphy, electronic diary data, and clinical diagnostic data as applied to affective psychological disorders. The candidate must possess experience in analyzing the role of activity patterns in underlying mood disorders, and possess a working knowledge of MARCH and subtypes of depression. Information System Security Plan: N/A Data Rights: The National Institute of Mental Health shall have unlimited rights to and ownership of all data including reports. 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 made a part of this contract/order. 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: Ownership of results will be retained by the federal government. The contractor may not reproduce the results, nor distribute to any other entity. The Contractor shall be entitled to first authorship on papers on which they play the lead writing role, and co-authorship on publications in which the play a secondary role. Confidentiality of Information: Participant data generated is considered confidential and will be freely exchanged with the contractor for the duration of the contract. The contractor is not to release, disclose, not disseminate data to any third party prior to publication of results.