SPECIAL NOTICE
A -- Notice of Intent to Award Sole Source Modification to The Feinstein Institute for Medical Research for Recovery After an Initial Schizophrenia Episode (RAISE) Assessment Extension
- Notice Date
- 2/10/2014
- Notice Type
- Special Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Mental Health, Contracts Management Branch, 6001 Executive Blvd, Rm 8154, MSC 9661, Bethesda, Maryland, 20892-9661
- ZIP Code
- 20892-9661
- Solicitation Number
- HHS-NIH-271-2009-000-19-C
- Archive Date
- 3/12/2014
- Point of Contact
- Marla Jacobson, Phone: 301-443-2696, Bruce E. Anderson, Phone: 301-443-2234
- E-Mail Address
-
jacobsonmj@mail.nih.gov, banderso@mail.nih.gov
(jacobsonmj@mail.nih.gov, banderso@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a notice of intent, not a request for proposals. A solicitation document will not be issued and proposals will not be requested. The National Institute on Drug Abuse (NIDA), Office of Acquisitions - Neurosciences, National Institute of Mental Health (NIMH)/National Institute on Aging (NIA) Research and Development Contracts Management Branch (R&D CMB), on behalf of the NIMH, intends to negotiate a modification to an existing contract on a sole source basis pursuant to 41 U.S.C. 253[c](1) as implemented by FAR 6.302-1, (Only one responsible source and no other services will satisfy agency requirement) with: Feinstein Institute for Medical Research 350 Community Drive Manhasset, NY 11030 BACKGROUND Approximately 100,000 adolescents and young adults in the United States experience a first episode of psychosis (FEP) every year. The early phase of psychotic illness is widely viewed as a promising opportunity for indicated prevention, and a chance to alter the downward trajectory and poor outcomes associated with serious mental disorders such as schizophrenia. Compared to traditional treatment approaches, programs that integrate pharmacologic, psychological, and rehabilitation interventions for FEP are associated with a range of positive outcomes, including remission of psychotic symptoms, lower-rates of re-hospitalization, shorter hospital stays, improved quality of life and social functioning, increased cognitive performance, and reductions in substance use. Studies also suggest that the timing of treatment is critical; short and long-term outcomes are better when individuals begin treatment close to the onset of psychosis. "Recovery After an Initial Schizophrenia Episode," awarded on a competitive basis on 07/13/2009 to The Feinstein Institute for Medical Research (FIMR) under Contract HHSN271200900019C, is a cost-reimbursement research and development type contract and expires on September 20, 2014. Under this contract, FIMR developed and is testing a multi-component, coordinated FEP specialty care treatment program, termed "NAVIGATE." FIMR has enrolled 404 patients experiencing FEP into the Randomized Controlled Trial (RCT). Seventeen intervention sites deliver NAVIGATE and 17 sites deliver enhanced standard community care. Patients enrolled in each condition are offered mental health care through the study for a minimum of two years. All participants have in-person research assessments conducted at baseline and at 3, 6, 12, 18, and 24 months; participants who enrolled early continue to receive assessments at 30 and 36 months. However, a knowledge gap exists with respect to the impact of the intervention over an extended period of time after the intervention has been delivered. The purpose of this modification is to lengthen the assessment period by 36 months, from 2-3 years to 5 or 6 years (depending on participants' enrollment date), for participants already enrolled in the RAISE study, both in the NAVIGATE (intervention) and enhanced community care conditions, thus filling a knowledge gap regarding the extended impact of multi-component coordinated FEP specialty care. FIMR is uniquely qualified to perform this work and the existing RAISE sample is uniquely poised to provide the most useful information in the timeliest and most cost efficient manner. Under the existing contract, the 34 RAISE clinical sites associated with FIMR have established ongoing clinical relationships with the enrolled RAISE participants. These patients have already participated in the research assessments for 2-3 years with good study retention, and are available to continue to participate in the same series of assessments. Existing IRB-approved protocols at all 34 RAISE study sites contain provisions to allow for rapid initiation of the proposed work, which involves continuing to conduct the same assessments already administered to the same RAISE participants but over an additional 36 months. The high retention rate among RAISE participants in the ongoing research assessments demonstrates that FIMR, with its existing research infrastructure and personnel, has successfully conducted the schedule of patient assessments and would be able to continue to conduct the same assessments for another 36 months. Furthermore, because the current contract has not yet ended, existing research staff can be retained to continue conducting the assessments during the contract extension without the need to hire and train new staff or perform start-up activities, such as developing research protocols and obtaining IRB approval across 34 sites. FIMR's conduct of the proposed work would leverage the Federal Government's resources already invested in establishing the RAISE research infrastructure and study. Under the requirements of 41 U.S.C. 253[c](1) and FAR 6.302-1, FIMR is the only source capable of meeting the requirements of this project and no other services will satisfy agency requirement(s). PURPOSE AND OBJECTIVES The purpose OF THIS PROPOSED ACTION is to extend the period of performance for the current contract for an additional 39 months (to 12/20/2017) to allow for time to: 1. Conduct research assessments for an additional 36 months (from 5/1/2014 to 5/1/2017) with participants currently enrolled in RAISE, both in the NAVIGATE (intervention) and enhanced community care conditions, in order to assess the extended impact of the NAVIGATE intervention on patient-level outcomes; 2. Clean the assessment data collected during this 36-month period and prepare a cumulative data set that includes all assessments conducted under this contract extension as well as all assessments conducted previously under the existing RAISE contract; 3. Analyze the extended outcome data collected during the extended assessment period; and 4. Prepare a Final Report and submit for publication a report on the extended impact of the NAVIGATE intervention. Note that the proposed contract modification is anticipated to commence on 5/1/2014, while the current contract is still in effect, and conclude on 12/20/2017, a period of 43 months and 19 days. REQUIREMENTS This work will be performed in the context of the Randomized Controlled Trial (RCT) conducted under the RAISE contract no. HHSN271200900019C. The RCT involves 34 clinical sites nationwide and 404 enrolled patients with FEP. Research assessments will be conducted for a period of 36 months, with patients enrolled in the RCT, at the minimum frequency sufficient to characterize the longitudinal profile of illness course and recovery over the 5-6 years from time of study enrollment. REPORTS/DELIVERABLES All reports shall be submitted in electronic form as PC-formatted computer files in Microsoft Word and Microsoft Excel and/or searchable PDF format. The following reports will be required: 1. Cumulative Final Data Set and Documentation, submitted electronically as a CD. 2. Final Report on Extended Impact of the NAVIGATE Intervention, submitted electronically and one hardcopy. 3. Report for Publication, submitted electronically and one hardcopy. The Contractor will submit for publication a report on the extended impact of the NAVIGATE intervention. 4. Semi-Annual Technical Progress Reports, one (1) electronic copy, to include but not limited to the following sections: a. Summary of accomplishments during the reporting period b. Major activities conducted during the reporting period c. Problems encountered during the reporting period and plans for resolution d. Activities to be performed during the next reporting period 5. Final Progress Report, one electronic copy and one hardcopy. The Final Progress Report shall cover the period of performance from date of modification award through completion. This report shall be in sufficient detail to comprehensively describe the Tasks accomplished and the results achieved. The report shall have an abstract of no more 250 words that summarizes the work performed and research findings produced. The report shall have two sections. Section 1 shall describe the tasks accomplished and it should include but not be limited to tables summarizing the number and percentage of participants completing each assessment instrument at each assessment period as well as the number of participants retained in the study each year. Section 2 of this report shall describe the results of the analyses conducted in detail, using text, tabular and graphical formats. 6. NIMH Data and Safety Monitoring Board Reports, submitted three times per year, or as determined by the COR. Note: This requirement may be omitted prior to solicitation and/or award of the resultant contract modification. 7. Other Reports and Deliverables: a. Report of Government Owned, Contractor Held Property (annually and final); b. Small Business Subcontracting Reports (twice per year); c. Roster of Employees Requiring Suitability Investigations (updated annually and within 14 days of new contractor/subcontractor employees start date; d. Information Security Training Report - updates with each technical progress report and within 14 days of new contractor/subcontractor employees start date; e. Contractor-Employee Non-Disclosure Agreement - as applicable before contractor/subcontractor employee begins work; f. NIST SP 800-53 Self-Assessment - Annually; g. Updated ISSP due within 30 days of modification award; h. Section 508 Annual Report; i. Annual and Final Invention Disclosure Reports; j. Required Education - Protection of Human Research Participants (as applicable). k. Annual Technical Progress Report for Clinical Research Study Populations (use Inclusion Enrollment Report as format) l. New and Departing Employees Report ANTICIPATED PERIOD OF PERFORMANCE The anticipated period of performance for this contract modification is 5/1/2014 - 12/20/2017 (43 months and 19 days). Note that this period of performance overlaps with the current RAISE contract, which ends 9/20/2014. GENERAL INFORMATION This is a Presolicitation Notice in advance of intended solicitation for modification to existing contract to The Feinstein Institute for Medical Research. This notice of intent is NOT a request for competitive proposals. There is no solicitation package available. However, the Government shall consider all responses received within fifteen (15) days of this posting. Interested parties may identify their interest and capability to respond to the requirement, in writing no later than the response date. Written responses to this notice shall contain sufficient documentation to establish a bona fide capability to fulfill the requirement. Written responses shall reference this Notice of Intent No. HHS-N-271-2009-00019-C and may be submitted electronically NO LATER THAN 3:30P.M. EASTERN STANDARD TIME February 25, 2014 to the Contracting Officer, Bruce E. Anderson at banderso@mail.nih.gov and Contract Specialist, Marla Jacobson at jacobsonmj@mail.nih.gov. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Written responses to this synopsis shall contain sufficient documentation to establish a bonafide capability to fulfill this requirement. The Government will not be responsible for any costs incurred by interested parties in responding to this notice.
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