SPECIAL NOTICE
A -- Recovery After an Initial Schizophrenia Episode (RAISE) Assessment Extension
- Notice Date
- 6/17/2013
- 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-N-271-2009-00019-C
- Archive Date
- 7/17/2013
- Point of Contact
- Marla Jacobson, Phone: 301-443-3775, 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
- DESCRIPTION This is a Research and Development (R&D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential R&D requirement. Small Businesses are encouraged to respond. 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 with the Feinstein Institute for Medical Research, 350 Community Drive, Manhasset, NY 11030, Contract HHSN271200900019C, entitled "Recovery After Initial Schizophrenia Episode" (RAISE) 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 requirements). 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 participant's 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 42 months and 19 days. REQUIREMENTS This work will be performed in the context of the Randomized Control 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 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: o Summary of accomplishments during the reporting period o Major activities conducted during the reporting period o Problems encountered during the reporting period and plans for resolution o 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 (42 months and 19 days). Note that this period of performance overlaps with the current RAISE contract, which ends 9/20/2014. CAPABILITY STATEMENT/INFORMATION SOUGHT a. Capability Statement - Respondents to this notice must provide, as part of their responses, a capability statement. At a minimum prospective Offerors must document capabilities in the following areas: (a) staff expertise, including their availability, experience, and formal and other training; (b) access to the participants enrolled in the RAISE RCT in order to conduct research assessments; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. Please provide your DUNS number, organization name, address, technical and administrative points of contact (including names, titles, addresses, telephone and fax numbers, and e-mail addresses), and size and type of business (e.g., 8(a), HUBZone, etc) pursuant to the applicable NAICS code. Please identify your size classification relative to North American Industry Classification System (NAICS) code of 541712. Include a statement regarding your small business status; HUBZone small business; service-disabled, veteran-owned small businesses; 8(a) small business; women-owned small business; or small disadvantaged business in order to assist the government in determining the appropriate acquisition method, including whether a set-aside is possible. b. Information Submission Instructions - Respondents should provide responses accordingly: (1) submit information both electronically and by mail. No telephone and facsimile responses will be accepted; (2) format capability statements using Microsoft Word or Adobe PDF including attachments, resumes, charts, etc. Use single space, 12 font minimum and 8 ½ x 11 size paper; (3) organize material in such a manner that clearly identifies and address capability requirements and provide an executive summary; (4) capability statement should not exceed ten (10) single sided pages including references; (5) respondents must send two (2) original copies via mail and one electronic copy via email; (6) RESPONSES SHOULD BE RECEIVED NO LATER THAN July 2, 2013 at 2:00 PM LOCAL TIME (Eastern); and (7) send responses to this notice via email to jacobsonmj@mail.nih.gov. The original statements mailed using the U.S. Postal Service should be sent to ATTN: Marla Jacobson, National Institutes of Health, Office of Acquisitions - NIDA Neuroscience COAC, NIMH/NIA R&D Contracts Management Branch, 6001 Executive Boulevard, Room 8154, MSC 9661, Bethesda, MD 20892-9661. If using a courier service such as the UPS, Federal Express, etc., change the City, State and Zip Code to Rockville, MD 20852. (Please be aware that the U.S. Postal Service's "Express Mail" DOES NOT deliver to the Rockville, Maryland address.) DISCLAIMER AND IMPORTANT NOTES 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. 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 Sources Sought announcement shall contain sufficient documentation to establish capability to fulfill this requirement. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. CONFIDENTIALITY No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
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