SOURCES SOUGHT
A -- A TARGETED APPROACH TO A SAFER USE OF ANTIPSYCHOTICS IN YOUTH
- Notice Date
- 10/30/2014
- Notice Type
- Sources Sought
- NAICS
- 541720
— Research and Development in the Social Sciences and Humanities
- 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-SBSS-14-005
- Archive Date
- 12/5/2014
- Point of Contact
- Danny Cohn, Phone: 301-402-7111
- E-Mail Address
-
danny.cohn@nih.gov
(danny.cohn@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) the classification/ type of small business (e.g., whether they are small businesses, 8(a) small businesses, HubZone small businesses, service-disabled veteran-owned small businesses, veteran-owned small business, economically disadvantaged women-owned small business (EDWOSB) or women-owned small business (WOSB)) and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Teaming and partnering arrangements among small businesses is encouraged. Background. The National Institute of Mental Health (NIMH) and the National Institutes of Health (NIH) seek to launch a research initiative to address the rising use of antipsychotic medications by youth who do not suffer from a psychotic disorder. Most of the antipsychotic use in communities is for the management of non-psychotic conditions. Antipsychotic use increases the risk of metabolic syndrome and consequently, higher rates of obesity and diabetes. Additionally, the long-term implications of antipsychotic use in youth are unknown. For these reasons, efforts should be made to develop successful alternative treatment approaches that allow a more targeted and appropriate use of antipsychotics with the goal to minimize their usage by youths who do not suffer from a psychotic disorder. Purpose and Objectives. NIMH is seeking information on all small businesses capable of providing potential contract services for a project entitled: "A Targeted Approach to a Safer Use of Antipsychotics in Youth". The objective of this study is to successfully identify alternative treatments to the use of antipsychotics in youth (ages 5-17) that are not psychotic, which can manage the emotional and behavior disturbances of these children and adolescents. Project requirements. Interested small businesses must have the requisite capabilities and experience to successfully conduct this three-phase project, over an estimated 5-year period, which requires: 1) the development and preparation of the treatment algorithm (Phase 1); 2) the feasibility testing including a 12-month pilot study utilizing approximately 40 youth subjects (Phase 2); and 3) the implementation of the effectiveness testing through a clinical study of several hundred youth (Phase 3). Phases 2 and 3 must be conducted in at least 2 non-academic practice settings. To successfully conduct this Project, capable small businesses should demonstrate the following: 1. Experience in managing and conducting comparable multi-site clinical trials (provide details) 2. Access to an appropriate study population of youth and adolescents, through mental health service provider(s) in non-academic settings, who are willing to collaborate in this particular study (i.e., service delivery system partner(s) where the feasibility study and the practical trail can be conducted). Capability statements should provide names of potential partners and relationship if possible. To adequately demonstrate the capability to perform this study the NIMH believes that it is necessary to have a current or recent working relationship with mental health service provider(s) in non-academic settings, involved in the treatment of children and adolescents with mood and behavioral disturbances, who can provide clinical resources and partner/collaborate in performing the study. Capability statements must reasonably demonstrate the ability to enlist these partners to conduct Phases 2 and 3 of this study. 3. Access to local Institutional Review Boards (IRBs) 4. Available personnel and a research team with the appropriate education and experience in the following: a. The treatment of children and adolescents with mood and behavioral disturbances and in the conduct of clinical trials in this patient population. b. Clinical trial project management skills and experience c. Knowledge of and ability to access existing publicly available data regarding treatment of child and adolescent mental disorders to be utilized in the development of a proposed treatment algorithm for the defined target population (ages 5-17) d. Working knowledge of all regulatory requirements regarding research with human subjects e. Information technology expertise in research database design and documentation; knowledge of computer software for statistical analysis addressing key aims of the study (e.g., acceptability, adherence, and reliability of assessment measures); data management capabilities in a multi-site setting; IT security of Personally Identifiable Information (PII). Other important considerations. 1. This requirement is based on a phased approach with unilateral Government options to proceed to each successive phase. Continuation and progression in the Project will depend on satisfactory completion of each phase (and submission of required deliverables), and feasibility to proceed into the next phase. 2. The Government estimates that Phase 1 will take approximately 6 months to complete; Phase 2 approximately 12 months to complete; and Phase 3 approximately 3.5 years to complete (total 5 years). 3. No Government property will be provided. 4. The Contractor will be responsible for compliance with Information Technology (IT) Security regulations (i.e., Federal Information Security Management Act of 2002 (FISMA)) to ensure security of all data generated over the life of the contract 5. One (1) contract award is anticipated. 6. Reporting Requirements Regular technical progress reports will be required (depending upon the phase, these will be submitted monthly, quarterly, semi-annually, or annually); and Final reports by each phase and for the entire contract will be required. Anticipated period of performance. August 2015 - September 2020 (including all options) Capability statement /information sought. Capability statements should clearly state/describe your ability, experience, and resources to design and carry out the services described above under Project Requirements. Also include the following: 1) Prior completed projects of similar nature (description, dollar amount, with period of performance) 2) Your business size (number of employees and gross annual revenue), your eligibility under 8(a) or other set-aside programs, as applicable (note: the applicable NAICS code for this requirement is 541720, 500 employees); and 3) Your management structure, history of your organization (e.g., number of years in business and DUNS #) Disclaimer and Important Notes. Please note that in order to qualify as an eligible small business for purposes of a small business set-aside, at least 50% of the direct labor cost must be in-house. Specifically, FAR 52.219-14 - Limitations on Subcontracting, states that at least 50 percent of the cost of contract performance incurred for personnel shall be expended for employees of the concern. 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. Responses will be held in a confidential manner. 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. If the Government decides to issue a solicitation, a Request for Proposal (RFP) will be available solely via the FEDBIZOPPS web page at http://www.fedbizopps.gov/. It will be the offeror's responsibility to monitor the FEDBIZOPPS web page for the release of any solicitation and amendments, and to download the RFP and all attachments. Responses to this notice should be received no later than the posted due date, and can be sent either by mail, fax, or e-mail to the point of contact listed to Mr. Danny Cohn at: danny.cohn@nih.gov. If using the U.S. Postal Service or commercial overnight services, please send an original plus five (5) copies of your response. Note: for commercial overnight services, use the Rockville, MD. 20852 address. 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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- Record
- SN03562267-W 20141101/141031000353-412c6a81737665631b40f947c59e70d2 (fbodaily.com)
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