SOURCES SOUGHT
B -- Cortisol and Salivary Melatonin Sample Testing Services - Small Business Sources Sought Notice
- Notice Date
- 8/23/2016
- Notice Type
- Sources Sought
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 3155, MSC 9593, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA(SSSA)SBSS-16-696
- Archive Date
- 9/12/2016
- Point of Contact
- Keshia McDonald, Phone: 3014515042, Nancy Lamon-Kritikos, Phone: 301.480.2447
- E-Mail Address
-
keshia.mcdonald@nih.gov, nancy.lamon-kritikos@nih.gov
(keshia.mcdonald@nih.gov, nancy.lamon-kritikos@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Small Business Sources Sought Notice Background Information: The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. For the Institute to continue fulfilling this vital public health mission, it must foster innovative thinking and ensure that a full array of novel scientific perspectives are used to further discovery in the evolving science of brain, behavior, and experience. In this way, breakthroughs in science can become breakthroughs for all people with mental illnesses. The National Institute of Mental Health (NIMH), Intramural Research Program, Genetic Epidemiology Research Branch requires laboratory testing services on salivary cortisol and salivary melatonin samples with the goal of identifying biomarkers of mood disorder diagnostic subtypes and components and their familial heritability. The Contractor will be preforming assays on cortisol and melatonin samples and provide NIMH with a final report of analyzed data. The NIMH Family Study of Affective Spectrum Disorders is the largest contemporary controlled family study of the mood disorder spectrum that is based on a non-clinical sample of probands with mood disorders. The study includes assessment of comprehensive domains that may constitute biological markers of mood disorders including objective measures of daily rhythms of mood, sleep, activity and stressors using mobile technologies, psychophysiology, cognitive function, neuroimaging, sensory thresholds, temperamental measures, and autonomic reactivity. Most relevant to this proposed work is the in vivo sampling of salivary cortisol in conjunction with electronic diaries and activity monitors 4 times per day over two weeks in a subsample. This permits evaluation of circadian patterns of cortisol as well as its association with emotional states, dietary intake, pain, physical activity, sleep, and stressful events. Project Description: The Genetic Epidemiology Research Branch conducts population, clinical, and basic research on the developmental, genetic, and biological components of mood and anxiety disorders and comorbid medical disorders. Specifically, the goals of the section are to identify and study familial aspects of mood and anxiety disorders and comorbid conditions, and discern more clearly their early manifestations. This project examines salivary cortisol and melatonin levels. NIMH has established a large community based family study that covers the full range of the spectrum of mood disorders and related phenotypes in a sample of more than 500 probands and 1000 directly interviewed relatives including children. Saliva will be used to quantify cortisol and melatonin levels. The purpose of this contract is to obtain duplicate assays of salivary cortisol (4x per day for up to two weeks) and melatonin (last sample of the day for up to two weeks) from salivary samples collected in 50 participants in the NIMH Family Study of Affective Spectrum Disorders. Deliverables: 1. Description of Tasks and Associated Deliverables: (a) Duplicate analysis on ELISA for salivary cortisol will be performed on up to 2800 salivary samples (obtained from a patient pool of 50 subjects, 4 samples per day, 14 days). (b) Duplicate analysis on ELISA for salivary melatonin will be performed on up to 700 salivary samples (obtained from a patient pool of 50 subjects, 1 sample per day, 14 days). (c) Data will be sent on spreadsheet with study variables in a mutually agreed upon format by the contractor and NIMH investigator. (d) Assays to be completed within 90 days for receipt of the samples. 2. Reporting Requirements: The contractor is required to send a printed hard copy, and an electronic summary report and spreadsheet with the results of the cortisol and the melatonin assays within 90 days of receipt of the samples. The spreadsheet will contain the ID, number of the sample, and the cortisol level, and melatonin level for evening samples. The data will be provided in a mutually agreeable format by the Contractor and NIMH. The report shall cover all work completed during the contract period. This report shall also identify any problems that arose and a statement explaining how the problem was resolved. This report shall also identify any problems that have arisen but have not been completely resolved and provide an explanation. Contractor Requirements: The contractor laboratory testing service is to be an expert in salivary cortisol and salivary melatonin detection and measurement methods. This project would entail performing duplicate analysis for saliva cortisol on 50 subjects. Each subject will give 4 samples per day for 14 days for a total of up to 2800 samples. At $XX/reportable result the cortisol component will cost up to $XX,XXX. Duplicate salivary melatonin analysis will be performed on the forth daily collected sample from each subject (the same sample used for cortisol analysis) for a total of up to 700 samples. At $XX/reportable sample the total cost for melatonin will be up to $XX,XXX. The cost for both melatonin and cortisol will be up to $XX,XXX. The cortisol assays on these samples will be completed within 90 business days of receipt of the samples. Melatonin assays will be completed within 90 business days of receipt of the samples. Thus, this project entails performing duplicate analysis on up to a total of 3500 saliva assays. The contractor must have the ability to complete the cortisol assays within 90 business days of receipt of the samples. The LoQ for cortisol is to be 1-8 ng/ml (3.5-27 nM), unless the contractor can provide adequate reason otherwise, to which the government must first agree. In addition, the contractor must have the ability to complete the melatonin assays within 90 business days of receipt of the samples. The LoQ for melatonin assays is to be 0-20.5 pg/ml, unless the contractor can provide adequate reason otherwise, to which the government must first agree. NIMH also wishes to incorporate an option for an additional 3000 analyses of samples if needed in FY2017. Government Responsibilities: The Government will provide up to 2,800 salivary samples. During the 12 month period of performance, the Government may provide up to 3,000 additional salivary samples for testing purposes. Saliva will be used to quantify cortisol and melatonin. Saliva was obtained 4 times a day for 14 days for youth under age 30. Electronic diaries were used to determine the timing of sample collection. Measures of emotional states, pain, stressful life events, dietary intake and sleep were collected concomitant to the saliva samples at each measure. Intra familial correlations of daily cortisol patterns and nighttime melatonin levels will be evaluated. This study is unique in that it includes electronic diaries. These diaries permit the comparison of cortisol levels with mood, current context (location and current activity), last meal, and sleep data in addition to many other features. All samples will be provided frozen in storage boxes (up to 81 vials per box) in a single shipment to the contractor. Each individual sample is stored in a 1.25 ml vial, and labeled with an ID number, date of storage, and a tube number associated with time of collection (no barcode). Anticipated period of performance: The period of performance for this potential acquisition is one year (12 months) from date of award with a possible additional option year. A firm fixed-price is contemplated for this award based on unit cost of assay up to the total number of assays performed (up to 2,800 cortisol assays and up to 700 melatonin assays) for up to $XXX,XXX ($XX,XXX for FY2016, with an option for additional analyses of $XXX,XXX for FY 2017). Capability Statement / Information Sought: Contractors that believe they possess the ability to provide the required services should submit documentation of their ability to meet the project requirements to the Contract Specialist. Contractors should also provide their Company Name, DUNS number, Physical Address, and Point of Contact Information and if applicable, Federal Supply Schedule (FSS) contract number. Interested organizations are required to identify their type of business, applicable North American Industry Classification System Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted. All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Keshia McDonald, Contract Specialist, at keshia.mcdonald@nih.gov in MS Word format within 7 calendar days of the date of this announcement. All responses must be received by the specified due date and time in order to be considered. The response must be received on or before August 28, 2016 by 10:30 AM (EDT)
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