Inactive

This notice of intent is not a request for competitive proposals. A solicitation document will not be issued, and proposals will not be requested. However, responsible sources may express their intere... This notice of intent is not a request for competitive proposals. A solicitation document will not be issued, and proposals will not be requested. However, responsible sources may express their interest by submitting a capability statement or proposal. All capability statements or proposals received within this notice's response date will be considered by the Government. A determination by the Government not to complete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. The solicitation number is NIMH-NOI-20-004040 and the solicitation is issued as a PRE-SOLICITATION, NOTICE OF INTENT, to award a contract on a non-competitive basis to Johns Hopkins University on or about August 20, 2020. The Government is expected to use procedures in FAR Part 6.302-1 and (2) The North American Industry Classification System (NAICS) Code 541714 with a size standard of 1,000 employees. ACQUISITION AUTHORITY: This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13--Simplified Acquisition Procedures and Subpart 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13--Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6--Competition Requirements. The non-competitive determination is based upon the market research conducted as prescribed in FAR Part 10--Market Research, specifically the results of market research concluded no other source of supply or service has the capability to provide the required services. BACKGROUND: The National Institute of Mental Health (NIMH), Behavioral Endocrinology Branch is committed to understanding how changes in reproductive hormones trigger mood disorders, why these hormones trigger mood disturbances only in some women, and how the pathogenic mechanisms underlying these disorders translate into novel therapies or novel uses of existing therapies. Our scientists are working to identify the causes of, treatments for, and predictors of risk for reproductive endocrine-related mood disorders including postpartum depression, premenstrual dysphoric disorder (PMDD, a severe premenstrual syndrome) and perimenopausal depression. PURPOSE AND OBJECTIVES: The purpose of this requirement is to perform assays (laboratory tests) on clinical samples or specimens to determine levels of a hormone or chemical in these samples. These samples have been collected from study subjects in NIMH Section on Behavioral Endocrinology protocols. PROJECT REQUIREMENTS: Hopkins Core Laboratory is a core laboratory that will be responsible for performing assays (laboratory tests) on clinical samples or specimens to determine levels of a hormone or chemical in these samples. These samples have been collected from study subjects in NIMH Section on Behavioral Endocrinology protocols. The assays relevant to this Statement of Work involve the measurement of plasma levels of IFN-gamma, IL-6, IL-10, TFN-alpha, CXCL9(Fractalkine), CXCL10(PI10), CXCL11 (TAC) by Chemiluminescent ELIZA, and CRP, FSH, LH, DHEA, DHEAS, TSH, Pregnenolone by ELIZA. Specifically, the Hopkins Core Laboratory will: - maintain a continuous quality control program to ensure accuracy in their hormone assays; - set-up to run assays for pediatric patients as well as adult patients and therefore can perform assays on very small quantities of plasma, which in our case is critical when there is limited plasma available for testing from some subjects; - careful hand-batching of our study samples to maintain the assignment of subjects and controls in the same assay run – other commercial labs have repeatedly failed to attend to these batching needs, resulting in unusable data and ultimately in increased assay costs; The batching reduces two important sources of confound in this type of study related mainly to inter-assay variability. Inter-assay variability arises when samples are assayed under different conditions within the same laboratory and can introduce a systematic bias into a study. In this study, we need all samples in each woman run together in the same assay so that we can observe possible changes related to reproductive aging – for example, if an individual woman’s samples were divided split into two samples and the second assay was performed under different conditions and all samples were relatively lower values that those run in the first assay – then this would spuriously lower values in the second assay and we would incorrectly assume a change in levels that was related to say aging. Similarly, since we are testing whether women who developed depression have differing levels from those who remained asymptomatic, then clearly samples from a woman with depression should be run proximate to those from an asymptomatic woman to avoid introducing systematic bias related to differing assay parameters in women with depression compared with controls. - ensure the limits of detection for hormone levels are more sensitive than those from other commercial labs, a quality critical in the field of reproductive aging research; and ensure compatibility with a previous set of samples from this and a companion study which have been measured at this facility and to maintain comparability within this study in the measures obtained. Thus, it is critical that our present samples run within the same facility. GOVERNMENT RESPONSIBILITIES The government will ship the assays to the Contractor to determine the levels of a particular hormone or chemical in the samples. DELIVERY OR DELIVERABLES Timely submission of deliverables is essential to successful completing this requirement. Schedules for deliverables are specified in the attached Contract Data Requirement Lists (CDRLs). All deliverables shall be prepared and submitted according to format, content, and schedule described in the CDRL and SOW. All “hard copy” deliverables will be submitted on recycled-content paper and printed double-sided. REPORTING REQUIREMENTS The Contractor is required to return the first 300 completed assays back by October 1, 2020 and the remainder completed by December 31, 2020. The Contractor shall also identify any problems that have arisen and report to COR within 48 hours. ANTICIPATED PERIOD OF PERFORMANCE The period of performance will be five months from the award of the contract. DISCLAIMER AND IMPORTANT NOTES: 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. 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). CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted. Specifically, Johns Hopkins University is the only vendor in the marketplace that can provide the services required by NIH. In accordance with FAR part 10, extensive market research was conducted to reach this determination. The material or service must be compatible in all aspects (form, fit, and function) with existing systems presently installed. Since this request is covering several assays at different intervals of the experiment it is imperative that consistency is maintained. The Behavioral Endocrinology Branch has previously worked with the Hopkins Core Laboratory for such studies. These studies will use an ongoing base for several experiments planned for the future. The Behavioral Endocrinology Branch must use Hopkins Core Laboratory services to consistency and the integrity of the data as with the prior service Hopkins has provided in the past with this project and related projects. The intended source is: Johns Hopkins University 3400 N Charles St Baltimore, MD, 21218-2608 CLOSING STATEMENT THIS SYNOPSIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. The response must also identify where the product(s) and parts are manufactured. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. All responses must be received by the closing date and time of this announcement and must reference the solicitation number, NIMH-NOI-20-004040. Responses must be submitted electronically to kim.stapleton@nih.gov. U.S. Mail and Fax responses will not be accepted.