Sensing: Mapping gene expression networks that distinguish opioid use disorder from chronic pain

Notice of Intent to Sole Source HHS-NIH-OD-OLAO-SS-19-006 National Institute of Nursing Research (NINR) Resource Center Title: Sensing: Mapping gene expression networks that distinguish opioid use disorder from chronic pain. Contracting Office Address: Department of Health and Human Services (DHHS), National Institutes of Health (NIH), Office of Logistics and Acquisition Operations (OLAO), Office of Acquisitions (OA), Research and Development (R&D) Section, 6011 Executive Blvd., Rockville, MD 20852. Introduction: This a Notice of Intent to Sole Source in support of Research and Development (R & D). 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 business sources; (2) whether they are small businesses, HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your response to this information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. The NAICS code is 541712. 1. BACKGROUND The National Institute of Nursing Research (NINR) is one of the 27 Institutes that comprise the National Institutes of Health (NIH). The mission of the National Institute of Nursing Research (NINR) is to promote and improve the health of individuals, families, communities, and populations. NINR supports and conducts clinical and basic research and research training on health and illness across the lifespan to build the scientific foundation for clinical practice, prevent disease and disability, manage and eliminate symptoms caused by illness, and improve palliative and end-of-life care. NINR's research programs, both extramural and intramural, incorporate a broad range of interdisciplinary approaches designed to promote scientific exploration that will lead to better health outcomes and health services. Such approaches include clinical intervention studies, translational and implementation research. Mapping gene expression to distinguish opioid use disorder from chronic pain uses existing mechanistic insight into the potential factors that contribute to susceptibility to develop opioid use disorder and/or chronic pain. Many of these factors are sociodemographic in nature or are subjective and fail to replicate across studies. Thus, there is an urgent unmet need to identify the mechanisms that confer susceptibility to, or resilience against, the development of each in isolation and, the chronic pain patient with concomitant opioid use disorder. The main goal of this collaboration between NIH investigators and Dr. Dorsey's laboratory and the University of Maryland is to gain mechanistic insight into the genes/biological pathways that are activated or repressed in response to chronic opioid use, chronic pain, and the combination of opioid use and chronic pain. Results could be used to develop biomarkers of opioid use disorder, chronic pain, or the combination. In addition, new therapeutic targets may be identified. ? OBJECTIVE The technical objectives are to develop several mouse models, including chronic pain following nerve injury, opioid use disorder, and mice with both chronic pain and opioid use disorder. Following the development of the model, we will conduct rigorously defined behavioral assays to ensure the adequacy of the models with respect to the two phenotypes. Once we define that the behavioral phenotypes are appropriate, we will examine gene expression profiles in neural and non-neural tissues that could indicate shared and distinct gene expression networks. In addition to normal mice, we will perform the same tests on mice that lack a truncated isoform of the brain-derived neurotrophic factor (BDNF) receptor, trkB.T1. The mice experience less pain relative to mice with normal levels of trkB.T1, and there are perturbations in the morphine tolerance pathway. 2. TASKS A. General Requirements The contractor shall: 1. Independently perform and provide some of the necessary materials for the work proposed. This lab has unique resources, unavailable at NINR, to generate the mouse models, perform the behavioral phenotyping, and examine the gene expression profiles from tissues and perform RNA sequence analysis. 2. The relevant institution and governmental offices will monitor this research as appropriate. Of note, Institutional Animal Care and Use (IACUC) approval has been granted for this project. B. Specific Requirements. The contractor shall: 1. Procure or breed the mice necessary for this study. 2. Data will be collected in the animal protocol. using previously established procedures. 3. Perform RNAseq assays. 4. Perform a statistical analysis of data collected using the custom-built R scripts that will be available to all interested parties via the internet site Github. 5. All samples will be from mouse models; all appropriate institutional approvals will be in place before the work proceeds, and all necessary precautions taken for analysis of this type of sample in the laboratory environment. The contractor will use the general workflow as outlined in this application to collect pilot data that supports this project. 3. Period of Performance The period of performance is a 12-month base period and one (1) 12-month option periods. September 1, 2019 - August 31, 2020 September 1, 2020-Auguest 31, 2021 4. DELIVERABLES - Development of mouse models of chronic pain and opioid use disorder - Behavioral phenotyping of the mouse models and data analysis and interpretation of the results - Extraction of RNA from neural and non-neural tissues that are relevant for pain and opioid use disorder (e.g., brain, spinal cord, dorsal root ganglion, blood, hindpaw) and assays to ensure quality control for the RNA including reports of the RNA integrity number (RIN) for each sample - RNA sequencing of each sample - RNA sequencing analysis of each sample, including provision of FASTQ files, alignment to the reference genome and production of BAM files, downstream computation of differential gene and isoform expression, canonical and non-canonical signaling pathway enrichment, gene co-expression network analysis. INITIAL BUSINESS AND TECHNICAL (KICK-OFF) MEETING Within ten (10) business days following the award date, contractor shall attend a kick-off meeting to review goals and objectives, and to discuss technical requirements, administrative matters, security requirements, and invoicing. The meeting shall be attended by all contractor key personnel and can be held via conference call. MONTHLY PROGRESS REPORT The following will be provided in the monthly progress report and covers: - Hours expended during the reporting period by individual - Cumulative hours expended throughout the reporting period by job category - Contract funds expended during the reporting period 15. PROPOSED CONTRACT VEHICLE This is a Firm Fixed Price contract. Anticipated Period of Performance: The Government intends to issue one (1) award with a 12-month base period and one (1) 12-month option periods. Capability Statement: Business concerns that believe they possess the capabilities necessary to undertake these tasks should submit complete documentation of their capabilities to the Contracting Officer. The capabilities statement should include 1) the total number of employees, 2) the professional qualifications of scientists, medical experts, and technical personnel as it relates to the above outlined requirements, 3) a description of general and specific facilities and equipment available, including computer equipment and software, 4) an outline of previous projects in which the organization and proposed personnel have participated, and 5) any other information considered relevant to this program. The capability statement must not exceed 10 single sided or 5 double sided pages in length and using a 12-point font size minimum. Business organizations are required to identify their size standards in accordance. 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 numbers 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 not be considered. When submitting this information, please reference the solicitation notice number. Information Submission Instructions: All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Shirlene Smith, Contract Specialist, at ssmith@od.nih.gov, in either MS Word or Adobe Portable Document Format (PDF), on or before 12:00 p.m. Eastern on July 23, 2019. All responses must be received by the specified due date and time in order to be considered. Disclaimer and Important Notices: 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 review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The solicitation release date is pending. 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). Primary Point of Contact: Shirlene Smith, Contracting Officer ssmith@od.nih.gov Phone: (301) 443-7979