Inactive

This is a 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 ca... This is a 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) 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; small disadvantaged businesses; or other-than-small businesses 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 under the applicable NAICS code should not submit a response to this notice. PROJECT REQUIREMENTS: The National Institute on Drug Abuse (NIDA) seeks capability statements from qualified small businesses and other-than-small businesses having in-house capability to perform the following tasks: 1. Maintenance of software, database and infrastructure, such as: Supporting and maintaining IT software and infrastructure. A brief description of systems supported and a summary of maintenance (i.e. ability to apply software upgrades and patches, security upgrades, etc.) will be acceptable. Experience with National Institutes of Health (NIH)-required security measures and familiarity with National Institute of Standards and Technology (NIST) Special Publication 800-53, Revision 4 security controls and continuous monitoring requirements is preferable. Maintaining and supporting a document management system (OpenText’s Content Server) that supports at least 550 individual password protected users and that is available 24 hours a day, 7 days a week with equal to, or less than, 5% downtime. Interested organizations should provide evidence of their experience and expertise with OpenText Livelink as this system is an integral part of NIDA’s existing IT structure. Maintaining a data management system with data repository, data warehouse and data share capabilities. A description of system(s) developed and what types of data were housed and how access was made available to the public will be acceptable. Creating and maintaining documents required for compliance with all Federal, Department of Health and Human Services (DHHS), and NIH Automated Information System security requirements as prescribed by Office of Management and Budget (OMB) Circular A-130, Appendix III, "Security of Federal Automated Information Systems," and the DHHS Automated Information Systems Security Program (AISSP) Handbook. A listing of the types of Federal Information Security Management Act (FISMA) compliant documents developed, a description of experience with the Security Assessment and Authorization (SA&A) process and demonstrated familiarity with the continuous monitoring process and NIST standards will be acceptable. De-identifying clinical trial datasets following Health Insurance Portability and Accountability Act (HIPAA) guidelines and making them available to the public for download and data analysis. Interested organizations should provide evidence of their experience and expertise with de-identifying clinical trial datasets. Maintaining a controlled, secure environment in which eligible researchers can access, request, and obtain clinical trial data in Statistical Analysis System (SAS) and/or other formats. A brief description of system(s) developed including what security measures were implemented (i.e. multifactor authentication, strong encryption of the data at rest and in transit, etc.) and how they were made available to the public will be acceptable. 2. Systems development, such as: Creating and maintaining new research support software applications. A brief description of systems developed, and a summary of their use will be acceptable. Interested organizations should also provide a description of their experience and expertise with integrating Commercial Off-The-Shelf (COTS) software into a custom development solution. 3. Workflow development, such as: Creating and maintaining multi-step workflows in document management software. A brief description of workflows developed will be acceptable. The NIDA Informatics Program provides an enterprise-wide architecture for NIDA’s programs for the scientific discovery and clinical evaluation of promising new anti-addiction therapies and companion behavioral interventions. NIDA depends on specialized information applications to support collaboration among development partners, monitor program operations and regulatory compliance, provide electronic document repositories, and analytical and report tools and services to the NIDA research community. These applications provide critical functions in supporting and assisting NIDA research. R&D support systems include, but may not be limited to, the following applications. The Addiction Treatment Development Team Information Management System (AIMS) application allows for the authorization of preclinical pharmacology and toxicology studies, tracking the progress of potential medication development candidates and allowing decisions to be made regarding the continued progress of a candidate through the medications development process. The NIDA Data Share provides access to NIDA Clinical Trials data for a variety of scientists which helps them generate new analyses or hypotheses to support new research projects. The application also allows NIDA to remain in compliance with current rules and regulations regarding making clinical trial data available to the public. Additionally, the application allows NIDA staff to review and analyze clinical trial results for the purposes of developing original research projects. The Serious Adverse Event Tracking and Reporting System (SAETRS) allows NIDA medical monitors and Project Officers to be made aware of safety issues, in real time, that arise during the course of grantee conducted clinical trials. The Livelink application allows for the filing, easy retrieval and sharing of study documents with clinical trial sites during the development and execution of clinical trials by NIDA’s Center for Clinical Trials Network (CCTN) and Division of Therapeutics and Medical Consequences (DTMC). The Informatics Program supports two principal computing environments that are fully integrated with the NIH enterprise. Internal NIDA users rely on a combination of desktop and local and wide area network services provided to all NIH users. External users access information assets and services via web-based applications built and maintained by the Informatics Program. Currently, the Informatics Program supports over 600 users that access one or more core services of document management, database management, or specialized line-of- business applications supporting pre-clinical or clinical programs. The Informatics Program must successfully support new projects and provide information through a variety of reporting vehicles. On-going informatics initiatives currently support grantees as users and continue development of analytic reporting capabilities regarding specialized content focused on safety, efficacy and effectiveness. CAPABILITY STATEMENT/INFORMATION SOUGHT: The established NAICS code is 541512. Information sent should be relevant and specific in the technical area under consideration, on each of the following qualifications: (1) Experience: An outline of previous similar projects and work in the field of drug development; (2) Personnel: Name, professional qualifications and specific experience of scientific and/or technical personnel who may be assigned as project director and other key positions; (3) Facilities: Availability and description of facilities and equipment required to conduct this type of work. Any other specific and relevant information about this particular area of procurement that would improve our consideration and evaluation of the information presented is desirable. Interested organizations must demonstrate and document, in any capability statements submitted, extensive experience with and the ability to perform the above tasks. Organizations should demonstrate capability to administer and coordinate interrelated tasks in an effective and timely manner. Documentation may include, but not be limited to, contracts both Government and commercial the organization performed, references, i.e., names, titles, telephone numbers and any other information serving to document the organizations capability, e.g., awards, commendations, etc. All capability statements must provide the following: 1) company name and address; 2) point of contact, 3) phone/fax/email; 4) NAICS Code(s); 5) business size and status; 6) capability information in response to the requirement and qualifications identified in this notice; and 7) type of small business your organization classifies itself as (i.e.: women-owned, HUBZONE, etc.). Written capability statements must be RECEIVED NO LATER THAN November 26, 2019 and should be sent electronically to Andrew Varley (andrew.varley@nih.gov) and Andrew Hotaling (andrew.hotaling@nih.gov). THIS NOTICE IS NOT A REQUEST FOR PROPOSALS (RFP) OR A REQUEST FOR QUOTATIONS (RFQ). 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. Any proprietary information should be so marked. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or to provide feedback to the respondents with respect to any information submitted. After a review of the responses received, an RFQ or RFP may be published. However, responses to this notice will not be considered an adequate response to a RFQ or RFP.