SOURCES SOUGHT
70 -- FDA support for Health Level Seven (HL7) Structured Product Lanagauge (SPL) - Sources Sought RFI
- Notice Date
- 1/13/2017
- Notice Type
- Sources Sought
- NAICS
- 541519
— Other Computer Related Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- 17-223-SOL-00013
- Archive Date
- 2/7/2017
- Point of Contact
- Jacob A. O'Hatnick, Phone: 3018276758
- E-Mail Address
-
jacob.ohatnick@fda.hhs.gov
(jacob.ohatnick@fda.hhs.gov)
- Small Business Set-Aside
- Competitive 8(a)
- Description
- This is a U.S. Food and Drug Administration (FDA) Sources Sought / Request for Information (RFI for the following Requirement: Health Level Seven (HL7) Structured Product Labeling (SPL) Service Support Note: This text is also attached in pdf format. Sources Sought / Request for Information # 17-223-SOL-00013 Health Level Seven (HL7) Structured Product Labeling (SPL) The U.S. Food & Drug Administration is issuing this Sources Sought and Request for Information as a means of conducting market research to identify parties having an interest in and the resources to support the described requirement. Description of Requirement Title: Health Level Seven (HL7) Structured Product Labeling (SPL) Service Support Department/Agency: Department of Health and Human Services, U.S. Food & Drug Administration Requiring Offices: FDA Office of Information Management and Technology (OIMT) FDA Center for Drug Evaluation and Research (CDER) Contracting Office: Office of Acquisition and Grant Services (OAGS) Summary of Requirement: The FDA is working on an agency wide strategy for improving the management of structured data and unstructured data across agency enterprise initiatives. This work involves implementation management of interoperable standards for exchanging and storing the Health Level Seven (HL7) Structured Product Labelling (SPL) data. One data standard for exchanging and storing information is based on the Health Level Seven (HL7) Reference Information Model (RIM). The standard being developed for information related to facilities and product information is the HL7 SPL. The FDA HL7 Message Data Exchange Services - Electronic Listing (ELIST) system has been developed for accepting, validating, data storing, and data distribution. Various peripherals systems are established for supporting Centers specific missions or for supporting industry with SPL submissions. The scope of this IDIQ contract will include all activities necessary to address the system development, system operation and maintenance support, and system enhancement of the FDA HL7/SPL submission data essential applications. Expected Award Basis: Competitive 8(a) per FAR 19.805-1, resulting in a single-award IDIQ or BPA. General Instructions: This is both a Sources Sought and a Request for Information. The FDA is seeking potential sources (Sources Sought), especially 8(a) firms and other socio-economic classifications, which can meet this requirement generally. The FDA is also seeking industry feedback (RFI) on the extent to which industry has specific technical capabilities anticipated to be critical to meeting the requirement. The FDA seeks responses to the Sources Sought and/or RFI issues described below. There is no required format for responses, but FDA recommends pdf files. There is no page limit or formatting restrictions. Partial responses will be accepted. Late responses may be accepted. Contact Information and Where to Send Responses: Send responses via email to Jacob O'Hatnick at Jacob.ohatnick@fda.hhs.gov. Please include the solicitation number 17-223-SOL-00013 in the subject line. The full contact information and mailing address for this Sources Sought / RFI is: Attn: Jacob O'Hatnick Contract Specialist - Systems Technology Acquisitions Branch Office of Acquisition and Grants Services U.S. Food & Drug Administration 5630 Fishers Lane, Room 2078A, HFA-500, Rockville MD 20857 240-402-7545 Jacob.ohatnick@fda.hhs.gov Sources Sought Instructions: If your organization has the potential capacity to perform these contract services, please provide the following information: 1) Organization name, DUNS number, contact information and size/socio-economic status. 2) Any existing or expected federal acquisition vehicles your organization is a party to (for example, GSA's Schedule 70) that may be appropriate for the FDA to use for this requirement, and the applicable contract number. 3) Your proposed NAICS code for this effort. 4) Optional: A brief statement addressing organizational capability and/or experience to support the FDA's HL7 SPL requirement. Request for Information Instructions The FDA requests responses to the following technical questions regarding your organization's capabilities and experience with HL7/SPL. 1) Do you have experience with HL7/SPL submissions? Does it include SPL generation and parsing? What SPL types have you worked on? If yes, for how many years and please elaborate on all of the above. 2) Do you have experience with Oracle XMLdb and xml file processing? Please elaborate. 3) Do you have experience with developing web applications with Oracle APEX v5.0? Please elaborate. Does your experience include any of the following: data search, reports, heat map, graphical data statistics presentation, web services, and data entry with field validation, especially with the WYSIWYG enabled features, and the file uploading/attachments capabilities? Please provide details including application description, system architecture description, user authentication/authorization mechanism, security measurements, 508 compliance handling, and technology stack. 4) Do you have development experience with MoveIT v9.0 for MoveIT tasks handling automatic file distribution amongst the systems, especially the development experience with the MoveIT API utility? Please provide details including application description, system architecture description, and technology stack. 5) How many years of development experience with chemoinformatics development toolkits such as Indigo, OpenBabel, RDKit, CACTVS using C/C++/C#, and handling of MOLFILE data (a structured format for chemical structures). Please provide details including application description, system architecture description, and technology stack. 6) Do you have development experience with java, UNIX scripting on Windows Servers (2012R2), Lynx scripting, and scheduled background processes? Please provide details including application description, system architecture description, possible interface protocol description, and technology stack. 7) How many years of experience of developing systems to respond to the FDA regulations and policies with understanding of the Post Market Drug quality and safety control? What is the system development methodology, processes, and software engineering practice principles? Please elaborate. Disclaimers There is no solicitation at this time. This request for capability information does not constitute a request for proposals; submission of any information in response to this market survey is purely voluntary; the government assumes no financial responsibility for any costs incurred. The government will evaluate market information to ascertain potential market capacity to 1) provide services consistent in scope and scale with those described in this notice and otherwise anticipated; 2) secure and apply the full range of corporate financial, human capital, and technical resources required to successfully perform similar requirements; 3) implement a successful project management plan that includes: compliance with program schedules; cost containment; meeting and tracking performance; hiring and retention of key personnel and risk mitigation; and 4) provide services under a performance based service acquisition contract. Based on the responses to this sources sought notice/market research, this requirement may be set-aside for small businesses or procured through full and open competition, and multiple awards may be made. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/17-223-SOL-00013/listing.html)
- Place of Performance
- Address: The US Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN04371481-W 20170115/170113234112-a0583d4052d5b65afe9e2367cb26ac80 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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