SOURCES SOUGHT
R -- Extend the HL7 SPL standard
- Notice Date
- 6/12/2009
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-09-1057439-SS
- Point of Contact
- Karen R. Petty, Phone: 301-827-8774
- E-Mail Address
-
karen.petty@fda.hhs.gov
(karen.petty@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Document Type: Sources Sought Release Date:June 12, 2009 Response Date: June 18, 2009 at 5:00pm, EST via e-mail to Contract Specialist: Karen Petty at karen.petty@fda.hhs.gov. Contracting Office Address: Food and Drug Administration 5630 Fisher Lane Rockville, Maryland 20857 Description: Capability of extending the HL7 SPL standard to include the data elements required for food and medical device product facility registration and food and medical device product listing data for processing, reviewing, and archiving by FDA. This is a SOURCES SOUGHT NOTICE to determine the availability and capability of small business (including certified 8(a), Small Disadvantage businesses, HUB Zone businesses; veteran-owned small businesses, and women-owned small businesses. This notice is being posted for fact finding and planning purposes only and shall not be construed as an Invitation for Bid, a Request for Proposal, Solicitation, Request for Quotes, or an indication the Government will contract for the items or services herein. This notice is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. The Government does not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this source sought. Any response received will not be used as a proposal. No official solicitation currently exists in connection to this request for information (RFI). Also, if in the future an official solicitation is released, there is no guarantee that sources responding to this RFI will be included on the source list. **QUESTIONS WILL NOT BE ENTERTAINED AS A RESULT OF THIS NOTICE** The Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS), Division of Acquisition Operations (DAO) is seeking to identify sources with capabilities and prior experience in extending the HL7 SPL standard to include the data elements required for food and medical device product facility registration and food and medical device product listing data for processing, reviewing, and archiving by FDA. Objective: In support of the FDA Product Quality Compliance Business Review Board’s Harmonized Inventory project, which was approved by the Bioinformatics Board, a health and regulatory data standard to be utilized by industry to generate food facility registration and food product listing information files for submission to FDA is needed. In the spirit of harmonization, the Structured Product Labeling (SPL) standard should also be extended to accommodate medical device product files for submission to FDA. One of the purposes of the Harmonized Inventory project is to create a reliable, complete, up-to-date, master inventory of FDA-related firms, facilities and products, and their associated information. As of July 2008, FDA began receiving electronic drug establishment registration and drug listing data. The HL7 SPL standard is the data standard which permits the capture of content of labeling, drug establishment registration and drug listing data in a format that FDA can process, review, and archive. The centralized storage of this standardized data, which will include food facility registration and food product data, in the Agency’s HL7 RIM-based database permits the tracking of registered facilities which manufacture multiple types of regulated products and the product-component/ingredient data. Standardization of the data will also assist in the improvement of the accuracy, validation, capturing, and integration of regulatory data as well as the facilitation of design of reporting and analytical tools. Food facility registration and food and medical device product listing SPL documents submitted to the FDA need to undergo quality control to ensure that the data conform to SPL XML schema and FDA business rules. A Schematron document will be utilized to validate the data submitted in food facility registration and food and medical device product listing SPL documents to ensure conformance with the SPL schema and FDA business validation procedures. An implementation guide is needed by the FDA-regulated foods and medical device industry to create SPL files for submission to FDA. This implementation guide is an HL7 document that is used by industry and SPL software developers who create HL7 SPL messages with food and medical device facility registration and product listing data for submission to FDA. The foods and medical device product industry and FDA employees will need to view the data in foods SPL documents submitted to FDA. SPL documents, which are XML documents can be rendered and displayed in hypertext markup (HTML) or XHTML language using an Extensible Stylesheet Language Transformation (XSLT). XSLT is the language that can be utilized to transform XML document into HTML or XHTML documents. The SPL XSLT stylesheet specifies the default font, indentation, orientation, formatting, word wrapping, line spacing, and other properties that will be used for the display of product information submitted in SPL format. A contractor would be required to extend the HL7 SPL standard to include the data elements required for food and medical device product facility registration and food and medical device product listing data for processing, reviewing, and archiving by FDA. This contractor would also possess the capability of developing and maintaining an open source Schematron 1.5 document based on the business rules and data relationships for food facility registration and product data and medical device data defined by FDA which, when processed through an Extensible Stylesheet Language Transform (XSLT), XForms, can be used to assist in quality control by validating a SPL file and producing a report outlining the detected errors. The organization must also be able to generate a HL7 SPL implementation guide to be utilized by industry and SPL software developers to generate valid regulatory submissions for processing, reviewing, and archiving by FDA and software to create the aforementioned documents respectively. Company would create an implementation guide for the creation of SPL for a specific product and instructions on the use of extensible mark up language (XML). The FDA anticipates using a labor hour type contract with a base and two (2) option years for these services. The NAICS code is 541712. Part A. Capability and Technical Experience – Interested parties should submit capability statement describing adequate training and experience in scientific and technical appropriateness in reference to the potential work to be conducted in extending the HL7 SPL standard to include the data elements required for food and medical device product facility registration and food and medical device product listing data for processing, reviewing, and archiving by FDA.. The ability to develop and maintain an open source Schematron 1.5 document based on the business rules and data relationships for food facility registration and product data and medical device data defined by FDA which, when processed through an Extensible Stylesheet Language Transform (XSLT), XForms, can be used to assist in quality control by validating a SPL file and producing a report outlining the detected errors.. The ability to generate a HL7 SPL implementation guide to be utilized by industry and SPL software developers to generate valid regulatory submissions for processing, reviewing, and archiving by FDA and software to create the aforementioned documents respectively. The ability to create an implementation guide for the creation of SPL for a specific product and instructions on the use of extensible mark up language (XML). Part B. Size of Business – Please provide your business size (including certified 8(a), Small Disadvantage businesses, HUB Zone businesses; veteran-owned small businesses, and women-owned small businesses) and submit copies of any documentation such as letters of certifications to indicate the firm status. Part C. Organizational Conflict of Interest (OCI) – If any; provide disclosure of business activities of your company, your affiliates, and your team members and affiliates of your team members which create either a conflict of interest or the appearance of a conflict of interest in the performance of the possible work on evaluation listed above. Part D. Cost Estimate – Please provide a cost estimate for the prospective services to be conducted under the potential to extend the HL7 SPL standard to include the data elements required for food and medical device product facility registration and food and medical device product listing data for processing, reviewing, and archiving by FDA. Cost should consist of the type of personnel need, hourly rate/days, material and travel expense if applicable or related to the proposed project. Part E. Small Business – Describe your ability to meet the requirements in accordance with 52.219.14 – Limitation of Subcontracting. Responses shall adhere to the following: 1. Reference the Sources Sought number when submitting Capability Statement. 2. The capability statement shall be no more than five (5) pages in length. 3. The marketing materials shall not be included. 4. The capability statement shall be e-mailed to the attention of the Contract Specialist listed above. FDA makes no implied or in fact contract by issuing this Sources Sought. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA’s view of the information received. Material that requires a non-disclosure agreement or that may be business sensitive will not be accepted. Please note that responses to this notice will not be returned.
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