******************************************The purpose of this amendment is to add attachment #1 (past performance questionnaire) to solicitation. This announcement is hereby extended until July 23, 2009 @ 5:00 p.m. Eastern Standard Time.****************************************************** This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code 541712, is to notify contractors that the Food and Drug Administration (FDA) is seeking competition of this requirement in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procures. Under the simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-32. This synopsis is designated for 100% Small Business Set Aside competition for a fixed price purchase order. Prospective offerors are responsible for monitoring the FedBizOpps website for the release of any amendments to this solicitation. Hard copies will be provided to individuals eligible under the Americans with Disabilities Act and Rehabilitation Act upon request. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. This combined synopsis solicitation is issued as a Request for Quotations (RFQ). The FDA intends to award a purchase order 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. The Statement of Work is as follows: I. Background FDA is charged with protecting the safety and security of the United States food and drug supply. On September 28, 2005, Department of Health and Human Services and Department of Homeland Security announced the issuance of the Bioterrorism Act Food Facilities Registration Final Rule. This rule requires domestic and foreign facilities that manufacture, process, pack, or hold food for consumption in the United States to register with FDA. The rule implemented the food facilities registration provision of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. FDA has been collecting the food facility registration data in a format which is not consistent with the standard utilized to collect other FDA-regulated facility and product data. The standardization of the format of regulatory data received by the agency will afford an opportunity for FDA to share data amongst its centers and other Federal agencies using one standard and store that data in a single authoritative database which is based on the Health Level Seven (HL7) Reference Information Model (RIM). II. 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. III. Scope FDA is seeking an organization whose capable 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. The contractor shall: 1. 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 and other software, can be used to assist in quality control by validating a SPL file and producing a report outlining the detected errors. 2. 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. 3. Create an implementation guide for the creation of SPL for a specific product and instructions on the use of Extensible Markup Language (XML). 4. Possess an extensive knowledge of Extensible Markup Language (XML), Extensible Stylesheet Language Transformation (XSLT). IV. Detailed Requirements/Tasks The contractor shall complete the following tasks: Task # 1 Task Title Description SPL Data Standard Development 1.1 Identify data elements Gather data element requirements from FDA subject matter experts 1.2 Model data elements Model data element requirements against the HL7 v3 Reference Information Model 1.3 Create schema and model interchange format files (MIF) Develop HL7 SPL schema (.xsd) and HL7 MIF files for food and medical device facility registration and food and medical device product listing submissions. 1.4 Harmonize model Harmonize food and device model against existing HL7 models. 1.5 Create HL7 ballot material for standard Create HL7 ballot material for standard 1.6 Ballot standard Manage standard through the HL7 ballot process. Participate in ballot reconciliation activities and, if necessary, reconcile ballot comments. Task # 2 Task Title Description SPL Schematron Development 2.1 Requirements gathering Gather business requirements for food facility and food product, and medical device product submissions 2.2 Develop schematron Develop a Schematron 1.5 framework design and tool which is capable of validating food facility and product, including medical devices SPL files based on business rules and data relationships that are defined in the Food Facility Registration and Product Listing and Medical Devices implementation guide document. Schematron document should be editable using Microsoft Word software. 2.3 Develop XSLT file for schematron Develop an Extensible Stylesheet Language Transformation (XSLT) file using the food facility registration and product listing as well as medical devices data Schematron document to produce a human readable report outlining the detected validation errors. 2.4 Develop graphical user interface for schematron Develop a graphical user interface allowing users to execute the XSLT file designed for the food facility registration and product listing and medical devices schematron. 2.5 Support and maintenance for schematron Provide training and maintenance for food facility registration and product listing and medical devices schematron for one year following delivery of schematron. 2.6 Attend teleconferences Meet telephonically with FDA subject matter experts to discuss business requirements Task # 3 Task Title Description SPL Implementation Guide 3.1 Write implementation guide for food facility and medical device establishment registration and product listing SPL message Create a document which provides technical conformance criteria for SPL files based on the food and medical device facility registration and product listing process at the United States Food and Drug Administration (FDA). 3.2 Discuss implementation guide with FDA and industry members of HL7 Meet with FDA subject matter experts Health Level Seven members, and members of the foods and medical device industry as necessary to discuss implementation guide. 3.3 Ballot implementation guide Manage implementation guide through the HL7 ballot process. Participate in ballot reconciliation activities and, if necessary, reconcile ballot comments. Task # 4 Task Title Description 4.1 Gather requirements for views Meet with FDA subject matter experts to discuss the rendering of the food and medical device product facility and product listing data in SPL documents 4.2 Create one of more stylesheets Create one or more stylesheets with XSLT, concomitant cascading stylesheet files, Javascript files, and XML files designed against the XHTML transform of SPL to yield a FDA-specified standard rendering of the transformed SPL documents with food facility and product listing data. 4.3 Provide release notes Provide complete release notes which describe the stylesheet rules. 4.4 Support and maintenance of stylesheet files Update and perform maintenance on XSLT stylesheets for SPL based on functional requirements for the stylesheet viewing via an internet browser. Deliverables The contractor shall furnish the following deliverables: # Data Standard Deliverable Due Date 1 Extended SPL model including Food and medical device product facility and product Six months after award 2 Food and medical device product facility and product SPL model interchange format (MIF) file Six months after award 3 SPL schema files in .xsd format and references Six months after award 4 Develop a work plan indicating the planning, design, test, implementation, and support phases for all tasks described. Six months after award 5 Provide SPL food and medical device product facility registration and product listing SPL ballot material (schema (.xsd) and HL7 MIF files) Six months after award 6 Meetings with FDA subject matter exports and HL7 members to discuss development of standard and schematron. As needed # SPL Schematron Deliverables 1 Foods data SPL Schematron document Two months after completion of task # 1 2 XLST files for food facility and medical device registration and food product and medical device listing Schematron document Two months after completion of task # 1 3 Graphical user interface utilized for food facility and medical device establishment registration and food and medical device product listing Schematron document Two months after completion of task # 1 4 Perform maintenance updates to the Schematron document, XSLT files and user interface for a one and one-half year period after delivery. As needed for duration of contract 5 Provide validation procedures document in Word format and a user manual for schematron document. Two months after completion of task # 1 # SPL Implementation Guide Deliverables Due Date 1 HL7 implementation guide for food facility registration and product listing SPL message Three months after completion of task # 1 2 HL7 ballot material for implementation guide Three months after completion of task # 1 # SPL Stylesheet Deliverables Due Date 1 Foods and Medical Device Product data SPL stylesheets One month after completion of task # 1 2 Perform maintenance updates to the stylesheets for a one and one-half year period after delivery. As needed for duration of contract 5 Provide release notes for stylesheets and updates One month after completion of task # 1 PRICING SCHEDULE The contractor shall provide all services order 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, including furnishing all professional services, labor, material, equipment and services, unless otherwise specified herein, required under this contract line items for the following fully loaded firm fixed price labor categories and within the time specified herein. This price shall include all labor, materials, overhead insurance and fees, and profit. Year One (1) – August 31, 2009 – August 30, 2010 CLINS Labor Category Estimated Hours/Quantity Fully Loaded Hourly Rates Total 0001 Technical Writer 150 $ 0002 Technical Lead, Architect 154 $ 0003 Senior Developer 1000 $ 0004 Project Manager 400 $ 0005 Travel 1 LOT $2,000.00 Base Year Total $ Year Two (2) – August 31, 2010 – August 30, 2011 CLINS Labor Category Estimated Hours/Quantity Fully Loaded Hourly Rates Total 0001 Technical Writer 150 $ 0002 Technical Lead, Architect 154 $ 0003 Senior Developer 1000 $ 0004 Project Manager 400 $ 0005 Travel 1 LOT $2,000.00 Base Year Total $ Period of Performance: Period of performance shall be for a base year and two (2) option years. Place of Performance: Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun & Bradstreet number and banking information. All responsible sources that can provide and meet the above requirements, shall submit written quotation by the response date. QUESTIONS DUE: All questions must be received by email to: [email protected], no later than 5:00pm, EST on or before Wednesday July 15, 2009. QUOTATIONS DUE: All quotations must be received by email to: [email protected], no later than 5:00pm, EST on or before, Tuesday, July 21, 2009. Telephone calls will not be accepted. EVALUATION AND AWARD: The Government intends to evaluate proposals and, if necessary conduct discussions with all responsible offerors within the competitive range. The award will be made to the offeror whose proposal conforms to the terms and conditions of the solicitation and awrd may be made to other than the lowest priced or the highest technically rated offer. Relative importance and trade-offs. The Government will base the determination of best value on performance and evaluation factors based on the following evaluation criteria: Each Offeror must submit a proposal, which consists of three (3) parts: (1) Demonstrated Technical Approach The Offeror shall describe its proposed technical approach demonstrating it fully understands the requirements set forth in the Statement of Work and its overall approach for achieving the requirements set forth in the Statement of Work. The technical approach shall include: • The Offeror’s proposed approach to managing the tasks set forth in the Statement of Work. • The proposed personnel will be evaluated on their qualifications and experience as they relate to the tasks described in the Statement of Work. All personnel must meet the required education and experience requirements as set forth in the Statement of Work. The contractor must have personnel with specific experience in the development for each of the deliverables listed in the Statement of Work. • The contractor shall establish a clear understanding of the issues faced in the SOW. • The contractor shall show a clear understanding of the intent of the project, a clear awareness of the contract objectives. • The contractor’s technical approach shall be representative of the broad disciplines described in the Statement of Work. • The contractor’s technical approach shall demonstrate a logical progressive step-by-step path to the completion. • The contractor’s technical approach shall address each of the program objectives and deliverables listed in the Statement of Work. • The contractor shall provide evidence that the designated personnel are competent and experienced in the skills required in the Statement of Work. Resumes of personnel and consultants reflect not only academic qualifications, but also length and variety of experiences in similar tasks. (2) Past Performance Information The Offeror shall describe previous experience in performance of technical projects similar in size, scope, technical difficulty, and complexity to the requirement being competed. Past performance information must include: • A demonstrated historical relationship performing the tasks referenced in the SOW. • Evidence of prior experience in education / curriculum development for the disciplines represented in the Statement of Work. The Government’s evaluation of past performance shall examine: the services delivered, timeliness of performance, and cost effectiveness. The Offeror shall request completion of past performance questionnaires (see Attachment 1) from a total of three (3) references. In order to facilitate the evaluation of the Offeror’s past performance, the Offeror shall present the following information for its three (3) references: a) Name and Address of Customer b) Contract Number c) Brief Description of Contract d) Brief Description of Services provided and Technologies Used e) Name, address, and current phone number for the Customer’s Business Manager (Contracting Officer) f) Name, address, and current phone number for the Customer’s Technical Manager. The Past Performance Questionnaire attached to this RFQ must be submitted by the Offeror’s references and submitted directly to FDA/OAGS at the address shown in the questionnaire no later than the close of business on or before the date proposals are due. It is the Offeror’s responsibility to forward the past performance questionnaires to the references and to have those references complete the questionnaires and fax them in a timely manner. Offerors shall not submit past performance questionnaires with their proposals. If the Offeror has no past performance, the Offeror shall submit a certification indicating the Offeror has no past performance. The certification shall be in a separately sealed envelope clearly marked with a notation indicating past performance certification and the solicitation number, and accompanied with the RFQ volumes. (3) Pricing Information The Offeror shall prepare a Price Proposal that contains all information necessary to allow for a comprehensive evaluation of the prices proposed by the Offeror. The Price Proposal shall consist of pricing discounts with the proposed labor categories and hours, and an accompanying narrative that fully describes all assumptions made by the Offeror. PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following agenda has been attached to the clause: None. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition.

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