SOLICITATION NOTICE
D -- HL7 Stability Data Submissions Model - Implementation Guide
- Notice Date
- 8/24/2009
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541519
— Other Computer Related Services
- 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
- 1062711
- Archive Date
- 9/15/2009
- Point of Contact
- Jaclyn Stielper, , Doreen Williams, Fax: 301-827-7106
- E-Mail Address
-
jaclyn.stielper@fda.hhs.gov, doreen.williams@fda.hhs.gov
(jaclyn.stielper@fda.hhs.gov, doreen.williams@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Implementation Guide This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-35. This announcement constitutes the only 100% total small business set aside solicitation and a written solicitation will not be issued. This synopsis, NAICS code 541519, is to notify contractors that the government intends to issue a Firm Fixed Price Purchase Order in accordance with FAR Part 13 for the following statement of work, under the simplified acquisition procedures. Any firm that believes it is capable of providing the required service as stated herein may submit a capability statement to document its ability to provide the required services. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. 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. Award will be made to the party whose quote offers the best value to the Government. The Government may award this contract to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability, 2) Past Performance and 3) Price. Technical Capability and Past Performance, when combined, are significantly more important than price. This solicitation is issued as a Request for Quotation (RFQ). The Food and Drug Administration (FDA) intends to award a purchase order for an HL7 Stability Data Submissions Model. Statement of Objective To facilitate availability of the Draft Standard for Trial Use (DSTU), during review of submissions, FDA needs a thoroughly validated style sheet. In addition, we need support for modifications to the style sheet during this voluntary implementation phase of HL7 stability data submissions. The objective of the proposed work is to 1) enhance and complete the current style sheet in preparation for trial submissions under the DSTU. Enhancement will include adding the capability to generate output in tabular format required by other reviewer tools, in addition to lesser adjustments identified by the Working Group; and 2) provide support during the implementation of the project. FDA’s experience with the Structured Product Labeling style sheet, also developed using XSL and CSS, indicates that changes were required at regular intervals during the implementation phase, to adjust to real data submissions. Statement of Work •The contractor will deliver a style sheet, written using XSL standard in combination with CSS not later than two months after contract award. •The contractor will provide three upgrades to style sheet during the remainder of the six month contract period. •In order to minimize the need for training the contractor, the contractor will demonstrate previous activity in the following topics: 1.Programming XML 2.Programming style sheets (XSL and CSS) 3.Specific experience indicating experience with and understanding of the HL7 stability data standard 4.FDA needs for stability data presentation and content 5.Industry needs for transporting stability data 6.FDA Drug Application Requirements Estimated Duration of the Project Six months from Date of Award. Deliverables 1.The initial version of the style sheet, including the capability to output stability data in tabular format and other adjustments indicated by the Working Group within two months from the contract award date 2.Three upgrades to style sheet within three to six months from the contract award date Site Visits Three site visits are anticipated in conjunction with the support phase of the contract. Evaluation Factors: 1. Prior experience indicating and understanding of xml technology, programming and development of style sheets to view xml data 2. Experience indicating an understanding of the HL7 data architecture and the stability data submission standard 3. Specific experience indicating knowledge of FDA needs for stability data presentation and content 4. Understanding of industry needs for transporting stability data 5. Understanding of FDA Drug Application Requirements 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. QUESTIONS DEADLINE: All questions are to be submitted via email to Jaclyn.Stielper@fda.hhs.gov no later than August 26, 2009 at 4:30 PM EST. Telephone calls will not be accepted. QUOTATIONS DUE: All quotations are due, via email to: Jaclyn.Stielper@fda.hhs.gov, no later than 4:30 PM EST on August 31, 2009. 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 52.217-9, 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/1062711/listing.html)
- Place of Performance
- Address: Contractor's Facility, United States
- Record
- SN01923941-W 20090826/090825002047-ab25b15f76aa8439fe274c7271c0ac99 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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