Loren Data's SAM Daily™

FBO DAILY ISSUE OF DECEMBER 03, 2006 FBO #1833
MODIFICATION

D -- Study Data Tabulation Model/HL7 Version 3 Extensible Markup Language (XML) Standardization

Notice Date

8/11/2006
 

Notice Type

Modification
 

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, MD, 20857-0001
 

ZIP Code

20857-0001
 

Solicitation Number

1010423-06
 

Response Due

8/18/2006
 

Point of Contact

Debbie Hammond, Contract Specialist, Phone (301) 827-7157, Fax (301) 827-7151, - Sandra Bellinger , Contracting Officer , Phone 301-827-7159, Fax 301-827-7101,
 

E-Mail Address

dhammon1@fda.hhs.gov, sandra.bellinger@fda.hhs.gov
 

Small Business Set-Aside

Total Small Business
 

Description

THIS IS AN AMENDMENT TO THE PREVIOUS COMBINED SYNOPSIS/SOLICITATION. This amendment provides clarification of instructions to respond to this request for quotations and provides responses to questions received. This is a COMBINED SYNOPSIS/SOLICITATION for commercial items prepared in accordance with the format in FAR Subpart 12.6 as supplemented with the additional information included in this notice. This announcement constitutes the only solicitation; a written solicitation will not be issued. PAPER COPIES OF THIS SOLICITATION ARE NOT BE AVAILABLE. The reference number is 1010423-06. ALL REQUIREMENTS FOR RESPONDING TO THIS REQUEST FOR QUOTATIONS ARE CONTAINED WITHIN THIS ANNOUNCEMENT. No further documents are available from the contacts. This solicitation documents and incorporates provisions and clauses in effect through FAC 2005-12. It is the responsibility of the contractor to be familiar with the applicable clauses and provisions. The clauses may be accessed in full text at these addresses: www.acqnet.gov/far. PLACE OF PERFORMANCE: Contractor’s Site - the Government does not require any onsite performance at the Government's site. The NAICS code is 541519 and the Small Business Standard is $23 Million. This a 100% Small Business Set Aside. Offeror’s should complete their representations and certifications at Online Representations and Certifications Application (ORCA) at http://orca.bpn.gov. The Food and Drug Administration requests responses from qualified sources capable of provided these services in accordance with the statement of work. Note 1 applies. Contractor unit prices, when incorporated into a Government contract, will be released under the Freedom of Information Act (FOIA) without further notice to the contractor submitter. If the Contractor takes issue with the release, it should submit its proposal data with the appropriate legends and explain in detail why such data cannot be released as a public record under the Freedom of Information Act. STATEMENT OF WORK: The Food and Drug Administration (FDA) has a requirement that requires the need to obtain professional services to develop a Health Level 7 (HL7) version 3 (XML) standard message specification for the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) including study data, study protocol and study summary, lead the specification through the appropriate HL7 committee(s), balloting and reconciliation, and prepare an implementation guide for the approved version. The following tasks are required: 1-Develop HL7 version 3 (XML) standards for the CDISC STDM including study data, study protocol (i.e., study flow, inclusion/exclusion criteria, planned interventions and assessments, statistical analysis plan) and study summary. 2- Create mapping document showing relationship/reconciliation between the Regulated Clinical Research Information Management Technical Committee (RCRIM) and Biomedical Research Integrated Domain Group (BRIDG) domain analysis model and HL7 Reference Information Model (RIM). 3-Develop formal message specification based on the HL7 RIM coherent with other related HL7 specifications (e.g., Observation Results, Clinical Trials). 4-Prepare submissions of RIM extensions and lead them through the HL7 committee, ballot and reconciliation process. 5-Prepare a complete specification document with explanatory text and examples. 6-Present the specification to stakeholders, FDA, and interested HL7 committees to arrive at a consensus. 7-Lead the specification through committee and membership ballots, work out ballot reconciliations, and manage specification versioning. 8-Prepare an implementation guide and tutorial material for parties without extensive knowledge in HL7. The following deliverables will be required: 1-Data mapping between RCRIM and BRIDG domain analysis models and HL7 RIM; 2-Formal message specification for HL7 v3 standard (draft and final versions of ballot a NOTE: THIS NOTICE MAY HAVE POSTED ON FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (11-AUG-2006). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 01-DEC-2006, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
 

Web Link

Link to FedBizOpps document.
(http://www.fbo.gov/spg/HHS/FDA/DCASC/1010423-06/listing.html)
 

Place of Performance

Address: DHHS/Food and Drug Administration 5600 Fishers Lane Rockville, Maryland

Zip Code: 20857

Country: UNITED STATES
 

Record

SN01189723-F 20061203/061201223603 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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