Loren Data's SAM Daily™

FBO DAILY ISSUE OF AUGUST 10, 2006 FBO #1718
MODIFICATION

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

Notice Date

8/8/2006
 

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
 

Archive Date

9/2/2006
 

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 and schema); 3-Implementation guide and tutorial material. The following FAR provision and clauses are applicable to the procurement: 52.212-1, Instruction to Offerors – Commercial Items: 52.212-3 and its ALT I, Offeror Representations and Certifications – Commercial Items; 52.212-4, Contract Terms and Conditions – Commercial Items: Contract Terms and Conditions – Commercial Items; Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes Or Executive Orders-Commercial Items; 52.222-21, Prohibition of Segregated Facilities; 52.222-26, Equal Opportunity; 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans; 52.222-36, Affirmative Action for Workers with Disabilities; 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans; 52.232-33, Payment by Electronic Funds Transfer – Central Contractor Registration; 52.222-41, Service Contract Act of 1965, As Amended. The Government may award a contract on the basis of initial offers received, without discussions. Therefore, each initial offer should contain the offer’s best terms from a cost or price and technical standpoint. However, if considered necessary by the Contracting Officer, discussions will be conducted with only those offeror’s determined to have a reasonable chance for award. 52.212-2 Evaluation – Commercial Items is applicable to this procurement. Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The EVALUATION CRITERIA: 1) Offeror’s technical capability to provide the services required to meet the Government’s requirements, including offeror’s knowledge and familiarity with standards development and modeling using the HL7 Reference Information Model and knowledge of the standards work of the Regulated Clinical Research Information Management Technical Committee to HL7 (references requested for three similar projects) and 2) Price. Relative importance of evaluation factors: technical criteria will be considered to be more important than price, however, as offers are judged by the Government to be more equal, price will control the Government’s award determination. Central Contractor Registration (CCR). Offeror’s must be registered in the CCR database to be considered for award. Registration is free and can be completed on-line at http://www.ccr.gov/. All quotes shall include price(s), FOB point, a point of contact, name and phone number, business size, and payment terms. Offers shall be no more than 10 pages, including reference, and will be accepted via U.S. mail (Food and Drug Adminstration, Attn: Debbie Hammond, 5600 Fishers Lane HFS-500, Rockville, MD 20857) or electronically via email to dhammon1@oc.fda.gov to arrive not later than August 18, 2006. Each response must clearly indicate the capability of the offeror to meet all specifications and requirements. QUESTIONS AND ANSWERS: Q1. Past Performance Evaluation Sheet - Where can it be obtained? A1. This requirement has been removed. Quoters are requested to submit references for 3 similar projects. Q2. As an offshore corporation, are we eligible for applying to this tender? A2. Yes, you have offices within the U.S. Q3. What are the other eligibility requirements? A3. The eligibility requirements are contained in this combined synopsis/solicitation. Potential offerors should review the full text of the provisions and clauses referenced herein for instructions on responding. Q4. Can we bid for a particular service that is within our scope? A4. You must respond to the requirement in its entirety. This requirement is under the Simplified Acquisition Threshold and multiple awards will not be considered. Q5. Which are onsite services are required? A5. None. See above. Q6. What are the mandatory requirements? A6. Stated in the statement of work above and the overall combined synopsis/solicitation. Q7. What documents are required to respond? Quotation from vendor must contain both technical (including references) and business aspects fully addressing the offeror's understanding of the Government's requirements and the contractor. Additionally, the offeror must complete the online representations and certifications required in ORCA by due date of solicitation and be registered in the Central Contractor Registration. Further response items to include are included in the referenced provisions and clauses. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (08-AUG-2006); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS 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

SN01109733-F 20060810/060808223604 (fbodaily.com)
 

Source

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

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