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FBO DAILY ISSUE OF SEPTEMBER 11, 2008 FBO #2481
DOCUMENT

D -- Technical Support for Operation and Maintenance of Advanced Signal Detection Software - ATTACHMENT 1 Statement of Work

Notice Date

9/9/2008
 

Notice Type

ATTACHMENT 1 Statement of Work
 

NAICS

541511 — Custom Computer Programming 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

FDA-SOL-08-00931
 

Point of Contact

Brenda K Lee,, Phone: 301-827-7036, ZetherineGore ,, Phone: (301) 827-5093
 

E-Mail Address

brenda.lee@fda.hhs.gov, zetherine.gore@fda.hhs.gov
 

Small Business Set-Aside

N/A
 

Description

The U. S. Food and Drug and Administration intend to award a contract using full and open competition to provide the followings: 1) obtain services for the operation and maintenance of software designed to detect signals of potential drug safety problems 2) to expand the use of this software throughout other CDER divisions, and 3) develop a signal annotation feature that allows users to differentiate signals that are already labeled or disease related. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subparts 12.6 and 13.5 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation. Quotations are being requested and a written solicitation will not be issued. Solicitation FDA-SOL-08-00931 is issued as a Request for Quotation (RFQ) using Simplified Acquisition Procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-26. The NAICS Code is 541511. The small business size standard is 23M. This is a firm fixed price contract. There is an indefinite quantity line item for labor hours (loaded hours rates/or fixed price).The period of performance is from effective date of award through 12 months plus one 12 month option period. The Contractor shall provide technical support for operation and maintenance of Advanced Signal Detection Software in accordance with the Statement of Work Attachment 1 to this solicitation. All contractor and subcontractor employees are required to sign the Contractor's Commitment to Protect Non-Public Information (NPI) Agreement (Form FDA 3398) which will be provide at time of award. FAR 52-217-8 Option to Extend Services (NOV 1999), FAR 52-217-9 Option to Extend the Term of the Contract (MAR 2000) FAR 52.216-18 Ordering (OCT 1995) FAR 52.216-19 Order Limitations (October 1995) FAR 52.216-22 Indefinite Quantity (OCT 1995) 52.227-14, Rights in Data-General (June 1987), Alternate I (June 1987), Alternate II (June 1987), and Alternate II (June 1987), 52.217-7 Option for Increased Quantity- Separately Priced Line Item. (MAR 1989) are hereby incorporated by reference and apply to this acquisition. To determine its technical merit, each quotation will be evaluated against the technical evaluation factors. The evaluation factors are listed in descending order of importance. Technical and Past Performance when combined are significantly more important than cost or price. The Government intends to make one award. The following factors shall be used to evaluate offers: Factor 1. Product Functionality: A written technical quotation which demonstrates the following signal management capabilities: 1.Detection and quantification of safety signals through the use of disproportionality analyses (sometimes referred to as “data mining”) that can be applied to FDA’s spontaneous adverse event report database. Strong consideration will be given to those proposals demonstrating a thorough knowledge of disproportionality analyses incorporating Bayesian statistical methods applied to large drug safety databases to detect potential drug safety signals. 2.Signal strength that is derived from looking systematically at all the possible drug-event associations occurring in FDA’s adverse event reports, using disproportionally analysis to identify suspect drug-event pairs. 3.Resulting disproportionality scores (“signal scores”) should be viewable in tabular or graphical format. 4.Generated reports will need to provide full and direct access to signal scores and to underlying adverse event report data. 5.The system shall provide the capability to investigate specific data: case series, database queries, and standard and user-designed reports. 6.Identify unexpectedly frequent combinations of drugs and events, and to organize, identify, and analyze patterns in safety data Factor 2 Management Plan: The offeror shall propose a plan for providing consulting and technical services, training, and account management in accordance with the Statement of Work Attachment 1, which clearly demonstrates the technical requirements, customer service and training capabilities required to properly maintain a Customer-Off-The-Shelf (COTS) product. The Management Plan shall include a Service Level Agreement (SLA) to address the Performance Requirements. All proposed personnel shall demonstrate their expertise, experience, knowledge to successfully carry out the SOW. The offeror shall submit resumes of all proposed personnel in support of the quotation. (2 page limitation per resume) The documented experience shall be sufficient to demonstrate a working knowledge of the subject matter. 1)Name of Contracting Organization 2) Contract Number (for subcontracts, provide the prime contract number and the subcontract number 3) Contract Type, 4) Total Contract Value 5) Description of Requirement 6) Contracting Officer's Name and Telephone Number 7)Program Manager's Name and Telephone Number. Factor 3 Past Performance: Offerors shall submit the following information as part of their technical proposal. A list of the last 3 contracts completed during the past three years and the last three contracts currently being performed that are similar in nature to the solicitation work scope. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial concerns. Include the following information for each contract or subcontract listed: 1) Name of Contracting Organization 2) Contract Number (for subcontracts, provide the prime contract number and the subcontract number) Contract Type 4) Total Contract Value 5) Description of Requirement 6) Contracting Officer's Name and Telephone Number 7) Program Manager's Name and Telephone Number Offerors may provide information on problems encountered on the identified contracts and the offeror’s corrective action. The offeror shall submit comparable information on all subcontractors that the offeror proposed to perform a major subcontract under this effort. For the purpose of this solicitation, a major subcontract’ is defined as a subcontract over $550,000. The Government will contact each reference by phone to verify information past performance references. The Government may use the NIH Contractor Past Performance System, technical personnel, or contact other government agencies. The Government is not required to contact all references provided by the offeror. Also, references other than those identified by the offeror may be contacted by the Government to obtain additional information that will be used in the evaluation of the offeror's past performance. There is an Indefinite Quantity contract line item that requires additional training services and associated maintenance such as additional custom reports, minor application enhancements, upgrade Oracle, and additional security requirements that may be required. A task order may be issued against this line item for these services as stated in the Statement of Work as directed by the project officer. The maximum amount for the life of the contract, including options, is $500,000. For each task order issued under the indefinite quantity line item, the Government may order on a labor hour rate or a fixed price. The labor rates shall include all direct and indirect costs and profit for the applicable labor category. The contractor’s rates in pricing the individual task orders will be the rates in effect at the start of each task order or at the time an option if exercised. The contractor will not vary the labor hour rates during the pricing period for any task order, the pricing will remain constant. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial prices are fair and reasonable and that discussions are not necessary. FAR 52.212-1 Instructions to Offerors- Commercial Items (November 2007), FAR 52.212-2, Evaluation - Commercial Items (January 1999) 52.217-5 Evaluation of Options (July 1990) apply to this solicitation. Office shall comply with the provision at FAR 52.212-1(b) and submit 1 original and 6 hard copy and 2 CD to Brenda K. Lee, 5630 Fishers Lane, Room 2129, HFA-500 Rockville, MD 20857.) Electronic copies are not accepted. A technical description of the services being offered in sufficient detail to evaluate compliance with the requirements in this solicitation. 3) Offeror shall include a completed copy of the provision FAR 52-212-3 Offeror Representations and Certifications- Commercial Items (Mar 2008) which can be accessed electronically from the INTERNET at the following address: https://orca.bpn.gov. Offerors responding to this RFQ must be registered with the Central Contractor Registration (CCR), http://www.ccr.gov/ FAR 52-212-4 Contract Terms and Conditions- Commercial Item (February 2007) FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (February 2008) applies and these clauses are hereby incorporated into this contract by reference: 52.203-6 Restrictions on Subcontractor Sales to the Government (Sep 2006), 52.219-8 Utilization of Small Business Concerns( May 2004), 52.219-9 Small business Subcontracting Plan, 52.222-3 Convict Labor (June 2003) (E.O. 11755), 52.222-21 Prohibition of Segregated Facilities )FED 1999)(29 U.S.C. 793),52.222-26 Equal Opportunity (March 2007) (E.O. 11246, 52-222-35 Equal Opportunity for Special disabled Veterans, Veterans of the Vietnam Era, and Other eligible Veterans (SEP 2006)(38 U.S.C.4212), 52.222-36 Affirmative Action for workers with disabilities (Jun 1998)(29 U.S.C. 793), 52.222-37 Employment Report on Special Disabled Veterans of the Vietnam Era, and Other Eligible Veterans (Sept 2006)(38 U.S.C.4212), 52.222-39 Notification of Employee Rights Concerning Payment of Union Dues or Fees (DEC 20040(E.O. 13201), 52.222-50 Combating Trafficking in Person (AUG 2007), 52.232-33 Payment by Electronic funds Transfer-Central Contractor Registration (Oct 2003) (31 U.S.C. 3332), 52.239-1 Privacy or Security Safeguards (AUG 1996)(5 U.S.C.552a).FAR provisions and clauses may be found at http://www.acquisition.gov/far/index.html. Offerors may submit questions to Brenda Lee via email at brenda.lee@fda.hhs.gov. Please reference the specific area and location in the statement of work when asking a question. All questions must be submitted not later than 12:00 pm Eastern Time on September 11, 2008. All responsible sources that can provide and meet the above requirement shall submit a written quotation. Quotations must be received by September 15, 2008 4:30 p.m. Eastern Time. If you have any questions regarding this announcement, please email Brenda K. Lee. No telephone inquiries.
 

Web Link

FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=e45297203f2934ea10912c2d66a839d2&tab=core&_cview=1)
 

Document(s)

ATTACHMENT 1 Statement of Work
 

File Name: ATTACHMENT 1 STATEMENT OF WORK (Attachment 1 Statement of Work FDA-SOL-08-00931.pdf)

Link: https://www.fbo.gov//utils/view?id=b919423969629c972c9eafcb18e51338

Bytes: 109.72 Kb
 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: Contractor's facility, United States
 

Record

SN01663787-W 20080911/080909220511-e45297203f2934ea10912c2d66a839d2 (fbodaily.com)
 

Source

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

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