FILE | D | Data Mining Internet Sites for FDA compliance - Statement of Work

FBO DAILY ISSUE OF SEPTEMBER 10, 2008 FBO #2480
DOCUMENT

D -- Data Mining Internet Sites for FDA compliance - Statement of Work

Notice Date: 9/8/2008
Notice Type: Statement of Work
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: FDA-SOL-08-1046462
Archive Date: 9/27/2008
Point of Contact: Rafael Taylor,, Phone: 301-827-7169, Jody L. O'Kash,, Phone: 301-827-5094
E-Mail Address: Rafael.Taylor@fda.hhs.gov, Jody.O'Kash@fda.hhs.gov
Small Business Set-Aside: Total Small Business
Description: (i) This is a combined/synopsis solicitation for commercial items prepared in accordance with the format in FAR 12.6, as supplemented with additional information included in this notice. (ii) This is solicitation number FDA-SOL-08-1046462 and this solicitation is being issued as a Request for Quote (RFQ). (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-12. This is a total small business set-aside. (iv) The NAICS code is 541519. The size standard $25M. (v) See attached lists for line items required for this order. (vi) DESCRIPTION OF REQUIREMENTS: STATEMENT OF WORK: The objectives of this project are (1) to use commercial, off-the-shelf software (COTS) solution for intelligent searching and report of internet sites; and (2) to facilitate development of intelligent web and database searching capability in search scenarios of FDA interest. Once customized for FDA, the software is to be implemented as a permanent, updatable search and analysis tool. TASK 1 – Discovery. Assist FDA risk and data experts in developing user scenarios and targeted web sites for data mining of internet web sites offering finished drugs, active pharmaceutical ingredients (APIs) and excipients for drug manufacturing. In particular, results of data mining that support risk identification for products and markets prone to (a) supply chain substitutions and (b) direct-to-consumer marketing are of high value in supporting compliance program decision making concerning risks from either approved or unapproved drug products. 1.1 Meet with FDA work group to review project requirements and define user scenarios and segments. 1.2 Conduct high-level architecture reviews with FDA technical resources including •data sources and updating strategy, •hardware requirements, and •user interface and experience requirements. 1.3 Finalize project scope and Release Plan. TASK 2 – Development Iterations. Work with FDA risk and data experts to validate functionality in short, “design/develop/test” work spirals that are focused on FDA’s data mining scenarios. This task includes: 2.1 Coordinate planning meetings and demo each round of design/develop/tests for FDA feedback. 2.2 Incorporate the scope and functional feedback into future work spirals. TASK 3 – Release Iteration. Work with FDA risk and data experts to confirm client acceptance criteria and finalize a release “go/no-go” decision. This task includes: 3.1 Review and confirmation of client acceptance criteria. 3.2 Coordination and support of a User Acceptance Test. 3.3 Completion of performance and load testing. 3.4 A “go/no-go” decision with FDA’s project manager. TASK 4 – Go Live Support. Migrate the data mining application to a staging and production environment, resident on FDA servers and transition the FDA team to general application support. This task shall include: 4.1 Migration to a production environment 4.2 Documentation of lessons learned and outcomes of the development phase. 4.3 Identification of future enhancement and any known backlog. 4.4 Updating and delivery of technical and end-user documentation. 4.5 Development of go-live and launch materials. 4.6 Training of FDA personnel (users and IT support). TASK 5 –Enabling Support. Provide continuing technical support for the remaining “Proof of Concept” year. (vii) Place of Performance: Customization of the software will take place at the contractor’s place of business. Task 4 will require the contractor to work with FDA personnel at the FDA facility in White Oak to install the customized software and train the users. Task 5 may require the contractor to visit the FDA facility if technical support is required during the course of the contract. Deliverables – Reporting Requirements and Deliverable Items. • Customized software application to be hosted on FDA’s servers. • Perpetual software licenses for five seats. • User training in-house at FDA. • Staging and release of “developed” software to a production environment that identifies sites for repeated data mining. • Professional services consulting on optimal search frames, given the software capabilities and FDA scenarios. 1. Progress/ Reports Biweekly status reports that contain a list of completed tasks, list of planned tasks, list of known risks, issues, and dependencies. 2. Final Report This report is to include a summation of the work performed for the entire contract period of performance. All reports are to be in Microsoft Word or Excel format and accompanied by an electronic version. (viii) The provision at 52.212-1, Instructions to Offerors (APR 2008) -- Commercial, applies to this acquisition and is available at website: http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/12.htm#P257_45709. (ix) The provision at 52.212-1, Evaluation -- Commercial Items (Jan 1999) The Government will award a purchase order contract resulting from this solicitation to the lowest responsible offeror whose offer conforming to the solicitation will offer the best value to the Government. (x) Vendors shall complete FAR 52.212-3, Offerors Representations and Certifications - Commercial Items (JUN 2003). This can be done electronically at http://orca.bpn.gov. The contracting officer will review the vendor’s online certifications at http://orca.bpn.gov to ensure that they are accurate and complete. If the vendor does not have active representations and certifications registered online they will be disqualified from being considered for award. (xi) The clause at 52.212-4, Contract Terms and Conditions - Commercial Items (FEB 2007), applies to this acquisition. (xii) The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (JUNE 2007), applies to this acquisition as well as the following clauses cited therein: 52.219-6, Notice of Total Small Business Set-Aside (JUN 2003) (Alternate I OCT 1995), 52.222-3, Convict Labor (JUN 2003)(EO 11755); 52.222-19, Child Labor - Cooperation with Authorities and Remedies (JAN 2006)(EO13126); 52.222-21, Prohibition of Segregated Facilities (FEB 1999); 52.222-26, Equal Opportunity (MAR 2007)(EO11246); 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era and other Eligible Veterans (SEP 2006)(38 USC 4212); 52.222-36, Affirmative Action for Workers with Disabilities (JUN 1998)(29 USC 793); 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era and other Eligible Veterans; 52.222-50, Combat Trafficking in Persons (AUG 2007); 52.232-33 Payment by Electronic Funds Transfer - Central Contractor Registration (OCT 2003), 52.225-1 52.225-13 Restriction on Certain Foreign Purchases (FEB 2006), 52.239-1 Privacy or Security Safeguards (AUG 1996) (5 U.S.C. 552a). Full text of clauses and provisions can be accessed at www.arnet.gov/far. (xiii) In order to comply with Section 508 of the Rehabilitation Act, the Government asks vendors to complete a Voluntary Product Accessibility Template (VPAT) and submit it with their quote. The technical standards applicable to this requirement are: 1194.21 Software Applications and Operating Systems (a,b,c,d,e,f,g,h,i,j,k,l ), 1194.22 Web-based Intranet and Internet Information and Applications, 1194.31 Functional Performance Criteria (a,b,c,d,e,f) and 1194.41 Information, Documentation, and Support (a,b,c). The 508 technical standards are available at http://www.section508.gov/. All questions, if any, must be submitted in writing to Rafael.taylor@fda.hhs.gov or Jody.O’Kash@fda.hhs.gov no later than Wednesday, September 10, 2008 at 4pm EST. Answers to all questions will be posted as an amendment to the solicitation. Proposals and VPAT may be submitted electronically at Rafael.taylor@fda.hhs.gov and/or Jody.O'Kash@fda.hhs.gov no later than Friday, September 12, 2008 at 4pm EST.
Web Link: FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=6b10aeba12a104ff9eed0c83a345fb96&tab=core&_cview=1)
Document(s): Statement of Work; File Name: SOW (STATEMENT OF WORK_8-22-08.doc); Link: https://www.fbo.gov//utils/view?id=6394db7f477fbe7456a13f7ca1ee1692; Bytes: 49.50 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: 10903 New Hampshire Ave W051, Silver Spring, Maryland, 20993, United States; Zip Code: 20993
Record: SN01662495-W 20080910/080908220046-6b10aeba12a104ff9eed0c83a345fb96 (fbodaily.com)
Source: FedBizOpps Link to This Notice
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D -- Data Mining Internet Sites for FDA compliance - Statement of Work