SPECIAL NOTICE
D -- Project Management / Workflow Software Solution
- Notice Date
- 7/6/2011
- Notice Type
- Special Notice
- 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-RFI-11-1090513
- Archive Date
- 8/2/2011
- Point of Contact
- Jody L. O'Kash, Phone: 301-827-5094
- E-Mail Address
-
Jody.O'Kash@fda.hhs.gov
(Jody.O'Kash@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This Request for Information (RFI) is for information, planning and market research purposes only and shall not be construed as either a solicitation or obligation on the part of the Food and Drug Administration (FDA) or its Centers. The purpose of this RFI is to help the FDA understand the market availability, technical characteristics, and functionality of solutions, tools, or products capable of satisfying the technical, functional, and/or operational characteristics described in this RFI. FDA will use this market research information to assess the market's capability to provide a comprehensive solution to the requirements described in the RFI. FDA welcomes responses from all interested parties. FDA does not intend to make a selection decision or award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or FDA's use of such information. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the outcome of the FDA's evaluation of the information received. Additionally, the FDA does not intend to hold discussions concerning this RFI with any interested parties. However, FDA reserves the right to contact vendors if additional information is required. 1. INTRODUCTION 1. Background and Key Objectives FDA is seeking a Project Management / Workflow Software tool to support 300 - 3,000 users within the Center for Drug and Evaluation (CDER) during the course of five years. The FDA will utilize the tool to support regulatory business processes and associated work assignments within CDER. Preferably, the solution should be a Commercial Off the Shelf (COTS) product that can be customized to meet the specific Workflow needs of individual Offices within CDER. The desired functionality that the solution should provide includes but is not limited to the following: 1.1. Portfolio management of work assignments at the center, office and division level 1.2. Resource capacity planning including availability check of resources 1.3. Tracking of individual employee work plans, work load and utilization along with time reporting. 1.4. Capability to define a work breakdown structure of tasks for each work assignment. 1.5. Capability to maintain an organizational structure which allows for delegation of tasks and maintaining approval chains. 1.6. Automatic import of work assignments using standard exchange standards 1.7. Manual creation of work assignments associated with key internal and external regulatory deliverables. 1.8. Performance tracking and flexible reporting capability at multiple levels including organizational, work assignment and resource levels 1.9. Basic workflow capability via email to close, update and edit work assignments/ tasks driven by due dates. 1.10. Basic pipeline management to determine whether projects can be executed in a specified time given resources applied 1.11. Role-based security access control. 1.12. Web based user interface 2.0 TECHNICAL ENVIRONMENT The current state of the CDER software environment includes the list below. 2.1 Server Operating Systems Sun Solaris 10 Microsoft Windows Server 2003 Microsoft Windows Server 2008 VMware ESX Server 3.5 2.2 Database Oracle 10G Enterprise Server (database) Oracle 11G Enterprise Server (database) Microsoft SQL Server 2005 Oracle Lite Oracle Grid Control Microsoft Access FileMaker Pro 2.3 Application Server Apache TomCat 5.5 Adobe ColdFusion 7 Adobe Cold Fusion 9 Oracle Application Server 10.1 WebLogic Servers 2.4 Web Servers Apache Web Server 5.0.x Embedded Apache web server in Oracle Application Server 10.1.x.x Microsoft IIS 6.x 2.5 Programming Languages and Frameworks Java EE5 and EJB 3.x Oracle 10g Forms and Reports Oracle 6i Forms and Reports.NET 2.x Business Objects XI R2 Business Objects XI R3 Visual Basic Adobe Flex PL/SQL Strut XML J2EE J2EE Ajax Framework Secure Shell (SSH) Secure File Transfer Protocol (SFTP) 2.6 Integrated Development Environment Oracle JDeveloper 10.1.2 Net Beans 6.x Eclipse Adobe Flash Builder 4.x Dreamweaver 3.0 GENERAL REQUIREMENTS: 3.1 PILOT PHASE: In the effort to determine whether or not to proceed with the full implementation of the proposed software tool, the FDA has determined it is in the best interest of the Government to issue a task order upon award of a contract for the contractor to demonstrate their suggested solution during a Pilot Phase with CDER's Office of Compliance. 3.1.1 Pilot in Office of Compliance (PART I): Configuration and Implementation The contractor shall review FDA Constraints and Business Processes, install, configure, implement, and conduct training of the accepted Software tool for a maximum of 300 users within CDER's Office of Compliance as part of a pilot phase. The use of the tool by users in the Office of Compliance will assist the FDA in determining the tool's capability to meet CDER's need. 3.1.2 Pilot in Office of Compliance (PART II): Propose Customizations As part of the Pilot Phase, the contractor will interview key contacts from between one to three sub offices within the Office of Compliance. Based on interview feedback, the contractor can propose customizations to the software tool that will further meet the needs of the Office of Compliance. The FDA COTR will review the proposed customizations and determine if they would provide an added value to CDER. Any / All accepted customizations will be executed via a separate task order to the contract. 3.1.3 Pilot in Office of Compliance (PART III): Customer Support The contractor shall be available to ensure the selected tool is defect free in the FDA provided software environment and address any questions that cannot be answered internally. 3.2 FULL IMPLEMENTATION Upon completion of the pilot phase the FDA will determine if it is in the best interest of the Government to issue additional task orders for broad implementation and support for up to 3,000 CDER users. Support shall cover the following CDER Offices: • Office of New Drugs (OND) • Office of Surveillance and Epidemiology (OSE) • Office of Pharmaceutical Science (OPS) • Office of Translational Sciences (OTS) • Office of Medical Policy (OMP) 3.3 SUPPORT, TRAINING, AND ADDITIONAL ENHANCEMENTS Upon full implementation the FDA CDER may issue individual task orders for additional licenses, support, training, and enhancements. 4.0 INSTRUCTIONS: Interested parties shall submit the following information along with other documentation that would help the FDA better understand the functional capabilities of available solutions. 1. Provide a suggested Available Commercial Off-the-Shelf (COTs) solution and / or solutions that may meet the FDA's objectives as listed above and general rationale for suggested solutions (s). 2. Please advise what FDA requirements listed above can be developed out of the box, with configuration or as a customization. 3. Please note whether your COTS software tool is a perpetual or a term licenses 4. Provide a written explanation for points that standard marketing or technical reference materials do not explain about your suggested solution (s). 5. Generally, are the solutions purchased directly from the manufacturer or are they available through licensed resellers? 6. If the products are only offered by the manufacturer, are there licensed small businesses, 8a, women-owned, veteran-owned, HUB Zone vendors, etc... that are available to provide training and customizations? 7. Would it be beneficial for the Government to issue two contracts (one for the purchase of license / maintenance / the other for configuration, training, customization) to promote competition and fair opportunity? 8. What acquisition vehicles are available to purchase proposed software tools and services that would make the acquisition process more efficient? (GSA, GWACs, NASA SEWP etc...) 9. Please provide any additional input on how the FDA can best procure the software licenses. 10. Generally, what tasks are associated with implementing your suggested solution(s)? 11. What information would be helpful in determining the level-of-effort for implementation of the software tool? 12. What standardized support is provided by the manufacturer with purchase of the selected COTs tool? 13. Do you suggest the FDA purchase customized support in addition to the standardized support? If so, what type of customized support is offered for suggested solutions? 14. What information would be helpful in determining the level-of-effort for customized support of the software? 15. Do most companies that sell Project Management and Workflow Solutions offer standardized training at a fixed price? If so, is it possible to customize the standardize training to meet the FDA's needs? 16. Explain the standardized training and/or online help that would be available to the end users with your product/solution. 17. Provide publicly available pricing information, price lists, pricing strategies, discount strategies, etc. Provide and explain pricing model(s) (i.e., license-based, user based, number of documents, peak queries per second (qps), average qps, size of all documents/files/text within documents, size of index file(s), other. Include annual maintenance model. Provide the pricing model for training offered. Provide the pricing model for your professional services offering. 18. Please identify product modules that are included in your pricing estimate. 19. Disclose whether your business is in the manufacturer of the product/solution or if your business is a reseller or third party. 20. Please provide documentation of the size of your business. If you are classified as a small business, HubZone small business, Service Disabled Veteran Owned Small Business, Woman-owned small business and/or 8(a) certified small business, please provide a capability statement in addition to the other information for acquisition strategy determination. 21. Please provide the following: a. Organization name b. DUNS Number c. Organization's website d. Contact Name e. Contact Telephone f. Contact E-mail address g. Size designation h. Number of employees in your organization 22. Explain whether or not your product adheres to Section 508 Accessibility Requirements which requires Federal agencies to ensure that individuals with disabilities who are members of the public or Federal employees have access to and use of electronic and information technology (EIT) that is comparable to that provided to individuals without disabilities. See http://www.access-board.gov/508.htm for more information. 23. Explain how the suggested solutions is compatible with FDA's Technical Environment identified in section 2.0 or can be configured to be compatible. Identify risks that would be associated with configuring the software to be compatible with the FDA enviroment. 24. List of where product/solution is currently in use. Provide point of contact, telephone number, contract number, period of performance, organization supported, indication of whether a prime or subcontractor, contract value, and a brief description of how the contract referenced relates to the technical services described herein. 25. Skills and Certifications: Provide unique technical skills and relevant certification your staff and company possesses, which demonstrates capability to perform the tasks. All Interested Parties shall respond by sending their responses via email to Contracting Officer Jody O'Kash at jody.okash@fda.hhs.gov.
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