SOURCES SOUGHT
70 -- FDA Master Data Management - Key Technologies Support Matrix - Draft BPA SOW - Draft Call 3 SOW - Draft Call 1 SOW
- Notice Date
- 5/30/2013
- Notice Type
- Sources Sought
- 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-RFI-13-IntegrityII
- Archive Date
- 7/5/2013
- Point of Contact
- Danielle Pena, Phone: 301-443-5860
- E-Mail Address
-
Danielle.Pena@fda.hhs.gov
(Danielle.Pena@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Draft Call 1 SOW Draft Call 3 SOW Draft BPA SOW Key Technologies Support Matrix Notice to Small Businesses The purpose of this Sources Sought Notice/RFI is to seek declarations of technical capabilities and various information, data, and materials from qualified small business concerns [Woman-owned Small Businesses (WOSB), Historically Underutilized Business Zone (HUBZone), Small Businesses, and Service-Disabled Veteran-owned Small Businesses (SDVOSB)]. Food and Drug Administration intends to provide maximum practicable opportunities in its acquisitions to small business, service-disabled veteran-owned small business, and HUBZone small business. Background This Sources Sought 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 or its Centers. The purpose of this RFI is to help the FDA understand the industry best practices and technical solutions capable of providing the full range of services described in this RFI and the draft SOW. FDA will use this market research information to assess the market's capability to successfully meet FDA's Master Data Management requirements. 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 review 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. General Instructions Responses to the RFI should not exceed 20 pages in length. The 20 page limit excludes the completed version of the "Key Technologies Support Matrix" and the labor category descriptions. They should be submitted via email to Danielle Pena at by 3:00PM on Thursday, June 6th. A complete response to the RFI should include answers to all of the questions below and a completed version of the attached "Key Technologies Support Matrix". Please note that a respondent's failure to provide a complete response to a question will be interpreted to mean that it does not understand the question and does not demonstrate the capability to provide services required. Responses should demonstrate capability, not merely affirm the respondent's capability (e.g.: The response must go beyond the statement that, "XYZ company can provide O&M support."). Questions: 1. The Draft SOWs describes the following high-level task areas under which task orders may be released to obtain specific master data management engineering and technical support services. The representative technologies described in the SOW are not comprehensive; they are intended to provide an overall understanding of the breadth and technical sophistication of the technologies employed by the FDA and the level of expertise and capabilities sought by the FDA under this contract. Please demonstrate your capability in the task areas provided below. A. From Master Data Management BPA: I. Project Management II. Documentation Management III. Concept Development / Business Analysis IV. MDM Governance V. HHS FDA Enterprise Performance Life Cycle Development VI. Operations and Maintenance Support VII. Training Support B. From Integrated MDM - INTEGRITY Phase II: BPA Call 1 I. Work Item 1: Development of the integrated Facility/Site and Supply Chain Master Data Repositories II. Work Item 2: Development of the Drug Product Dictionary C. From ORA Establishment MDM BPA CALL 3: I. Develop Strategy and Roadmap II. Conduct Requirements and Impact Analysis III. Develop Governance and Standards Process IV. Support Hardware Procurement and Provisioning V. Implement Pilot Please demonstrate your firm's capability with supporting planned Operations & Maintenance releases. Tentatively FDA has planned quarterly O&M releases for the Integrity platform and all supporting MDM repositories as detailed in BPA Call 1. Examples of enhancements may include features and functions identified to support business operations, graphical user interface (GUI) changes, adding/updating source data system(s) to existing master data repositories, providing master data to additional downstream system(s), adding data entities and data fields, development and implementation of data upload/supply scripts, etc. For the base year of the Integrity O&M contract, the Contractor shall provide the following enhancements to support the Integrity MDM platform and Product Master Data Repository: • First O&M release enhancement (3-6 months after contract award): a) upgrade the Integrity SPL Enrichment/Validation module in order to validate and consume all types of structured product labeling (SPL) documents beyond the product listing SPLs implemented in Integrity Phase I (e.g., self-identified facility, NDC labeler code, etc.); b) integrate additional source data system(s) and support additional downstream system(s) as identified during the business operation. • Second O&M release enhancement (6-9 months after contract award): a) upgrade the Product Master Data Repositories to include Product Specifications and Patents as part of the master data; b)integrate additional source data system(s) and support additional downstream system(s) as identified during the business operation. In addition, please describe your firm's capability with cloud computing solutions and technology and with iterative, incremental development approaches, including rapid prototyping and other agile methodologies that involve frequent interaction and feedback from end users. These are not specific task areas in the Draft Statements of Work, but are methodologies that FDA is interested in exploring. 2. Please provide a brief narrative explaining how you would approach providing the range of highly specialized, highly technical IT and services in implementing master data management principle, including appropriate governance structure. Describe how the approach has proven successful in past efforts that are similar to this one in size, scope and complexity. Recommend performance and customer satisfaction measures and indicators that would give FDA adequate ability to monitor the quality of the services provided. 3. Please provide a list of suggested Labor Categories to support the work described in the draft SOW. Include a brief narrative description of each Labor Category that identifies education, certification, and experience you deem critical or necessary to successfully execute this work. Please describe the difference between senior and junior level categories. 4. The IGCE for this requirement is not yet finalized; however, it is estimated that the ceiling could be as high as $100M across the entire agency. There will be multiple simultaneous task orders that require specialized capabilities in diverse technologies (both existing and emerging). Please describe your capability to staff and manage a project of this magnitude and complexity in terms of project scope, multidisciplinary scientific and technical skill sets required. Discuss methods of attracting and retaining technical expertise, whether within your firm or by using partners/subcontractors, and describe any certifications (e.g. ISO or CMMI) that demonstrate proven management and quality outcomes. 5. Have you supported the key technologies that are inherent in our solution in the past? If so, please describe this support. Please refer to the Master Data Management Key Technologies Support Matrix for the list key technologies. To answer this question please utilize the attached document- "Key Technologies Support Matrix". 6. Please provide documentation of the size of your business. If you are classified as a small business, Historically Underutilized Business Zone small business, Service Disabled Veteran Owned Small Business, Woman-Owned Small Business and/or SBA 8(a) certified small business. Please provide a capability statement in addition to the other information for acquisition strategy determination. Additionally, please demonstrate your firm's capability to meet the requirements of FAR 52.219-14, Limitations on Subcontracting. 7. Please provide suggested appropriate North American Industry Classification System (NAICS) code and rationale. 8. 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 i. Your organization's current and gross revenue 9. Provide information concerning contract vehicles available to be used by the FDA in acquiring the services outlined in the draft SOW (GSA Federal Schedules, Government wide Acquisition Contract, etc.). Attachments: 1. Draft BPA and Call Order SOW's 2. Key Technologies Support Matrix
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