Data Validation Program

Amendment #1: This requirement is for the Food and Drug Administration. (FDA). Responses are limited to 6 pages. This is a SOURCES SOUGHT NOTICE to determine the availability and capability of businesses, specifically small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, women-owned small businesses, and economically disadvantaged women-owned small businesses) to provide a dashboard-driven, data standards checking platform in CDER that shall support CDER's multiple needs. Responses from all firms will be accepted. Interested small business potential offerors are highly encouraged to respond to this notice. However, be advised that generic capability statements are not sufficient for effective evaluation of respondents' capacity and capability to perform the specific work as required. Responses must directly demonstrate the company's capability, experience, and ability to marshal resources to effectively and efficiently perform the tasks described in the Statement of Work (SOW), at a sufficient level of detail to allow definitive evaluation; and evidence that the contractor can satisfy the minimum requirements listed above while in compliance with FAR 52.219-14 ("Limitations on Subcontracting"). Failure to specifically address these requirements will result in a finding that respondent lacks capability to perform the work. Responses to this notice shall be limited to 6 pages, and must include: 1. Company name, mailing address, e-mail address, telephone and FAX numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2. Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3. Business size for NAICS 541511 (size standard $25 million) and status, if qualified as an 8(a) firm (must be certified by SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, Economically Disadvantaged Women-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran-Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 4. DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the Central Contractor Registry (CCR, at www.ccr.gov) to be considered as potential sources. 5. Identification of the firm's contract vehicles, including GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6. If the company has a Government approved accounting system, please identify the agency that approved the system. Your response must also address each specific technical question as follows: 7. Working knowledge of CDISC standards for clinical and pre-clinical study data including SDTM, ADaM, and SEND 8. Proven enterprise-level integration of your data quality assessment program with at least OpenCDISC data conformance checking software 9. Detailed familiarity with CDER Data Standards requirements 10. Expertise in integration of data quality assessment tools with databases 11. Expertise with development of user interface technology such as java 12. Expertise with xml, sas, and R programming 13. Please provide comments, suggestions, or questions concerning the attached draft statement of work. Please submit copies of any documentation such as letters or certificates to indicate the firm's status (see item #3, above). This is not included in the overall page count. Teaming arrangements are acceptable, and the information required above on the company responding to this announcement, should also be provided for each entity expected to be teammates of the respondent for performance of this work. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, a Solicitation, a Request for Quotes, or an indication the Government will contract for the items contained in this announcement. This request is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government will not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. Responses to this notice must be received by the Contracting Officer named in this announcement no later than 12:00 p.m. ET on Tuesday, July 19, 2011 for consideration. E-Mail is the only acceptable method of delivery for this sources sought notice. Responses to this announcement will not be returned, nor will there be any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, and FDA may contact one or more respondents for clarifications and to enhance the Government's understanding. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses. Thank you for your interest.