RIF-RIM

Sources Sought Notice FDARIM U.S. Food and Drug Administration (FDA) - Center for Drug Evaluation and Research (CDER) - Records Information Management (RIM) Contract THIS IS NOT A REQUEST FOR PROPOSALS/QUOTES - THIS IS A SOURCES SOUGHT NOTICE/REQUEST FOR INFORMATION, AND INFORMATION SUBMITTED WILL BE USED FOR MARKET RESEARCH PURPOSES ONLY. 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 and its Centers. The purpose of this RFI is to identify INTERESTED 8(a) contractors that are capable of providing the full range of services described in this RFI and the draft statement of work (SOW). FDA will use this market research information to assess the market's capability to successfully meet FDA's Center's requirements for On?Site Records Information Management. FDA welcomes responses from all interested8(a) contractors. FDA does not intend to make a decision or award a contract on the basis of responses nor otherwise reimburse interested sources for the preparation of any information submitted for FDA's use of such information. FDA reserves the right to contact contractors if additional information is required. Overview: The mission of the Food and Drug Administration (FDA) is to protect the health of the American public (www.fda.gov). For more than one hundred years, FDA has been the international leader ensuring safe food, cosmetics, human drugs and biologics, veterinary products, medical and radiological devices, and tobacco products. As part of its mission the FDA receives records materials from a variety of public and private entities including regulated industry. Throughout FDA's history, records management has played a vital role in the agency's regulation process and ultimately, in the mission to protect public health. This allows FDA to comply with federally mandated record keeping requirements while maintaining a high level of accountability to the citizens of the United States. In order to ensure proper organization and management of records the FDA complies with regulations set forth in the Federal Records Act per United States Code (U.S.C.), Title 44, Chapters 29 thru 33; Title 36 Code of Federal Regulations (CFR), Chapter 12; and National Archives and Records Administration (NARA) guidance. In addition, the FDA strives towards a streamlined 21st Century electronic Records Information Management (RIM) environment that preserves the integrity of public records while creating cost efficiencies that allows the agency to focus on advancing in scientific and public health efforts. Over the last quarter century major shifts in records storage, multimedia management, disclosure requirements, electronic product submission, scientific computing and federally mandated records keeping requirements make it necessary for FDA to move from a paper centric agency to a media neutral information-based organization. This contract will provide direct support to FDA's move to a broader information-based organization by supporting core functions related to the processing records material that support scientific advancement, public health issues and the regulatory review process. All FDA Offices and Centers are stakeholders under this Indefinite Delivery Indefinite Quantity (IDIQ) Vehicle. It is the Government's intention to award an Indefinite Delivery Indefinite Quantity (IDIQ) contract with a five (5) year performance period. General Instructions: Respondents to this notice must provide the following information: - Completed "Vendor Feedback Form" - CPARS evaluations for any contract identified in the Vendor Feedback Form - Company's Capability Statement - Capability to meet the requirements of FAR 52.219-14, Limitations on Subcontracting - A Cover Page that includes the following: 1. Company Name and Address 2. DUNS Number 3. Company socio-economic status (i.e. SB, 8(a), VOSB, SDVOSB, HUBZone, SDB, WOSB, etc.) 4. Point of Contact (Name, Email, and Phone Number) 5. Email Subject: Request for Information- FDARIM Responses to the RFI should not exceed 15 pages in length. The page limitation does not include the attached RFI FDARIM Vendor Feedback Form, completed CPARS evaluations, or comments on the attached draft documents. A complete response to the RFI must include the information requested below. 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 the requested services."). Please provide documentation of the size of your business for the selected North American Industry Classification System (NAICS) code: 541990: All Other Professional, Scientific and Technical Services. Attachments: 1. Draft SOW: See attached DRAFT statement of work (SOW), which is subject to change. Potential offerors responding to this notice are highly encouraged to review the attached DRAFT SOW, and provide comments and feedback using the Tracked Changes and comment features found in MS Word. 2. RFI FDARIM Vendor Feedback Form - Potential offerors must complete the attached response sheet and submit with their RFI submission. 3. DRAFT Evaluation Factors - See attached DRAFT evaluation factors, which is subject to change. Potential offerors responding to this notice are highly encouraged to review the attached DRAFT evaluation factors, and provide comments and feedback using the Tracked Changes and comment features found in MS Word. Responses to this notice must be submitted via email to Haritha Raja (Haritha.Raja@fda.hhs.gov) and Michelle Creenan (michelle.creenan@fda.hhs.gov). Responses will not be accepted by any other means. Responses are due by 10:00 PM Eastern Time (ET), Friday December 21, 2018. Late responses may not be considered. THERE IS NO SOLICITATION AT THIS TIME. This request for capability information does not constitute a request for quote/proposals; submission of any information in response to this market survey is purely voluntary; the government assumes no financial responsibility for any costs incurred. The result of this market research will contribute to determining the method of procurement.