Recall Audit Checks

Sources Sought Notice 1196575 U.S. Food and Drug Administration (FDA) - Office of Regulatory Affairs (ORA) - Recall Audit Checks 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 or its Centers. The purpose of this RFI is to identify INTERESTED VENDORS 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 OC/OHS's requirements for monitoring recalls. FDA welcomes responses from all interested small businesses. 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 vendors if additional information is required. Overview: The Food and Drug Administration (FDA) protects public health by coordinating, initiating, and/or monitoring regulatory and recall actions, reviewing and managing compliance policies and processes, and evaluating data to assess and enhance agency compliance activities. The Office of Regulatory Affairs (ORA) within FDA has substantially evolved its product safety and quality model to keep ahead of the possible risks in an ever-changing world of manufacturers and producers. While import growth, rates have accelerated, so too has the need for highly standardized operations within the government and the marketplace. The new global implications have forced FDA to recognize major implications such as pressures to reduce cost, increase productivity and capitalize on quality improvement activities while maintaining strong global safety standards. The FDA seeks to acquire contractor support for the FDA recall program. Specifically, the FDA seeks contractor support in conducting a combination of approximately 2,000 Recall Audit Checks (RACs) and reconciliation of distribution lists to the retail level. The primary duties will be to conduct RACs throughout the recall distribution channel for all FDA regulated products and secondarily to reconcile and consolidate recall distribution lists. The FDA has classified Recalls in a manner that indicates the relative degree of health hazard presented by the product being recalled. These classifications are: - Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. - Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. - Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. The RACs and reconciliation work will be requested on an incident basis, focused on Class I recalls and Class II recalls. 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- 1196575 Responses to the RFI should not exceed 10 pages in length. The page limitation does not include the attached RFI 1196575 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: 561990: All Other Support 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 1196575 Vendor Feedback Form - Potential offerors must complete the attached response sheet and submit with their RFI submission. Responses to this notice must be submitted via email to BOTH Piya Sawhney (Piya.Sawhney@fda.hhs.gov) and Michelle Creenan (michelle.creenan@fda.hhs.gov). Responses will not be accepted by any other means. Responses are due by 5:00 PM Eastern Time (ET), Thursday, December 13, 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.