RECALL AUDIT CHECKS

RECALL AUDIT CHECKS This SOURCES SOUGHT NOTICE is posted for informational purposes only. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform the project requirements identified below. This is strictly market research to assist in determining the appropriate acquisition strategy to obtain contractor support services to perform the same or similar requirements to those described in this notice. Responses to this sources sought notice shall be the submission of a capability statement; accordingly, the Food and Drug Administration will not entertain questions regarding the results of the market research. Background. 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 in order to keep ahead of the possible risks in an ever changing world of manufacturers and producers. A recall is a firm's removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers. A correction is further defined as the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location. Any firm may initiate a recall when its product is deemed to be in violation of FDA regulations and laws. Throughout the execution of a recall, it is the FDA's responsibility to provide guidance to recalling firms, determine the hazard posed by the recalled product, inform the public of potential health risks, and monitor firms' recall effectiveness, in part, by conducting recall audit checks (RACs) at recalling firm's consignees to determine whether the consignee received the recall notification and followed instructions in the notification. Recall classification means the numerical designation, i.e., I, II, or III, assigned by the Food and Drug Administration to a particular product recall to indicate the relative degree of health hazard presented by the product being recalled: 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; and Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. Purpose and Objectives. The purpose of this project is to acquire a contractor to conduct approximately 1,000 recall audit checks (RACs) of FDA regulated products. The RAC will be requested on an incident basis, focused on Class I recalls and Class II recalls. Additional audit recall checks may be added up to a maximum of 5,000. Project Requirements. The project will require a contractor to conduct recall audit checks based on the information contained in the RAC Assignment Memo issued by FDA. RACs shall be conducted in-person at each location identified in the RAC assignment. When conducting the RAC the contractor determines whether the consignee received the recall notification and is following or has followed the instructions in the notification. The contractor shall be able to recognize and adjust to the differences in a firm's recall strategy e.g. a recall strategy may not remove recalled product from the market but may correct recalled product in some manner. The contractor/auditor conducts a RAC primarily to confirm the consignee received and followed the instructions in the recall notification. The contractor shall have a computerized data system to be used for the management of recall audit checks that includes, but is not limited to, data collection, storage, reporting, and tracking. The FDA shall have permission to access the computerized data system. The system shall be capable of storing the data collected during the recall audit checks and allow access through a secure web-based system that is capable of scaling for up to 200 FDA employees working with the recall audit check information. Contractor shall provide written reports to FDA on each RAC assignment. Anticipated Period of Performance. It is anticipated that the period of performance will be for a base period of 12 months and have four 12 month option periods to be exercised at the discretion of the government. Capability Statements. Respondents are asked to submit a capability statement which provides information on organizational experience and current in-house capability and capacity to perform the project requirements. Respondents are requested to provide the following business information: DUNS Number, Company Name, Company Address, Company Point of Contact (name, telephone, and email address), and Type of Business (e.g., large, small, 8(a), woman owned, veteran, HUBZone, etc.) pursuant to the applicable NAICS Code 561990 - All Other Support Services, Size Standard - $11 million in annual receipts. Response Format. Capability statements should be provided in Adobe PDF with page size 8.5 x 11 inches. Font shall be Times New Roman Size 12 with no less than single spacing between lines. The maximum number of pages for submission is 15 pages. The Cover Page and the Table of Contents are not included in the page count. Due Date. Capability statements must be received by 1:00 p.m. (Eastern Standard Time) on Friday, May 15, 2015. Submission. Submit capability statements electronically via email to Zetherine Gore, Contract Specialist at zetherine.gore@fda.hhs.gov. Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).