Open Source Intelligence (OSINT) Services for Predicitve Risk-Based Evaluation and Dynamic Import Compliance Targeting System (PREDICT)

***All small businesses, regardless of classification are encouraged to reply to this Sources Sought notice*** THIS IS A SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses [HUBZone, Service-Disabled Veteran-owned, small disadvantaged, 8(a), and woman-owned] ONLY. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, Solicitation, Request for Quotes, or an indication the Government will contract for the items contained herein. This notice 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 notice. The Government does 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 sources sought. Any responses received will not be used as a proposal. The U.S. Food and Drug Administration (FDA) are seeking small businesses that are capable of providing the following services: OSINT (Open Source Intelligence) for PREDICT (Predictive Risk-Based Evaluation and Dynamic Import Compliance Targeting) Import Screening System 1. The Contractor shall continually monitor OSINT sources for, and produce reports about, events affecting the safety, legality, or security of FDA regulated products. The Contractor shall conduct specialized analysis in order to link companies, products, people, and/or warnings to each other in order to understand the potential impact of a product entering the US and, if possible, shed light on the cause and origin of a reported illness. The Contractor shall provide commentary on the impact that events or information within each one of the reports should have on PREDICT risk ratings. Representative events or circumstances that the Contractor would be expected to report on include, but are no means limited to, reports of: - A natural disaster in a foreign country exporting FDA regulated products to the US - An outbreak of a virus in a foreign country exporting FDA regulated products to the US - An outbreak of a virus in a species of fish consumed in the US - Abnormalities, such as unexplainable coloring, in a food product exported to the US - Adulteration of food products exported to the US - Weather conditions abroad affecting the production or safety of FDA regulated products, such as drought, air pollution, or heavy rainfall - A producer's implementation of new methods for producing an FDA regulated product, such as the use of genetic modification in the production of a food product - The production or sale abroad of medicines, dietary supplements, or other medical products that are banned in the US 2. In addition to conducting routine monitoring of OSINT sources in order to inform PREDICT risk ratings, the Contractor shall respond to information requests from other FDA Centers. These requests: - May be broadly or loosely phrased - May require a one-time response or a series of ongoing responses - May require quick turnaround (1-2 days or less) Responses to Information Requests could be about, among other topics: - The illegal importation of a particular product or a violation of FDA or Customs regulations - A new foreign produced medical device that was previously unknown to the FDA, its purpose, and the extent and manner to which it is being offered for commercial distribution or sale - Products used, sold, or marketed for the treatment of serious diseases, but which have not been FDA approved Small businesses are encouraged to respond if they have the capability and capacity to provide the identified services. Interested small business potential offerors are 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/or ability to marshal resources to effectively and efficiently perform the task described above at a sufficient level of detail to allow definitive numerical 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 definitively address each of these factors will result in a finding that respondent lacks capability to perform the work. Responses to this notice shall be limited to 5 pages, and must include: 1. Demonstrated experience of performance and/or ability to supply all required services and materials listed above. 2. 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. 3. Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 4. If qualified as an 8(a) firm (must be certified by the Small Business Administration (SBA), Small Disadvantaged Business (must be certified by SBA), Woman-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). 5. DUNS number, CAGE Code, Tax Identification Number (TIN), and company structure (Corporation, LLC, partnership, joint venture, etc). Companies also must be registered in the Central Contractor Registration (CCR) at www.ccr.gov to be considered as potential sources. 6. Identification of any GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 7. If the company has a Government approved accounting system, please identify the agency that approved the system. Please submit copies of any documentation, such as letters or certificates to indicate the firm's status (see item #3 above). 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. Interested offerors should submit their capability statement not exceeding five (5) pages in length. Phone calls will not be accepted or returned. Interested firms or individuals may submit the requested information to: emily.hunt@fda.hhs.gov or US Food and Drug Administration Emily Hunt 5630 Fishers Lane / HFA-500 OAGS/DAO Rm 2080 Rockville, MD 20857