Responses to this Request for Information (RFI) will be utilized for a potential solicitation for a competitive 8(a) and Alaska Native American Indefinite Delivery Indefinite Quantity (IDIQ) contract for FDA-ISS. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription, and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics. This is accomplished through the regulatory review of sponsor submissions with data in standardized formats.
The scope of this contract encompasses the technical and management services and subscriptions/licenses necessary to permit the FDA and all its Offices and Centers to meet the objectives of the FDA Cybersecurity Program presented in Section 1.2 above. The Contractor shall also provide all maintenance agreements, documentation, and training materials necessary to implement and continue to maintain FDA’s access to its solution.