In Vitro and Non-Clinical Evaluation of Locally-Acting Topical Dermal and Ophthalmic Formulation Properties

Amendment 2: The purpose of this amendment is to provide the FDA responses to questions submitted after the solicitation question period closed. While the solicitation question period had closed, the FDA thought it would be prudent to provide this clarifying information for potential offerors. See attached for amendment details..

Amendment 1: The purpose of this amendment is to respond to questions received during the solicitation question period. See attached for Amendment details.

.

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

This solicitation is a Request for Proposals (RFP). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2019-01. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 541714 - Research and Development in Biotechnology (Except Nanotechnology). Its associated Small Business Size Standard is 1000 employees.

This requirement is 100% set aside to small businesses. Only businesses that qualify as small businesses under the above referenced NAICS code are permitted to submit a proposal as a result of this solicitation.

The U.S. Food and Drug Administration intends to award a Single Award Indefinite Delivery Indefinite Quantity contract for services to support the requirement entitled, "In Vitro and Non-Clinical Evaluation of Locally-Acting Topical Dermal and Ophthalmic Formulation Properties." The contract will be awarded to the offeror
representing the best value to the Government. The Contractor shall furnish all necessary facilities, materials, and personnel, and shall perform all non-personal services and program support necessary in support of this requirement.

.