Economic Studies of FDA Regulations

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information. This announcement constitutes the only solicitation; proposals are being requested and a separate written solicitation will not be issued. FAR Provisions and Clauses set forth herein are current though Federal Acquisition Circular (FAC) The resultant task orders will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 2019-01 effective Jan 22, 2019. The North American Industrial Classification System (NAICS) code for this procurement is 541690, Other Scientific and Technical Consulting Services.

The Economics Staff of the Food and Drug Administration's (FDA) Office of Planning (OPl) has a requirement to provide accurate and timely economic assessments of FDA regulatory actions. These analyses have high public visibility and, therefore, must withstand intense scientific and technical review and scrutiny by diverse audiences including the public, regulated entities, Government agencies such as the Department of Health and Human Services and the Office of Management and Budget, the U.S. Congress, professional economists, and the scientific and medical community. The need of the Economics Staff for support by a contractor arises from the variety and complexity of the work, the need to have access to specialized resources to rapidly gather data to meet tight deadlines, and the need for research involving direct contact with regulated entities.

For full details/description please refer to attached document "FDA-19-RFP-119774".

In addition, this posting contains answers to the draft RFP that was previously posted on April 4th, 2019. (see 119774-DRAFT-Q&A.pdf)