Economic Studies of FDA Regulations

The purpose of this amendment is to post responses to questions, set a deadline for questions and correct a reference to section C.4.A.

Please see the attachment "Amendment 2 Questions" for Government responses.

A deadline of July 16, 2013 at 4:30 PM EST for questions of is hereby added to this solicitation. All questions submitted after this deadline may or may not receive a response.

All references to section C.4.A are hereby replaced with 2.4.A which can be located on page 5 of the solicitation.

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.

See attached RFP for further details.