DHHS/PHS/FDA/Office Of Facilities, Acquisition, And Central Services, Division of Contracts and Program Management, HFA-512(COB), 5600 Fishers Lane, Rockville, MD 20857

B -- ECONOMIC ANALYSIS OF IMPACT OF FDA REGULATIONS SOL 223-97-8002 POC Dee Gibson, Contract Administrator, M.Deborah Smith-Castle, Contracting Officer, (301) 443-0424, FAX (301) 443-3691 ECONOMIC ANALYSiS OF IMPACT OF FDA REGULATIONS The FDA has a requirement for accurate and timely economic assessments of FDA regulatory actions. Activities under the proposed contract will include, although not necessarily be limited to, the following: (1) Methods Development -- While the economic impact of certain FDA regulatory actions can be analyzed via an established methodology, other FDA initiatives will require novel analytical approaches to evaluate potential effects of economic impacts on consumers, the agency, and the regulated industry. (2) Baseline Measurement -- The FDA needs baseline data on the economic characteristics of regulated industries in order to estimate economic. These data may include the number and size of firms and the employment, sales, and number of stockkeeping units (labels). In many instances, industry profile studies will require supporting documentation for OMB survey clearance procedures. (3) Impact Assessments -- Since the FDA is required to prepare comprehensive Economic Impact Analysis for significant regulations under Executive Order 12866, and the Regulatory Flexibility, the expected impact of each agency rule must be reviewed to determine whether or not it will be considered significant. Both significant and non-significant assessments require extensive familiarity with numerous aspects of the regulated industries. All responsible sources may submit an offer which will be considered. All requests for the Request for Proposal (RFP) must be in writing to the address above. The RFP Package will be released on or about 6/12/97. (0118)

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