OMB’s GMP edits
This article was originally published in The Tan Sheet
Executive Summary
Dietary supplement GMP draft proposal's description of "uncertainties in the analysis" of the cost and benefits of the rule beefed up by the agency following pre-publication review by the OMB Office of Information & Regulatory Affairs. More than two pages outlining health benefit assumptions added to final Federal Register version. Industry groups have criticized the analysis as overestimating the benefits and underestimating the cost of the proposed GMPs (1"The Tan Sheet" Sept. 15, 2003, p. 13). FDA recently released the marked up version of the draft proposal in observation of Executive Order 12866 requirements for disclosure regarding "significant regulatory actions"...