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FDA SEES LITTLE IMPACT ON PENDING REGS FROM OMB RE-REVIEW ORDER

This article was originally published in The Gray Sheet

Executive Summary

FDA SEES LITTLE IMPACT ON PENDING REGS FROM OMB RE-REVIEW ORDER signed by new Office of Management and Budget Director Leon Panetta on Jan. 22. The memorandum, published in the Jan. 25 Federal Register, orders that "no proposed or final regulation should be sent to the Federal Register for publication until it has been approved by an agency head who, in either case, is a person appointed by President Clinton and confirmed by the Senate." FDA is sending a list of pending regulations to OMB in accordance with the Panetta memo. The list of approximately 30 regs being prepared for publication in the Federal Register includes the medical device tracking final rule and some OTC drug monograph final rules. FDA has indicated that it does not believe any of the regs will require reevaluation by OMB. In addition, the FDA desk at OMB retains the same staffing as during the Bush Administration, so unfamiliarity with the contents of the regs is not expected to be a hurdle. Panetta's memo directs all federal agencies to withdraw all regulations that had not yet been published in the Federal Register but had been sent to OMB. The order does not apply to "regulations that must be issued immediately because of a statutory or judicial deadline," the memo states. Agencies were requested to notify the director "promptly" of any such regulations. The memo adds that agencies should notify OMB of regulations that they believe should not be subject to OMB re- review prior to publication in the Federal Register.
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