Zdrowie i gospodarka · 2.07.1998
Agency Emergency Processing Under OMB Review
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information concerns the submission of applications to recognized accreditation bodies that will assess potential U.S. Conformity Assessment Bodies (CAB's) seeking to be designated under the U.S./ European Community (EC) Mutual Recognition Agreement (MRA) to assess medical devices produced for the EC market. This collection of information also concerns the submission of third-party evaluation reports by EC CAB's under the program. FDA is requesting OMB approval within 15 days of receipt of this submission.