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Zdrowie i gospodarka · 4.08.1998

Agency Information Collection Activities: Proposed Collection; Comment Request

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection and information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on 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 United States (U.S.)/European Community (EC) Mutual Recognition Agreement (MRA) to assess medical devices produced for the EC market. Elsewhere in this issue of the Federal Register, FDA is publishing a notice announcing OMB's approval of this collection of information (OMB control number 0910-0378). Since this was an emergency approval that expires on January 31, 1999, FDA is following the normal PRA clearance procedures by issuing this notice.

Source: Federal Register — Food and Drug AdministrationOpen original release →