Zdrowie i gospodarka · 18/07/2003

Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee and Modernization Act Small Business Qualification Certification (Form FDA 3602)

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 of information, and to allow 60 days for public comment in response to the notice. The proposed collection of information will permit an applicant to certify that it qualifies as a "small business" within the meaning of the Medical Device User Fee and Modernization Act (MDUFMA), will help the applicant organize the information FDA needs to verify each certification, and will collect contact information to facilitate rapid resolution of any questions FDA may have concerning information the applicant has provided. In the Federal Register of March 26, 2003 (68 FR 14664), FDA published a notice announcing OMB's approval of this collection of information (OMB control number 0910-0508). Since this was an emergency approval that expires on October 31, 2003, FDA is following the normal PRA clearance procedur