Zdrowie i gospodarka · 31/08/2001
Agency Information Collection Activities; Proposed Collection; Comment Request; Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report; Reopening of Comment Period
The Food and Drug Administration (FDA) is reopening the comment period on a proposed collection of certain information by the agency until October 15, 2001. Under the Paperwork Reduction Act of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice is reopening the comment period for a data collection effort to solicit comments on reporting and recordkeeping requirements obligating holders of approved new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) to submit information on adverse drug reactions, lack of effectiveness, and product defects.