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Zdrowie i gospodarka · 6.01.2000

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, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information contained in a guidance for industry entitled ``Changes to an Approved NDA or ANDA.'' The guidance is intended to assist applicants in determining how they should report changes to an approved new drug application (NDA) or abbreviated new drug application (ANDA) under section 116 of the Food and Drug Administration Modernization Act (the Modernization Act), which provides requirements for making and reporting manufacturing changes to an approved application and for distributing a drug product made with such changes.

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