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Zdrowie i gospodarka · 30.03.2001

Agency Information Collection Activities; Proposed Collection; Comment Request; Institutional Review Boards

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. This notice solicits comments on FDA's protection of human subjects recordkeeping and reporting requirements for institutional review boards (IRB's). IRB's are groups composed of members of varying backgrounds that are charged with reviewing the ethics and risk/benefit aspects of clinical studies involving human subjects to assure that the rights and welfare of human subjects are adequately protected.

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