Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Providing Waiver-Related Materials in Accordance With Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format

الملخص

The Food and Drug Administration (FDA) is announcing that a collection of information entitled Providing Waiver-Related Materials in Accordance with Draft Guidance for Industry on Providing "Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format" has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.