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FDA Estimates Citizen Petition Takes 12 Hours

January 7, 2009
Stakeholders spent a total of nearly 6,000 hours collecting information the FDA needs to take action on citizen petitions and related requests in 2007, according to the agency. The FDA received 162 citizen petitions, four petitions to reconsider its actions, seven requests to stay an action and two requests for advisory opinions in 2007. The agency estimates 162 stakeholders — including individuals, state and local governments, nonprofit groups and businesses — spend 5,832 hours collecting information for the citizen petitions, according to a Federal Register notice last week.
Washington Drug Letter