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FDA: New transparency report outlines proposals for enforcement data, for public comment

Mon, 10/03/2011 - 6:25am
Manufacturing.net

FDA: New transparency report outlines proposals for enforcement data, for public comment

The U.S Food and Drug Administration today released 8 new draft proposals in a report titled “Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment to Increase Transparency By Promoting Greater Access to the Agency’s Compliance and Enforcement Data.”

These draft proposals are focused on making FDA’s compliance and enforcement data more accessible and user-friendly, and they are part of our ongoing efforts to increase the transparency of FDA’s operations and decision-making. 

In developing these draft proposals, FDA met with the Environmental Protection Agency (EPA) and the Department of Labor (DOL), both of which have well-developed and well-regarded enforcement data websites (www.epa-echo.gov and http://ogesdw.dol.gov, respectively).  At these meetings, EPA and DOL shared their insights to help FDA learn from, and build upon, their experiences.  Like FDA, EPA and DOL recognize that transparency can drive good behavior and promote regulatory compliance.

After consulting with EPA and DOL, FDA developed the 8 draft proposals that it issued today.  The public may provide comments on the draft proposals at http://www.regulations.gov/#!docketDetail;dct=FR%252BPR%252BN%252BO%252BSR;rpp=10;po=0;D=FDA-2009-N-0247 until December 2, 2011.

FDA Commissioner Dr. Margaret Hamburg launched FDA’s Transparency Initiative in June 2009.  The initiative is overseen by a Task Force that includes key leaders of FDA.  The report issued today advances that initiative and is part of FDA’s response to President Obama’s Presidential Memorandum on Regulatory Compliance, which directed federal agencies to make compliance information more publicly available, easily accessible, downloadable and searchable online.

For more information:

FDA’s Transparency Initiative

FDA’s Compliance and Enforcement Actions

Inspections Database

Open Government Data Sets

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.  The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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