HHS Information Quality Web Site
Information Requests for Corrections and HHS' Responses
Response to RFC
Mr. Ralph M. Shenefelt
Vice President, Strategic Compliance
Health and Safety Institute
1450 Westec Drive
Eugene, OR 97402
Dear Mr. Shenefelt:
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This letter responds to your request, dated December 21, 2012, for correction of information under the FDA Guidelines for Ensuring the Quality of Information Disseminated to the Public. Your request was referred to the Center for Devices and Radiological Health (CDRH), because the material you objected to appeared on the FDA website under the Medical Devices tab. Specifically, you asked that we reword a bullet on the webpage titled ?Strategies for Home Users and Public Access AED Owners to Maintain Readiness of Automated External Defibrillators? to remove the reference and link to the American Heart Association (AHA). We appreciate you bringing this to our attention. We have already modified the webpage as you have suggested. It was not our intention to promote one organization over others.
You may appeal the agency's decision either in writing or electronically within 30 days of receiving this response. Your request must state the reason you believe this response is inadequate. The request should be sent electronically to Ombuds@OC.FDA.gov or in hard copy to Food and Drug Administration Office of the Ombudsman 10903 New Hampshire Avenue, WO #32, room 4260, Silver Spring, MD 20993. If the appeal is sent in hard copy, please clearly mark the appeal and outside envelope with the phrase "Information Quality Appeal.
We appreciate your comments. The FDA is committed to providing scientifically accurate information on a wide range of health-related subjects, including external defibrillators.
Sincerely yours,
/s/
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Linda Ricci
Acting Branch Chief, Cardiac
Diagnostic Devices Branch
Division of Cardiovascular Devices
Office of Device Evaluation
Center for Devices and Radiological Health
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Last Revised: 04/01/13