FDA Adverse Event Reports, dental amalgam, 1993 - 2003

Beryl Lipton filed this request with the Food and Drug Administration of the United States of America.
Tracking # 2015-4783
Status
Completed

Communications

From: Beryl Lipton

To Whom It May Concern:

This is a request under the Freedom of Information Act. I hereby request the following records:

All Adverse Event Reports regarding the use of dental amalgam submitted from 1993 through 2003. Please include all segregable data, including, but not limited to, the product name, the brand name (if applicable), ingredients, the nature of the complaint, etc.

This request is being made as part of a journalistic investigation. The requested documents will be made available to the general public, and this request is not being made for commercial purposes.

In the event that fees cannot be waived, I would be grateful if you would inform me of the total charges in advance of fulfilling my request. I would prefer the request filled electronically, by e-mail attachment if available or CD-ROM if not.

Thank you in advance for your anticipated cooperation in this matter. I look forward to receiving your response to this request within 20 business days, as the statute requires.

Sincerely,

Beryl C.D. Lipton

From: Food and Drug Administration

An interim response, stating the request is being processed.

From: MuckRock.com

To Whom It May Concern:

I wanted to follow up on the following Freedom of Information request, copied below, and originally submitted on July 24, 2015. Please let me know when I can expect to receive a response, or if further clarification is needed. You had assigned it reference number #2015-6071.

Thanks for your help, and let me know if further clarification is needed.

From: Lawrence, Lisa D

Hello Beryl C.D. Lipton,

This email is in regard to your FOI mentioned above. I wanted to notify you that we are in the process of processing your request.

Kind regards,
Lisa Lawrence

Should you have any questions or concerns, please feel free to contact me.

CDR Lisa D. Lawrence, RN, MSHS
Sr. Regulatory Research Officer
Division of Information Disclosure
Office of Communication & Education, Center for Devices and Radiological Health
Food and Drug Administration
Direct phone: 301-796-5945 ৷ Fax: 301-847-8526 ৷ Email: Lisa.Lawrence@fda.hhs.gov<mailto:Lisa.Lawrence@fda.hhs.gov>
FDA FOIA Webpage<http://www.fda.gov/RegulatoryInformation/FOI/default.htm>

Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer service you have received at: Customer Service Survey<https://www.research.net/s/cdrhcustomerservice?O=800&D=860&B=862&E=&S=E>

From: Lawrence, Lisa D

Good Morning Beryl C.D. Lipton,

Your request is currently in my queue and anticipate starting processing your request during the first week of November. Again, please don’t hesitate to contact me because I may get to your request sooner.

Kind regards,
Lisa Lawrence

Should you have any questions or concerns, please feel free to contact me.

CDR Lisa D. Lawrence, RN, MSHS
Sr. Regulatory Research Officer
Division of Information Disclosure
Office of Communication & Education, Center for Devices and Radiological Health
Food and Drug Administration
Direct phone: 301-796-5945 ৷ Fax: 301-847-8526 ৷ Email: Lisa.Lawrence@fda.hhs.gov<mailto:Lisa.Lawrence@fda.hhs.gov>
FDA FOIA Webpage<http://www.fda.gov/RegulatoryInformation/FOI/default.htm>

Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer service you have received at: Customer Service Survey<https://www.research.net/s/cdrhcustomerservice?O=800&D=860&B=862&E=&S=E>

From: Beryl Lipton

Hello Ms. Lawrence,

Thank you so much for your message! I really appreciate it. I look forward to hearing from you again, and I hope your days are lovely until then.

Best wishes,
Beryl

From: Lawrence, Lisa D

Hi Beryl,

Thank you for your kind email. As always please feel free to contact me for any questions.

Kind regards,
Lisa

From: Lawrence, Lisa D

Good Morning Beryl,

Thank you for contacting CDRH, Division of Information Disclosure. Your request will be sent out to by mail on Monday.

Kind regards,
Lisa

Should you have any questions or concerns, please feel free to contact me.

CDR Lisa D. Lawrence, RN, MSHS
Sr. Regulatory Research Officer
Division of Information Disclosure
Office of Communication & Education, Center for Devices and Radiological Health
Food and Drug Administration
Direct phone: 301-796-5945 ৷ Fax: 301-847-8526 ৷ Email: Lisa.Lawrence@fda.hhs.gov<mailto:Lisa.Lawrence@fda.hhs.gov>
FDA FOIA Webpage<http://www.fda.gov/RegulatoryInformation/FOI/default.htm>

Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer service you have received at: Customer Service Survey<https://www.research.net/s/cdrhcustomerservice?O=800&D=860&B=862&E=&S=E>

From: Food and Drug Administration

A letter stating the requester must agree to or prepay assessed or estimated fees in order for the agency to continue processing the request.

From: Food and Drug Administration

A copy of documents responsive to the request.

From: Food and Drug Administration

A cover letter granting the request and outlining any exempted materials, if any.

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