Allegations of Regulatory Misconduct
| Tracking # |
2023-4060 FDA23092529 |
| Submitted | May 14, 2023 |
| Due | June 12, 2023 |
| Est. Completion | None |
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Communications
From: Dhruv Mehrotra
To Whom It May Concern:
Pursuant to the Freedom of Information Act, I hereby request the following records:
Allegations of Regulatory Misconduct form submissions. These are submissions to the FDA alleging a claim of regulatory misconduct with regards to a medical device manufacturer or individuals marketing medical devices doing so in a manner that violates the law.
Responsive documents would be those submitted in response to
OMB Control No: 0910-0769,
ICR Reference No: 202010-0910-008,
Previous ICR Reference No: 201708-0910-001
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 there are fees, 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,
Dhruv Mehrotra
From: Food and Drug Administration
*** This is an automated message. Please do not reply to this email. ***
Reference: FDA23092529
Dear Requester,
This is to confirm that you submitted a request for record(s) from the Food and Drug Administration
pursuant to the Freedom of Information Act.
FOIA staff will review your request to determine whether it has sufficient information to be processed;
if so, you will receive another email as a formal acknowledgement of your request, with a control number for your request.
If your request is not sufficiently described,
or if there are any other deficiencies with your submission, FOIA staff will contact you via telephone or email.
From: Food and Drug Administration
Control number: 2023-4060
Please find the attached acknowledgement regarding your FOIA request. Note: Do NOT reply directly to this E-mail
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on May 14, 2023. Please let me know when I can expect to receive a response. You had assigned it reference number #2023-4060.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Dear Requester,
FDA received your status request for this FOIA request. Mr. Collins, copied here, can provide you with status when he returns to the office next week.
Sincerely,
Sarah B. Kotler, J.D.
Director, Division of Freedom of Information
US FDA
301-796-8976
From: Food and Drug Administration
Good morning,
My apologies for the delay in responding to you. Your status update request has been forwarded to me since this request has been assigned to my Branch. Please be advised that CDRH has an extensive backlog of FOIA requests - the estimated timeline for processing FOIA requests is currently 18 - 24 months from the date of their receipt.
Your request, case 2023-4060, is currently in Branch A's complex track of requests. There are approximately 374 requests ahead of yours in this queue. Your request will be assigned to an analyst for processing in the order in which it was received.
I trust this information is of assistance to you. Please let me know if you have any further questions.
Respectfully,
Leif
Leif M. Collins
Branch A Chief
Division of Information Disclosure (DID)
Office of Communication and Education (OCE)
Center for Devices and Radiological Health (CDRH)
U.S. Food and Drug Administration (FDA)
Tel: 301-357-0109
Leif.Collins@fda.hhs.gov<mailto:Leif.Collins@fda.hhs.gov>
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From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on May 14, 2023. Please let me know when I can expect to receive a response. You had assigned it reference number #2023-4060.
Thanks for your help, and let me know if further clarification is needed.
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on May 14, 2023. Please let me know when I can expect to receive a response. You had assigned it reference number #2023-4060.
Thanks for your help, and let me know if further clarification is needed.
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