FDA applicant Dr. Gary Davis and IND #BB7075 (Food and Drug Administration)
| Tracking # |
22-00023AA 2020-3750 FDA2064858 |
| Multi Request | FDA applicant Dr. Gary Davis and IND #BB7075 |
| Submitted | May 11, 2020 |
| Est. Completion | April 18, 2024 |
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Communications
From: Grant Michael Hill
To Whom It May Concern:
Pursuant to the Freedom of Information Act, I hereby request the following records:
Any and all documents or materials regarding the investigational new drug application #BB7075, including correspondence with the application's sponsor Dr. Gary Randolph Davis or those who corresponded on behalf of Dr. Gary Davis including, but not limited to, Linda Wilmes, Linda Riviera or Clyde Ashley Sherman.
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,
Grant Michael Hill
From: Food and Drug Administration
Grant Michael Hill Grant Michael Hill
Re: Confirmation # FDA2064858
Requester Ctrl #:
In Reply refer to: 2020-3750
The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records regarding:
Any and all documents or materials regarding the investigational new drug application #BB7075
We will respond as soon as possible and may charge you a fee for processing your request. If your informational needs change, and you no longer need the requested records, please contact us to cancel your request, as charges may be incurred once processing of your request has begun. For more information on processing fees, please see http://www.fda.gov/RegulatoryInformation/FOI/FOIAFees/default.htm.
Due to an increase in the number of incoming requests, we may be unable to comply with the twenty-working-day time limit in this case, as well as the ten additional days provided by the FOIA. The actual processing time will depend on the complexity of your request and whether sensitive records, voluminous records, extensive search, and/or consultation with other HHS components or other executive branch agencies are involved. Please note that requests for medical device approval records (e.g. 510K, PMA, DEN) may take up to 18 to 24 months to process.
If you have any questions about your request, please call Rochelle A. Coleman, Information Technician at 301-796-8982 or write to us at:
Division of Freedom of Information,
U.S. Food and Drug Administration
5630 Fishers Lane, Room 1050
Rockville, MD 20857
Fax: 301-827-9267
You also have the right to seek dispute resolution services from:
FDA FOIA Public Liaison
and/or:
Office of the Executive Secretariat
5630 Fishers Lane, Room 1050
Rockville, MD 20857
E-Mail: FDAFOIA@fda.hhs.gov
Office of Government
Information Services
National Archives and Administration
8601 Adelphi Road - OGIS
College Park, MD 20740-6001
Telephone: 202-741-5770
Toll-Free: 1-877-684-6448
E-Mail: ogis@nara.gov
Fax: 202-741-5769 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 11, 2020. Please let me know when I can expect to receive a response. You had assigned it reference number #FDA2064858.
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 11, 2020. Please let me know when I can expect to receive a response. You had assigned it reference number #FDA2064858.
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 11, 2020. Please let me know when I can expect to receive a response. You had assigned it reference number #FDA2064858.
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 11, 2020. Please let me know when I can expect to receive a response. You had assigned it reference number #FDA2064858.
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 11, 2020. Please let me know when I can expect to receive a response. You had assigned it reference number #FDA2064858.
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 11, 2020. Please let me know when I can expect to receive a response. You had assigned it reference number #FDA2064858.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Your request is open to CBER. I have copied them so they can provide an estimate of response.
Regards,
Katherine
-
~WRD0002
From: Food and Drug Administration
Hello Mr. Hill,
CBER hopes to respond to your FOIA request within the next month. Thank you for your patience.
Suzann Burk
Director, Division of Disclosure and Oversight Management
OCOD/CBER/FDA
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From: Food and Drug Administration
Attached is the response to your request.
Regards,
Katherine Uhl
Denials and Appeals Officer
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-8975
[cid:image001.png@01D7E5FC.5C9E5A80]<http://www.fda.gov/>
[cid:image002.jpg@01D7E5FC.5C9E5A80]<https://www.facebook.com/FDA> [cid:image003.jpg@01D7E5FC.5C9E5A80] <https://twitter.com/US_FDA> [cid:image004.jpg@01D7E5FC.5C9E5A80] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D7E5FC.5C9E5A80] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D7E5FC.5C9E5A80] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>
From: Food and Drug Administration
Dear Mr. Hill,
We are currently processing your appeal regarding FOIA request 2020-3750. We expect the review of this appeal will be complete in early 2023. Please confirm your continued interest in this matter.
Thanks,
Sarah B. Kotler, J.D.
Director, Division of Freedom of Information
US FDA
301-796-8976
From: Food and Drug Administration
Good afternoon,
Attached please find the response to your December 2, 2021, appeal.
C.
___________________________
Ms. Charis Wilson, PhD, CRM
Denials & Appeals Officer
Freedom of Information Division
Office of the Commissioner
Food & Drug Administration
From: Muckrock Staff
To Whom It May Concern:
I'm following up on the following Freedom of Information Act request, copied below, and originally submitted on May 11, 2020. You had previously indicated that it would be completed on April 18, 2024. I wanted to check on the status of my request, and to see if there was a new estimated completion date. You had assigned it reference number #22-00023AA.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Mr. Hill,
The response was sent to you on April 15th. However, We received an undeliverable message when we sent the FOIA response to requests@muckrock.com<mailto:requests@muckrock.com>. However, we found another email address in our files that you had used to correspond with us, so we sent it again to both the MuckRock adddress and grant@localtrancemedia.com. Please check your emails again, if you do not find the messages, let me know and we can resend them.
C.
___________________________
Ms. Charis Wilson, PhD, CRM
Denials & Appeals Officer
Freedom of Information Division
Office of the Commissioner
Food & Drug Administration
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