Tianeptine (Food and Drug Administration)
It is a clone of this request.
| Tracking # |
2018-6917 FDA1846255 |
| Multi Request | Tianeptine |
| Submitted | Aug. 22, 2018 |
| Due | Oct. 2, 2018 |
| Est. Completion | None |
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Communications
From: Anthony Roberts
To Whom It May Concern:
Pursuant to the Freedom of Information Act, I hereby request the following records:
I am seeking all FDA documents dealing with tianaptine. This should include Investigational New Drug Applications, compounding pharmacy requests, import alerts, import records and records of seizures, Investigational New Drug applications, New Dietary Ingredient Notifications and resulting correspondence, plus internal and external documents not limited to email correspondences, white papers, and opinions.
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,
Anthony Roberts
From: Food and Drug Administration
*** This is an automated message. Please do not reply to this email. ***
Reference: FDA1846255
Dear Requester,
This is to confirm that you submitted a request for record(s) from the Food and Drug Administrationpursuant 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
Note: Do NOT reply directly to this E-mail
Anthony Roberts Anthony Roberts
Re: Confirmation # FDA1846255
In Reply refer to: 2018-6917
The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records regarding:
Tianaptine recs
Original Subject: To Whom It May Concern: Pursuant to the Freedom of Information Act, I hereby request the following records: I am seeking all FDA documents dealing with tianaptine. This should include Investigational New Drug Applications, compounding pharmacy requests, import alerts, import records and records of seizures, Investigational New Drug applications, New Dietary Ingredient Notifications and resulting correspondence, plus internal and external documents not limited to email correspondences, white pa...
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. If you have any questions about your request, please call Rochelle A. Coleman, Information Technician at (301) 796-8982 or write to us at: (http://www.fda.gov/RegulatoryInformation/FOI/FOIAFees/default.htm)
Division of Freedom of Information, U.S. Food and Drug Administration
5630 Fishers Lane, Room 1035
Rockville, MD 20857
Fax:(301)827-9267
You also have the right to seek dispute resolution services from:
FDA FOIA Public Liaison
Office of the Executive Secretariat
5630 Fishers Lane, Room 1050
Rockville, MD 20857
E-Mail: FDAFOIA@fda.hhs.gov and/or:
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
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
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 request, copied below. Please let me know when I can expect to receive a response.
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Dear Mr. Roberts,
On 2/19/19, you requested a status update regarding your request 2018-6917, in which you sought "all FDA documents dealing with tianaptine. This should include Investigational New Drug Applications, compounding pharmacy requests, import alerts, import records and records of seizures, Investigational New Drug applications, New Dietary Ingredient Notifications and resulting correspondence, plus internal and external documents not limited to email correspondences, white papers, and opinions."
As you may know, FDA maintains a complex and a simple track and processes requests in each queue on a first-in, first-out basis. Due to the breadth of your request, it was deemed complex and consequently assigned to that queue. Your request is currently 398 out of 609 in the queue. Due to the large volume of requests ahead of yours and the breadth, volume and/or complexity of responsive records, we estimate a response time frame of 18-24 months.
Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
HILL-3138
Silver Spring, MD 20993-0002
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov>
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Hello,
As you may know, FDA maintains both a complex and a simple queue, and processes requests within each track on a first-in, first-out basis. Due to the breadth of your request it was assigned to the complex track; it is currently 376 of 589. We estimate a response time frame of 18-24 months, although the actual processing time may vary depending on the complexity and volume of requests ahead of yours.
Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
HILL-3138
Silver Spring, MD 20993-0002
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov%3cmailto:eli.landy@fda.hhs.gov>>
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Your request is currently 352 out of 576.
Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
Hillandale Building, Room 3138
Silver Spring, MD 20993
301-796-2697
-
~WRD000
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Hello,
Your request is currently 331 of 590.
Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
Hillandale Building, Room 3138
Silver Spring, MD 20993
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov>
-
~WRD000
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Hello,
Your request it number 318 out of 608.
Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
Hillandale Building, Room 3138
Silver Spring, MD 20993
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov>
-
~WRD000
From: Food and Drug Administration
Good day Anthony Roberts,
Please find the No Records response letter from FDA's Office of Regulatory Affairs (ORA) Division of Import Operations (DIO). You will find contact information in regards to other Offices in the Agency that will also be responding to your request. Thank you and have a nice day!
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: Anthony Roberts
As a media request, why is there a fee being requested here?
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Good morning, the Division of Import Operations already supplied you with our No Records letter back in July. The request is still open with our Center for Drug Evaluation and Research and they will be replying to you.
S. Max Brewster, MBA | Import Compliance Branch | ORA/OEIO/Division of Import Operations | US Food and Drug Administration |301-796-8994| max.brewster@fda.hhs.gov<mailto:max.brewster@fda.hhs.gov>
From: Food and Drug Administration
Good morning,
To follow up on Mr. Brewster's email below, your request is currently number 284 out of 595 in CDER's queue, and we proce4ss requests on a first-in, first out basis.
Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
Hillandale Building, Room 3138
Silver Spring, MD 20993
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov>
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Hello,
Your request is currently number 263 out of 595. As you may know, the FDA maintains both a simple and a complex track and processes requests in each queue on a first-in, first-out basis. Your request was assigned to the complex track due to its scope and/or volume/length/complexity of the requested records. In light of the current volume of requests ahead of it in the queue, we estimate a response time frame of 18-24 months.
Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
Hillandale Building, Room 3138
Silver Spring, MD 20993
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov>
-
~WRD000
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Hello,
Your request is currently 256 out of 577 in the queue.
Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
Hillandale Building, Room 3138
Silver Spring, MD 20993
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov>
-
~WRD000
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Hello,
Your request is currently 250 of 567 in CDER's queue.
Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
Hillandale Building, Room 3138
Silver Spring, MD 20993
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov>
-
~WRD000
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Good morning,
Your request is currently number 237 out of 599.
Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
Hillandale Building, Room 3138
Silver Spring, MD 20993
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov>
-
~WRD000
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Hello,
Your request is currently number 229 out of 609.
Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
Hillandale Building, Room 3138
Silver Spring, MD 20993
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov>
-
~WRD000
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Hello,
Your request is currently 198 out of 598.
Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
Hillandale Building, Room 3138
Silver Spring, MD 20993
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov>
-
~WRD000
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Hello,
Your request is currently 188 out of 599.
Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
Hillandale Building, Room 3138
Silver Spring, MD 20993
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov>
-
~WRD000
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Good afternoon,
Your request is currently 185 out of 616 in the queue. Please be advised that CDER has received a substantial amount of requests pertaining to COVID-19, many of which have been granted expedited processing (i.e., were moved to the front of the queue). This has impacted the time frame for processing your request.
Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
Hillandale Building, Room 3138
Silver Spring, MD 20993
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov>
-
~WRD000
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Good morning,
Your request is currently 185 out of 598. As mentioned in my previous response, CDER has received a substantial amount of requests pertaining to COVID-19, many of which have been granted expedited processing (i.e., were moved to the front of the queue). This has impacted both the time frame for processing your request and our ability to provide you with an estimated response time frame.
Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
Hillandale Building, Room 3138
Silver Spring, MD 20993
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov>
-
~WRD000
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Hello,
Your request is currently 163 out of 582.
Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
Hillandale Building, Room 3138
Silver Spring, MD 20993
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov>
-
~WRD000
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Good morning,
Your request is currently 159 out of 583 in the queue. CDER has received numerous requests for COVID-19 records, many of which were granted expedited processing. As a result, in addition to the requests ahead of yours in the queue, CDER has to prioritize processing the COVID-19-related requests ahead of yours, even though they were submitted after yours. For this reason we're unable to provide an estimated response timeframe at this time.
Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
Hillandale Building, Room 3138
Silver Spring, MD 20993
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov>
-
~WRD000
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Good morning,
Your request is currently 154 out of 587 in the queue. CDER has received numerous requests for COVID-19 records, many of which were granted expedited processing. As a result, in addition to the requests ahead of yours in the queue, CDER has to prioritize processing the COVID-19-related requests ahead of yours, even though they were submitted after yours. For this reason we're unable to provide an estimated response timeframe at this time.
Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
Hillandale Building, Room 3138
Silver Spring, MD 20993
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov>
-
~WRD000
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Good day, I have already completed your request on behalf on ORA's Division of Import Operations. This is still open with our Center for Drugs. You do not need to continue to copy me on these requests. Thank you!
S. Max Brewster | Import Compliance Branch | ORA/OEIO/Division of Import Operations | US Food and Drug Administration |Office: 301-796-8994; Mobile: 301-529-4327| max.brewster@fda.hhs.gov<mailto:max.brewster@fda.hhs.gov>
From: Food and Drug Administration
Hello,
Your request is currently number 147 out of 594.
Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
Hillandale Building, Room 3138
Silver Spring, MD 20993
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov>
-
~WRD000
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Hello,
Your request is currently 146 out of 608 in CDER's FOIA queue. Under normal circumstances we'd estimate a response time frame of 18-24 months. However, CDER has received numerous requests for COVID-19 records, many of which were granted expedited processing. As a result, in addition to the requests ahead of yours in the queue, CDER has to prioritize processing the COVID-19-related requests ahead of yours, even though they were submitted after yours. For this reason we're unable to provide an estimated response timeframe at this time.
Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
Hillandale Building, Room 3138
Silver Spring, MD 20993
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov>
-
~WRD000
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Good morning,
Your request is currently 142 out of 628 in CDER's FOIA queue. Under normal circumstances we'd estimate a response time frame of 18-24 months. However, CDER has received numerous requests for COVID-19 records, many of which were granted expedited processing. As a result, in addition to the requests ahead of yours in the queue, CDER has to prioritize processing the COVID-19-related requests ahead of yours, even though they were submitted after yours. For this reason we're unable to provide an estimated response timeframe at this time.
Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
Hillandale Building, Room 3138
Silver Spring, MD 20993
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov%3cmailto:eli.landy@fda.hhs.gov>>
-
~WRD000
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Good afternoon,
I apologize for the delayed response; your request is current 140 out of 629.
Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
Hillandale Building, Room 3138
Silver Spring, MD 20993
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov>
-
~WRD0000
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Good morning,
Your request is currently 138 out of 672.
Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
Hillandale Building, Room 3138
Silver Spring, MD 20993
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov>
-
~WRD0000
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Good morning,
Your request is currently 138 out of 673.
Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
Hillandale Building, Room 3138
Silver Spring, MD 20993
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov%3cmailto:eli.landy@fda.hhs.gov>>
-
~WRD0000
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Hello,
Your request is currently 137 out of 743. However, as noted previously, this request's spot in the queue does not necessarily reflect the order in which your request will be processed due to requests that were submitted subsequently that were granted expedited processing. Consequently, we cannot provide an estimated response timeframe with any degree of certainty.
Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
Hillandale Building, Room 3138
Silver Spring, MD 20993
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov>
-
~WRD0000
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Hello,
This request is currently 136 out of 764 in the queue. As noted previously, we cannot provide a meaningful estimated response timeframe due to the many COVID-related requests that were granted expedited processing.
Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
Hillandale Building, Room 3138
Silver Spring, MD 20993
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov>
-
~WRD0000
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Good morning,
Your request is currently 135 out of 777 in CDER's queue.
Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
Hillandale Building, Room 3138
Silver Spring, MD 20993
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov>
-
~WRD0000
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 Aug. 22, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Good morning,
Your request is currently 134 out of 782.
Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
Hillandale Building, Room 3138
Silver Spring, MD 20993
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov>
-
~WRD0000
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 Aug. 23, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-6917.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Good morning,
Your request is currently 133 out of 855.
Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
Hillandale Building, Room 3138
Silver Spring, MD 20993
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov>
-
~WRD0000
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