Office of Generic Drugs (OGD) Records Related to Jan 2013 Mefloquine Meeting

Dr. Remington Nevin filed this request with the Food and Drug Administration of the United States of America.
Tracking #

2015-893, 18-0007-AA

Est. Completion None
Status
Fix Required

Communications

From: Remington Nevin

To Whom It May Concern:

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

Records from the Office of Generic Drugs (OGD) related to the “mefloquine meeting” held January 11, 2013 at the FDA Center for Drug Evaluation and Research, White Oak Campus, 10903 New Hampshire Avenue, Building 22, Silver Spring, MD 20993, to include any agendas, presentations, internal memoranda, and executive summaries produced from July 2012 through July 2013, during preparation for or as a result of the meeting.

I also request that, if appropriate, fees be waived as I am a representative of a noncommercial scientific institution and believe this request is in the public interest. The requested documents will be made available to the general public free of charge as part of the public information service at MuckRock.com, processed by a representative of the news media/press and is made in the process of news gathering and educational activities and not for commercial usage.

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,

Dr. Remington Nevin

From: FDA

Acknowledgement.

From: Lee, Elizabeth J. (FDA)

Dr. Nevin,

Please contact me to discuss your requests. In order to streamline the search for responsive records, we suggest that your 3 similar requests be consolidated into one request. In addition, you requests fall under the complex track with a wait time of 18 to 24 months. I am available to discuss your requests further from Monday to Friday, 9:00 am to 5:00pm.

Thank you,

Elizabeth Lee
Lead Regulatory Counsel
FDA/CDER/ORP/Division of Information Disclosure Policy
301-796-3456 (direct)/301-796-3603 (main)/301-431-6351 (fax)
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 elizabeth.lee@fda.hhs.gov.
THINK, ACT, LIVE GREEN. * If you decide to print, print double-sided.

From: Lee, Elizabeth J. (FDA)

Dr. Nevin,

We have attempted to contact you via email, since no phone number was provided. In order to streamline the search for responsive records, we consolidated your 3 requests (2015-893 (OGD), 894 (OSE), 895 (OND)) into one request, 2015-893. As noted, this request falls under the complex track with a wait time of 18 to 24 months. I am available to discuss your request further on Monday to Friday, 9:00 am to 5:00pm.

Thank you,

Elizabeth Lee
Lead Regulatory Counsel
FDA/CDER/ORP/Division of Information Disclosure Policy
301-796-3456 (direct)/301-796-3603 (main)/301-431-6351 (fax)
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 elizabeth.lee@fda.hhs.gov.
THINK, ACT, LIVE GREEN. * If you decide to print, print double-sided.

From: Remington Nevin

Elizabeth Lee
Lead Regulatory Counsel
FDA/CDER/ORP/Division of Information Disclosure Policy

Dear Ms. Lee,

Thank you very much for your letter of February 26, 2015, in which you note your office will be consolidating my requests #2015-893, #2015-894, and #2015-895 into a single request, #2015-893, encompassing requests for responsive records from OGD, OSE, and OAP. I can acknowledge receipt of your message. While I appreciate your assistance with these three requests, I do reserve my right to appeal for constructive denial on the basis of the anticipated wait time of 18-24 months for completion.

I shall look forward to regular updates from your office as to the status of their processing and would be very appreciative if these requests would be able to be completed within the timeframes specified by statute.

Sincerely,

Dr. Remington Nevin

From: Lee, Elizabeth J. (FDA)

Dr. Nevin,

Thank you for your response. We process requests on a first-in-first-out basis and this request falls under the complex track with a wait time of 18 to 24 months. You may call me to discuss the possibility of placing your request on the simple track with a shorter wait time. I am available to discuss your request further on Monday to Friday, 9:00 am to 5:00pm. Otherwise, you are welcome to contact Gary Jackson for periodic status inquiries.
Thanks,
Elizabeth Lee
Lead Regulatory Counsel
FDA/CDER/ORP/Division of Information Disclosure Policy
301-796-3456 (direct)/301-796-3603 (main)/301-431-6351 (fax)
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 elizabeth.lee@fda.hhs.gov.
THINK, ACT, LIVE GREEN. P If you decide to print, print double-sided.

From: Remington Nevin

To Whom It May Concern:

I am writing to inquire as to the status of request #2015-893, for records from OGD, OSE, and OAP related to the “mefloquine meeting” held January 11, 2013 at the FDA Center for Drug Evaluation and Research.

I understand that this request is being processed under your "complex track", but would appreciate any updates as to its status, including its location in your processing queue, as well as any updates as to its expected completion.

Sincerely,

Dr. Remington Nevin

From: Jackson, Gary (CDER)

Dr. Nevin,

Your recent inquiry as to the status of your Freedom of Information Act request designated 2015-893 relating to records from OGD, OSE, and OAP regarding the Mefloquine meeting of January 11, 2013 at the FDA Center for Drug Evaluation and Research is currently number 500 in the queue.

You may request a status inquiry in 6 months given that the time frame for processing requests on the complex track is 18 to 24 months.
Regards,
Gary Jackson
Consumer Safety Officer
Office of Regulatory Policy
Division of Information Disclosure Policy
Center for Drug Evaluation and Research

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 Feb. 1, 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 #2015-893.

Thank you for your help.

From: Jackson, Gary (CDER)

Dr. Nevin,

As previously stated, your Freedom of Information Act request designated 2015-893 relating to records from OGD, OSE, and OAP regarding the Mefloquine meeting of January 11, 2013 at the FDA Center for Drug Evaluation and Research has been placed in the complex track. The time frame for processing requests in the complex track is 18 to 24 months.
Regards,
Gary Jackson
Consumer Safety Officer
Office of Regulatory Policy
Division of Information Disclosure Policy
Center for Drug Evaluation and Research

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 Feb. 1, 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 #2015-893.

Thank you for your help.

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 Feb. 1, 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 #2015-893.

Thank you for your help.

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 Feb. 1, 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 #2015-893.

Thank you for your help.

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 Feb. 1, 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 #2015-893.

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

From: Remington Nevin

Headquarters FOIA Officer
Food and Drug Administration
Division of Freedom of Information
5630 Fishers Lane, Room 1035
Rockville, MD 20857

Re: Appeal of Constructive Denial of Freedom of Information Act Request FDA 2015-893

Dear Sir or Madam,

This is an appeal under the Freedom of Information Act.

On February 1, 2015, I submitted a request for:

"Records from the Office of Generic Drugs (OGD) related to the 'mefloquine meeting' held January 11, 2013 at the FDA Center for Drug Evaluation and Research, White Oak Campus, 10903 New Hampshire Avenue, Building 22, Silver Spring, MD 20993, to include any agendas, presentations, internal memoranda, and executive summaries produced from July 2012 through July 2013, during preparation for or as a result of the meeting."

This request was acknowledged by FDA in a letter dated February 3, 2015. In a message dated May 21, 2015, FDA informed me that the request remained in its complex queue, with an expected processing time of 18-24 months. It has now been over 24 months, and despite monthly requests for an update on the status of this request, I have received no further response or correspondence from FDA.

The FDA's failure to respond to my request within the time period required by the Freedom of Information Act serves as a constructive denial of my request.

I respectfully request that FDA respond to my appeal within 20 business days.

Sincerely,

Dr. Remington Nevin

From:

Dear Dr. Nevin,
Please find attached to this email your acknowledgment letter pertaining to your request. If you have any questions please call us at 202-260-6933.
Sincerely,
Glenn Voelker

From:

Dear Dr. Nevin,
Please find attached to this email your acknowledgment letter pertaining to your request. If you have any questions please call us at 202-260-6933.
Sincerely,
Glenn Voelker

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: Food and Drug Administration

Good afternoon,

Regarding your request for the current processing status of FOIA submission 2015-893, your request is approximately number 61 in the queue. The FDA CDER processes FOI requests in a two track system. That system operates on a first in first out basis. Your request has been assigned to the complex queue and will be processed in turn.
Regards,
Gary W. Jackson
Consumer Safety Officer
Division of Information Disclosure Policy
Center for Drug Evaluation and Research

From: Food and Drug Administration

Good morning,
Regarding your request for the current processing status of FOIA submission 2018-6249, your request is approximately number 54 in the queue. The FDA CDER processes FOI requests in a two track system. That system operates on a first in first out basis. Your request has been assigned to the complex queue and will be processed in turn.
Regards,
Gary W. Jackson
Consumer Safety Officer
Division of Information Disclosure Policy
Center for Drug Evaluation and Research

From: Food and Drug Administration

Good morning,

This relates to FOIA 2015-893 which is now approximately number 54 in the queue. The previous communication referenced the wrong case number only.
Regards,
Gary W. Jackson
Consumer Safety Officer
Division of Information Disclosure Policy
Center for Drug Evaluation and Research

From: Food and Drug Administration

Good afternoon Dr. Remington,

Please see the attachments concerning Appeal #s 18-0007-AA and 18-0008-AA.

Should you have questions concerning this matter, please email FOIARequest@psc.hhs.gov<mailto:FOIARequest@psc.hhs.gov>.

Thank you.

Jacqueline R. Trent
FOIA Analyst
HHS Office of Assistant Secretary for Public Affairs (ASPA)
Freedom of Information (FOI)/Privacy Acts Division

Mailing Address:
200 Independence Avenue, SW
Washington, DC 20201
<mailto:Jacqueline.Trent@hhs.gov>

  • Constructive Denial Letter 18-0008-AA - MM Approved 2019-09-30

  • Constructive Denial Letter 18-0007 AA - MM Approved 2019-09-30

From: Food and Drug Administration

Good afternoon Dr. Remington,

Your appeals - 18-0007-AA and 18-0008-AA, were closed in our office, and remanded back to the FDA for completion of the processing of your initial requests. Letters concerning this information (dated 9/30/2019) was sent to you per the email below (copies of the letters are attached to this email).

Please contact the FDA FOIA Office directly at fdafoia@fda.hhs.gov<mailto:fdafoia@fda.hhs.gov> for an updated status.

Thank you.

Kind regards,

Jackie Trent

Jacqueline Trent
Government Information Specialist (Contractor)

Department of Health and Human Services (HHS)
Freedom of Information/Privacy Act Division
200 Independence Avenue, S.W.
Washington, DC

  • Constructive Denial Letter 18-0008-AA - MM Approved 2019-09-30

  • Constructive Denial Letter 18-0007 AA - MM Approved 2019-09-30

From: Dr. Remington Nevin

Dear FDA FOIA Staff,

Please provide an update on the status of FOIA 2015-893, which on March 22, 2019, was described by your office as approximately number 54 in the complex request processing queue.

Sincerely,

Dr. Remington Nevin

From: Food and Drug Administration

Thank you for your email.

Please contact the FDA FOIA Office directly at fdafoia@fda.hhs.gov<mailto:fdafoia@fda.hhs.gov%3cmailto:fdafoia@fda.hhs.gov>> for an updated status.

Have a great day!
-HHS FOIA Intake Team

From: Food and Drug Administration

Thank you for your email.

Please contact the FDA FOIA Office directly at fdafoia@fda.hhs.gov<mailto:fdafoia@fda.hhs.gov> for an updated status.

Have a great day!
-HHS FOIA Intake Team

From: Food and Drug Administration

Dr. Remington,

We have located some documents and most of them are documents you should already have as you were the author. Do you only want documents that you did not author? If you are still interested in receiving a response to this FOIA request, respond to the question and let us know by March 4, 2020.
Regards,

Katherine

From: Food and Drug Administration

Updated with correct due date

From: Dr. Remington Nevin

Dear FDA Staff/Katherine,

Thank you very much for your response. For the completeness of the record please do provide all responsive documents.

Sincerely,

Dr. Remington Nevin

From: Food and Drug Administration

Dr. Nevin,

Your request is open to CDER. I have copied Cheree here so that she can provide an estimate of response.
Regards,

Katherine

From: Food and Drug Administration

Dear Dr. Nevin,

We are still reviewing your request. The estimated time of completion is approximately 2 months. Please let me know if you need any additional information.

Best Regards,
Cheree

Cheree N. Simpson, JD
Lead Consumer Safety Officer
Food and Drug Administration
Division of Information Disclosure Policy
Office of Regulatory Policy
Center for Drug Evaluation and Research
(301)796-3458 Direct Line

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 cheree.simpson@fda.hhs.gov<mailto:cheree.simpson@fda.hhs.gov>

From: Food and Drug Administration

Dear MuckRock News:

Unfortunately, we are still reviewing your request. Once we complete, I will contact you. If you need any additional information, please let me know.

Best Regards,

Cheree

Cheree N. Simpson, JD
Lead Consumer Safety Officer
Food and Drug Administration
Division of Information Disclosure Policy
Office of Regulatory Policy
Center for Drug Evaluation and Research
(301)796-3458 Direct Line

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 cheree.simpson@fda.hhs.gov<mailto:cheree.simpson@fda.hhs.gov>

From: Food and Drug Administration

Dear MuckRock News:

Unfortunately, we are still reviewing your request. Once we complete, I will contact you. If you need any additional information, please let me know.

Best Regards,
Cheree

Cheree N. Simpson, JD
Lead Consumer Safety Officer
Food and Drug Administration
Division of Information Disclosure Policy
Office of Regulatory Policy
Center for Drug Evaluation and Research
(301)796-3458 Direct Line

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 cheree.simpson@fda.hhs.gov<mailto:cheree.simpson@fda.hhs.gov>

From: Food and Drug Administration

Good morning. Ms. Simpson, copied here, will provide you with an update. Thanks.

Sarah B. Kotler, J.D.
Director, Division of Freedom of Information
US FDA
301-796-8976

From: Food and Drug Administration

Unfortunately, we are still reviewing your request. If you are interested in narrowing your request to specific documents, please let me know.

Best Regards,
Cheree

Cheree N. Simpson, JD
Lead Consumer Safety Officer
Food and Drug Administration
Division of Information Disclosure Policy
Office of Regulatory Policy
Center for Drug Evaluation and Research
(301)796-3458 Direct Line

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 cheree.simpson@fda.hhs.gov<mailto:cheree.simpson@fda.hhs.gov>

From: Food and Drug Administration

Dear MuckRock News:

Unfortunately, we are still reviewing your request. Please let me know whether you would be interested in narrowing your request to the documents, we have located thus far. If you need any additional information, please let me know.

Best Regards,
Cheree

Cheree N. Simpson, JD
Lead Consumer Safety Officer
Food and Drug Administration
Division of Information Disclosure Policy
Office of Regulatory Policy
Center for Drug Evaluation and Research
(301)796-3458 Direct Line

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 cheree.simpson@fda.hhs.gov<mailto:cheree.simpson@fda.hhs.gov>

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