Date of Substantial Equivalence submissions to FDA

ben zeidler filed this request with the Food and Drug Administration of the United States of America.
Tracking #

2017-1184

Status
Completed

Communications

From: ben zeidler

To Whom It May Concern:

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

Please provide the dates that Xcaliber International Ltd., LLC submitted Substantial Equivalence reports for each of its products by brand and subbrand.

Echo Cigarettes (all brand styles)

Edgefield Cigarettes (all brand styles)

Exeter Cigarettes (all brand styles)

http://www.xcaliberinternational.com/products/

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,

Ben Zeidler

From: Food and Drug Administration

An acknowledgement letter, stating the request is being processed.

From: Monroe, Tamu

Hello Mr. Zeidler,

This email concerns your eight Freedom of Information Act (FOIA) requests dated, October 21, 2015. Your requests were received in the FDA Center for Tobacco Products on October 23, 2015.

We have completed our search. We will write to you again once our review is completed and our disclosure determinations are made. In the meantime, if you have any questions concerning the processing of your request, please feel free to contact me by email or call me at (301) 796-7397.

Regards,
Tamu Monroe
Government Information Specialist
Office of Health Communications & Education
FDA Center for Tobacco Products
tamu.monroe@FDA.hhs.gov<mailto:tamu.monroe@FDA.hhs.gov> | 301.796.7397

www.FDA.gov/Tobacco<http://www.fda.gov/Tobacco> | @FDATobacco

[Center for Tobacco Products Logo]

From: MuckRock

Hi there,

Could you please confirm whether or not separate tracking numbers were assigned to each unique request?

Thank you very much for your help.

From: Monroe, Tamu

Hello Mr. Zeidler,

Yes, unique tracking numbers were assigned to each unique request.

If I have any questions, may I contact you by phone? If so, what is the best contact number to reach you?

Thanks,
Tamu Monroe
Government Information Specialist

Office of Health Communications & Education
FDA Center for Tobacco Products
tamu.monroe@FDA.hhs.gov<mailto:tamu.monroe@FDA.hhs.gov> | 301.796.7397

www.FDA.gov/Tobacco<http://www.fda.gov/Tobacco> | @FDATobacco

[Center for Tobacco Products Logo]

From: ben zeidler

Hi Tamu,

The best way to reach me is by giving my attorney a call. I only say that because he just understands this process better than me. He can be reached at 201-803-4388.

Or you can call me directly at (267) 242-6260.

Best,
Ben

From: Monroe, Tamu

Hi Mr. Zeidler,

I’ll give you a call this afternoon regarding your multiple FOIA requests.

Thanks,
Tamu Monroe
Government Information Specialist

Office of Health Communications & Education
FDA Center for Tobacco Products
tamu.monroe@FDA.hhs.gov<mailto:tamu.monroe@FDA.hhs.gov> | 301.796.7397

www.FDA.gov/Tobacco<http://www.fda.gov/Tobacco> | @FDATobacco

[Center for Tobacco Products Logo]

From: Monroe, Tamu

Hello Mr. Zeidler,

Thanks for your inquiry regarding the status. We are still processing your request. The estimated date of completion is mid July.

What email address would you like the responsive documents sent?

Thanks,
Tamu Monroe
Government Information Specialist
Office of Health Communications & Education
FDA Center for Tobacco Products
tamu.monroe@FDA.hhs.gov<mailto:tamu.monroe@FDA.hhs.gov> | 301.796.7397
www.FDA.gov/Tobacco<http://www.fda.gov/Tobacco> | @FDATobacco

[Center for Tobacco Products Logo]

From: MuckRock

Hi,

Thank you for the update. This email address works best.

From: Monroe, Tamu

Hello Mr. Zeidler,

I know longer work at CTP. Please contact the general FOIA mailbox for updates.
Regards,
Tamu Monroe

From: MuckRock

Could you please provide a status update on this account? The FOIA officer to whom it was tasked is no longer with CTP.

Thanks for your help.

From: Kotler, Sarah

Dear Mr. Zeidler,

Your request was completed in June. I am attaching here the response that was sent to you over 6 months ago. Please either contact me by telephone or stop sending faxes for status of a request that is already closed.

Sincerely,

Sarah B. Kotler, J.D.
Director
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-8976
Sarah.Kotler@fda.hhs.gov<mailto:Sarah.Kotler@fda.hhs.gov>

[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>

[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D1C57E.DFA022A0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>

From: Food and Drug Administration

An acknowledgement letter, stating the request is being processed.

From: Kotler, Sarah

Good morning. I will check and get back to you. In the meantime, please have the auto-faxes discontinued for requests that are closed. Thanks.

Sarah Kotler, J.D.
Director, Division of Freedom of Information
U.S. Food and Drug Administration
301-796-8976

From: Kotler, Sarah

Hi, again. I have asked the CTP FOIA Officer to contact you regarding status. Thanks.

Sarah B. Kotler, J.D.
Director
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-8976
Sarah.Kotler@fda.hhs.gov<mailto:Sarah.Kotler@fda.hhs.gov>

[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>

[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D1C57E.DFA022A0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>

From: Hill, Melinda

Hello Mr. Zeidler

Please find attached our response letter and responsive record to your Freedom of Information Act request 2017-1184.

Sincerely,

Melinda

--------------------------------------------
Melinda Hill
Government Information Specialist

Center for Tobacco Products
Office of Health Communications & Education
Food and Drug Administration
Tel: 240-402-3558
Melinda.hill@fda.hhs.gov<mailto:Melinda.hill@fda.hhs.gov>

[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>

[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/fdatobacco> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D1C57E.DFA022A0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>

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