Update to Premarket Tobacco Product Application (PMTA) Review Process: Deficiency Letters and Major Amendments
| Tracking # |
2022-4094 FDA22083843 |
| Submitted | May 27, 2022 |
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Communications
From: Alex Norcia
To Whom It May Concern:
Pursuant to the Freedom of Information Act, I hereby request the following records:
internal Center for Tobacco Products (CTP) memorandum “Update to Premarket Tobacco Product Application (PMTA) Review Process: Deficiency Letters and Major Amendments,” dated August 12, 2020.
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,
Alex Norcia
From: Food and Drug Administration
*** This is an automated message. Please do not reply to this email. ***
Reference: FDA22083843
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: 2022-4094
Please find the attached acknowledgement regarding your FOIA request. Note: Do NOT reply directly to this E-mail
From: Food and Drug Administration
Good afternoon Mr. Norcia,
I am the FOIA Specialist that has been assigned to process your attached Freedom of Information Act (FOIA) request to the U.S. Food and Drug Administration (FDA), Center for Tobacco Products (CTP). Your request was received in CTP on June 3, 2022. It has been assigned FOIA Case number: 2022-4094.
We will conduct a search for records responsive to your request. If responsive records are located they will be reviewed, pursuant to the FOIA, for release to you.
Should you have any questions/concerns in the interim please do not hesitate to contact me via email at anissa.williams@fda.hhs.gov<mailto:anissa.williams@fda.hhs.gov>.
Thank you,
Anissa Williams
Quality Assurance Specialist
Center of Tobacco Products (CTP)
Office of Health Communication Education (OHCE)
U.S. Food and Drug Administration
Tel: 240-402-5354
Anissa.Williams@fda.hhs.gov<mailto:Anissa.Williams@fda.hhs.gov>
[U.S. Food and Drug Administration logo.]<http://www.fda.gov/>
[Facebook logo.]<https://www.facebook.com/FDA> [Twitter logo.] <https://twitter.com/FDATobacco> [YouTube logo.] <http://www.youtube.com/user/USFoodandDrugAdmin> [Flickr logo.] <http://www.flickr.com/photos/fdaphotos/> [RSS feed icon.] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>
From: Food and Drug Administration
Good afternoon Mr. Norcia,
I am the FOIA Specialist that has been assigned to process your attached Freedom of Information Act (FOIA) request to the U.S. Food and Drug Administration (FDA), Center for Tobacco Products (CTP). Your request was received in CTP on June 3, 2022. It has been assigned FOIA Case number: 2022-4094.
We will conduct a search for records responsive to your request. If responsive records are located they will be reviewed, pursuant to the FOIA, for release to you.
Should you have any questions/concerns in the interim please do not hesitate to contact me via email at anissa.williams@fda.hhs.gov.
Thank you,
Anissa Williams
Quality Assurance Specialist
Center of Tobacco Products (CTP)
Office of Health Communication Education (OHCE)
U.S. Food and Drug Administration
Tel: 240-402-5354
Anissa.Williams@fda.hhs.gov<mailto:Anissa.Williams@fda.hhs.gov>
[U.S. Food and Drug Administration logo.]<http://www.fda.gov/>
[Facebook logo.]<https://www.facebook.com/FDA> [Twitter logo.] <https://twitter.com/FDATobacco> [YouTube logo.] <http://www.youtube.com/user/USFoodandDrugAdmin> [Flickr logo.] <http://www.flickr.com/photos/fdaphotos/> [RSS feed icon.] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>
From: Food and Drug Administration
Good afternoon Mr. Norcia,
This is a status update for your CTP FOIA Request 2022-4094.
The request is still being processed and it is unclear when we will complete processing the request.
You will receive a follow-up within a week for a status update. If you have any questions, please do not hesitate to contact me via email at anissa.williams@fda.hhs.gov<mailto:anissa.williams@fda.hhs.gov>.
Thank you for your patience,
Anissa Williams
Quality Assurance Specialist
Center of Tobacco Products (CTP)
Office of Health Communication Education (OHCE)
U.S. Food and Drug Administration
Tel: 240-402-5354
Anissa.Williams@fda.hhs.gov<mailto:Anissa.Williams@fda.hhs.gov>
[U.S. Food and Drug Administration logo.]<http://www.fda.gov/>
[Facebook logo.]<https://www.facebook.com/FDA> [Twitter logo.] <https://twitter.com/FDATobacco> [YouTube logo.] <http://www.youtube.com/user/USFoodandDrugAdmin> [Flickr logo.] <http://www.flickr.com/photos/fdaphotos/> [RSS feed icon.] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>
From: Food and Drug Administration
Good morning Mr. Norcia,
This is a status update for your CTP FOIA Request 2022-4094.
The request is still being processed and it is unclear when we will complete processing the request.
You will receive a follow-up within a week for a status update. If you have any questions, please do not hesitate to contact me via email at anissa.williams@fda.hhs.gov<mailto:anissa.williams@fda.hhs.gov>.
Thank you for your patience,
Anissa Williams
Quality Assurance Specialist
Center of Tobacco Products (CTP)
Office of Health Communication Education (OHCE)
U.S. Food and Drug Administration
Tel: 240-402-5354
Anissa.Williams@fda.hhs.gov<mailto:Anissa.Williams@fda.hhs.gov>
[U.S. Food and Drug Administration logo.]<http://www.fda.gov/>
[Facebook logo.]<https://www.facebook.com/FDA> [Twitter logo.] <https://twitter.com/FDATobacco> [YouTube logo.] <http://www.youtube.com/user/USFoodandDrugAdmin> [Flickr logo.] <http://www.flickr.com/photos/fdaphotos/> [RSS feed icon.] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>
From: Food and Drug Administration
Good afternoon Mr. Norcia,
This is a status update for your CTP FOIA Request 2022-4094.
The request is still being processed and it is unclear when we will complete processing the request.
You will receive a follow-up within a week for a status update. If you have any questions, please do not hesitate to contact me via email at anissa.williams@fda.hhs.gov<mailto:anissa.williams@fda.hhs.gov>.
Thank you for your patience,
Anissa Williams
Quality Assurance Specialist
Center of Tobacco Products (CTP)
Office of Health Communication Education (OHCE)
U.S. Food and Drug Administration
Tel: 240-402-5354
Anissa.Williams@fda.hhs.gov<mailto:Anissa.Williams@fda.hhs.gov>
[U.S. Food and Drug Administration logo.]<http://www.fda.gov/>
[Facebook logo.]<https://www.facebook.com/FDA> [Twitter logo.] <https://twitter.com/FDATobacco> [YouTube logo.] <http://www.youtube.com/user/USFoodandDrugAdmin> [Flickr logo.] <http://www.flickr.com/photos/fdaphotos/> [RSS feed icon.] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>
From: Food and Drug Administration
Good afternoon Mr. Norcia,
This is a status update for your CTP FOIA Request 2022-4094.
The request is still being processed and it is unclear when we will complete processing the request.
You will receive a follow-up within a week for a status update. If you have any questions, please do not hesitate to contact me via email at anissa.williams@fda.hhs.gov<mailto:anissa.williams@fda.hhs.gov>.
Anissa Williams
Quality Assurance Specialist
Center of Tobacco Products (CTP)
Office of Health Communication Education (OHCE)
U.S. Food and Drug Administration
Tel: 240-402-5354
Anissa.Williams@fda.hhs.gov<mailto:Anissa.Williams@fda.hhs.gov>
[U.S. Food and Drug Administration logo.]<http://www.fda.gov/>
[Facebook logo.]<https://www.facebook.com/FDA> [Twitter logo.] <https://twitter.com/FDATobacco> [YouTube logo.] <http://www.youtube.com/user/USFoodandDrugAdmin> [Flickr logo.] <http://www.flickr.com/photos/fdaphotos/> [RSS feed icon.] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>
From: Food and Drug Administration
Good afternoon Mr. Norcia,
This is a status update for your CTP FOIA Request 2022-4094.
The request is still being processed and it is unclear when we will complete processing the request.
Thank you in advance for your patience. If you have any questions, please do not hesitate to contact me via email at anissa.williams@fda.hhs.gov<mailto:anissa.williams@fda.hhs.gov>.
Anissa Williams
Quality Assurance Specialist
Center of Tobacco Products (CTP)
Office of Health Communication Education (OHCE)
U.S. Food and Drug Administration
Tel: 240-402-5354
Anissa.Williams@fda.hhs.gov<mailto:Anissa.Williams@fda.hhs.gov>
[U.S. Food and Drug Administration logo.]<http://www.fda.gov/>
[Facebook logo.]<https://www.facebook.com/FDA> [Twitter logo.] <https://twitter.com/FDATobacco> [YouTube logo.] <http://www.youtube.com/user/USFoodandDrugAdmin> [Flickr logo.] <http://www.flickr.com/photos/fdaphotos/> [RSS feed icon.] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>
From: Food and Drug Administration
Good afternoon Mr. Norcia,
This is a status update for your CTP FOIA Request 2022-4094.
The request is still being processed and the estimated completion date is August 25, 2022.
Thank you in advance for your patience. If you have any questions, please do not hesitate to contact me via email at anissa.williams@fda.hhs.gov<mailto:anissa.williams@fda.hhs.gov>.
Anissa Williams
Quality Assurance Specialist
Center of Tobacco Products (CTP)
Office of Health Communication Education (OHCE)
U.S. Food and Drug Administration
Tel: 240-402-5354
Anissa.Williams@fda.hhs.gov<mailto:Anissa.Williams@fda.hhs.gov>
[U.S. Food and Drug Administration logo.]<http://www.fda.gov/>
[Facebook logo.]<https://www.facebook.com/FDA> [Twitter logo.] <https://twitter.com/FDATobacco> [YouTube logo.] <http://www.youtube.com/user/USFoodandDrugAdmin> [Flickr logo.] <http://www.flickr.com/photos/fdaphotos/> [RSS feed icon.] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>
From: Food and Drug Administration
Good afternoon,
Yes, the expected completion date is August 25, 2022.
Please let me know if you have any questions or concerns. Thank you.
Anissa Williams
Quality Assurance Specialist
Center of Tobacco Products (CTP)
Office of Health Communication Education (OHCE)
U.S. Food and Drug Administration
Tel: 240-402-5354
Anissa.Williams@fda.hhs.gov<mailto:Anissa.Williams@fda.hhs.gov>
[U.S. Food and Drug Administration logo.]<http://www.fda.gov/>
[Facebook logo.]<https://www.facebook.com/FDA> [Twitter logo.] <https://twitter.com/FDATobacco> [YouTube logo.] <http://www.youtube.com/user/USFoodandDrugAdmin> [Flickr logo.] <http://www.flickr.com/photos/fdaphotos/> [RSS feed icon.] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>
From: Food and Drug Administration
Mr. Norcia,
Please see the attached final response letter and document responsive to your June 3, 2022, Freedom of Information Act (FOIA) request to the Food and Drug Administration (FDA), Center for Tobacco Products. If you have any questions, please contact me via email. See below.
Best Regards,
Noella Goliatha
Quality Assurance Specialist
Center for Tobacco Products (CTP)
Office of Health Communication Education (OHCE)
U.S. Food and Drug Administration
Tel: 301-796-5427
Noella.Goliatha@fda.hhs.gov<mailto:Noella.Goliatha@fda.hhs.gov>
[cid:image001.png@01D8C835.6DEFE5D0]<http://www.fda.gov/>
[cid:image002.jpg@01D8C835.6DEFE5D0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D8C835.6DEFE5D0] <https://twitter.com/FDATobacco> [cid:image004.jpg@01D8C835.6DEFE5D0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D8C835.6DEFE5D0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D8C835.6DEFE5D0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>
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