Premarket Tobacco Application For ENDs
| Tracking # |
FDA2063168 |
| Submitted | Feb. 28, 2020 |
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Communications
From: Sandra Rothenberg
To Whom It May Concern:
Pursuant to the Freedom of Information Act, I hereby request the following records:
We would like to receive copies (redacted if necessary) of any Premarket Tobacco Product Applications for electronic cigarettes submit to the FDA in 2018 and 2019. We would also like copies of any Substantial Equivalence Reports for electronic cigarettes submit to the FDA in 2018 and 2019.
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,
Sandra Rothenberg
From: Food and Drug Administration
*** This is an automated message. Please do not reply to this email. ***
Reference: FDA2063168
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
Sandra Rothenberg Sandra Rothenberg
Re: Confirmation # FDA2063168
Requester Ctrl #:
In Reply refer to: 2020-2067
The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records regarding:
Premarket Tobacco Product Applications for electronic cigarettes submit to the FDA in 2018 and 2019. We would also like copies of any Substantial Equivalence Reports for electronic cigarettes submit to the FDA in 2018 and 2019.
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: Food and Drug Administration
Good Morning, Ms. Rothenberg:
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 March 6, 2020.
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 directly. Please find my contact information below.
Kind Regards,
Noella Goliatha
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@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>
From: Food and Drug Administration
Attached is FDA's 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@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>
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