CTP Software Malfunction
| Tracking # |
2023-580 FDA23089139 |
| Submitted | Jan. 12, 2023 |
| Est. Completion | None |
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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:
all communications, correspondence, and documents, including electronic mail, between October 10, 2022 and January 10, 2023 relating to any potential defects, errors, anomalies, or mistakes resulting from the use of computer software, applications, or programs to review, filter, or organize, or assist in the review for acceptance of premarket tobacco product applications that were submitted to the Center for Tobacco Products between March 15, 2022, and May 15, 2022.
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: FDA23089139
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: 2023-580
Please find the attached acknowledgement regarding your FOIA request. Note: Do NOT reply directly to this E-mail
From: Food and Drug Administration
Dear Mr. Norcia,
This email acknowledges receipt of your Freedom of Information Act (FOIA) request dated January 23, 2023 to the U.S. Food and Drug Administration (FDA), Center for Tobacco Products (CTP). Your request was received in this office on January 23, 2023.
FDA has a decentralized FOIA program. Each FDA Center processes its own FOIA requests independently. CTP FOIA processes requests on behalf of the following CTP program/leadership offices: Office of the Center Director (OCD), Office of Science (OS), Office of Health Communication and Education (OHCE), Office of Compliance and Enforcement (OCE), Office of Regulations (OR) and the Office of Management (OM). CTP’s FOIA program is under the purview of OHCE.
FOIA regulation 5 U.S.C. § 552(a)(6)(A)(i) require us to make a determination in response to a FOIA request within 20 business days from the date of its receipt. In unusual circumstances, the Federal agency time limit may be extended by 10 business days as stated in 5 U.S.C. § 552(a)(6)(B). If your request seeks numerous records that will necessitate a wide-ranging search, including searches with components and possible consultations with components that have a substantial interest in the determination of this request, we will invoke a 10 business day extension for determination of your request. You have the option to narrow the scope of your request to limit the number of potentially responsive records.
Educational Institution, Non –Commercial Scientific Institution, Media Requesters
Provisions of the FOIA allow us to recover part of the cost of complying with your request. For purposes of fee assessment, you were categorized as media requester, pursuant to 21 C.F.R. §20.45(a)(2). In accordance with 21 C.F.R. §20.45(b)(4), no charge will be made if the costs of routine collection and processing of the fee are likely to equal or exceed the amount of the fee ($25). You will be contacted if fees are assessed.
A search will be conducted for records responsive to your request. If any responsive records are located, they will be reviewed for determination of releasability. Please be assured that we will respond to your request as expeditiously as possible. We appreciate your patience as we proceed with your request.
Your request has been assigned FOIA Request 2023-580 . Please refer to this number in any future correspondence with us. If you have any questions regarding the processing of your request, please contact me at 240-402-8325 or via email at Melinda.Batson@fda.hhs.gov<mailto:Melinda.Batson@fda.hhs.gov> or CTPFOIA@fda.hhs.gov<mailto:CTPFOIA@fda.hhs.gov>. For additional information regarding FDA’s FOIA regulations and processes, please refer to the information available on-line at https://www.fda.gov/RegulatoryInformation/FOI/default.htm.
We appreciate the opportunity to assist you in this matter.
Melinda S. Batson, B.S. (she/her/hers)
Government Information Specialist
Center for Tobacco Products
Office of Health Communication and Education
U.S. Food and Drug Administration
Telephone: (240) 402-8325
Melinda.batson@fda.hhs.gov<mailto:Melinda.batson@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>
This e-mail, and any attachments, is for the sole use of the intended recipient(s) and may contain confidential and/or protected information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message.
From: Food and Drug Administration
Dear Alex,
I am assigned to process your FOIA request FDA CTP 2023-580. Could you provide a good time to contact you and if your contact number is 617-299-1832?
I am trying to understand if you are seeking responsive records as it relates to abnormalities encountered during submission process of PMTAs or records about abnormalities encountered during the actual scientific review of PMTA. I am trying to determine which CTP program office to submit a search request. Although you provided a date range, but including additional information such as keywords may help with the search for responsive records.
Your prompt response is appreciated. When responding to this email, please respond to all recipients.
Thank you
Melinda S. Batson, B.S. (she/her/hers)
Government Information Specialist
Center for Tobacco Products
Office of Health Communication and Education
U.S. Food and Drug Administration
Telephone: (240) 402-8325
Melinda.batson@fda.hhs.gov<mailto:Melinda.batson@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>
This e-mail, and any attachments, is for the sole use of the intended recipient(s) and may contain confidential and/or protected information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message.
From: Food and Drug Administration
Dear Alex,
This is a follow-up email about your request. Could you advise when it is a good time to contact you?
I have yet to receive a reply and I want to be sure the email address you provided is correct.
Melinda S. Batson, B.S. (she/her/hers)
Government Information Specialist
Center for Tobacco Products
Office of Health Communication and Education
U.S. Food and Drug Administration
Telephone: (240) 402-8325
Melinda.batson@fda.hhs.gov<mailto:Melinda.batson@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>
This e-mail, and any attachments, is for the sole use of the intended recipient(s) and may contain confidential and/or protected information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message.
From: Food and Drug Administration
Dear Alex,
As you can, I sent two emails to the address highlighted below.
Melinda S. Batson, B.S. (she/her/hers)
Government Information Specialist
Center for Tobacco Products
Office of Health Communication and Education
U.S. Food and Drug Administration
Telephone: (240) 402-8325
Melinda.batson@fda.hhs.gov<mailto:Melinda.batson@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>
This e-mail, and any attachments, is for the sole use of the intended recipient(s) and may contain confidential and/or protected information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message.
From: Food and Drug Administration
Dear Alex,
I left you a voicemail message at the phone number you provided in your FOIA request; so far I have not received a response to my email inquiries.
When you receive my voicemail message could you please contact me at the number below or you may respond to my email dated January 25, 2023.
I want to clarify which program office within CTP to initiate a search for responsive records. Your responsive is appreciated.
Thank you
Melinda S. Batson, B.S. (she/her/hers)
Government Information Specialist
Center for Tobacco Products
Office of Health Communication and Education
U.S. Food and Drug Administration
Telephone: (240) 402-8325
Melinda.batson@fda.hhs.gov<mailto:Melinda.batson@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>
This e-mail, and any attachments, is for the sole use of the intended recipient(s) and may contain confidential and/or protected information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message.
From: Food and Drug Administration
Dear Alex,
From: Food and Drug Administration
Dear Alex,
This is an update your FOIA request 2023-580. Since you have not responded regarding the clarification of the request; this FOIA case has been administrately closed.
Please refer to the attached letter.
Thank you
Melinda S. Batson, B.S. (she/her/hers)
Government Information Specialist
Center for Tobacco Products
Office of Health Communication and Education
U.S. Food and Drug Administration
Telephone: (240) 402-8325
Melinda.batson@fda.hhs.gov<mailto:Melinda.batson@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>
This e-mail, and any attachments, is for the sole use of the intended recipient(s) and may contain confidential and/or protected information. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message.
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