FDA: Noopept (N-phenylacetyl-L-prolylglycine ethyl ester)

Anthony Roberts filed this request with the Food and Drug Administration of the United States of America.

It is a clone of this request.

Tracking #

2018-615

Est. Completion None
Status
Fix Required

Communications

From: anthony roberts

To Whom It May Concern:

This is a request under the Freedom of Information Act.

I am seeking all FDA documents dealing with Noopept (N-phenylacetyl-L-prolylglycine ethyl ester). This should include Investigational New Drug Applications, compounding pharmacy requests, import alerts, import records and records of seizures, New Dietary Ingredient Notifications and resulting correspondence, plus internal and external documents not limited to email correspondences, white papers, and opinions.

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,

anthony roberts

From: anthony roberts

I am seeking confirmation of receipt on my FOIA request asking for FDA documents dealing with Noopept (N-phenylacetyl-L-prolylglycine ethyl ester. It's been over a month and I've not received acknowledgment of the request.

From: Anthony Roberts

I am seeking confirmation of receipt on my FOIA request asking for FDA documents dealing with Noopept (N-phenylacetyl-L-prolylglycine ethyl ester. It's been over a month and I've not received acknowledgment of the request.

The request was filed in July of 2017.

From: Food and Drug Administration

*** This is an automated message. Please do not reply to this email. ***

Reference: FDA1840767
Dear Requester,
This is to confirm that you submitted a request for record(s) from the Food and Drug Administrationpursuant 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

An acknowledgement letter, stating the request is being processed.

From: Food and Drug Administration

Note: Do NOT reply directly to this E-mail
Re: Confirmation # FDA1840767
The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records regarding:
To Whom It May Concern: This is a request under the Freedom of Information Act. I am seeking all FDA documents dealing with Noopept (N-phenylacetyl-L-prolylglycine ethyl ester). This should include Investigational New Drug Applications, compounding pharmacy requests, import alerts, import records and records of seizures, New Dietary Ingredient Notifications and resulting correspondence, plus internal and external documents not limited to email correspondences, white papers, and opinions. 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, anthony roberts
The request has been declined for following reason:
THIS APPEARS TO BE A DUPLICATE OF REQUEST 2018-615.
FOIA staff may contact you via telephone or email.

From: Food and Drug Administration

Subject: FW: Action Office Selection on Disclosure/FOI Control #
2018-615
Date: 2018-02-06 23:06
From: "Brewster, Max" <Samuel.Brewster@fda.hhs.gov>
To: "anthonyroberts@riseup.net" <anthonyroberts@riseup.net>
Cc: "Elrand, Lisa M" <Lisa.Elrand@fda.hhs.gov>

Good day Muckrock News, please find the attached response letter and
production for your FOIA request from the FDA's Office of Regulatory
Affairs, Division of Import Operations. Thank you!

S. Max Brewster, MBA | Division of Import Operations (OEIO) | Office of
Regulatory Affairs | US Food and Drug Administration |301-796-8994|
max.brewster@fda.hhs.gov

FROM: aimssystem@fda.hhs.gov [mailto:aimssystem@fda.hhs.gov]
SENT: Wednesday, January 24, 2018 8:25 AM
TO: Mata, Selina <Selina.Mata@fda.hhs.gov>; Williams, Ashley
<Ashley.Williams@fda.hhs.gov>; Elrand, Lisa M <Lisa.Elrand@fda.hhs.gov>;
Brewster, Max <Samuel.Brewster@fda.hhs.gov>
SUBJECT: Action Office Selection on Disclosure/FOI Control # 2018-615

Note: Do NOT reply directly to this E-mail

A request to your office on Disclosure/FOI for Control # 2018-615 has
been made. A summary of the request appears below.

Requester:

MUCKROCK NEWS

Due Date:

WEDNESDAY, FEBRUARY 21, 2018

Subject:

NOOPEPT - NDA, IMPORT ALERTS, CORR, ETC

Access the record information by logging in and clicking the menu option
"Accept/Decline Requests" link. (unless the request to your office was
withdrawn, denied, or appealed).

Aims Homepage [1] | Documentation [2]

From: Food and Drug Administration

Your FOIAonline user account for requests@muckrock.com has been locked due to inactivity. Your account can be unlocked using the Forgot Password link at the top of any page within FOIAonline.

From: Food and Drug Administration

Good morning Mr. Roberts,

I'm writing to clarify the scope of your request for records concerning Noopept (N-phenylacetyl-L-prolylglycine ethyl ester). Specifically, what is the relevant timeframe for which you seek responsive documents?

Thank you for your assistance in this matter.

Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
HILL-3138
Silver Spring, MD 20993-0002
301-796-2697

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 eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov>

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