COVID-19 FOIA impact (Food and Drug Administration)

Emma North-Best filed this request with the Food and Drug Administration of the United States of America.
Tracking #

FDA2063489

Multi Request COVID-19 FOIA impact
Est. Completion None
Status
No Responsive Documents

Communications

From: Emma North-Best


To Whom It May Concern:

Pursuant to the Freedom of Information Act, I hereby request the following records:

Records mentioning or describing any impact on the processing of FOIA requests caused by COVID-19 AKA the Corona virus.

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,

Emma Best

From: Food and Drug Administration

*** This is an automated message. Please do not reply to this email. ***
Reference: FDA2063489
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

*** This is an automated message. Please do not reply to this email. ***
Reference: FDA2063489
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

Emma Best Emma Best
Re: Confirmation # FDA2063489
Requester Ctrl #:
In Reply refer to: 2020-2527
The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records regarding:
Records mentioning or describing any impact on the processing of FOIA requests caused by COVID-19 AKA the Corona virus.
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

Dear Requester,

FDA received your FOIA request for:

Records mentioning or describing any impact on the processing of FOIA requests caused by COVID-19 AKA the Corona virus.

The processing of FOIA requests at FDA remains the same as it was prior to the COVID-18/Coronavirus outbreak. The agency continues to receive, log, and process requests according 5 USC 552 and FDA's regulations at 21 CFR Part 20. Therefore, we have no responsive records.

You have the right to appeal this determination. By filing an appeal, you preserve your rights under FOIA and give the agency a chance to review and reconsider your request and the agency's decision. Your appeal must be mailed within 90 days from the date of this response, to: Agency Chief FOIA Officer, U.S. Department of Health and Human Services, Office of the Assistant Secretary for Public Affairs, Room 729H, 200 Independence Avenue, S.W., Washington, DC 20201; e-mail FOIARequest@PSC.hhs.gov<mailto:FOIARequest@PSC.hhs.gov>. Please clearly mark both the envelope and your letter or e-mail "FDA Freedom of Information Act Appeal."
If you would like to discuss our response before filing an appeal to attempt to resolve your dispute without going through the appeals process, please contact me at 301-796-8976 or Sarah.Kotler@fda.hhs.gov<mailto:Sarah.Kotler@fda.hhs.gov>. You may also contact the FDA FOIA Public Liaison for assistance at:

Office of the Executive Secretariat

US Food & Drug Administration

5630 Fishers Lane, Room 1050

Rockville, MD 20857

E-mail: FDAFOIA@fda.hhs.gov<mailto:FDAFOIA@fda.hhs.gov>

If you are unable to resolve your FOIA dispute through our FOIA Public Liaison, the Office of Government Information Services (OGIS), the Federal FOIA Ombudsman's office, offers mediation services to help resolve disputes between FOIA requesters and Federal agencies. The contact information for OGIS is:

Office of Government Information Services
National Archives and Records 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<mailto:ogis@nara.gov>

Fax: 202-741-5769

Sincerely,

Sarah B. Kotler, J.D.
Director, Division of Freedom of Information
US FDA
301-796-8976

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