Request for Emergency Use Authorization for Use of Chloroquine or Hydroxychloroquine for Treatment of COVID-19 (Food and Drug Administration)

Dr. Remington Nevin filed this request with the Food and Drug Administration of the United States of America.
Multi Request Request for Emergency Use Authorization for Use of Chloroquine or Hydroxychloroquine for Treatment of COVID-19
Status
Rejected

Communications

From: Dr. Remington Nevin


To Whom It May Concern:

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

A copy of the request made by Dr. Rick Bright, Director, Biomedical Advanced Research and Development Authority, Office of Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services, to the U.S. Food and Drug Administration, for Authorization for use of chloroquine phosphate or hydroxychloroquine sulfate supplied from the strategic national stockpile for treatment of 2019 Coronavirus Disease. This request was approved by the FDA on March 28, 2020, as indicated in this document: https://www.fda.gov/media/136534/download

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,

Dr. Remington Nevin

From: Food and Drug Administration

Dr. Remington Nevin Dr. Remington Nevin
Re: Confirmation # FDA2063960
Requester Ctrl #:
In Reply refer to: 2020-2892
The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records regarding:
copy of the request made by Dr. Rick Bright, Director, Biomedical Advanced Research and Development Authority, Office of Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services, to the U.S. Food and Drug Administration, for Authorization for use of chloroquine phosphate or hydroxychloroquine sulfate supplied from the strategic national stockpile for treatment of 2019 Coronavirus Disease.
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 request for:

A copy of the request made by Dr. Rick Bright, Director, Biomedical Advanced Research and Development Authority, Office of Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services, to the U.S. Food and Drug Administration, for Authorization for use of chloroquine phosphate or hydroxychloroquine sulfate supplied from the strategic national stockpile for treatment of 2019 Coronavirus Disease.

As you are seeking a record created by the Department of Health and Human Services, we are referring your request to that agency. Contact information for the HHS FOIA Office is at:

https://www.hhs.gov/foia/index.html

Please contact me if you have questions about your request. 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>.

Sincerely,

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

From: Food and Drug Administration

RE: 2020-00932-FOIA-OS Dr. Remington Nevin
411A Highland Avenue, MR91311
Somerville, MA 02144 Dear Dr. Nevin: This is in response to your Freedom of Information Act (FOIA) request, dated April 08, 2020.  We received your request from the on Food and Drug Administration (FDA) April 08, 2020 and have begun processing your request.

Sincerely,
Jacqueline Trent
FOIA Specialist
Main Office Line:  202-690-7453

From: Food and Drug Administration

RE: FOIA Request # 2020-00932-FOIA-OS

May 01, 2020

Dear Dr. Remington Nevin,

Please see attached regarding your request.

Sincerely,

Kris Zadrovitz

Files

pages

Close