Records - Dr. Marion Gruber and Dr. Philip Krause (FDA Office of Vaccines Research and Review)

To Whom It May Concern:

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

1. All records related to the retirement, resignation and/or termination of Dr. Marion Gruber, former director of the Office of Vaccines Research and Review at FDA's Center for Biologics Evaluation and Research, including but not limited to drafts and final copies of any separation or retirement agreements. Please make sure to also include all attachments to any emails.

2. All records related to the retirement, resignation and/or termination of Dr. Philip Krause, former deputy director of the Office of Vaccines Research and Review at FDA's Center for Biologics Evaluation and Research, including but not limited to drafts and final copies of any separation or retirement agreements. Please make sure to also include all attachments to any emails.

The time frame for your search would likely be between July 1, 2021 and Nov. 1, 2021. During your search, it would be a good idea to also search communications between the aforementioned parties and CBER director Dr. Peter Marks.

For further clarification about the retirement/resignation records I am seeking, please refer to the following news article: https://www.cnn.com/2021/08/31/health/fda-vaccine-officials-step-down/index.html

When delivering the responsive documents related to this request, please make sure to specifically certify that no other responsive documents exist beyond those provided by your agency as part of this request.

The requested documents and information will be made available to the general public, and this request is not being made for commercial purposes. Disclosure of the requested information is in the public interest because it is likely to contribute significantly to public understanding of the operations and activities of the government and is not primarily in the commercial interest of the requester.

In order to help determine my status to assess fees, you should know that I am a freelance journalist whose work is published frequently by print and digital news outlets and magazines. I have previously been classified as a media requester by other federal agencies, including the CDC, when requesting information under the FOIA. You can view my work at www.erinmariemiller.com/clips. As a member of the media, I request a waiver of all fees.

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 am willing to pay up to $25 for the requested information. If there is a fee that exceeds that amount, please notify me prior to initiating work on the 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,

Erin Miller

Hi Sarah,

Thank you for your confirmation letter regarding FDA request control # 2022-637.

To clarify the parameters of my request, I am primarily interested in records relating to Dr. Gruber's and Dr. Krause's separations from the FDA, including the details regarding the basis for such separation and any agreements reached regarding the terms of separation.

At your recommendation on my previous request (FDA Request #2022-97), I filed a separate request for these records with the U.S. Office of Personnel Management (OPM). In response to that request (OPM Request 2022-00403), Steven Gitelman confirmed by email that the OPM does not have the requested records. Mr. Gitelman also confirmed that the FDA would be the correct agency to request these records from.

Please let me know if you have any additional questions for me related to this request. I would prefer that our correspondence be in writing, by email, for the remainder of this request due to the difficulties I experienced in contacting you about my previous request after our phone conversation.

Best,

Erin Marie Miller

Hi Sarah,

Thank you for your confirmation letter regarding FDA request control # 2022-637.

To clarify the parameters of my request, I am primarily interested in records relating to Dr. Gruber's and Dr. Krause's separations from the FDA, including the details regarding the basis for such separation and any agreements reached regarding the terms of separation.

At your recommendation on my previous request (FDA Request #2022-97), I filed a separate request for these records with the U.S. Office of Personnel Management (OPM). In response to that request (OPM Request 2022-00403), Steven Gitelman confirmed by email that the OPM does not have the requested records. Mr. Gitelman also confirmed that the FDA would be the correct agency to request these records from.

Please let me know if you have any additional questions for me related to this request. I would prefer that our correspondence be in writing, by email, for the remainder of this request due to the difficulties I experienced in contacting you about my previous request after our phone conversation.

Best,

Erin Marie Miller

Hi Sarah,

Thank you for your confirmation letter regarding FDA request control # 2022-637.

To clarify the parameters of my request, I am primarily interested in records relating to Dr. Gruber's and Dr. Krause's separations from the FDA, including the details regarding the basis for such separation and any agreements reached regarding the terms of separation.

At your recommendation on my previous request (FDA Request #2022-97), I filed a separate request for these records with the U.S. Office of Personnel Management (OPM). In response to that request (OPM Request 2022-00403), Steven Gitelman confirmed by email that the OPM does not have the requested records. Mr. Gitelman also confirmed that the FDA would be the correct agency to request these records from.

Please let me know if you have any additional questions for me related to this request. I would prefer that our correspondence be in writing, by email, for the remainder of this request due to the difficulties I experienced in contacting you about my previous request after our phone conversation.

Best,

Erin Marie Miller

Hello,

Thank you for your confirmation letter regarding FDA request control # 2022-637.

After attempting to send a response email to Sarah Kotler, I was informed by MuckRock staff that my emails were bounced back again, as they were on a previous request. Per MuckRock staff, my response is now en route to the FDA by mail.

In light of that, I am also following up with the FDA's general FOIA email address here in hopes that you might forward this email to Ms. Kotler, or whoever is currently responsible for this request.

To clarify the parameters of FDA request control # 2022-637, I am primarily interested in records relating to Dr. Gruber's and Dr. Krause's separations from the FDA, including the details regarding the basis for such separation and any agreements reached regarding the terms of separation.

Following Ms. Kotler's recommendation on my previous request (FDA Request #2022-97) during my phone conversation with her, I filed a separate request for these records with the U.S. Office of Personnel Management (OPM). In response to that request (OPM Request 2022-00403), Steven Gitelman confirmed by email that the OPM does not have the requested records. Mr. Gitelman also confirmed that the FDA would be the correct agency to request these records from.

Please let me know if your agency has any additional questions for me related to this request. I would prefer that our correspondence be in writing, by email, for the remaining duration of this request due to the difficulties I experienced in contacting Ms. Kotler about my previous request after our phone conversation.

Best,

Erin Marie Miller

To Whom It May Concern:

I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on Jan. 24, 2022. Please let me know when I can expect to receive a response. You had assigned it reference number #2022-637.

Despite receiving an acknowledgment letter for this request on Jan. 27, 2022, letting me know my request would take longer than 20 working days, I was never provided with responsive documents related to this request. The agency has also ignored multiple follow-up emails. It has now been 11 months since the agency received my request. I am requesting an immediate response from your agency regarding the delay on this FOIA request.

Please let me know if further clarification is needed. Due to the FDA adding my email address to a spam filter list under a previous request, I am requesting that all communications related to this request be in writing. This will provide me with documentation in the event that a FOIA lawsuit becomes necessary.

Thank you,

Erin Marie Miller