Emails Mentioning "Embargo" 2020-2021 (FDA Office of Media Affairs)

To Whom It May Concern:

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

1. All emails that include and/or contain the word "embargo" that were sent to, from, and/or between any of the following email addresses between the dates of 3/1/2020 and the date this request is ultimately processed:

abigail.Capobianco@fda.hhs.gov
alison.hunt@fda.hhs.gov
amanda.turney@fda.hhs.gov
angela.stark@fda.hhs.gov
april.grant@fda.hhs.gov
audra.Harrison@fda.hhs.gov
brad.kimberly@fda.hhs.gov
brittney.Manchester@fda.hhs.gov
chanapa.Tantibanchachai@fda.hhs.gov
courtney.Rhodes@fda.hhs.gov
daniel.Hetlage@fda.hhs.gov
emma.Spaulding@fda.hhs.gov
fdaoma@fda.hhs.gov
gloria.sanchez-contreras@fda.hhs.gov
heather.Janik@fda.hhs.gov
heidi.Rebello@fda.hhs.gov
james.McKinney@fda.hhs.gov
jane.hubbard@fda.hhs.gov
jennifer.dooren@fda.hhs.gov
jeremy.kahn@fda.hhs.gov
kimberly.DiFonzo@fda.hhs.gov
kristin.jarrell@fda.hhs.gov
Lauren-Jei.McCarthy@fda.hhs.gov
lindsey.okeefe@fda.hhs.gov
lyndsay.meyer@fda.hhs.gov
megan.mcseveney@fda.hhs.gov
michael.felberbaum@fda.hhs.gov
monique.Richards@fda.hhs.gov
nathan.arnold@fda.hhs.gov
nicole.mueller@fda.hhs.gov
peter.Cassell@fda.hhs.gov
sarah.Peddicord@fda.hhs.gov
shannon.Hatch@fda.hhs.gov
shirley.Simson@fda.hhs.gov
stephanie.caccomo@fda.hhs.gov
tara.rabin@fda.hhs.gov
usfda@public.govdelivery.com
veronika.Pfaeffle@fda.hhs.gov

Please also make sure to include all attachments to those emails.

None of the keywords cited in this request should be interpreted by your agency as being case sensitive during the search and retrieval process.

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.

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,

I called the number listed in your email signature (301-796-8976) and left a message on your voicemail today (1/6/2022) at 1:13 p.m. Eastern Time. Feel free to call me back at the number I provided in my message at your earliest convenience; you can also send me your availability if you'd prefer to schedule a time to talk.

Thank you,

Erin Miller

Hi Sarah,

Thank you so much for taking the time to discuss my requests, and for your recommendations about how to narrow my requests for efficiency. I really appreciate it! Per our conversation about FOIA request Control #2022-98, please narrow it down to the following parameters:

1. All emails that include and/or contain the word "embargo" that were sent to, from, and/or between the following email addresses between the dates of 3/1/2020 and the date this request is ultimately processed: heidi.Rebello@fda.hhs.gov ; michael.felberbaum@fda.hhs.gov

Please let me know once you know how many responsive emails your agency will need to review under this more narrow request, prior to beginning any further work. If necessary at that time, we can discuss narrowing the search further depending on the volume of emails.

I will email you separately about the other requests we discussed, in order to keep everything organized.

Thank you, again!

- Erin Miller

FDA FOIA Public Liaison
Office of the Executive Secretariat
US Food Administration
5630 Fishers Lane, Room 1050

Re: APPEAL - Freedom of Information Act

To Whom It May Concern:

This is an appeal under the Freedom of Information Act regarding FDA FOIA Control #: 2022-98.

On Dec. 28, 2021, I requested records under the Freedom of Information Act from the FDA pertaining to "All emails that include and/or contain the word 'embargo' that were sent to, from, and/or between specific email addresses between the dates of 3/1/2020 and the date this request is ultimately processed, including their attachments." I also provided a specific list of email addresses belonging to officials at the FDA.

On Dec. 29, 2021, I received confirmation from the FDA that my request had been received and was provided with reference number FDA2179960.

On Jan. 4, 2022, I received an acknowledgement letter from director Sarah Kotler letting me know that the agency would respond to my request with a determination and let me know about fees, and informing me that the agency needed an extra 10 days to respond.

On Jan. 5, 2022, Sarah Kotler contacted me asking to speak with me by phone about my request.

On Jan. 6, 2022, I called the number Ms. Kotler had provided to me but was unable to reach her.

On Jan. 7, 2022, I finally spoke with Ms. Kotler by phone. She recommended that I narrow my search parameters down to the following to speed up the process of retrieving the requested information: "All emails that include and/or contain the word 'embargo' that were sent to, from, and/or between the following email addresses between the dates of 3/1/2020 and the date this request is ultimately processed: heidi.Rebello@fda.hhs.gov ; michael.felberbaum@fda.hhs.gov."

I agreed to Ms. Kotler's recommendation to narrow the request to the above parameters by phone, and then sent a follow-up email immediately following our conversation confirming the same.

After my phone conversation with Ms. Kotler, my email address was suddenly classified as spam by the FDA. Because of that, my follow-up emails would not go through to Ms. Kotler. Instead, a traditional letter was sent by mail, which Ms. Kotler confirmed receipt of in an email sent to me on 1/25/2022.

It is now June 28, 2022 and I still have not received a determination letter for my request. I assume the request was approved, because Ms. Kotler sent an email response to my follow-up questions on 3/28/2022 and 4/27/2022 letting me know the agency was preparing a significant volume of records. However, I was never provided with a determination letter letting me know whether my request was approved or denied, or informing me of my fee status as a media requester.

As far as I am aware, the FDA is required by the FOIA to provide me with a determination about my request status and my fee status within 30 days of my request, both of which I still have not received over six months later.

I have attached copies of the only two letters I've received from Ms. Kotler regarding FDA FOIA Control #: 2022-98.

If you have any questions while handling this appeal, you can contact me at the email address listed below. I would prefer that all communications related to this appeal be in writing if possible, so I am not providing a phone number.

Thank you for your consideration of this appeal.

Sincerely,

Erin Miller
requests@muckrock.com
MuckRock News DEPT MR 122415 411A Highland Ave
Somerville MA 02144-2516 US

Hi,

Thanks so much for your help with this request! I really appreciate it.

Sincerely,
Erin Marie Miller

Hi Christa,

Thank you for following up about FOI Request FOI# 2022-98. I am still very interested in receiving the records I requested from your agency via that FOIA request.

As far as your question asking for "a topic" related to the records I am seeking, please refer to this article in Scientific American: https://www.scientificamerican.com/article/how-the-fda-manipulates-the-media

As far as your question about specific keywords to search for, please follow the instructions in my original request and simply search for the term "embargo." You may also include "embargoes" and "embargoed," in addition to "embargo," if you think it might turn up additional records (although, presumably, a search for "embargo" should automatically include those additional terms).

Finally, as a reminder, I submitted this FOIA request to your agency on Dec. 28, 2021. It is now January 25, 2025. In over four years, your agency still has not provided me with the responsive records for this request.

Given the extraordinary amount of time that has lapsed between the submission of my FOIA request and today's date, I believe it is appropriate to remind your agency of its duty to transparency under the FOIA, including your duty to make public records "promptly available" to requesters after a determination has been issued by your agency (which typically occurs within 20 days of the initial request, per 5 U.S.C. § 552(a)(6)(A)).

On 2/24/2022, Sarah B. Kotler emailed me about this request, stating: "The assigned office is currently searching for responsive records." On 3/28/2022, Sarah B. Kotler followed up again, stating: "We are in the process of collecting records for this request."

It has been almost three years since Ms. Kotler emailed me those updates about my FOIA request.

Per 5 U.S.C. § 552(a)(6)(C)(i), agencies must provide requested records "promptly" after issuing a determination: "Any person making a request to any agency for records under paragraph (1), (2), or (3) of this subsection shall be deemed to have exhausted his administrative remedies with respect to such request if the agency fails to comply with the applicable time limit provisions of this paragraph. If the Government can show exceptional circumstances exist and that the agency is exercising due diligence in responding to the request, the court may retain jurisdiction and allow the agency additional time to complete its review of the records. Upon any determination by an agency to comply with a request for records, the records shall be made promptly available to such person making such request. Any notification of denial of any request for records under this subsection shall set forth the names and titles or positions of each person responsible for the denial of such request."

Even in cases of supposed "extraordinary circumstances," the Court of Appeals for the D.C. Circuit Court has already addressed the problem of unusually long delays in making public records available to requesters. In Citizens for Responsibility & Ethics in Washington v. Fed. Election Comm'n, 711 F.3d 180, 188 (D.C. Cir. 2013), the Court stated:

"Second, the statute requires that the agency immediately notify the requester of the right 'to appeal to the head of the agency any adverse determination.- Id. The requirement that the agency notify the requester about administrative appeal rights further indicates that the “determination” must be substantive, not just a statement of a future intent to produce non-exempt responsive documents. Otherwise, this right of administrative appeal would make little sense because there would be nothing to appeal at the time the agency makes its supposed 'determination' in response to a properly filed FOIA request.

"This critical point both highlights and unravels the maneuver that the FEC (backed by the Department of Justice) is attempting here. Under the FEC's theory, an agency could respond to a request within 20 working days in terms not susceptible to immediate administrative appeal—by simply stating, in essence, that it will produce documents and claim exemptions over withheld documents in the future. Then, the agency could process the request at its leisure, free from any timelines. All the while, the agency's actions would remain immune from suit because the requester would not yet have been able to appeal and exhaust administrative appeal remedies. Therein lies the Catch–22 that the agency seeks to jam into FOIA: A requester cannot appeal within the agency because the agency has not provided the necessary information. Yet the requester cannot go to court because the requester has not appealed within the agency. Although the agency may desire to keep FOIA requests bottled up in limbo for months or years on end, the statute simply does not countenance such a system, as we read the statutory text." (Citizens for Responsibility & Ethics in Wash. v. Fed. Election Comm'n, 711 F.3d 180, 186-87 (D.C. Cir. 2013))

Keeping in mind the laws and court rulings cited above, it is unacceptable that I have waited over four years to receive the requested records under this FOIA request.

That said, please be aware that if I have not received all of the requested records pertaining to this request by 1/31/2025, I will have no choice but to seek dispute resolution from the OGIS, per my rights as a requester under the federal FOIA. Should that happen, considering the amount of time that has lapsed between my original request, and the fact that there is a six-year statute of limitations for filing FOIA lawsuits against the federal government, there is also a strong chance that I will begin to seek legal counsel regarding this request at the same time.

Please feel free to contact me in writing at this email address if you have any further questions. I do not wish to be contacted by phone, as I am now requesting that all further communications be in writing moving forward, so that I may have legal documentation to provide to OGIS and possibly an attorney.

Sincerely,

Erin Marie Miller

Erin Miller
MuckRock News DEPT MR 122415
411A Highland Ave
Somerville MA 02144-2516 US

Department of Health and Human Services (HHS) Office of the Secretary (OS)
APPEAL - FOIA Request - FDA FOIA Control #2022-98
Attn: Paula Formoso, HHS Public Liaison
Freedom of Information Act Office
Hubert H. Humphrey Building, Room 729H
200 Independence Avenue, SW
Washington, D.C. 20201

APPEAL: FOIA Request - FDA FOIA Control #2022-98

March 12, 2025

Dear Paula Formoso,

I am writing to submit an appeal for a FOIA request that I submitted to the U.S. Food and Drug Administration (FDA) on December 8, 2021, which sought records of emails containing the word “embargo” that were sent to, from, and/or between a set of specific email addresses belonging to specific officials at FDA and HHS between the dates of March 1, 2020, and the date the FOIA request was ultimately processed.

My request (FDA FOIA Control #2022-98) was acknowledged by Sarah B. Kotler, Director of the FDA Division of Freedom of Information, on January 4, 2022. Part of the responsive records related to my request were apparently referred to HHS for review in December 2023, but were never provided to me.

You can review my original request and my communications with the FDA’s FOIA office staff about this request on the MuckRock website (an online FOIA requester service and public database through which my request was filed), where you can also review scans of the FDA’s acknowledgement letters and the partial records related to my request: https://www.muckrock.com/foi/united-states-of-america-10/emails-mentioning-embargo-2020-2021-fda-office-of-media-affairs-122415/

To my knowledge, none of the acknowledgement letters I received related to this FOIA request provided a deadline for appeal. To date, the request has not been completed by HHS or FDA, and because of HHS and FDA’s unusually long delays in providing the requested records, I am appealing both agencies' responses to this request, which I believe violate the FOIA in spirit and letter.

On December 28, 2023 (over a year after my request was submitted), I received a small batch of records related to my request. In an email to me on the same date, Ms. Kotler explained the partial delivery of records and informed me that additional records would be released to me the following month (January 2024). Ms. Kotler also informed me in that email about other records related to my request that had been referred to HHS and told me those records would be made available to me after review by your agency. You can view Ms. Kotler’s email at the MuckRock link above, under the “Communications” tab.

As of today’s date, March 12, 2025, I have not received any more documents related to my FOIA request beyond the partial delivery in December 2023, described above, despite Sarah Kotler’s assurances that more records would be provided to me.

It is unclear to me whether the remainder of my request will ever be completed, as it has been over three years since I originally submitted this request to the FDA, and it has been over a year since the agency last produced a small portion of the requested records and referred additional records to HHS for review. As a result of the unusually lengthy delay in the production of the requested records by both agencies, I am submitting this appeal to both agencies' public liaisons for review.

Per 5 U.S.C. § 552(a)(6)(C)(i), agencies must provide requested records "promptly" after issuing a determination: "Any person making a request to any agency for records under paragraph (1), (2), or (3) of this subsection shall be deemed to have exhausted his administrative remedies with respect to such request if the agency fails to comply with the applicable time limit provisions of this paragraph. If the Government can show exceptional circumstances exist and that the agency is exercising due diligence in responding to the request, the court may retain jurisdiction and allow the agency additional time to complete its review of the records. Upon any determination by an agency to comply with a request for records, the records shall be made promptly available to such person making such request. Any notification of denial of any request for records under this subsection shall set forth the names and titles or positions of each person responsible for the denial of such request."

Even in cases of supposed "extraordinary circumstances," the Court of Appeals for the D.C. Circuit Court has already addressed the problem of unusually long delays in making public records available to requesters, which also addressed the strategic tactic of failing to deliver documents timely in order to prevent requesters from appealing or seeking recourse in federal court. In Citizens for Responsibility & Ethics in Washington v. Fed. Election Comm'n, 711 F.3d 180, 188 (D.C. Cir. 2013), the Court stated:

"Second, the statute requires that the agency immediately notify the requester of the right 'to appeal to the head of the agency any adverse determination.- Id. The requirement that the agency notify the requester about administrative appeal rights further indicates that the “determination” must be substantive, not just a statement of a future intent to produce non-exempt responsive documents. Otherwise, this right of administrative appeal would make little sense because there would be nothing to appeal at the time the agency makes its supposed 'determination' in response to a properly filed FOIA request.

"This critical point both highlights and unravels the maneuver that the FEC (backed by the Department of Justice) is attempting here. Under the FEC's theory, an agency could respond to a request within 20 working days in terms not susceptible to immediate administrative appeal—by simply stating, in essence, that it will produce documents and claim exemptions over withheld documents in the future. Then, the agency could process the request at its leisure, free from any timelines. All the while, the agency's actions would remain immune from suit because the requester would not yet have been able to appeal and exhaust administrative appeal remedies. Therein lies the Catch–22 that the agency seeks to jam into FOIA: A requester cannot appeal within the agency because the agency has not provided the necessary information. Yet the requester cannot go to court because the requester has not appealed within the agency. Although the agency may desire to keep FOIA requests bottled up in limbo for months or years on end, the statute simply does not countenance such a system, as we read the statutory text." Citizens for Responsibility & Ethics in Wash. v. Fed. Election Comm'n, 711 F.3d 180, 186-87 (D.C. Cir. 2013).

Later in the decision, the Court went on to state: “Put simply, the unusual circumstances provision to extend the time for making a 'determination' makes sense only if the statute contemplates that responsive documents must be collected and examined, and decisions made about which to produce, in order for the agency to make a 'determination.'” Citizens for Responsibility & Ethics in Wash. v. Fed. Election Comm'n, 711 F.3d 180, 188 (D.C. Cir. 2013).

Because my request includes records that should have been reviewed and provided to me by both FDA and HHS over a year ago, I believe appealing to both agencies is appropriate here. Bearing in mind the FOIA and court rulings cited above, it is unacceptable that I have waited over three years for the completion of a straightforward FOIA request.

Please consider my appeal and let me know whether I should redirect my complaints about this FOIA request to the Office of Government Information Services (OGIS) instead.

Sincerely,

Erin Miller

Erin Miller
MuckRock News DEPT MR 122415
411A Highland Ave
Somerville MA 02144-2516 US

FDA FOIA Public Liaison
Office of the Executive Secretariat
US Food Administration
5630 Fishers Lane, Room 1050

APPEAL: FOIA Request - FDA FOIA Control #2022-98

March 12, 2025

Dear Martina Varnado or Current FDA FOIA Public Liaison:

I am writing to submit an appeal for a FOIA request that I submitted to the U.S. Food and Drug Administration (FDA) on December 8, 2021, which sought records of emails containing the word “embargo” that were sent to, from, and/or between a set of specific email addresses belonging to specific officials at FDA and HHS between the dates of March 1, 2020, and the date the FOIA request was ultimately processed.

My request (FDA FOIA Control #2022-98) was acknowledged by Sarah B. Kotler, Director of the FDA Division of Freedom of Information, on January 4, 2022.

You can review my original request and my communications with the FDA’s FOIA office staff about this request on the MuckRock website (an online FOIA requester service and public database through which my request was filed), where you can also review scans of the FDA’s acknowledgement letters and the partial records related to my request: https://www.muckrock.com/foi/united-states-of-america-10/emails-mentioning-embargo-2020-2021-fda-office-of-media-affairs-122415/

To my knowledge, none of the acknowledgement letters I received related to this FOIA request provided a deadline for appeal. To date, the request has not been completed by FDA or HHS, and because of both agencies' unusually long delays in providing the requested records, I am appealing both agencies' responses to this request, which I believe violate the FOIA in spirit and letter.

On December 28, 2023 (over a year after my request was submitted), I received a small batch of records related to my request. In an email to me on the same date, Ms. Kotler explained the partial delivery of records and informed me that additional records would be released to me the following month (January 2024). Ms. Kotler also informed me in that email about other records related to my request that had been referred to HHS and told me those records would be made available to me after review by your agency. You can view Ms. Kotler’s email at the MuckRock link above, under the “Communications” tab.

As of today’s date, March 12, 2025, I have not received any more documents related to my FOIA request beyond the partial delivery in December 2023, described above, despite Sarah Kotler’s assurances that more records would be provided to me.

It is unclear to me whether the remainder of my request will ever be completed, as it has been over three years since I originally submitted this request to the FDA, and it has been over a year since the agency last produced a small portion of the requested records and referred additional records to HHS for review. As a result of the unusually lengthy delay in the production of the requested records by both agencies, I am submitting this appeal to both agencies' public liaisons for review.

Per 5 U.S.C. § 552(a)(6)(C)(i), agencies must provide requested records "promptly" after issuing a determination: "Any person making a request to any agency for records under paragraph (1), (2), or (3) of this subsection shall be deemed to have exhausted his administrative remedies with respect to such request if the agency fails to comply with the applicable time limit provisions of this paragraph. If the Government can show exceptional circumstances exist and that the agency is exercising due diligence in responding to the request, the court may retain jurisdiction and allow the agency additional time to complete its review of the records. Upon any determination by an agency to comply with a request for records, the records shall be made promptly available to such person making such request. Any notification of denial of any request for records under this subsection shall set forth the names and titles or positions of each person responsible for the denial of such request."

Even in cases of supposed "extraordinary circumstances," the Court of Appeals for the D.C. Circuit Court has already addressed the problem of unusually long delays in making public records available to requesters, which also addressed the strategic tactic of failing to deliver documents timely in order to prevent requesters from appealing or seeking recourse in federal court. In Citizens for Responsibility & Ethics in Washington v. Fed. Election Comm'n, 711 F.3d 180, 188 (D.C. Cir. 2013), the Court stated:

"Second, the statute requires that the agency immediately notify the requester of the right 'to appeal to the head of the agency any adverse determination.- Id. The requirement that the agency notify the requester about administrative appeal rights further indicates that the “determination” must be substantive, not just a statement of a future intent to produce non-exempt responsive documents. Otherwise, this right of administrative appeal would make little sense because there would be nothing to appeal at the time the agency makes its supposed 'determination' in response to a properly filed FOIA request.

"This critical point both highlights and unravels the maneuver that the FEC (backed by the Department of Justice) is attempting here. Under the FEC's theory, an agency could respond to a request within 20 working days in terms not susceptible to immediate administrative appeal—by simply stating, in essence, that it will produce documents and claim exemptions over withheld documents in the future. Then, the agency could process the request at its leisure, free from any timelines. All the while, the agency's actions would remain immune from suit because the requester would not yet have been able to appeal and exhaust administrative appeal remedies. Therein lies the Catch–22 that the agency seeks to jam into FOIA: A requester cannot appeal within the agency because the agency has not provided the necessary information. Yet the requester cannot go to court because the requester has not appealed within the agency. Although the agency may desire to keep FOIA requests bottled up in limbo for months or years on end, the statute simply does not countenance such a system, as we read the statutory text." Citizens for Responsibility & Ethics in Wash. v. Fed. Election Comm'n, 711 F.3d 180, 186-87 (D.C. Cir. 2013).

Later in the decision, the Court goes on to state: “Put simply, the unusual circumstances provision to extend the time for making a 'determination' makes sense only if the statute contemplates that responsive documents must be collected and examined, and decisions made about which to produce, in order for the agency to make a 'determination.'” Citizens for Responsibility & Ethics in Wash. v. Fed. Election Comm'n, 711 F.3d 180, 188 (D.C. Cir. 2013).

Because my request includes records that should have been reviewed and provided to me by both FDA and HHS over a year ago, I believe appealing to both agencies is appropriate here. Bearing in mind the FOIA and court rulings cited above, it is unacceptable that I have waited over three years for the completion of a straightforward FOIA request, in addition to having never been afforded the right to appeal due to the agencies' failure to complete the request.

Please consider my appeal and let me know whether I should redirect my complaints about this FOIA request to the Office of Government Information Services (OGIS) instead.

Sincerely,

Erin Miller