COVID-19 Vaccine Pregnancy Studies and Data (CDC)

To Whom It May Concern:

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

1. Copies of all data, reports, presentations, records, agendas, and meeting minutes related to COVID-19 vaccines and pregnancy and/or pregnant people as part of the CDC's v-safe COVID-19 Vaccine Pregnancy Registry that were presented to, or included in, meetings of the Advisory Committee on Immunization Practices (ACIP), including but not limited to all relevant data collected and/or reported by Abt Associates (https://www.abtassociates.com/projects/expanding-v-safe-covid-19-vaccine-pregnancy-registry-0) between Dec. 1, 2020 and the date this request is ultimately processed.

2. Copies of all data, studies, reports, documents, and records related to COVID-19 vaccines and pregnancy and/or pregnant people provided to the CDC's v-safe COVID-19 Vaccine Pregnancy Registry, including but not limited to data collected and/or reported by Abt Associates, between Dec. 1, 2020 and the date this request is ultimately processed.

3. Copies of all data, studies, reports, documents, and records provided to the CDC related to COVID-19 vaccines and pregnancy and/or pregnant people that were part of the CDC's three pregnancy monitoring programs including the v-safe COVID-19 Vaccine Pregnancy Registry program; the Vaccine Safety Datalink (VSD) program; and the Vaccine Adverse Event Reporting System (VAERS) between Dec. 1, 2020 and the date this request is ultimately processed. (For more clarity about the aforementioned monitoring programs, please view following the CDC website: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/monitoring-pregnant-people.html)

It is important to note that the VSD website (https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/index.html) states that its pregnancy monitoring data related to vaccines is not public but is sometimes made available to scientists outside of the CDC depending on the study. I believe this data should be available under the FOIA, given its obvious interest to the public. If there are any doubts about this on your agency's part, please feel free to let me know so that I can contact an attorney that specializes in the FOIA to work it out.

The requested information is in the immediate interest of the general public because of the following reasons:

As per the CDC website page entitled "Vaccine Pregnancy Registry" (https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vsafepregnancyregistry.html), as of today's date: "There is currently no evidence that any vaccines, including COVID-19 vaccines, cause fertility problems. However, data are limited about the safety of COVID-19 vaccines for people who are pregnant. CDC established the v-safe COVID-19 Vaccine Pregnancy Registry to learn more about this issue."

According to that webpage, "As of December 20, 2021, more than 180,000 v-safe participants have indicated they were pregnant at the time they received COVID-19 vaccination." In spite of this, the webpage states that the v-safe program has enrolled only 8,749 pregnant people as of Dec. 20, 2021.

The webpage also states, "As CDC learns more about the effects of vaccination during pregnancy, data will be presented at the Advisory Committee on Immunization Practices (ACIP) meetings, which are open to the public, and in published reports." Upon reviewing the meeting agendas of ACIP from the last year, I was unable to locate presentations or reports specifically related to the v-safe program. However, I may have missed those reports in my research, which is part of why I am filing this FOIA request.

I was able to locate an initial study related to the CDC's monitoring, entitled "Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons," which is cited on the v-safe webpage and which was published in NEJM on April 21, 2021 (https://www.nejm.org/doi/full/10.1056/NEJMoa2104983). That initial study analyzed 3,958 pregnant people over 11 weeks in late 2020/early 2021 and indicated in its conclusions that "more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes."

As per the CDC website page entitled "COVID-19 Vaccine Monitoring Systems for Pregnant People" (https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/monitoring-pregnant-people.html): "Pregnant and recently pregnant people are at increased risk for severe illness from COVID-19." In the absence of reliable government data from large populations of pregnant people over long periods of time, however, many pregnant people in the U.S. have understandably expressed concerns and hesitation until better data becomes publicly available in order to potentially protect their babies from the perceived risk of potential complications.

Because of this, it is vital to interest of the public, as well as to the journalism, scientific, medical, public policy, and statistical analysis communities, that access to higher quality data related to pregnancy and COVID-19 vaccines is released and made available by the CDC and its various monitoring programs, in order for the public and non-government scientists to more accurately assess and fully understand the impact on pregnant people.

The requested information will be made available to the general public, and this request is not being made for commercial purposes. Disclosure of the requested information to me is in the public interest because it is likely to contribute significantly to public understanding of public health and policy, as well as the operations and/or activities of the government, in addition to the other reasons mentioned above, and is not primarily in my commercial interest.

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. You can view my portfolio at www.erinmariemiller.com/clips. I have previously been determined a media requester by the CDC in earlier FOIA requests. As a member of the media, I request a waiver of all fees.

In the event that there are fees, I am willing to pay up to $25 for the requested information. If the fee for this request exceeds this amount, please notify me in writing for permission prior to beginning 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

Thank you for your message. As to my requester status, please note that my request includes a fee waiver request as a media requester. I appreciate your help and look forward to hearing back from you.

Hi Emerique,

Unfortunately, the email you sent today regarding 22-01035-FOIA was delivered to the wrong email address. (See attached.)

It is a violation of the FOIA to respond to FOIA requests at random email addresses that are not associated with the original request.

It also appears that your agency has changed the mailing address for this request and replaced it with an outdated and incorrect residential address. Please change the mailing address for this request back to the original MuckRock address listed on my request.

Please address all future responses, and all responsive documents, related to this request to THIS email address only ( requests@muckrock.com ).

This is the email address from which the FOIA request originated, as your agency acknowledged in its acknowledgement letter dated 2/24/2022.

This is the only email address you should use to respond to this request for all future communications. Do not send documents or responses related to this request to any email address or mailing address other than than those listed on the original request.

Best,

Erin Miller

As I discussed yesterday via email with Emerique Magyar, it appears that someone at your agency altered my contact information on this request without my knowledge or permission sometime after its formal acknowledgement, and replaced my original contact information with an incorrect private residential address and one of my private email addresses.

The correct contact information that should be associated with this request is listed on your agency's acknowledgement letter for this request, dated 2/28/2022 (see attached).

Please refer to that letter and update my contact information to correct the appropriate mailing address and email address for this request. When responding to this request in the future, please respond and send documents to THIS email address ONLY.

Finally, please remove the incorrect contact information from your system immediately. It is outdated/incorrect, and the documents will not be received by me if delivered there.

I am not sure how, or why, this happened, but I expect that your agency will correct the situation immediately.

Thank you,

Erin

To Whom It May Concern:

Regarding 22-01035-FOIA:

An original version of this request was initially submitted on Jan. 3, 2022. You can see the original submission date on the MuckRock website, here: https://www.muckrock.com/foi/united-states-of-america-10/covid-19-vaccine-pregnancy-studies-and-data-cdc-122531/

After failing to receive an acknowledgement from the CDC about the original request for almost two months, it was discovered that the original request did not exist in the CDC FOIA portal. Despite the MuckRock contact information associated with this request being visible in the portal, the request itself was not there.

On Feb. 24, 2022, the original request was re-submitted by MuckRock staff via email to ensure its delivery to your agency. (This is why some of the information contained in this request is now outdated.)

After receiving an acknowledgement letter from your agency dated Feb. 28, 2022, which included the correct MuckRock mailing address and email address for this request, that contact information was somehow altered to my personal address and email address (I'm not sure how this happened, but I didn't change it), before your agency sent a fee category update to my personal email address on March 11, 2022, rather than the MuckRock email address that should have been associated with this request in the CDC FOIA portal.

That said, these events are highly unusual when filing a FOIA request. I would like to report a potential breach of my CDC FOIA portal account. I am writing to request that the CDC FOIA staff ask the CDC I.T. department investigate the login history associated with my CDC FOIA portal login, and to report to me any changes that may have been made to requests since 1/3/2022, including the possible removal of my original request dated Jan. 3, 2022, and the altering of any contact information associated with this current request.

Sincerely,

Erin Miller

To Whom It May Concern:

I'm writing to the CDC IT Service Desk regarding a potential breach of my account in the CDC FOIA portal (login email address requests@muckrock.com ). See the following:

On Jan. 3, 2022, I submitted an original version of CDC FOIA request 22-01035-FOIA via MuckRock, a nonprofit collaborative news site that enables journalists, researchers, citizens, etc. to file FOIA requests and share government documents for the purpose of increasing transparency in government.

That original request was submitted through the CDC FOIA portal under login email address requests@muckrock.com .

You can view the original request's submission date of Jan. 3, 2022, on the MuckRock website here: https://www.muckrock.com/foi/united-states-of-america-10/covid-19-vaccine-pregnancy-studies-and-data-cdc-122531/

After failing to receive an acknowledgement letter from the CDC for almost two months regarding that original request, it was discovered in late Feb. that the original request did not exist in the CDC FOIA portal. Despite being able to log in, and despite the MuckRock contact information associated with the request being visible in the portal, the request itself was not there.

On Feb. 24, 2022, following multiple failed attempts to re-submit the original request via the CDC portal, a copy of the original request was re-submitted by MuckRock staff via email to ensure its delivery to your agency. (This is why some of the information contained in the language of the current version of the request was outdated by the time it was submitted.)

On Feb. 28, 2022, I received an acknowledgement letter for request 22-01035-FOIA that included the MuckRock mailing address and email address for the request. However, that contact information was apparently changed in the CDC FOIA portal to my personal mailing address and email address at some point after the acknowledgement letter was sent to me. I'm not sure how that happened, but I did not change the contact information.

On March 11, 2022, I received an update about request 22-01035-FOIA at my personal email address instead of the MuckRock email address it was filed under. This obviously alerted me to the fact that the request's contact information had been changed by someone other than myself at some time between receiving the acknowledgement letter on Feb. 28, 2022, and when the email notifying me of my requester status change at my private email address was delivered on March 11, 2022.

After a brief back-and-forth with Emerique Magyar via my personal email address about the issue on the morning of March 11, 2022, I was able to establish proof that the email and mailing address associated with request 22-01035-FOIA had been changed without my knowledge by showing them the acknowledgement letter associated with this request. To my knowledge, the correct MuckRock contact information for request 22-01035-FOIA should now be reflected on request 22-01035-FOIA.

However, I did not make any of the aforementioned changes to the contact information for this request, and I would very much like to know how all of this happened.

That said, I would like to report a potential breach of my CDC FOIA portal account. I am writing to request the CDC I.T. department investigate the login history associated with the CDC FOIA portal account belonging to email address requests@muckrock.com , and report to me any changes that may have been made to my requests from Jan. 3, 2022 until today's date, including the possible removal of the original request dated Jan. 3, 2022, and the possible alteration of any contact information associated with CDC FOIA request 22-01035-FOIA and/or portal login requests@muckrock.com .

Please feel free to contact me directly with any questions.

Sincerely,

Erin Miller

Hi Emerique,

I contacted the I.T. desk at the CDC instead, so I believe they will be looking into it.

It looks like someone at the agency went through all of my former FOIA requests to the CDC, including ones I submitted last year independently of MuckRock, and removed them from their original portals and then compiled them all under one portal login without letting me know the correct login information. That may explain the abrupt change in my contact information associated with this request. I'm not sure why or how that happened, however, as no other federal agency has taken the time to go back through all of my old FOIA requests to condense them under one login (and under the wrong email/mailing address), but it seems that was the case here.

Regardless, please free to contact me only at this MuckRock email address and MuckRock mailing address for all further communications regarding this FOIA request.

Thank you.

- Erin

Deputy Agency Chief FOIA Officer, 

Office of the Assistant Secretary for Public Affairs, 

U.S. Department of Health and Human Services

Re: Freedom of Information Act Appeal

July 19, 2022

To Whom It May Concern:

This is an appeal under the Freedom of Information Act regarding CDC FOIA request #22-01035-FOIA.

On Feb. 24, 2022, I requested the following records and information from the Centers for Disease Control and Prevention (CDC):

1. Copies of all data, reports, presentations, records, agendas, and meeting minutes related to COVID-19 vaccines and pregnancy and/or pregnant people as part of the CDC's v-safe COVID-19 Vaccine Pregnancy Registry that were presented to, or included in, meetings of the Advisory Committee on Immunization Practices (ACIP), including but not limited to all relevant data collected and/or reported by Abt Associates (https:// www.abtassociates.com/projects/expanding-v-safe-covid-19-vaccine-pregnancy- registry-0) between Dec. 1, 2020 and the date this request is ultimately processed.

2. Copies of all data, studies, reports, documents, and records related to COVID-19 vaccines and pregnancy and/or pregnant people provided to the CDC's v-safe COVID-19 Vaccine Pregnancy Registry, including but not limited to data collected and/or reported by Abt Associates, between Dec. 1, 2020 and the date this request is ultimately processed.

3. Copies of all data, studies, reports, documents, and records provided to the CDC related to COVID-19 vaccines and pregnancy and/or pregnant people that were part of the CDC's three pregnancy monitoring programs including the v-safe COVID-19 Vaccine Pregnancy Registry program; the Vaccine Safety Datalink (VSD) program; and the Vaccine Adverse Event Reporting System (VAERS) between Dec. 1, 2020 and the date this request is ultimately processed. (For more clarity about the aforementioned monitoring programs, please view following the CDC website: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/monitoring-pregnant- people.html)

On April 21, 2022, Roger Andoh, CDC/ATSDR FOIA Officer at the Office of the Chief Operating Officer, partially granted my request and provided me with a final response letter containing links to various publicly-available studies and meeting minutes related to my request.

However, in the aforementioned final response letter dated April 21, 2022 from Roger Andoh, my request for Vaccine Safety Datalink (VSD) data related to pregnancy and COVID-19 vaccines was denied. The agency cited the following reasons for its denial of the requested data:

“With regard to your request for Vaccine Safety Datalink data the Immunization Safety Office indicated the data requested does not exist in the requested format. Under the Freedom of Information Act (FOIA) agencies are not required to conduct research or create records in response to a FOIA request.
“Additionally, VSD data is collected under an Assurance of Confidentiality, and we are precluded from releasing that information and consequently all VSD data was withheld from release pursuant to 5 U.S.C. §552 Exemption (b)(3). The foreseeable harm standard was considered when applying these redactions.

“EXEMPTION (b)(3) 
Exemption (b)(3) protects information that has been specifically exempted from disclosure by statute. In this case, the information is being withheld under the authority of an Assurance of Confidentiality issued under 42 U.S.C. §308(d) (specifically, §242(k) and §242(m)(d)) and withheld in full under the authority of 5 U.S.C. §552 Exemption (b)(3).”

I appeal the denial of my request for Vaccine Safety Datalink (VSD) data related to pregnancy and COVID-19 vaccinations based on the following arguments:

1. The agency’s cited Assurance of Confidentiality exemptions under 42 U.S.C. §308(d) (specifically, §242(k) and §242(m)(d)) and 5 U.S.C. §552 Exemption (b)(3) do not apply to the requested records. The agency’s claims about Assurance of Confidentiality are directly contradicted by the V-safe Pregnancy Surveillance (amendment) Protocol that the agency itself provided a link to in its final response letter (final response letter: pg. 2, paragraph 5: https://www.cdc.gov/vaccinesafety/pdf/vsafe-pregnancy-surveillance-protocol-508.pdf). The paragraph on page 6 of the V-safe Pregnancy Surveillance (amendment) Protocol relating to Human subjects considerations and confidentiality clearly states:

“This protocol will require human subjects determination at CDC because CDC is the lead site and surveillance data will include collection of personal identifiable information (PII). This data will be collected for public health surveillance, not for research purposes. No PII will be included in any v-safe analyses, manuscripts, or datasets shared externally. Participation is voluntary and individuals self-enroll. Participants can opt-out of the v-safe pregnancy registry at any time and their data will only be used for the time they were considered an active participant. In addition, this activity presents minimal risk to subjects, and use of patient data for this purpose will not adversely affect subjects’ rights or welfare.”

Based on the protocol linked in the response, the purpose of the requested data’s collection is for public health surveillance and “no PII will be included in any v-Safe analyses, manuscripts, or datasets shared externally.” Because of that, the agency’s cited confidentiality exemptions do not apply to the requested records. Based on the requested data’s collection protocol, it also seems that the requested data does in fact exist in the requested form under the V-safe Pregnancy Surveillance (amendment) Protocol, in that is should not contain PII of the participants.

2. The agency’s application of the foreseeable harm standard does not apply to the requested records. On page 6 of the aforementioned V-safe Pregnancy Surveillance (amendment) Protocol, the paragraph relating to Human Subjects Considerations and Confidentiality states:

“No PII will be included in any v-safe analyses, manuscripts, or datasets shared externally. Participation is voluntary and individuals self-enroll. Participants can opt-out of the v-safe pregnancy registry at any time and their data will only be used for the time they were considered an active participant. In addition, this activity presents minimal risk to subjects, and use of patient data for this purpose will not adversely affect subjects’ rights or welfare.”

Based on the agency-provided protocol under this request, v-Safe Pregnancy Surveillance data does not meet the requirements of the foreseeable harm standard because it does not include any personal identifiable information (PII) and, according to the program’s own protocol, “presents minimal risk to subjects” and will ultimately be released to the public in a final analysis, as outlined on page 7 (see next point).

3. The requested data does not meet the Assurance of Confidentiality or standard of harm criteria. On page 7 of the aforementioned V-safe Pregnancy Surveillance (amendment) Protocol, the paragraph related to Dissemination of Information states:

“Safety profile information from the registry may be presented to Advisory Committee on Immunization Practices (ACIP) subgroups (such as the Vaccine Safety Technical Subgroup [VaST]), ACIP meetings and other meetings that are requested. Further, at the conclusion of the registry, a final report will be written detailing the findings of this surveillance activity.”

Because release of the requested data is left to the discretion of the agency (as outlined in the protocol above), and the data is available for presentation at public meetings, the Assurance of Confidentiality and foreseeable harm standard does not apply to the requested records.

4. The foreseeable harm standard also does not apply to this request because the agency failed to provide a specific and concrete explanation as to how or why disclosure of the requested data would create legitimate foreseeable harm, particularly in light of the fact that the v-Safe Pregnancy Surveillance data does not include PII under its own collection protocol and is undeniably more in the public interest to release than not.

In past FOIA litigation related to the foreseeable harm standard, numerous courts at the federal and district levels have ruled that an agency must provide a requester with a specific and concrete explanation about how disclosing the requested data would cause legitimate foreseeable harm in a denial under the foreseeable harm standard. (See Center for Investigative Reporting v. Department of Labor; Center for Investigative Reporting v. U.S. Customs & Border Protection; and Ecological Rights Foundation v. FEMA). (Source: Foreseeable Harm Standard. (2021, July 2). FOIA.Wiki, Retrieved 17:26, July 19, 2022 from https://foia.wiki/w/index.php?title=Foreseeable_Harm_Standard&oldid=6300.)

In a memo issued by the Dept. of Justice providing guidance on the application of the foreseeable harm standard, Attorney General Janet Reno established specific standards of open government that strongly encouraged “agency decisionmaking under the FOIA toward the Act’s goal of maximum responsible disclosure.” That memo, issued Oct. 4, 1993, stated:

“In short, it be shall the policy of the Department of Justice to defend the assertion of a FOIA exemption only in those cases where the agency reasonably foresees that disclosure would be harmful to an interest protected by that exemption.” (Source: https://www.justice.gov/oip/blog/foia-update-oip-guidance-applying-forseeable-harm-standard-under-exemption-five)

Having already established that the Assurance of Confidentiality and foreseeable harm standard should not apply to the requested records due to the lack of PII in the requested data and a lack of clarity on the actual harm that would be caused by its disclosure, it is important to cite the aforementioned DOJ guidance, which states:

“Where ‘only a government interest would be affected’ by a FOIA disclosure, there is a far greater potential for discretionary disclosure than exists where such interests as personal privacy or business confidentiality.”

I strongly encourage whoever handles this appeal to consider the possibility that the "foreseeable harm" in the case of this request could potentially be to protect the government's interests. I also encourage you to consider the DOJ’s strong urging toward transparency in support of the spirit of the Freedom of Information Act, which was designed to promote government transparency and accountability, which are both significant components of a well-functioning democracy.

Finally, in March 2022, someone at the CDC went back through all of the requests I have filed with the agency both independently and via MuckRock (a nonprofit organization that provides automated public records requests services), and moved many of those requests from their separate original portals into a different portal under login credentials that were different from the original credentials used to access several of the requests, including this one. Those changes rendered me unable to access the requests in their original portals and created confusion about how to access updates about each request.
The contact information for this request (#22-01035-FOIA) was changed from the original MuckRock email address I had filed it under, to my personal email address; the mailing address related to this request was also temporarily changed to one of my former residential addresses without my knowledge. It was eventually changed back after a back-and-forth with Emerique C. Magyar.

Proof of the aforementioned unauthorized portal credential changes can be found in my email communications with Emerique C. Magyar dated March 11 through March 14, 2022, as well as my email communication to the CDC IT Service Desk (ITServiceDesk@cdc.gov) on March 14, 2022, in which I complained about the changes and reported a possible security breach related to my CDC FOIA portal account.

In addition to my login credentials being changed without my knowledge or permission on this request (#22-01035-FOIA), the password to the portal for this request now seems to have also changed, which has prevented me from accessing the portal to file this appeal in time to meet the appeal deadline July 20, 2022, as noted in the agency’s final response letter.

Due to my inability to access the portal to electronically file an appeal today, which appears to again be due to actions by someone other than myself changing my portal login password, I am submitting this appeal to email addresses associated with the CDC’s FOIA office and liaisons including FOIARequest@psc.hhs.gov, ogis@nara.gov and foiarequests@cdc.gov.

I have also alerted MuckRock staff about my inability to log into the portal also, as the request was originally filed via MuckRock. However, if my appeal does not reach the CDC by its deadline, I intend to request a formal investigation into the matter due to the unusual nature of the agency’s prior unauthorized changes to my CDC portal login credentials for this request.

If you have any questions while handling this appeal, please provide me with a phone number where I can reach you directly.
Thank you for your consideration of this appeal.

Sincerely,

Erin Miller 

MuckRock News Dept.

411A Highland Ave

Somverville, Massachusetts 02144

Via email: requests@muckrock.com

Deputy Agency Chief FOIA Officer, 

Office of the Assistant Secretary for Public Affairs, 

U.S. Department of Health and Human Services

Re: Freedom of Information Act Appeal

July 19, 2022

To Whom It May Concern:

This is an appeal under the Freedom of Information Act regarding CDC FOIA request #22-01035-FOIA.

On Feb. 24, 2022, I requested the following records and information from the Centers for Disease Control and Prevention (CDC):

1. Copies of all data, reports, presentations, records, agendas, and meeting minutes related to COVID-19 vaccines and pregnancy and/or pregnant people as part of the CDC's v-safe COVID-19 Vaccine Pregnancy Registry that were presented to, or included in, meetings of the Advisory Committee on Immunization Practices (ACIP), including but not limited to all relevant data collected and/or reported by Abt Associates (https:// www.abtassociates.com/projects/expanding-v-safe-covid-19-vaccine-pregnancy- registry-0) between Dec. 1, 2020 and the date this request is ultimately processed.

2. Copies of all data, studies, reports, documents, and records related to COVID-19 vaccines and pregnancy and/or pregnant people provided to the CDC's v-safe COVID-19 Vaccine Pregnancy Registry, including but not limited to data collected and/or reported by Abt Associates, between Dec. 1, 2020 and the date this request is ultimately processed.

3. Copies of all data, studies, reports, documents, and records provided to the CDC related to COVID-19 vaccines and pregnancy and/or pregnant people that were part of the CDC's three pregnancy monitoring programs including the v-safe COVID-19 Vaccine Pregnancy Registry program; the Vaccine Safety Datalink (VSD) program; and the Vaccine Adverse Event Reporting System (VAERS) between Dec. 1, 2020 and the date this request is ultimately processed. (For more clarity about the aforementioned monitoring programs, please view following the CDC website: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/monitoring-pregnant- people.html)

On April 21, 2022, Roger Andoh, CDC/ATSDR FOIA Officer at the Office of the Chief Operating Officer, partially granted my request and provided me with a final response letter containing links to various publicly-available studies and meeting minutes related to my request.

However, in the aforementioned final response letter dated April 21, 2022 from Roger Andoh, my request for Vaccine Safety Datalink (VSD) data related to pregnancy and COVID-19 vaccines was denied. The agency cited the following reasons for its denial of the requested data:

“With regard to your request for Vaccine Safety Datalink data the Immunization Safety Office indicated the data requested does not exist in the requested format. Under the Freedom of Information Act (FOIA) agencies are not required to conduct research or create records in response to a FOIA request.
“Additionally, VSD data is collected under an Assurance of Confidentiality, and we are precluded from releasing that information and consequently all VSD data was withheld from release pursuant to 5 U.S.C. §552 Exemption (b)(3). The foreseeable harm standard was considered when applying these redactions.

“EXEMPTION (b)(3) 
Exemption (b)(3) protects information that has been specifically exempted from disclosure by statute. In this case, the information is being withheld under the authority of an Assurance of Confidentiality issued under 42 U.S.C. §308(d) (specifically, §242(k) and §242(m)(d)) and withheld in full under the authority of 5 U.S.C. §552 Exemption (b)(3).”

I appeal the denial of my request for Vaccine Safety Datalink (VSD) data related to pregnancy and COVID-19 vaccinations based on the following arguments:

1. The agency’s cited Assurance of Confidentiality exemptions under 42 U.S.C. §308(d) (specifically, §242(k) and §242(m)(d)) and 5 U.S.C. §552 Exemption (b)(3) do not apply to the requested records. The agency’s claims about Assurance of Confidentiality are directly contradicted by the V-safe Pregnancy Surveillance (amendment) Protocol that the agency itself provided a link to in its final response letter (final response letter: pg. 2, paragraph 5: https://www.cdc.gov/vaccinesafety/pdf/vsafe-pregnancy-surveillance-protocol-508.pdf). The paragraph on page 6 of the V-safe Pregnancy Surveillance (amendment) Protocol relating to Human subjects considerations and confidentiality clearly states:

“This protocol will require human subjects determination at CDC because CDC is the lead site and surveillance data will include collection of personal identifiable information (PII). This data will be collected for public health surveillance, not for research purposes. No PII will be included in any v-safe analyses, manuscripts, or datasets shared externally. Participation is voluntary and individuals self-enroll. Participants can opt-out of the v-safe pregnancy registry at any time and their data will only be used for the time they were considered an active participant. In addition, this activity presents minimal risk to subjects, and use of patient data for this purpose will not adversely affect subjects’ rights or welfare.”

Based on the protocol linked in the response, the purpose of the requested data’s collection is for public health surveillance and “no PII will be included in any v-Safe analyses, manuscripts, or datasets shared externally.” Because of that, the agency’s cited confidentiality exemptions do not apply to the requested records. Based on the requested data’s collection protocol, it also seems that the requested data does in fact exist in the requested form under the V-safe Pregnancy Surveillance (amendment) Protocol, in that is should not contain PII of the participants.

2. The agency’s application of the foreseeable harm standard does not apply to the requested records. On page 6 of the aforementioned V-safe Pregnancy Surveillance (amendment) Protocol, the paragraph relating to Human Subjects Considerations and Confidentiality states:

“No PII will be included in any v-safe analyses, manuscripts, or datasets shared externally. Participation is voluntary and individuals self-enroll. Participants can opt-out of the v-safe pregnancy registry at any time and their data will only be used for the time they were considered an active participant. In addition, this activity presents minimal risk to subjects, and use of patient data for this purpose will not adversely affect subjects’ rights or welfare.”

Based on the agency-provided protocol under this request, v-Safe Pregnancy Surveillance data does not meet the requirements of the foreseeable harm standard because it does not include any personal identifiable information (PII) and, according to the program’s own protocol, “presents minimal risk to subjects” and will ultimately be released to the public in a final analysis, as outlined on page 7 (see next point).

3. The requested data does not meet the Assurance of Confidentiality or standard of harm criteria. On page 7 of the aforementioned V-safe Pregnancy Surveillance (amendment) Protocol, the paragraph related to Dissemination of Information states:

“Safety profile information from the registry may be presented to Advisory Committee on Immunization Practices (ACIP) subgroups (such as the Vaccine Safety Technical Subgroup [VaST]), ACIP meetings and other meetings that are requested. Further, at the conclusion of the registry, a final report will be written detailing the findings of this surveillance activity.”

Because release of the requested data is left to the discretion of the agency (as outlined in the protocol above), and the data is available for presentation at public meetings, the Assurance of Confidentiality and foreseeable harm standard does not apply to the requested records.

4. The foreseeable harm standard also does not apply to this request because the agency failed to provide a specific and concrete explanation as to how or why disclosure of the requested data would create legitimate foreseeable harm, particularly in light of the fact that the v-Safe Pregnancy Surveillance data does not include PII under its own collection protocol and is undeniably more in the public interest to release than not.

In past FOIA litigation related to the foreseeable harm standard, numerous courts at the federal and district levels have ruled that an agency must provide a requester with a specific and concrete explanation about how disclosing the requested data would cause legitimate foreseeable harm in a denial under the foreseeable harm standard. (See Center for Investigative Reporting v. Department of Labor; Center for Investigative Reporting v. U.S. Customs & Border Protection; and Ecological Rights Foundation v. FEMA). (Source: Foreseeable Harm Standard. (2021, July 2). FOIA.Wiki, Retrieved 17:26, July 19, 2022 from https://foia.wiki/w/index.php?title=Foreseeable_Harm_Standard&oldid=6300.)

In a memo issued by the Dept. of Justice providing guidance on the application of the foreseeable harm standard, Attorney General Janet Reno established specific standards of open government that strongly encouraged “agency decisionmaking under the FOIA toward the Act’s goal of maximum responsible disclosure.” That memo, issued Oct. 4, 1993, stated:

“In short, it be shall the policy of the Department of Justice to defend the assertion of a FOIA exemption only in those cases where the agency reasonably foresees that disclosure would be harmful to an interest protected by that exemption.” (Source: https://www.justice.gov/oip/blog/foia-update-oip-guidance-applying-forseeable-harm-standard-under-exemption-five)

Having already established that the Assurance of Confidentiality and foreseeable harm standard should not apply to the requested records due to the lack of PII in the requested data and a lack of clarity on the actual harm that would be caused by its disclosure, it is important to cite the aforementioned DOJ guidance, which states:

“Where ‘only a government interest would be affected’ by a FOIA disclosure, there is a far greater potential for discretionary disclosure than exists where such interests as personal privacy or business confidentiality.”

I strongly encourage whoever handles this appeal to consider the possibility that the "foreseeable harm" in the case of this request could potentially be to protect the government's interests. I also encourage you to consider the DOJ’s strong urging toward transparency in support of the spirit of the Freedom of Information Act, which was designed to promote government transparency and accountability, which are both significant components of a well-functioning democracy.

Finally, in March 2022, someone at the CDC went back through all of the requests I have filed with the agency both independently and via MuckRock (a nonprofit organization that provides automated public records requests services), and moved many of those requests from their separate original portals into a different portal under login credentials that were different from the original credentials used to access several of the requests, including this one. Those changes rendered me unable to access the requests in their original portals and created confusion about how to access updates about each request.
The contact information for this request (#22-01035-FOIA) was changed from the original MuckRock email address I had filed it under, to my personal email address; the mailing address related to this request was also temporarily changed to one of my former residential addresses without my knowledge. It was eventually changed back after a back-and-forth with Emerique C. Magyar.

Proof of the aforementioned unauthorized portal credential changes can be found in my email communications with Emerique C. Magyar dated March 11 through March 14, 2022, as well as my email communication to the CDC IT Service Desk (ITServiceDesk@cdc.gov) on March 14, 2022, in which I complained about the changes and reported a possible security breach related to my CDC FOIA portal account.

In addition to my login credentials being changed without my knowledge or permission on this request (#22-01035-FOIA), the password to the portal for this request now seems to have also changed, which has prevented me from accessing the portal to file this appeal in time to meet the appeal deadline July 20, 2022, as noted in the agency’s final response letter.

Due to my inability to access the portal to electronically file an appeal today, which appears to again be due to actions by someone other than myself changing my portal login password, I am submitting this appeal to email addresses associated with the CDC’s FOIA office and liaisons including FOIARequest@psc.hhs.gov, ogis@nara.gov and foiarequests@cdc.gov.

I have also alerted MuckRock staff about my inability to log into the portal also, as the request was originally filed via MuckRock. However, if my appeal does not reach the CDC by its deadline, I intend to request a formal investigation into the matter due to the unusual nature of the agency’s prior unauthorized changes to my CDC portal login credentials for this request.

If you have any questions while handling this appeal, please provide me with a phone number where I can reach you directly.
Thank you for your consideration of this appeal.

Sincerely,

Erin Miller 

MuckRock News Dept.

411A Highland Ave

Somverville, Massachusetts 02144

Via email: requests@muckrock.com

Deputy Agency Chief FOIA Officer, 

Office of the Assistant Secretary for Public Affairs, 

U.S. Department of Health and Human Services

Re: Freedom of Information Act Appeal

July 19, 2022

To Whom It May Concern:

This is an appeal under the Freedom of Information Act regarding CDC FOIA request #22-01035-FOIA.

On Feb. 24, 2022, I requested the following records and information from the Centers for Disease Control and Prevention (CDC):

1. Copies of all data, reports, presentations, records, agendas, and meeting minutes related to COVID-19 vaccines and pregnancy and/or pregnant people as part of the CDC's v-safe COVID-19 Vaccine Pregnancy Registry that were presented to, or included in, meetings of the Advisory Committee on Immunization Practices (ACIP), including but not limited to all relevant data collected and/or reported by Abt Associates (https:// www.abtassociates.com/projects/expanding-v-safe-covid-19-vaccine-pregnancy- registry-0) between Dec. 1, 2020 and the date this request is ultimately processed.

2. Copies of all data, studies, reports, documents, and records related to COVID-19 vaccines and pregnancy and/or pregnant people provided to the CDC's v-safe COVID-19 Vaccine Pregnancy Registry, including but not limited to data collected and/or reported by Abt Associates, between Dec. 1, 2020 and the date this request is ultimately processed.

3. Copies of all data, studies, reports, documents, and records provided to the CDC related to COVID-19 vaccines and pregnancy and/or pregnant people that were part of the CDC's three pregnancy monitoring programs including the v-safe COVID-19 Vaccine Pregnancy Registry program; the Vaccine Safety Datalink (VSD) program; and the Vaccine Adverse Event Reporting System (VAERS) between Dec. 1, 2020 and the date this request is ultimately processed. (For more clarity about the aforementioned monitoring programs, please view following the CDC website: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/monitoring-pregnant- people.html)

On April 21, 2022, Roger Andoh, CDC/ATSDR FOIA Officer at the Office of the Chief Operating Officer, partially granted my request and provided me with a final response letter containing links to various publicly-available studies and meeting minutes related to my request.

However, in the aforementioned final response letter dated April 21, 2022 from Roger Andoh, my request for Vaccine Safety Datalink (VSD) data related to pregnancy and COVID-19 vaccines was denied. The agency cited the following reasons for its denial of the requested data:

“With regard to your request for Vaccine Safety Datalink data the Immunization Safety Office indicated the data requested does not exist in the requested format. Under the Freedom of Information Act (FOIA) agencies are not required to conduct research or create records in response to a FOIA request.
“Additionally, VSD data is collected under an Assurance of Confidentiality, and we are precluded from releasing that information and consequently all VSD data was withheld from release pursuant to 5 U.S.C. §552 Exemption (b)(3). The foreseeable harm standard was considered when applying these redactions.

“EXEMPTION (b)(3) 
Exemption (b)(3) protects information that has been specifically exempted from disclosure by statute. In this case, the information is being withheld under the authority of an Assurance of Confidentiality issued under 42 U.S.C. §308(d) (specifically, §242(k) and §242(m)(d)) and withheld in full under the authority of 5 U.S.C. §552 Exemption (b)(3).”

I appeal the denial of my request for Vaccine Safety Datalink (VSD) data related to pregnancy and COVID-19 vaccinations based on the following arguments:

1. The agency’s cited Assurance of Confidentiality exemptions under 42 U.S.C. §308(d) (specifically, §242(k) and §242(m)(d)) and 5 U.S.C. §552 Exemption (b)(3) do not apply to the requested records. The agency’s claims about Assurance of Confidentiality are directly contradicted by the V-safe Pregnancy Surveillance (amendment) Protocol that the agency itself provided a link to in its final response letter (final response letter: pg. 2, paragraph 5: https://www.cdc.gov/vaccinesafety/pdf/vsafe-pregnancy-surveillance-protocol-508.pdf). The paragraph on page 6 of the V-safe Pregnancy Surveillance (amendment) Protocol relating to Human subjects considerations and confidentiality clearly states:

“This protocol will require human subjects determination at CDC because CDC is the lead site and surveillance data will include collection of personal identifiable information (PII). This data will be collected for public health surveillance, not for research purposes. No PII will be included in any v-safe analyses, manuscripts, or datasets shared externally. Participation is voluntary and individuals self-enroll. Participants can opt-out of the v-safe pregnancy registry at any time and their data will only be used for the time they were considered an active participant. In addition, this activity presents minimal risk to subjects, and use of patient data for this purpose will not adversely affect subjects’ rights or welfare.”

Based on the protocol linked in the response, the purpose of the requested data’s collection is for public health surveillance and “no PII will be included in any v-Safe analyses, manuscripts, or datasets shared externally.” Because of that, the agency’s cited confidentiality exemptions do not apply to the requested records. Based on the requested data’s collection protocol, it also seems that the requested data does in fact exist in the requested form under the V-safe Pregnancy Surveillance (amendment) Protocol, in that is should not contain PII of the participants.

2. The agency’s application of the foreseeable harm standard does not apply to the requested records. On page 6 of the aforementioned V-safe Pregnancy Surveillance (amendment) Protocol, the paragraph relating to Human Subjects Considerations and Confidentiality states:

“No PII will be included in any v-safe analyses, manuscripts, or datasets shared externally. Participation is voluntary and individuals self-enroll. Participants can opt-out of the v-safe pregnancy registry at any time and their data will only be used for the time they were considered an active participant. In addition, this activity presents minimal risk to subjects, and use of patient data for this purpose will not adversely affect subjects’ rights or welfare.”

Based on the agency-provided protocol under this request, v-Safe Pregnancy Surveillance data does not meet the requirements of the foreseeable harm standard because it does not include any personal identifiable information (PII) and, according to the program’s own protocol, “presents minimal risk to subjects” and will ultimately be released to the public in a final analysis, as outlined on page 7 (see next point).

3. The requested data does not meet the Assurance of Confidentiality or standard of harm criteria. On page 7 of the aforementioned V-safe Pregnancy Surveillance (amendment) Protocol, the paragraph related to Dissemination of Information states:

“Safety profile information from the registry may be presented to Advisory Committee on Immunization Practices (ACIP) subgroups (such as the Vaccine Safety Technical Subgroup [VaST]), ACIP meetings and other meetings that are requested. Further, at the conclusion of the registry, a final report will be written detailing the findings of this surveillance activity.”

Because release of the requested data is left to the discretion of the agency (as outlined in the protocol above), and the data is available for presentation at public meetings, the Assurance of Confidentiality and foreseeable harm standard does not apply to the requested records.

4. The foreseeable harm standard also does not apply to this request because the agency failed to provide a specific and concrete explanation as to how or why disclosure of the requested data would create legitimate foreseeable harm, particularly in light of the fact that the v-Safe Pregnancy Surveillance data does not include PII under its own collection protocol and is undeniably more in the public interest to release than not.

In past FOIA litigation related to the foreseeable harm standard, numerous courts at the federal and district levels have ruled that an agency must provide a requester with a specific and concrete explanation about how disclosing the requested data would cause legitimate foreseeable harm in a denial under the foreseeable harm standard. (See Center for Investigative Reporting v. Department of Labor; Center for Investigative Reporting v. U.S. Customs & Border Protection; and Ecological Rights Foundation v. FEMA). (Source: Foreseeable Harm Standard. (2021, July 2). FOIA.Wiki, Retrieved 17:26, July 19, 2022 from https://foia.wiki/w/index.php?title=Foreseeable_Harm_Standard&oldid=6300.)

In a memo issued by the Dept. of Justice providing guidance on the application of the foreseeable harm standard, Attorney General Janet Reno established specific standards of open government that strongly encouraged “agency decisionmaking under the FOIA toward the Act’s goal of maximum responsible disclosure.” That memo, issued Oct. 4, 1993, stated:

“In short, it be shall the policy of the Department of Justice to defend the assertion of a FOIA exemption only in those cases where the agency reasonably foresees that disclosure would be harmful to an interest protected by that exemption.” (Source: https://www.justice.gov/oip/blog/foia-update-oip-guidance-applying-forseeable-harm-standard-under-exemption-five)

Having already established that the Assurance of Confidentiality and foreseeable harm standard should not apply to the requested records due to the lack of PII in the requested data and a lack of clarity on the actual harm that would be caused by its disclosure, it is important to cite the aforementioned DOJ guidance, which states:

“Where ‘only a government interest would be affected’ by a FOIA disclosure, there is a far greater potential for discretionary disclosure than exists where such interests as personal privacy or business confidentiality.”

I strongly encourage whoever handles this appeal to consider the possibility that the "foreseeable harm" in the case of this request could potentially be to protect the government's interests. I also encourage you to consider the DOJ’s strong urging toward transparency in support of the spirit of the Freedom of Information Act, which was designed to promote government transparency and accountability, which are both significant components of a well-functioning democracy.

Finally, in March 2022, someone at the CDC went back through all of the requests I have filed with the agency both independently and via MuckRock (a nonprofit organization that provides automated public records requests services), and moved many of those requests from their separate original portals into a different portal under login credentials that were different from the original credentials used to access several of the requests, including this one. Those changes rendered me unable to access the requests in their original portals and created confusion about how to access updates about each request.
The contact information for this request (#22-01035-FOIA) was changed from the original MuckRock email address I had filed it under, to my personal email address; the mailing address related to this request was also temporarily changed to one of my former residential addresses without my knowledge. It was eventually changed back after a back-and-forth with Emerique C. Magyar.

Proof of the aforementioned unauthorized portal credential changes can be found in my email communications with Emerique C. Magyar dated March 11 through March 14, 2022, as well as my email communication to the CDC IT Service Desk (ITServiceDesk@cdc.gov) on March 14, 2022, in which I complained about the changes and reported a possible security breach related to my CDC FOIA portal account.

In addition to my login credentials being changed without my knowledge or permission on this request (#22-01035-FOIA), the password to the portal for this request now seems to have also changed, which has prevented me from accessing the portal to file this appeal in time to meet the appeal deadline July 20, 2022, as noted in the agency’s final response letter.

Due to my inability to access the portal to electronically file an appeal today, which appears to again be due to actions by someone other than myself changing my portal login password, I am submitting this appeal to email addresses associated with the CDC’s FOIA office and liaisons including FOIARequest@psc.hhs.gov, ogis@nara.gov and foiarequests@cdc.gov.

I have also alerted MuckRock staff about my inability to log into the portal also, as the request was originally filed via MuckRock. However, if my appeal does not reach the CDC by its deadline, I intend to request a formal investigation into the matter due to the unusual nature of the agency’s prior unauthorized changes to my CDC portal login credentials for this request.

If you have any questions while handling this appeal, please provide me with a phone number where I can reach you directly.
Thank you for your consideration of this appeal.

Sincerely,

Erin Miller 

MuckRock News Dept.

411A Highland Ave

Somverville, Massachusetts 02144

Via email: requests@muckrock.com

Deputy Agency Chief FOIA Officer, 

Office of the Assistant Secretary for Public Affairs, 

U.S. Department of Health and Human Services

Re: Freedom of Information Act Appeal

July 19, 2022

To Whom It May Concern:

This is an appeal under the Freedom of Information Act regarding CDC FOIA request #22-01035-FOIA.

On Feb. 24, 2022, I requested the following records and information from the Centers for Disease Control and Prevention (CDC):

1. Copies of all data, reports, presentations, records, agendas, and meeting minutes related to COVID-19 vaccines and pregnancy and/or pregnant people as part of the CDC's v-safe COVID-19 Vaccine Pregnancy Registry that were presented to, or included in, meetings of the Advisory Committee on Immunization Practices (ACIP), including but not limited to all relevant data collected and/or reported by Abt Associates (https:// www.abtassociates.com/projects/expanding-v-safe-covid-19-vaccine-pregnancy- registry-0) between Dec. 1, 2020 and the date this request is ultimately processed.

2. Copies of all data, studies, reports, documents, and records related to COVID-19 vaccines and pregnancy and/or pregnant people provided to the CDC's v-safe COVID-19 Vaccine Pregnancy Registry, including but not limited to data collected and/or reported by Abt Associates, between Dec. 1, 2020 and the date this request is ultimately processed.

3. Copies of all data, studies, reports, documents, and records provided to the CDC related to COVID-19 vaccines and pregnancy and/or pregnant people that were part of the CDC's three pregnancy monitoring programs including the v-safe COVID-19 Vaccine Pregnancy Registry program; the Vaccine Safety Datalink (VSD) program; and the Vaccine Adverse Event Reporting System (VAERS) between Dec. 1, 2020 and the date this request is ultimately processed. (For more clarity about the aforementioned monitoring programs, please view following the CDC website: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/monitoring-pregnant- people.html)

On April 21, 2022, Roger Andoh, CDC/ATSDR FOIA Officer at the Office of the Chief Operating Officer, partially granted my request and provided me with a final response letter containing links to various publicly-available studies and meeting minutes related to my request.

However, in the aforementioned final response letter dated April 21, 2022 from Roger Andoh, my request for Vaccine Safety Datalink (VSD) data related to pregnancy and COVID-19 vaccines was denied. The agency cited the following reasons for its denial of the requested data:

“With regard to your request for Vaccine Safety Datalink data the Immunization Safety Office indicated the data requested does not exist in the requested format. Under the Freedom of Information Act (FOIA) agencies are not required to conduct research or create records in response to a FOIA request.
“Additionally, VSD data is collected under an Assurance of Confidentiality, and we are precluded from releasing that information and consequently all VSD data was withheld from release pursuant to 5 U.S.C. §552 Exemption (b)(3). The foreseeable harm standard was considered when applying these redactions.

“EXEMPTION (b)(3) 
Exemption (b)(3) protects information that has been specifically exempted from disclosure by statute. In this case, the information is being withheld under the authority of an Assurance of Confidentiality issued under 42 U.S.C. §308(d) (specifically, §242(k) and §242(m)(d)) and withheld in full under the authority of 5 U.S.C. §552 Exemption (b)(3).”

I appeal the denial of my request for Vaccine Safety Datalink (VSD) data related to pregnancy and COVID-19 vaccinations based on the following arguments:

1. The agency’s cited Assurance of Confidentiality exemptions under 42 U.S.C. §308(d) (specifically, §242(k) and §242(m)(d)) and 5 U.S.C. §552 Exemption (b)(3) do not apply to the requested records. The agency’s claims about Assurance of Confidentiality are directly contradicted by the V-safe Pregnancy Surveillance (amendment) Protocol that the agency itself provided a link to in its final response letter (final response letter: pg. 2, paragraph 5: https://www.cdc.gov/vaccinesafety/pdf/vsafe-pregnancy-surveillance-protocol-508.pdf). The paragraph on page 6 of the V-safe Pregnancy Surveillance (amendment) Protocol relating to Human subjects considerations and confidentiality clearly states:

“This protocol will require human subjects determination at CDC because CDC is the lead site and surveillance data will include collection of personal identifiable information (PII). This data will be collected for public health surveillance, not for research purposes. No PII will be included in any v-safe analyses, manuscripts, or datasets shared externally. Participation is voluntary and individuals self-enroll. Participants can opt-out of the v-safe pregnancy registry at any time and their data will only be used for the time they were considered an active participant. In addition, this activity presents minimal risk to subjects, and use of patient data for this purpose will not adversely affect subjects’ rights or welfare.”

Based on the protocol linked in the response, the purpose of the requested data’s collection is for public health surveillance and “no PII will be included in any v-Safe analyses, manuscripts, or datasets shared externally.” Because of that, the agency’s cited confidentiality exemptions do not apply to the requested records. Based on the requested data’s collection protocol, it also seems that the requested data does in fact exist in the requested form under the V-safe Pregnancy Surveillance (amendment) Protocol, in that is should not contain PII of the participants.

2. The agency’s application of the foreseeable harm standard does not apply to the requested records. On page 6 of the aforementioned V-safe Pregnancy Surveillance (amendment) Protocol, the paragraph relating to Human Subjects Considerations and Confidentiality states:

“No PII will be included in any v-safe analyses, manuscripts, or datasets shared externally. Participation is voluntary and individuals self-enroll. Participants can opt-out of the v-safe pregnancy registry at any time and their data will only be used for the time they were considered an active participant. In addition, this activity presents minimal risk to subjects, and use of patient data for this purpose will not adversely affect subjects’ rights or welfare.”

Based on the agency-provided protocol under this request, v-Safe Pregnancy Surveillance data does not meet the requirements of the foreseeable harm standard because it does not include any personal identifiable information (PII) and, according to the program’s own protocol, “presents minimal risk to subjects” and will ultimately be released to the public in a final analysis, as outlined on page 7 (see next point).

3. The requested data does not meet the Assurance of Confidentiality or standard of harm criteria. On page 7 of the aforementioned V-safe Pregnancy Surveillance (amendment) Protocol, the paragraph related to Dissemination of Information states:

“Safety profile information from the registry may be presented to Advisory Committee on Immunization Practices (ACIP) subgroups (such as the Vaccine Safety Technical Subgroup [VaST]), ACIP meetings and other meetings that are requested. Further, at the conclusion of the registry, a final report will be written detailing the findings of this surveillance activity.”

Because release of the requested data is left to the discretion of the agency (as outlined in the protocol above), and the data is available for presentation at public meetings, the Assurance of Confidentiality and foreseeable harm standard does not apply to the requested records.

4. The foreseeable harm standard also does not apply to this request because the agency failed to provide a specific and concrete explanation as to how or why disclosure of the requested data would create legitimate foreseeable harm, particularly in light of the fact that the v-Safe Pregnancy Surveillance data does not include PII under its own collection protocol and is undeniably more in the public interest to release than not.

In past FOIA litigation related to the foreseeable harm standard, numerous courts at the federal and district levels have ruled that an agency must provide a requester with a specific and concrete explanation about how disclosing the requested data would cause legitimate foreseeable harm in a denial under the foreseeable harm standard. (See Center for Investigative Reporting v. Department of Labor; Center for Investigative Reporting v. U.S. Customs & Border Protection; and Ecological Rights Foundation v. FEMA). (Source: Foreseeable Harm Standard. (2021, July 2). FOIA.Wiki, Retrieved 17:26, July 19, 2022 from https://foia.wiki/w/index.php?title=Foreseeable_Harm_Standard&oldid=6300.)

In a memo issued by the Dept. of Justice providing guidance on the application of the foreseeable harm standard, Attorney General Janet Reno established specific standards of open government that strongly encouraged “agency decisionmaking under the FOIA toward the Act’s goal of maximum responsible disclosure.” That memo, issued Oct. 4, 1993, stated:

“In short, it be shall the policy of the Department of Justice to defend the assertion of a FOIA exemption only in those cases where the agency reasonably foresees that disclosure would be harmful to an interest protected by that exemption.” (Source: https://www.justice.gov/oip/blog/foia-update-oip-guidance-applying-forseeable-harm-standard-under-exemption-five)

Having already established that the Assurance of Confidentiality and foreseeable harm standard should not apply to the requested records due to the lack of PII in the requested data and a lack of clarity on the actual harm that would be caused by its disclosure, it is important to cite the aforementioned DOJ guidance, which states:

“Where ‘only a government interest would be affected’ by a FOIA disclosure, there is a far greater potential for discretionary disclosure than exists where such interests as personal privacy or business confidentiality.”

I strongly encourage whoever handles this appeal to consider the possibility that the "foreseeable harm" in the case of this request could potentially be to protect the government's interests. I also encourage you to consider the DOJ’s strong urging toward transparency in support of the spirit of the Freedom of Information Act, which was designed to promote government transparency and accountability, which are both significant components of a well-functioning democracy.

Finally, in March 2022, someone at the CDC went back through all of the requests I have filed with the agency both independently and via MuckRock (a nonprofit organization that provides automated public records requests services), and moved many of those requests from their separate original portals into a different portal under login credentials that were different from the original credentials used to access several of the requests, including this one. Those changes rendered me unable to access the requests in their original portals and created confusion about how to access updates about each request.
The contact information for this request (#22-01035-FOIA) was changed from the original MuckRock email address I had filed it under, to my personal email address; the mailing address related to this request was also temporarily changed to one of my former residential addresses without my knowledge. It was eventually changed back after a back-and-forth with Emerique C. Magyar.

Proof of the aforementioned unauthorized portal credential changes can be found in my email communications with Emerique C. Magyar dated March 11 through March 14, 2022, as well as my email communication to the CDC IT Service Desk (ITServiceDesk@cdc.gov) on March 14, 2022, in which I complained about the changes and reported a possible security breach related to my CDC FOIA portal account.

In addition to my login credentials being changed without my knowledge or permission on this request (#22-01035-FOIA), the password to the portal for this request now seems to have also changed, which has prevented me from accessing the portal to file this appeal in time to meet the appeal deadline July 20, 2022, as noted in the agency’s final response letter.

Due to my inability to access the portal to electronically file an appeal today, which appears to again be due to actions by someone other than myself changing my portal login password, I am submitting this appeal to email addresses associated with the CDC’s FOIA office and liaisons including FOIARequest@psc.hhs.gov, ogis@nara.gov and foiarequests@cdc.gov.

I have also alerted MuckRock staff about my inability to log into the portal also, as the request was originally filed via MuckRock. However, if my appeal does not reach the CDC by its deadline, I intend to request a formal investigation into the matter due to the unusual nature of the agency’s prior unauthorized changes to my CDC portal login credentials for this request.

If you have any questions while handling this appeal, please provide me with a phone number where I can reach you directly.

Thank you for your consideration of this appeal.

Sincerely,

Erin Miller 

MuckRock News Dept.

411A Highland Ave

Somverville, Massachusetts 02144

Via email: requests@muckrock.com

Deputy Agency Chief FOIA Officer, 

Office of the Assistant Secretary for Public Affairs, 

U.S. Department of Health and Human Services

Re: Freedom of Information Act Appeal

July 19, 2022

To Whom It May Concern:

This is an appeal under the Freedom of Information Act regarding CDC FOIA request #22-01035-FOIA.

On Feb. 24, 2022, I requested the following records and information from the Centers for Disease Control and Prevention (CDC):

1. Copies of all data, reports, presentations, records, agendas, and meeting minutes related to COVID-19 vaccines and pregnancy and/or pregnant people as part of the CDC's v-safe COVID-19 Vaccine Pregnancy Registry that were presented to, or included in, meetings of the Advisory Committee on Immunization Practices (ACIP), including but not limited to all relevant data collected and/or reported by Abt Associates (https:// www.abtassociates.com/projects/expanding-v-safe-covid-19-vaccine-pregnancy- registry-0) between Dec. 1, 2020 and the date this request is ultimately processed.

2. Copies of all data, studies, reports, documents, and records related to COVID-19 vaccines and pregnancy and/or pregnant people provided to the CDC's v-safe COVID-19 Vaccine Pregnancy Registry, including but not limited to data collected and/or reported by Abt Associates, between Dec. 1, 2020 and the date this request is ultimately processed.

3. Copies of all data, studies, reports, documents, and records provided to the CDC related to COVID-19 vaccines and pregnancy and/or pregnant people that were part of the CDC's three pregnancy monitoring programs including the v-safe COVID-19 Vaccine Pregnancy Registry program; the Vaccine Safety Datalink (VSD) program; and the Vaccine Adverse Event Reporting System (VAERS) between Dec. 1, 2020 and the date this request is ultimately processed. (For more clarity about the aforementioned monitoring programs, please view following the CDC website: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/monitoring-pregnant- people.html)

On April 21, 2022, Roger Andoh, CDC/ATSDR FOIA Officer at the Office of the Chief Operating Officer, partially granted my request and provided me with a final response letter containing links to various publicly-available studies and meeting minutes related to my request.

However, in the aforementioned final response letter dated April 21, 2022 from Roger Andoh, my request for Vaccine Safety Datalink (VSD) data related to pregnancy and COVID-19 vaccines was denied. The agency cited the following reasons for its denial of the requested data:

“With regard to your request for Vaccine Safety Datalink data the Immunization Safety Office indicated the data requested does not exist in the requested format. Under the Freedom of Information Act (FOIA) agencies are not required to conduct research or create records in response to a FOIA request.
“Additionally, VSD data is collected under an Assurance of Confidentiality, and we are precluded from releasing that information and consequently all VSD data was withheld from release pursuant to 5 U.S.C. §552 Exemption (b)(3). The foreseeable harm standard was considered when applying these redactions.

“EXEMPTION (b)(3) 
Exemption (b)(3) protects information that has been specifically exempted from disclosure by statute. In this case, the information is being withheld under the authority of an Assurance of Confidentiality issued under 42 U.S.C. §308(d) (specifically, §242(k) and §242(m)(d)) and withheld in full under the authority of 5 U.S.C. §552 Exemption (b)(3).”

I appeal the denial of my request for Vaccine Safety Datalink (VSD) data related to pregnancy and COVID-19 vaccinations based on the following arguments:

1. The agency’s cited Assurance of Confidentiality exemptions under 42 U.S.C. §308(d) (specifically, §242(k) and §242(m)(d)) and 5 U.S.C. §552 Exemption (b)(3) do not apply to the requested records. The agency’s claims about Assurance of Confidentiality are directly contradicted by the V-safe Pregnancy Surveillance (amendment) Protocol that the agency itself provided a link to in its final response letter (final response letter: pg. 2, paragraph 5: https://www.cdc.gov/vaccinesafety/pdf/vsafe-pregnancy-surveillance-protocol-508.pdf). The paragraph on page 6 of the V-safe Pregnancy Surveillance (amendment) Protocol relating to Human subjects considerations and confidentiality clearly states:

“This protocol will require human subjects determination at CDC because CDC is the lead site and surveillance data will include collection of personal identifiable information (PII). This data will be collected for public health surveillance, not for research purposes. No PII will be included in any v-safe analyses, manuscripts, or datasets shared externally. Participation is voluntary and individuals self-enroll. Participants can opt-out of the v-safe pregnancy registry at any time and their data will only be used for the time they were considered an active participant. In addition, this activity presents minimal risk to subjects, and use of patient data for this purpose will not adversely affect subjects’ rights or welfare.”

Based on the protocol linked in the response, the purpose of the requested data’s collection is for public health surveillance and “no PII will be included in any v-Safe analyses, manuscripts, or datasets shared externally.” Because of that, the agency’s cited confidentiality exemptions do not apply to the requested records. Based on the requested data’s collection protocol, it also seems that the requested data does in fact exist in the requested form under the V-safe Pregnancy Surveillance (amendment) Protocol, in that is should not contain PII of the participants.

2. The agency’s application of the foreseeable harm standard does not apply to the requested records. On page 6 of the aforementioned V-safe Pregnancy Surveillance (amendment) Protocol, the paragraph relating to Human Subjects Considerations and Confidentiality states:

“No PII will be included in any v-safe analyses, manuscripts, or datasets shared externally. Participation is voluntary and individuals self-enroll. Participants can opt-out of the v-safe pregnancy registry at any time and their data will only be used for the time they were considered an active participant. In addition, this activity presents minimal risk to subjects, and use of patient data for this purpose will not adversely affect subjects’ rights or welfare.”

Based on the agency-provided protocol under this request, v-Safe Pregnancy Surveillance data does not meet the requirements of the foreseeable harm standard because it does not include any personal identifiable information (PII) and, according to the program’s own protocol, “presents minimal risk to subjects” and will ultimately be released to the public in a final analysis, as outlined on page 7 (see next point).

3. The requested data does not meet the Assurance of Confidentiality or standard of harm criteria. On page 7 of the aforementioned V-safe Pregnancy Surveillance (amendment) Protocol, the paragraph related to Dissemination of Information states:

“Safety profile information from the registry may be presented to Advisory Committee on Immunization Practices (ACIP) subgroups (such as the Vaccine Safety Technical Subgroup [VaST]), ACIP meetings and other meetings that are requested. Further, at the conclusion of the registry, a final report will be written detailing the findings of this surveillance activity.”

Because release of the requested data is left to the discretion of the agency (as outlined in the protocol above), and the data is available for presentation at public meetings, the Assurance of Confidentiality and foreseeable harm standard does not apply to the requested records.

4. The foreseeable harm standard also does not apply to this request because the agency failed to provide a specific and concrete explanation as to how or why disclosure of the requested data would create legitimate foreseeable harm, particularly in light of the fact that the v-Safe Pregnancy Surveillance data does not include PII under its own collection protocol and is undeniably more in the public interest to release than not.

In past FOIA litigation related to the foreseeable harm standard, numerous courts at the federal and district levels have ruled that an agency must provide a requester with a specific and concrete explanation about how disclosing the requested data would cause legitimate foreseeable harm in a denial under the foreseeable harm standard. (See Center for Investigative Reporting v. Department of Labor; Center for Investigative Reporting v. U.S. Customs & Border Protection; and Ecological Rights Foundation v. FEMA). (Source: Foreseeable Harm Standard. (2021, July 2). FOIA.Wiki, Retrieved 17:26, July 19, 2022 from https://foia.wiki/w/index.php?title=Foreseeable_Harm_Standard&oldid=6300.)

In a memo issued by the Dept. of Justice providing guidance on the application of the foreseeable harm standard, Attorney General Janet Reno established specific standards of open government that strongly encouraged “agency decisionmaking under the FOIA toward the Act’s goal of maximum responsible disclosure.” That memo, issued Oct. 4, 1993, stated:

“In short, it be shall the policy of the Department of Justice to defend the assertion of a FOIA exemption only in those cases where the agency reasonably foresees that disclosure would be harmful to an interest protected by that exemption.” (Source: https://www.justice.gov/oip/blog/foia-update-oip-guidance-applying-forseeable-harm-standard-under-exemption-five)

Having already established that the Assurance of Confidentiality and foreseeable harm standard should not apply to the requested records due to the lack of PII in the requested data and a lack of clarity on the actual harm that would be caused by its disclosure, it is important to cite the aforementioned DOJ guidance, which states:

“Where ‘only a government interest would be affected’ by a FOIA disclosure, there is a far greater potential for discretionary disclosure than exists where such interests as personal privacy or business confidentiality.”

I strongly encourage whoever handles this appeal to consider the possibility that the "foreseeable harm" in the case of this request could potentially be to protect the government's interests. I also encourage you to consider the DOJ’s strong urging toward transparency in support of the spirit of the Freedom of Information Act, which was designed to promote government transparency and accountability, which are both significant components of a well-functioning democracy.

Finally, in March 2022, someone at the CDC went back through all of the requests I have filed with the agency both independently and via MuckRock (a nonprofit organization that provides automated public records requests services), and moved many of those requests from their separate original portals into a different portal under login credentials that were different from the original credentials used to access several of the requests, including this one. Those changes rendered me unable to access the requests in their original portals and created confusion about how to access updates about each request.
The contact information for this request (#22-01035-FOIA) was changed from the original MuckRock email address I had filed it under, to my personal email address; the mailing address related to this request was also temporarily changed to one of my former residential addresses without my knowledge. It was eventually changed back after a back-and-forth with Emerique C. Magyar.

Proof of the aforementioned unauthorized portal credential changes can be found in my email communications with Emerique C. Magyar dated March 11 through March 14, 2022, as well as my email communication to the CDC IT Service Desk (ITServiceDesk@cdc.gov) on March 14, 2022, in which I complained about the changes and reported a possible security breach related to my CDC FOIA portal account.

In addition to my login credentials being changed without my knowledge or permission on this request (#22-01035-FOIA), the password to the portal for this request now seems to have also changed, which has prevented me from accessing the portal to file this appeal in time to meet the appeal deadline July 20, 2022, as noted in the agency’s final response letter.

Due to my inability to access the portal to electronically file an appeal today, which appears to again be due to actions by someone other than myself changing my portal login password, I am submitting this appeal to email addresses associated with the CDC’s FOIA office and liaisons including FOIARequest@psc.hhs.gov, ogis@nara.gov and foiarequests@cdc.gov.

I have also alerted MuckRock staff about my inability to log into the portal also, as the request was originally filed via MuckRock. However, if my appeal does not reach the CDC by its deadline, I intend to request a formal investigation into the matter due to the unusual nature of the agency’s prior unauthorized changes to my CDC portal login credentials for this request.

If you have any questions while handling this appeal, please provide me with a phone number where I can reach you directly.
Thank you for your consideration of this appeal.

Sincerely,

Erin Miller 

MuckRock News Dept.

411A Highland Ave

Somverville, Massachusetts 02144

Via email: requests@muckrock.com

Deputy Agency Chief FOIA Officer, 

Office of the Assistant Secretary for Public Affairs, 

U.S. Department of Health and Human Services

Re: Freedom of Information Act Appeal

July 20, 2022

To Whom It May Concern:

This is an appeal under the Freedom of Information Act regarding CDC FOIA request #22-01035-FOIA.

On Feb. 24, 2022, I requested the following records and information from the Centers for Disease Control and Prevention (CDC):

1. Copies of all data, reports, presentations, records, agendas, and meeting minutes related to COVID-19 vaccines and pregnancy and/or pregnant people as part of the CDC's v-safe COVID-19 Vaccine Pregnancy Registry that were presented to, or included in, meetings of the Advisory Committee on Immunization Practices (ACIP), including but not limited to all relevant data collected and/or reported by Abt Associates (https:// www.abtassociates.com/projects/expanding-v-safe-covid-19-vaccine-pregnancy- registry-0) between Dec. 1, 2020 and the date this request is ultimately processed.

2. Copies of all data, studies, reports, documents, and records related to COVID-19 vaccines and pregnancy and/or pregnant people provided to the CDC's v-safe COVID-19 Vaccine Pregnancy Registry, including but not limited to data collected and/or reported by Abt Associates, between Dec. 1, 2020 and the date this request is ultimately processed.

3. Copies of all data, studies, reports, documents, and records provided to the CDC related to COVID-19 vaccines and pregnancy and/or pregnant people that were part of the CDC's three pregnancy monitoring programs including the v-safe COVID-19 Vaccine Pregnancy Registry program; the Vaccine Safety Datalink (VSD) program; and the Vaccine Adverse Event Reporting System (VAERS) between Dec. 1, 2020 and the date this request is ultimately processed. (For more clarity about the aforementioned monitoring programs, please view following the CDC website: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/monitoring-pregnant- people.html)

On April 21, 2022, Roger Andoh, CDC/ATSDR FOIA Officer at the Office of the Chief Operating Officer, partially granted my request and provided me with a final response letter containing links to various publicly-available studies and meeting minutes related to my request.

However, in the aforementioned final response letter dated April 21, 2022 from Roger Andoh, my request for Vaccine Safety Datalink (VSD) data related to pregnancy and COVID-19 vaccines was denied. The agency cited the following reasons for its denial of the requested data:

“With regard to your request for Vaccine Safety Datalink data the Immunization Safety Office indicated the data requested does not exist in the requested format. Under the Freedom of Information Act (FOIA) agencies are not required to conduct research or create records in response to a FOIA request.
“Additionally, VSD data is collected under an Assurance of Confidentiality, and we are precluded from releasing that information and consequently all VSD data was withheld from release pursuant to 5 U.S.C. §552 Exemption (b)(3). The foreseeable harm standard was considered when applying these redactions.

“EXEMPTION (b)(3) 
Exemption (b)(3) protects information that has been specifically exempted from disclosure by statute. In this case, the information is being withheld under the authority of an Assurance of Confidentiality issued under 42 U.S.C. §308(d) (specifically, §242(k) and §242(m)(d)) and withheld in full under the authority of 5 U.S.C. §552 Exemption (b)(3).”

I appeal the denial of my request for Vaccine Safety Datalink (VSD) data related to pregnancy and COVID-19 vaccinations based on the following arguments:

1. The agency’s cited Assurance of Confidentiality exemptions under 42 U.S.C. §308(d) (specifically, §242(k) and §242(m)(d)) and 5 U.S.C. §552 Exemption (b)(3) do not apply to the requested records. The agency’s claims about Assurance of Confidentiality are directly contradicted by the V-safe Pregnancy Surveillance (amendment) Protocol that the agency itself provided a link to in its final response letter (final response letter: pg. 2, paragraph 5: https://www.cdc.gov/vaccinesafety/pdf/vsafe-pregnancy-surveillance-protocol-508.pdf). The paragraph on page 6 of the V-safe Pregnancy Surveillance (amendment) Protocol relating to Human subjects considerations and confidentiality clearly states:

“This protocol will require human subjects determination at CDC because CDC is the lead site and surveillance data will include collection of personal identifiable information (PII). This data will be collected for public health surveillance, not for research purposes. No PII will be included in any v-safe analyses, manuscripts, or datasets shared externally. Participation is voluntary and individuals self-enroll. Participants can opt-out of the v-safe pregnancy registry at any time and their data will only be used for the time they were considered an active participant. In addition, this activity presents minimal risk to subjects, and use of patient data for this purpose will not adversely affect subjects’ rights or welfare.”

Based on the protocol linked in the response, the purpose of the requested data’s collection is for public health surveillance and “no PII will be included in any v-Safe analyses, manuscripts, or datasets shared externally.” Because of that, the agency’s cited confidentiality exemptions do not apply to the requested records. Based on the requested data’s collection protocol, it also seems that the requested data does in fact exist in the requested form under the V-safe Pregnancy Surveillance (amendment) Protocol, in that is should not contain PII of the participants.

2. The agency’s application of the foreseeable harm standard does not apply to the requested records. On page 6 of the aforementioned V-safe Pregnancy Surveillance (amendment) Protocol, the paragraph relating to Human Subjects Considerations and Confidentiality states:

“No PII will be included in any v-safe analyses, manuscripts, or datasets shared externally. Participation is voluntary and individuals self-enroll. Participants can opt-out of the v-safe pregnancy registry at any time and their data will only be used for the time they were considered an active participant. In addition, this activity presents minimal risk to subjects, and use of patient data for this purpose will not adversely affect subjects’ rights or welfare.”

Based on the agency-provided protocol under this request, v-Safe Pregnancy Surveillance data does not meet the requirements of the foreseeable harm standard because it does not include any personal identifiable information (PII) and, according to the program’s own protocol, “presents minimal risk to subjects” and will ultimately be released to the public in a final analysis, as outlined on page 7 (see next point).

3. The requested data does not meet the Assurance of Confidentiality or standard of harm criteria. On page 7 of the aforementioned V-safe Pregnancy Surveillance (amendment) Protocol, the paragraph related to Dissemination of Information states:

“Safety profile information from the registry may be presented to Advisory Committee on Immunization Practices (ACIP) subgroups (such as the Vaccine Safety Technical Subgroup [VaST]), ACIP meetings and other meetings that are requested. Further, at the conclusion of the registry, a final report will be written detailing the findings of this surveillance activity.”

Because release of the requested data is left to the discretion of the agency (as outlined in the protocol above), and the data is available for presentation at public meetings, the Assurance of Confidentiality and foreseeable harm standard does not apply to the requested records.

4. The foreseeable harm standard also does not apply to this request because the agency failed to provide a specific and concrete explanation as to how or why disclosure of the requested data would create legitimate foreseeable harm, particularly in light of the fact that the v-Safe Pregnancy Surveillance data does not include PII under its own collection protocol and is undeniably more in the public interest to release than not.

In past FOIA litigation related to the foreseeable harm standard, numerous courts at the federal and district levels have ruled that an agency must provide a requester with a specific and concrete explanation about how disclosing the requested data would cause legitimate foreseeable harm in a denial under the foreseeable harm standard. (See Center for Investigative Reporting v. Department of Labor; Center for Investigative Reporting v. U.S. Customs & Border Protection; and Ecological Rights Foundation v. FEMA). (Source: Foreseeable Harm Standard. (2021, July 2). FOIA.Wiki, Retrieved 17:26, July 19, 2022 from https://foia.wiki/w/index.php?title=Foreseeable_Harm_Standard&oldid=6300.)

In a memo issued by the Dept. of Justice providing guidance on the application of the foreseeable harm standard, Attorney General Janet Reno established specific standards of open government that strongly encouraged “agency decisionmaking under the FOIA toward the Act’s goal of maximum responsible disclosure.” That memo, issued Oct. 4, 1993, stated:

“In short, it be shall the policy of the Department of Justice to defend the assertion of a FOIA exemption only in those cases where the agency reasonably foresees that disclosure would be harmful to an interest protected by that exemption.” (Source: https://www.justice.gov/oip/blog/foia-update-oip-guidance-applying-forseeable-harm-standard-under-exemption-five)

Having already established that the Assurance of Confidentiality and foreseeable harm standard should not apply to the requested records due to the lack of PII in the requested data and a lack of clarity on the actual harm that would be caused by its disclosure, it is important to cite the aforementioned DOJ guidance, which states:

“Where ‘only a government interest would be affected’ by a FOIA disclosure, there is a far greater potential for discretionary disclosure than exists where such interests as personal privacy or business confidentiality.”

I strongly encourage whoever handles this appeal to consider the possibility that the "foreseeable harm" in the case of this request could potentially be to protect the government's interests. I also encourage you to consider the DOJ’s strong urging toward transparency in support of the spirit of the Freedom of Information Act, which was designed to promote government transparency and accountability, which are both significant components of a well-functioning democracy.

Finally, in March 2022, someone at the CDC went back through all of the requests I have filed with the agency both independently and via MuckRock (a nonprofit organization that provides automated public records requests services), and moved many of those requests from their separate original portals into a different portal under login credentials that were different from the original credentials used to access several of the requests, including this one. Those changes rendered me unable to access the requests in their original portals and created confusion about how to access updates about each request.
The contact information for this request (#22-01035-FOIA) was changed from the original MuckRock email address I had filed it under, to my personal email address; the mailing address related to this request was also temporarily changed to one of my former residential addresses without my knowledge. It was eventually changed back after a back-and-forth with Emerique C. Magyar.

Proof of the aforementioned unauthorized portal credential changes can be found in my email communications with Emerique C. Magyar dated March 11 through March 14, 2022, as well as my email communication to the CDC IT Service Desk (ITServiceDesk@cdc.gov) on March 14, 2022, in which I complained about the changes and reported a possible security breach related to my CDC FOIA portal account.

In addition to my login credentials being changed without my knowledge or permission on this request (#22-01035-FOIA), the password to the portal for this request now seems to have also changed, which has prevented me from accessing the portal to file this appeal in time to meet the appeal deadline July 20, 2022, as noted in the agency’s final response letter.

Due to my inability to access the portal to electronically file an appeal today, which appears to again be due to actions by someone other than myself changing my portal login password, I am submitting this appeal to email addresses associated with the CDC’s FOIA office and liaisons including FOIARequest@psc.hhs.gov, ogis@nara.gov and foiarequests@cdc.gov.

I have also alerted MuckRock staff about my inability to log into the portal also, as the request was originally filed via MuckRock. However, if my appeal does not reach the CDC by its deadline, I intend to request a formal investigation into the matter due to the unusual nature of the agency’s prior unauthorized changes to my CDC portal login credentials for this request.

If you have any questions while handling this appeal, please provide me with a phone number where I can reach you directly.
Thank you for your consideration of this appeal.

Sincerely,

Erin Miller 

MuckRock News Dept.

411A Highland Ave

Somverville, Massachusetts 02144

Via email: requests@muckrock.com

Hi Bruno,

The link provided to me in the final response letter for appealing FOIA request included the email address mailto:FOIARequest@psc.hhs.gov. You can confirm this by reviewing the letter and clicking on the appeal link, which will automatically open your email client with an email addressed to that email address.

A copy of my appeal was sent via email to that email address (FOIARequest@psc.hhs.gov) on July 19, 2022.

I expect that the agency will fully honor their instructions to me for filing an appeal.

Thank you,

Erin Miller

Deputy Agency Chief FOIA Officer,
Office of the Assistant Secretary for Public Affairs,
U.S. Department of Health and Human Services

Subject: RE: Freedom of Information Act Request #22-01035-FOIA

February 7, 2023

To Whom It May Concern:

This is an appeal under the Freedom of Information Act regarding CDC FOIA request #22-01035-FOIA.

On Feb. 24, 2022, I requested the following records and information from the Centers for Disease Control and Prevention (CDC):

1. Copies of all data, reports, presentations, records, agendas, and meeting minutes related to COVID-19 vaccines and pregnancy and/or pregnant people as part of the CDC's v-safe COVID-19 Vaccine Pregnancy Registry that were presented to, or included in, meetings of the Advisory Committee on Immunization Practices (ACIP), including but not limited to all relevant data collected and/or reported by Abt Associates (https:// www.abtassociates.com/projects/expanding-v-safe-covid-19-vaccine-pregnancy- registry-0) between Dec. 1, 2020 and the date this request is ultimately processed.

2. Copies of all data, studies, reports, documents, and records related to COVID-19 vaccines and pregnancy and/or pregnant people provided to the CDC's v-safe COVID-19 Vaccine Pregnancy Registry, including but not limited to data collected and/or reported by Abt Associates, between Dec. 1, 2020 and the date this request is ultimately processed.

3. Copies of all data, studies, reports, documents, and records provided to the CDC related to COVID-19 vaccines and pregnancy and/or pregnant people that were part of the CDC's three pregnancy monitoring programs including the v-safe COVID-19 Vaccine Pregnancy Registry program; the Vaccine Safety Datalink (VSD) program; and the Vaccine Adverse Event Reporting System (VAERS) between Dec. 1, 2020 and the date this request is ultimately processed. (For more clarity about the aforementioned monitoring programs, please view following the CDC website: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/monitoring-pregnant- people.html)

My initial request was partially denied by the agency. On July 20, 2022, I appealed the agency's partial denial.

On November 9, 2022, Roger Andoh partially approved my appeal and ordered the delivery of additional requested records under my request. According to Mr. Andoh's letter, some information was withheld under Exemption 5 (the letter specifically cited the deliberative process privilege) and Exemption 6.

I hereby appeal the withholding of information under Exemption 5 (the deliberative process privilege) based on the following arguments, per FOIA.Wiki:

1. In Chilivis v. S.E.C., 673 F.2d 1205, 1212 (11th Cir. 1982), “Waiver can occur when communications are disclosed to private individuals or nonfederal agencies.” In this case, the agency waived the privilege when it voluntarily shared the requested records, data and information with other private individuals and nonfederal agencies, as indicated in the V-safe Pregnancy Surveillance (amendment) Protocol, which can be viewed here: https://www.cdc.gov/vaccinesafety/pdf/vsafe-pregnancy-surveillance-protocol-508.pdf. On page 7, the paragraph related to Dissemination of Information states: “Safety profile information from the registry may be presented to Advisory Committee on Immunization Practices (ACIP) subgroups (such as the Vaccine Safety Technical Subgroup [VaST]), ACIP meetings and other meetings that are requested. Further, at the conclusion of the registry, a final report will be written detailing the findings of this surveillance activity.” The requested information has also been voluntarily shared with Abt Associates (https://www.abtassociates.com/projects/expanding-v-safe-covid-19-vaccine-pregnancy-registry-0). Therefore, any reference to the requested data should not be excluded due to this fact.

2. Due to the fact that the agency has already publicly claimed that COVID-19 mRNA vaccines are "safe and effective" for use in pregnant women, the requested information is not pre-decisional. Therefore, the deliberative process privilege does not apply to the requested records. For evidence of the agency's claims, refer to the following links:
a) "CDC Recommends COVID-19 Vaccine During Pregnancy" - WebMD, April 26, 2021: https://www.webmd.com/vaccines/covid-19-vaccine/news/20210426/cdc-recommends-covid-19-vaccine-during-pregnancy
b) “The CDC recommends that pregnant people receive the COVID-19 vaccine,” said CDC director Rochelle Walensky, MD during a White House briefing on April 23, 2021: https://www.c-span.org/video/?511197-1/white-house-covid-19-response-team-briefing

3. The agency has not provided evidence that disclosure of drafts would cause public confusion about final public policy. Documents that have at least some markings that indicate they are drafts (including deliberative emails, which are obviously not final policy) are unlikely to be mistaken for final agency policy. (See Judicial Watch, Inc. v. United States Dep't of Justice, No. 19-CV-800 (TSC), 2020 WL 5798442, at *3 (D.D.C. Sept. 29, 2020).

4. The public interest vastly outweighs the need for deliberative secrecy here. As early as April 23, 2021, representatives of the agency publicly claimed multiple times that COVID-19 vaccines using mRNA technology were "safe and effective" for pregnant women (see “The CDC recommends that pregnant people receive the COVID-19 vaccine,” said CDC director Rochelle Walensky, MD during a White House briefing on April 23, 2021: https://www.c-span.org/video/?511197-1/white-house-covid-19-response-team-briefing). At the time that final policy was shared publicly, mRNA technology was being used on humans for the first time in history following a rushed development and approval process. There was extremely limited evidence to support the agency's safety claims. There was also an indisputable and total absence of long-term studies regarding the safety of mRNA vaccine use in pregnant women or their children, given the very short amount of time mRNA vaccines had been in use. The decision of the agency to make clearly premature safety claims for pregnant women in the absence of long-term data set a dangerous precedent for public health in America; the public interest in understanding why such decisions were made by the agency clearly outweighs the need for deliberative secrecy in this case. When it comes to ensuring the safety of pregnant human beings -- and the safety of future generations of Americans that have yet to be born -- deliberative privilege should never apply.

5. There is no foreseeable harm in the release of the requested information. Further, the agency has failed to identify any foreseeable harm related to the release of the requested information. In Reporters Committee for Freedom of the Press v. FBI, the D.C. Circuit Court stated: In the context of withholdings made under the deliberative process privilege, the foreseeability requirement means that agencies must concretely explain how disclosure “would”—not “could”—adversely impair internal deliberations. [...] A perfunctory statement that disclosure of all the withheld information—regardless of category or substance—would jeopardize the free exchange of information between senior leaders within and outside of the agenc will not suffice. [...] Instead, what is needed is a focused and concrete demonstration of why disclosure of the particular type of material at issue will, in the specific context of the agency action at issue, actually impede those same agency deliberations going forward. Naturally, this inquiry is context specific. (See Reporters Committee for Freedom of the Press v. Federal Bureau of Investigation, 3 F.4th 350 (D.C. Cir 2021). Because of the agency's failure to identify any foreseeable harm, the deliberative privilege does not apply.

6. Executive privilege only applies to materials “'solicited and received’ by the President or his immediate White House advisors.” (See Judicial Watch, Inc., 365 F.3d at 1114 (quoting In re Sealed Case, 121 F.3d. 729, 752 (D.C. Cir. 1997)). It does not extend to other any documents that were not actually "submitted for Presidential consideration." (See Judicial Watch, Inc., 365 F.3d at 1114 (quoting In re Sealed Case, 121 F.3d. 729, 752 (D.C. Cir. 1997)).

Finally, in a similar fashion to my initial appeal, my login password to the FOIA portal has again been changed without my knowledge or permission by one of your agency's staff. Should you attempt to dispute this claim, I will not hesitate to request that a formal investigation be opened into the matter of whether or not my account was breached from within your agency and whether or not my password was changed during that breach. I have no doubts that such an investigation would end favorably for me.

However, I expect that sending my appeal to this email address (which is listed on your agency's website as the correct email address to send appeals) will be sufficient.

If you have any questions about this appeal, please feel free to contact me at this email address. If a phone conversation is necessary, please provide a phone number where I can reach you directly.

Thank you for your consideration of this appeal.

Sincerely,

Erin Marie Miller

MuckRock News Dept.

411A Highland Ave

Somverville, Massachusetts 02144

Via email: requests@muckrock.com

Muckrock seems to have automatically overridden my ability to email the agency here. This appeal is being sent as a letter, according to the platform. I am not sure why, as this was supposed to be emailed to hhs.acfo@hhs.gov.

Deputy Agency Chief FOIA Officer,
Office of the Assistant Secretary for Public Affairs,
U.S. Department of Health and Human Services

Subject: RE: Freedom of Information Act Request #22-01035-FOIA

February 7, 2023

To Whom It May Concern:

This is an appeal under the Freedom of Information Act regarding CDC FOIA request #22-01035-FOIA.

On Feb. 24, 2022, I requested the following records and information from the Centers for Disease Control and Prevention (CDC):

1. Copies of all data, reports, presentations, records, agendas, and meeting minutes related to COVID-19 vaccines and pregnancy and/or pregnant people as part of the CDC's v-safe COVID-19 Vaccine Pregnancy Registry that were presented to, or included in, meetings of the Advisory Committee on Immunization Practices (ACIP), including but not limited to all relevant data collected and/or reported by Abt Associates (https:// www.abtassociates.com/projects/expanding-v-safe-covid-19-vaccine-pregnancy- registry-0) between Dec. 1, 2020 and the date this request is ultimately processed.

2. Copies of all data, studies, reports, documents, and records related to COVID-19 vaccines and pregnancy and/or pregnant people provided to the CDC's v-safe COVID-19 Vaccine Pregnancy Registry, including but not limited to data collected and/or reported by Abt Associates, between Dec. 1, 2020 and the date this request is ultimately processed.

3. Copies of all data, studies, reports, documents, and records provided to the CDC related to COVID-19 vaccines and pregnancy and/or pregnant people that were part of the CDC's three pregnancy monitoring programs including the v-safe COVID-19 Vaccine Pregnancy Registry program; the Vaccine Safety Datalink (VSD) program; and the Vaccine Adverse Event Reporting System (VAERS) between Dec. 1, 2020 and the date this request is ultimately processed. (For more clarity about the aforementioned monitoring programs, please view following the CDC website: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/monitoring-pregnant- people.html)

My initial request was partially denied by the agency. On July 20, 2022, I appealed the agency's partial denial.

On November 9, 2022, Roger Andoh partially approved my appeal and ordered the delivery of additional requested records under my request. According to Mr. Andoh's letter, some information was withheld under Exemption 5 (the letter specifically cited the deliberative process privilege) and Exemption 6.

I hereby appeal the withholding of information under Exemption 5 (the deliberative process privilege) based on the following arguments, per FOIA.Wiki:

1. In Chilivis v. S.E.C., 673 F.2d 1205, 1212 (11th Cir. 1982), “Waiver can occur when communications are disclosed to private individuals or nonfederal agencies.” In this case, the agency waived the privilege when it voluntarily shared the requested records, data and information with other private individuals and nonfederal agencies, as indicated in the V-safe Pregnancy Surveillance (amendment) Protocol, which can be viewed here: https://www.cdc.gov/vaccinesafety/pdf/vsafe-pregnancy-surveillance-protocol-508.pdf. On page 7, the paragraph related to Dissemination of Information states: “Safety profile information from the registry may be presented to Advisory Committee on Immunization Practices (ACIP) subgroups (such as the Vaccine Safety Technical Subgroup [VaST]), ACIP meetings and other meetings that are requested. Further, at the conclusion of the registry, a final report will be written detailing the findings of this surveillance activity.” The requested information has also been voluntarily shared with Abt Associates (https://www.abtassociates.com/projects/expanding-v-safe-covid-19-vaccine-pregnancy-registry-0). Therefore, any reference to the requested data should not be excluded due to this fact.

2. Due to the fact that the agency has already publicly claimed that COVID-19 mRNA vaccines are "safe and effective" for use in pregnant women, the requested information is not pre-decisional. Therefore, the deliberative process privilege does not apply to the requested records. For evidence of the agency's claims, refer to the following links:
a) "CDC Recommends COVID-19 Vaccine During Pregnancy" - WebMD, April 26, 2021: https://www.webmd.com/vaccines/covid-19-vaccine/news/20210426/cdc-recommends-covid-19-vaccine-during-pregnancy
b) “The CDC recommends that pregnant people receive the COVID-19 vaccine,” said CDC director Rochelle Walensky, MD during a White House briefing on April 23, 2021: https://www.c-span.org/video/?511197-1/white-house-covid-19-response-team-briefing

3. The agency has not provided evidence that disclosure of drafts would cause public confusion about final public policy. Documents that have at least some markings that indicate they are drafts (including deliberative emails, which are obviously not final policy) are unlikely to be mistaken for final agency policy. (See Judicial Watch, Inc. v. United States Dep't of Justice, No. 19-CV-800 (TSC), 2020 WL 5798442, at *3 (D.D.C. Sept. 29, 2020).

4. The public interest vastly outweighs the need for deliberative secrecy here. As early as April 23, 2021, representatives of the agency publicly claimed multiple times that COVID-19 vaccines using mRNA technology were "safe and effective" for pregnant women (see “The CDC recommends that pregnant people receive the COVID-19 vaccine,” said CDC director Rochelle Walensky, MD during a White House briefing on April 23, 2021: https://www.c-span.org/video/?511197-1/white-house-covid-19-response-team-briefing). At the time that final policy was shared publicly, mRNA technology was being used on humans for the first time in history following a rushed development and approval process. There was extremely limited evidence to support the agency's safety claims. There was also an indisputable and total absence of long-term studies regarding the safety of mRNA vaccine use in pregnant women or their children, given the very short amount of time mRNA vaccines had been in use. The decision of the agency to make clearly premature safety claims for pregnant women in the absence of long-term data set a dangerous precedent for public health in America; the public interest in understanding why such decisions were made by the agency clearly outweighs the need for deliberative secrecy in this case. When it comes to ensuring the safety of pregnant human beings -- and the safety of future generations of Americans that have yet to be born -- deliberative privilege should never apply.

5. There is no foreseeable harm in the release of the requested information. Further, the agency has failed to identify any foreseeable harm related to the release of the requested information. In Reporters Committee for Freedom of the Press v. FBI, the D.C. Circuit Court stated: In the context of withholdings made under the deliberative process privilege, the foreseeability requirement means that agencies must concretely explain how disclosure “would”—not “could”—adversely impair internal deliberations. [...] A perfunctory statement that disclosure of all the withheld information—regardless of category or substance—would jeopardize the free exchange of information between senior leaders within and outside of the agenc will not suffice. [...] Instead, what is needed is a focused and concrete demonstration of why disclosure of the particular type of material at issue will, in the specific context of the agency action at issue, actually impede those same agency deliberations going forward. Naturally, this inquiry is context specific. (See Reporters Committee for Freedom of the Press v. Federal Bureau of Investigation, 3 F.4th 350 (D.C. Cir 2021). Because of the agency's failure to identify any foreseeable harm, the deliberative privilege does not apply.

6. Executive privilege only applies to materials “'solicited and received’ by the President or his immediate White House advisors.” (See Judicial Watch, Inc., 365 F.3d at 1114 (quoting In re Sealed Case, 121 F.3d. 729, 752 (D.C. Cir. 1997)). It does not extend to other any documents that were not actually "submitted for Presidential consideration." (See Judicial Watch, Inc., 365 F.3d at 1114 (quoting In re Sealed Case, 121 F.3d. 729, 752 (D.C. Cir. 1997)).

Finally, in a similar fashion to my initial appeal, my login password to the FOIA portal has again been changed without my knowledge or permission by one of your agency's staff. Should you attempt to dispute this claim, I will not hesitate to request that a formal investigation be opened into the matter of whether or not my account was breached from within your agency and whether or not my password was changed during that breach. I have no doubts that such an investigation would end favorably for me.

However, I expect that sending my appeal to this email address (which is listed on your agency's website as the correct email address to send appeals) will be sufficient.

If you have any questions about this appeal, please feel free to contact me at this email address. If a phone conversation is necessary, please provide a phone number where I can reach you directly.

Thank you for your consideration of this appeal.

Sincerely,

Erin Marie Miller

MuckRock News Dept.

411A Highland Ave

Somverville, Massachusetts 02144

via email: requests@muckrock.com

Dear CDC FOIA IT Team,

I am writing because my password to log into the CDC FOIA portal to submit an administrative appeal re: Freedom of Information Act Request #22-01035-FOIA, which had a deadline of Feb. 7, 2023 (tonight), was changed without my knowledge or permission for the second time. I was unable to access my portal account to file my appeal by its deadline tonight because of those unauthorized changes. This is the second time this has happened under this particular FOIA request; each time, it has resulted in my almost missing the appeal deadline. In this case, I may have missed it due to having to send the request to by email instead. My emailed appeal was initially sent to the appropriate email address at the agency, per the instructions on your website, prior to the deadline. However, it was rejected by your system. This is obviously unacceptable and potentially unlawful.

The email address to which I attempted to send the appeal (hhs.acfo@hhs.gov) appears to have automatically rejected my appeal email, which subsequently caused me to potentially miss my appeal deadline -- by mere seconds -- while frantically searching for an alternative email address to send it to.

I am requesting that your department look into this situation, as I believe it was a violation of my rights under the Freedom of Information Act for your email system to reject my appeal email -- especially considering that your agency's website specifically lists hhs.acfo@hhs.gov as the correct email to send FOIA appeals (see the blue box at the top of https://www.hhs.gov/foia/index.html; an archived version of the page is also available here: https://archive.ph/FDTLo).

Because my initial emailed appeal was automatically rejected and the portal was inaccessible to me, I was forced to send my appeal to FOIARequest@hhs.gov in hopes that it would still reach your agency in time. I may have missed the deadline by seconds -- which is also unacceptable. I am requesting that the agency honor my appeal due to the technical obstacles created solely by your agency. Please make sure to share this with the appropriate people at your agency and address the technical obstacles I experienced while attempting to file my appeal before the deadline.

Finally, I am also requesting that the CDC I.T. team conduct an investigation into why my emailed appeal was rejected by hhs.acfo@hhs.gov tonight causing me to potentially miss my appeal deadline; whether my FOIA portal account has been accessed internally by anyone at your agency; and whether my FOIA portal password was changed internally by someone at your agency. The email address from which I attempted to send my appeal tonight was requests@muckrock.com.

As this is not the first time this has happened under this request, I would love to get to the bottom of why my password keeps changing before an appeal deadline under this specific request.

Thank you,

Erin Marie Miller

Office of Government Information Services (OGIS),
National Archives and Records Administration
8601 Adelphi Road-OGIS, College Park, Maryland 20740-6001

Subject: CDC FOIA request #22-01035-FOIA - Technical obstacles

February 9, 2023

To Whom It May Concern:

I am writing to you regarding an administrative appeal I attempted to file on February 7, 2023 related to CDC FOIA request #22-01035-FOIA. Below is the background of the request and a description of the situation I am hoping to remedy by writing to your agency. I am asking that the administrative appeal I filed be honored by the agency, due to the fact that the agency directly created the obstacles that led to my missing the administrative appeal deadline by mere seconds.

On Feb. 24, 2022, I requested the following records and information from the Centers for Disease Control and Prevention (CDC):

1. Copies of all data, reports, presentations, records, agendas, and meeting minutes related to COVID-19 vaccines and pregnancy and/or pregnant people as part of the CDC's v-safe COVID-19 Vaccine Pregnancy Registry that were presented to, or included in, meetings of the Advisory Committee on Immunization Practices (ACIP), including but not limited to all relevant data collected and/or reported by Abt Associates (https:// www.abtassociates.com/projects/expanding-v-safe-covid-19-vaccine-pregnancy- registry-0) between Dec. 1, 2020 and the date this request is ultimately processed.

2. Copies of all data, studies, reports, documents, and records related to COVID-19 vaccines and pregnancy and/or pregnant people provided to the CDC's v-safe COVID-19 Vaccine Pregnancy Registry, including but not limited to data collected and/or reported by Abt Associates, between Dec. 1, 2020 and the date this request is ultimately processed.

3. Copies of all data, studies, reports, documents, and records provided to the CDC related to COVID-19 vaccines and pregnancy and/or pregnant people that were part of the CDC's three pregnancy monitoring programs including the v-safe COVID-19 Vaccine Pregnancy Registry program; the Vaccine Safety Datalink (VSD) program; and the Vaccine Adverse Event Reporting System (VAERS) between Dec. 1, 2020 and the date this request is ultimately processed. (For more clarity about the aforementioned monitoring programs, please view following the CDC website: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/monitoring-pregnant- people.html)

My initial request was partially denied by the agency. As to the portion that was granted, I was provided only with a limited list of links to public-facing government websites.

On July 20, 2022, I appealed the agency's partial denial.

On November 9, 2022, Roger Andoh partially approved my appeal and ordered the delivery of additional requested records under my request. According to Mr. Andoh's letter, some information was withheld under Exemption 5 (the letter specifically cited the deliberative process privilege) and Exemption 6. I was given the option to file an administrative appeal to argue against those exemptions.

On February 7, 2023 (the deadline to file an administrative appeal regarding the redactions and exemptions cited in the records resulting my initial appeal), I attempted to log into the CDC FOIA portal to submit my appeal. Upon entering my most recently used login credentials (as of Aug. 9, 2022), I was informed that my password was invalid. I was unable to access my account to file my appeal via the agency's portal due to this fact, despite having never changed my password. This is the second time my password has been changed without my knowledge or permission prior to submitting an appeal regarding this FOIA request. It's getting tiresome.

Because I could not access the portal using my credentials, I then attempted to file my appeal by email. I addressed my appeal to the appropriate email address listed on the agency's website, which is hhs.acfo@hhs.gov. For evidence that is the correct email address to send appeals, please refer to the blue box at the top of the agency's FOIA website, here: https://www.hhs.gov/foia/index.html. (If the blue box or email address is no longer visible, an archived version of the webpage is also available here: https://archive.ph/FDTLo; retrieved February 8, 2023).

After hitting "send," however, the HHS server immediately rejected my appeal email.

Out of options, I submitted the appeal to FOIARequest@hhs.gov instead, hoping that it would reach the right people in time. I may have missed the deadline by mere seconds due to technical obstacles that were created by the agency itself (i.e., a changed password and the automatic rejection of my initial email appeal, which was submitted before the deadline).

I believe my rights under the Freedom of Information Act have been violated by HHS in its automatic rejection of my email address and thus my emailed administrative appeal. It is the agency's direct fault that I was unable to file my administrative appeal by its deadline.

On February 8, 2023, I emailed the CDC I.T. Team requesting that this situation be investigated, including looking into whether my portal account was compromised; whether my password was changed; and whether the agency automatically rejected my administrative appeal email. I suspect that HHS/CDC may have added my email address to a spam list, making it impossible for me to file my appeal on time (in an earlier separate FOIA request, the FDA previously included my email address on a spam list, which made it impossible to communicate with them about the request; this was confirmed by MuckRock staff after investigating bounced emails; Sarah Kotler at the FDA can confirm this as well).

I am contacting your office to request that my administrative appeal be honored despite missing the deadline due to technical obstacles that were literally created by the agency itself. I am also asking that your agency look into this situation and why my appeal email, which was submitted before the deadline, was automatically rejected by the agency.

If you have any questions, please provide your contact information so that we can speak further.

Sincerely,

Erin Marie Miller
MuckRock News Dept.
411A Highland Ave
Somverville, Massachusetts 02144
via email: requests@muckrock.com

Office of Government Information Services (OGIS),
National Archives and Records Administration
8601 Adelphi Road-OGIS, College Park, Maryland 20740-6001

Subject: CDC FOIA request #22-01035-FOIA

February 10, 2023

To Whom It May Concern:

I am writing to follow up with your agency in response to your acknowledgement email regarding CDC FOIA request #22-01035-FOIA.

Per your request, I have attached copies of my FOIA request and its acknowledgement letter, the agency's initial response, my initial appeal, the agency's responses to my appeal, and finally my attempt at an administrative appeal related to exemptions cited by the agency and redactions that I believe may have been applied improperly to the requested records. Unfortunately, I do not believe my administrative appeal was received by the agency by its deadline due to technical obstacles that were created by the agency that prevented me from filing the appeal on time (I may have missed it by seconds).

In addition to the attached documents, below you can find a detailed description of the problems I am seeking your agency's assistance with.

An administrative appeal I attempted to file on February 7, 2023 related to CDC FOIA request #22-01035-FOIA was prevented from being submitted by its deadline due to technical obstacles I experienced. I believe these technical obstacles were created by the agency itself. Below is the background of the request and a description of the situation I am hoping to remedy by writing to your agency. I am asking that the administrative appeal I filed be honored by the agency, due to the fact that the agency directly created the obstacles that led to my missing the administrative appeal deadline by mere seconds.

On Feb. 24, 2022, I requested the following records and information from the Centers for Disease Control and Prevention (CDC):

1. Copies of all data, reports, presentations, records, agendas, and meeting minutes related to COVID-19 vaccines and pregnancy and/or pregnant people as part of the CDC's v-safe COVID-19 Vaccine Pregnancy Registry that were presented to, or included in, meetings of the Advisory Committee on Immunization Practices (ACIP), including but not limited to all relevant data collected and/or reported by Abt Associates (https:// www.abtassociates.com/projects/expanding-v-safe-covid-19-vaccine-pregnancy- registry-0) between Dec. 1, 2020 and the date this request is ultimately processed.

2. Copies of all data, studies, reports, documents, and records related to COVID-19 vaccines and pregnancy and/or pregnant people provided to the CDC's v-safe COVID-19 Vaccine Pregnancy Registry, including but not limited to data collected and/or reported by Abt Associates, between Dec. 1, 2020 and the date this request is ultimately processed.

3. Copies of all data, studies, reports, documents, and records provided to the CDC related to COVID-19 vaccines and pregnancy and/or pregnant people that were part of the CDC's three pregnancy monitoring programs including the v-safe COVID-19 Vaccine Pregnancy Registry program; the Vaccine Safety Datalink (VSD) program; and the Vaccine Adverse Event Reporting System (VAERS) between Dec. 1, 2020 and the date this request is ultimately processed. (For more clarity about the aforementioned monitoring programs, please view following the CDC website: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/monitoring-pregnant- people.html)

My initial request was partially denied by the agency. As to the portion that was granted, I was provided only with a limited list of links to public-facing government websites.

On July 20, 2022, I appealed the agency's partial denial.

On November 9, 2022, Roger Andoh partially approved my appeal and ordered the delivery of additional requested records under my request. According to Mr. Andoh's letter, some information was withheld under Exemption 5 (the letter specifically cited the deliberative process privilege) and Exemption 6. I was given the option to file an administrative appeal to argue against those exemptions.

On February 7, 2023 (the deadline to file an administrative appeal regarding the redactions and exemptions cited in the records resulting my initial appeal), I attempted to log into the CDC FOIA portal to submit my appeal. Upon entering my most recently used login credentials (as of Aug. 9, 2022), I was informed that my password was invalid. I was unable to access my account to file my appeal via the agency's portal due to this fact, despite having never changed my password. This is the second time my password has been changed without my knowledge or permission prior to submitting an appeal regarding this FOIA request. It's getting tiresome.

Because I could not access the portal using my credentials, I then attempted to file my appeal by email. I addressed my appeal to the appropriate email address listed on the agency's website, which is hhs.acfo@hhs.gov. For evidence that is the correct email address to send appeals, please refer to the blue box at the top of the agency's FOIA website, here: https://www.hhs.gov/foia/index.html. (If the blue box or email address is no longer visible, an archived version of the webpage is also available here: https://archive.ph/FDTLo; retrieved February 8, 2023).

After hitting "send," however, the HHS server immediately rejected my appeal email.

Out of options, I submitted the appeal to FOIARequest@hhs.gov instead, hoping that it would reach the right people in time. I may have missed the deadline by mere seconds due to technical obstacles that were created by the agency itself (i.e., a changed password and the automatic rejection of my initial email appeal, which was submitted before the deadline).

I believe my rights under the Freedom of Information Act have been violated by HHS in its automatic rejection of my email address and thus my emailed administrative appeal. It is the agency's direct fault that I was unable to file my administrative appeal by its deadline.

On February 8, 2023, I emailed the CDC I.T. Team requesting that this situation be investigated, including looking into whether my portal account was compromised; whether my password was changed; and whether the agency automatically rejected my administrative appeal email. I suspect that HHS/CDC may have added my email address to a spam list, making it impossible for me to file my appeal on time (in an earlier separate FOIA request, the FDA previously included my email address on a spam list, which made it impossible to communicate with them about the request; this was confirmed by MuckRock staff after investigating bounced emails; Sarah Kotler at the FDA can confirm this as well).

I am contacting your office to request that my administrative appeal be honored despite missing the deadline due to technical obstacles that were literally created by the agency itself. I am also asking that your agency look into this situation and why my appeal email, which was submitted before the deadline, was automatically rejected by the agency.

If you have any questions, please provide your contact information so that we can speak further.

Sincerely,

Erin Marie Miller
MuckRock News Dept.
411A Highland Ave
Somverville, Massachusetts 02144
via email: requests@muckrock.com

Office of Government Information Services (OGIS),
National Archives and Records Administration
8601 Adelphi Road-OGIS, College Park, Maryland 20740-6001
ogis@nara.gov

Subject: CDC FOIA request #22-01035-FOIA

February 10, 2023

To Whom It May Concern:

I am writing to follow up with your agency in response to your acknowledgement email regarding CDC FOIA request #22-01035-FOIA.

Per your request, I have attached copies of my FOIA request and its acknowledgement letter, the agency's initial response, my initial appeal, the agency's responses to my appeal, and finally my attempt at an administrative appeal related to exemptions cited by the agency and redactions that I believe may have been applied improperly to the requested records. Unfortunately, I do not believe my administrative appeal was received by the agency by its deadline due to technical obstacles that were created by the agency that prevented me from filing the appeal on time (I may have missed it by seconds).

In addition to the attached documents, below you can find a detailed description of the problems I am seeking your agency's assistance with.

An administrative appeal I attempted to file on February 7, 2023 related to CDC FOIA request #22-01035-FOIA was prevented from being submitted by its deadline due to technical obstacles I experienced. I believe these technical obstacles were created by the agency itself. Below is the background of the request and a description of the situation I am hoping to remedy by writing to your agency. I am asking that the administrative appeal I filed be honored by the agency, due to the fact that the agency directly created the obstacles that led to my missing the administrative appeal deadline by mere seconds.

On Feb. 24, 2022, I requested the following records and information from the Centers for Disease Control and Prevention (CDC):

1. Copies of all data, reports, presentations, records, agendas, and meeting minutes related to COVID-19 vaccines and pregnancy and/or pregnant people as part of the CDC's v-safe COVID-19 Vaccine Pregnancy Registry that were presented to, or included in, meetings of the Advisory Committee on Immunization Practices (ACIP), including but not limited to all relevant data collected and/or reported by Abt Associates (https:// www.abtassociates.com/projects/expanding-v-safe-covid-19-vaccine-pregnancy- registry-0) between Dec. 1, 2020 and the date this request is ultimately processed.

2. Copies of all data, studies, reports, documents, and records related to COVID-19 vaccines and pregnancy and/or pregnant people provided to the CDC's v-safe COVID-19 Vaccine Pregnancy Registry, including but not limited to data collected and/or reported by Abt Associates, between Dec. 1, 2020 and the date this request is ultimately processed.

3. Copies of all data, studies, reports, documents, and records provided to the CDC related to COVID-19 vaccines and pregnancy and/or pregnant people that were part of the CDC's three pregnancy monitoring programs including the v-safe COVID-19 Vaccine Pregnancy Registry program; the Vaccine Safety Datalink (VSD) program; and the Vaccine Adverse Event Reporting System (VAERS) between Dec. 1, 2020 and the date this request is ultimately processed. (For more clarity about the aforementioned monitoring programs, please view following the CDC website: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/monitoring-pregnant- people.html)

My initial request was partially denied by the agency. As to the portion that was granted, I was provided only with a limited list of links to public-facing government websites.

On July 20, 2022, I appealed the agency's partial denial.

On November 9, 2022, Roger Andoh partially approved my appeal and ordered the delivery of additional requested records under my request. According to Mr. Andoh's letter, some information was withheld under Exemption 5 (the letter specifically cited the deliberative process privilege) and Exemption 6. I was given the option to file an administrative appeal to argue against those exemptions.

On February 7, 2023 (the deadline to file an administrative appeal regarding the redactions and exemptions cited in the records resulting my initial appeal), I attempted to log into the CDC FOIA portal to submit my appeal. Upon entering my most recently used login credentials (as of Aug. 9, 2022), I was informed that my password was invalid. I was unable to access my account to file my appeal via the agency's portal due to this fact, despite having never changed my password. This is the second time my password has been changed without my knowledge or permission prior to submitting an appeal regarding this FOIA request. It's getting tiresome.

Because I could not access the portal using my credentials, I then attempted to file my appeal by email. I addressed my appeal to the appropriate email address listed on the agency's website, which is hhs.acfo@hhs.gov. For evidence that is the correct email address to send appeals, please refer to the blue box at the top of the agency's FOIA website, here: https://www.hhs.gov/foia/index.html. (If the blue box or email address is no longer visible, an archived version of the webpage is also available here: https://archive.ph/FDTLo; retrieved February 8, 2023).

After hitting "send," however, the HHS server immediately rejected my appeal email.

Out of options, I submitted the appeal to FOIARequest@hhs.gov instead, hoping that it would reach the right people in time. I may have missed the deadline by mere seconds due to technical obstacles that were created by the agency itself (i.e., a changed password and the automatic rejection of my initial email appeal, which was submitted before the deadline).

I believe my rights under the Freedom of Information Act have been violated by HHS in its automatic rejection of my email address and thus my emailed administrative appeal. It is the agency's direct fault that I was unable to file my administrative appeal by its deadline.

On February 8, 2023, I emailed the CDC I.T. Team requesting that this situation be investigated, including looking into whether my portal account was compromised; whether my password was changed; and whether the agency automatically rejected my administrative appeal email. I suspect that HHS/CDC may have added my email address to a spam list, making it impossible for me to file my appeal on time (in an earlier separate FOIA request, the FDA previously included my email address on a spam list, which made it impossible to communicate with them about the request; this was confirmed by MuckRock staff after investigating bounced emails; Sarah Kotler at the FDA can confirm this as well).

I am contacting your office to request that my administrative appeal be honored despite missing the deadline due to technical obstacles that were literally created by the agency itself. I am also asking that your agency look into this situation and why my appeal email, which was submitted before the deadline, was automatically rejected by the agency.

If you have any questions, please provide your contact information so that we can speak further.

Sincerely,

Erin Marie Miller
MuckRock News Dept.
411A Highland Ave
Somverville, Massachusetts 02144
via email: requests@muckrock.com

Thank you for the information. I will file a new request. If the CDC gives me problems like this on my future requests, I will utilize litigation rather than dealing with this nonsense again.

Also, your letter did not address the causes behind the technical issues I experienced. Please let me know if OGIS opened an investigation into my changed password, as I requested. That is what I need OGIS's help with the most.

My password has been changed twice on this request without my knowledge or authorization. My contact information for this request was also changed to my personal email address and former residential address without my knowledge. I obviously didn't make those changes, because it wouldn't make sense for me to change my mailing information to a former address where I can no longer receive documents. Because of that, I would like to know who is changing my password and other information at the CDC without my permission or knowledge.

These unauthorized changes to my CDC FOIA portal account pose an obvious security risk that could have implications for other requesters and could even put requesters in danger (for example, how anyone at the CDC got ahold of my former residential address in order to change it in the portal without my knowledge is a question I would like answered immediately by OGIS).

This needs to be resolved as soon as possible by your agency. Please let me know as soon as possible.

Best,

Erin Marie Miller