COVID-19 Vaccine Pregnancy Studies and Data (CDC)

Erin Marie Miller filed this request with the Centers for Disease Control and Prevention of the United States of America.

It is a clone of this request.

Tracking #

2022-00213-A-PHS

22-01035-FOIA

Est. Completion None
Status
Awaiting Appeal

Communications

From: Erin Marie Miller

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

From: Centers for Disease Control and Prevention

Dear Erin Miller,

Your request has been received by the Centers for Disease Control and Prevention / Agency for Toxic Substances and Disease Registry. The request has been assigned tracking # 22-01035-FOIA, please log into your account and review your submission.

The application address is https://foia.cdc.gov/.

Thank you,
Centers for Disease Control and Prevention / Agency for Toxic Substances and Disease Registry

From: Centers for Disease Control and Prevention

February 28, 2022

Request Number: 22-01035-FOIA

Dear Ms. Miller: This is regarding your Freedom of Information Act (FOIA) request of February 24, 2022, for 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.

Please see the attached letter.

Sincerely,
CDC/ATSDR FOIA Office
770-488-6399

From: Erin Marie 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.

From: Erin Marie Miller

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

From: Centers for Disease Control and Prevention

March 11, 2022

Request Number: 22-01035-FOIA

Dear Ms. Miller: This is regarding your Freedom of Information Act (FOIA) request of February 24, 2022, for 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.

Please see the attached letter.

Sincerely,
CDC/ATSDR FOIA Office
770-488-6399

From: Erin Marie 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

From: Erin Marie Miller

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

From: Erin Marie 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

From: Centers for Disease Control and Prevention

Ms. Miller,

Can you please contact our FOIA Public Liaison, Bruno Viana at 770-488-6246.

v/r,
Emerique

Emerique C. Magyar
Government Information Specialist
Freedom of Information Act (FOIA) Office
Centers for Disease Control and Prevention
E: emerique.magyar@cdc.hhs.gov
O: 770-488-6359

From: Erin Marie 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

From: Centers for Disease Control and Prevention

April 21, 2022

Request Number: 22-01035-FOIA

Dear Ms. Miller: This is regarding your Freedom of Information Act (FOIA) request of February 24, 2022, for 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.

Please see the attached letter.

Sincerely,
CDC/ATSDR FOIA Office
770-488-6399

From: Erin Marie Miller

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

From: Erin Marie Miller

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

From: Erin Marie Miller

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

From: Erin Marie Miller

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

From:

Thank you for contacting the Office of Government Information Services. This is an auto reply message.

If you requested our assistance with resolving a Freedom of Information Act (FOIA) dispute and have not done so already, please send us a brief description of your dispute and copies of your FOIA request, the agency’s response to your request, your appeal letter (if you filed an appeal), and the agency's response to your appeal (if received a response).

Due to the COVID-19 outbreak, at present we can only receive and respond to inquiries via email. Please send materials as PDF attachments to ogis@nara.gov. Please note that there is an increased demand for our services; for this reason, there may be a delay in our response. We apologize for any inconvenience and look forward to assisting you.

Sincerely,
The OGIS Staff
--
OFFICE OF GOVERNMENT INFORMATION SERVICES
National Archives and Records Administration
Email: ogis@nara.gov
Phone: 202-741-5770
Website: https://www.archives.gov/ogis
Blog: http://foia.blogs.archives.gov/

From: Erin Marie Miller

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

From: Erin Marie Miller

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

From: Centers for Disease Control and Prevention

Good afternoon.

As we said in our final response letter, if you are not satisfied with the response to this request, you may administratively appeal to the Deputy Agency Chief FOIA Officer, Office of the Assistant Secretary for Public Affairs, U.S. Department of Health and Human Services, via the online portal at https://requests.publiclink.hhs.gov/App/Index.aspx.

Bruno Viana
Deputy Director
Freedom of Information Act (FOIA)
Office of the Chief Operating Officer (OCOO)

From: Erin Marie Miller

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

From: Centers for Disease Control and Prevention

I’ve forwarded your message to the HHS FOIA Office to ensure they’ve received it.

Bruno Viana
Deputy Director
Freedom of Information Act (FOIA)
Office of the Chief Operating Officer (OCOO)

From: Centers for Disease Control and Prevention

Dear Ms. Miller: Please see the attached acknowledgement letter for information concerning your FOIA matter. The tracking number for your appeal of CDC request 22-01035-FOIA is 2022-00213-A-PHS. For status updates or other inquiries, please contact me via email. Sincerely,
Jonathan Nelson

From: Centers for Disease Control and Prevention

Dear Erin Miller,

Please see OGIS's response to this submission (22-3317), attached to this
email.

Sincerely,
The OGIS Staff

On Tuesday, July 19, 2022 at 2:20:26 PM UTC-4
requests@muckrock.com wrote:

>
> Centers for Disease Control and Prevention
> FOIA Office
> 1600 Clifton Road
> Atlanta, GA 30329
>
> July 19, 2022
>
> This is a follow up to request number 22-01035-FOIA:
>
> 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
>
> View request history, upload responsive documents, and report problems
> here:
>
> https://www.muckrock.com/
>
> If prompted for a passcode, please enter:
> ••••••••
>
> Filed via MuckRock.com
> E-mail (Preferred): requests@muckrock.com
>
> PLEASE NOTE OUR NEW ADDRESS
> For mailed responses, please address (see note):
> MuckRock News
> DEPT MR 122531
> 263 Huntington Ave
> Boston, MA 02115
>
> PLEASE NOTE: This request is not filed by a MuckRock staff member, but is
> being sent through MuckRock by the above in order to better track, share,
> and manage public records requests. Also note that improperly addressed
> (i.e., with the requester's name rather than "MuckRock News" and the
> department number) requests might be returned as undeliverable.
>
> ---
>
> On July 19, 2022:
> Subject: RE: Freedom of Information Act Request #22-01035-FOIA
> 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
> ---
>
> On April 21, 2022:
> Subject: Your CDC FOIA Request #22-01035-FOIA
> April 21, 2022
>
> Request Number: 22-01035-FOIA
>
> Dear Ms. Miller: This is regarding your Freedom of Information Act (FOIA)
> request of February 24, 2022, for 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.
>
> Please see the attached letter.
>
> Sincerely,
> CDC/ATSDR FOIA Office
> 770-488-6399 <(770)%20488-6399>
> ---
>
> On April 1, 2022:
> Subject: RE: Freedom of Information Act Request #22-01035-FOIA
> 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
> ---
>
> On March 16, 2022:
> Subject: CDC FOIA Request 22-01035
> Ms. Miller,
>
> Can you please contact our FOIA Public Liaison, Bruno Viana at
> 770-488-6246 <(770)%20488-6246>.
>
> v/r,
> Emerique
>
> Emerique C. Magyar
> Government Information Specialist
> Freedom of Information Act (FOIA) Office
> Centers for Disease Control and Prevention
> E: emerique.magyar@cdc.hhs.gov
> O: 770-488-6359 <(770)%20488-6359>
> ---
>
> On March 14, 2022:
> Subject: RE: Freedom of Information Act Request #22-01035-FOIA
> 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
> ---
>
> On Jan. 3, 2022:
> Subject: Freedom of Information Act Request: 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
>
> View request history, upload responsive documents, and report problems
> here:
>
> https://www.muckrock.com/
>
> If prompted for a passcode, please enter:
> ••••••••
>
> Filed via MuckRock.com
> E-mail (Preferred): requests@muckrock.com
>
> PLEASE NOTE OUR NEW ADDRESS
> For mailed responses, please address (see note):
> MuckRock News
> DEPT MR 122531
> 263 Huntington Ave
> Boston, MA 02115
>
> PLEASE NOTE: This request is not filed by a MuckRock staff member, but is
> being sent through MuckRock by the above in order to better track, share,
> and manage public records requests. Also note that improperly addressed
> (i.e., with the requester's name rather than "MuckRock News" and the
> department number) requests might be returned as undeliverable.
>
>

Files

pages

Close