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EXHIBIT D
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IN T
HE UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF TEXAS
PUBLIC HEALTH AND MEDICAL
PROFESSIONALS FOR TRANSPARENCY,
Plaintiff,
-against-
FOOD AND DRUG ADMINISTRATION,
Defendant.Civil Action No. 4:21-cv-01058-P
DE
CLARATION OF SARAH B. KOTLER
I, Sarah B. Kotler, declare as follows:
1. I am the Director of the Division of Freedom of Information (DFOI), Office of the
Executive Secretariat, Office of the Commissioner, Food and Drug Administration (FDA),United
States Department of Health and Human Services (HHS), in Rockville, Maryland.
2. I have held the position of Director of DFOI since January 2015. Prior tobecoming
Director, I served as Acting Director of DFOI from November through December 2014, after the
former Director of DFOI retired. I previously served as DFOI’s Deputy Director and Denial &
Appeals Officer from September 2013 through October 2014; and as Denials & Appeals Officer
from March 2007 through August 2013.
3. As both Deputy Director and Director, I have had supervisory authority overDFOI,
which serves as FDA’s official point of receipt for all requests for records under the Freedom of
Information Act (“FOIA”), 5 U.S.C. § 552. See21 C.F.R. § 20.40. In addition, DFOI is
responsible for FDA’s FOIA reporting to HHS and the U.S. Department of Justice, consulting with
other federal agencies regarding FOIA requests, agency-wide FOIA training, and expedited
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-2-processing, among other functions. DFOI processes about 25% of all FOIA requests received by
FDA; the other 75% are processed by the FOIA reviewers within FDA’s other components.
4. As part of my duties, I have been coordinating FDA’s processing of FOIA requests
that relate to the novel coronavirus known as SARS-CoV-2, also known by the disease it causes,
COVID-19. Due to the nature of my official duties, I am familiar with the procedures followed
by FDA in responding to requests for information from its files pursuant to provisions of the FOIA,
5 U.S.C. § 552, among others. I am aware of the workload obligations of the various offices that
process FOIA requests across the agency.
5. The statements contained in this declaration are based upon my personal
knowledge, upon information provided to be in my official capacity, and upon conclusions I
reached based on that knowledge or information.
6. The purpose of this declaration is to provide an overview of FDA’s procedure for
handling FOIA requests and its capabilities in processing Plaintiff’s FOIA request in particular.
This declaration also documents the agency’s basis for denying Plaintiff’s request for expedited
processing.
7. As explained below, Plaintiff’s Request did not satisfy the standard for expedited
processing because it did not establish an urgent need to inform the public about federal
government activities. Further, Plaintiff’s suggestion that FDA should be able to reallocate
resources to respond to Plaintiff’s FOIA request is not feasible and could violate FDA’s
obligations with respect to other FOIA requesters. Since the beginning of the COVID-19
pandemic, FDA has experienced a sudden surge of incoming FOIA requests, an increase in the
complexity of those requests, and an uptick in the amount of FOIA litigation it faces. These
factors, when combined with the Agency’s existing FOIA and non-FOIA workload, prevent
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-3-other FDA components from being available to assist the Center for Biologics Evaluation and
Research (“CBER”) to process Plaintiff’s Request without diverting significant resources away
from the processing of other FOIA requests that are also in litigation, requests that are ahead of
Plaintiff’s, as well as other non-FOIA record requests. Such diversion would adversely impact
the Agency’s ability to meet stipulated document processing deadlines and prejudice other
pending requests.
FDA’S GENERAL PROCEDURE FOR INCOMING FOIA REQUESTS
8. Under FDA’s regulations, DFOI is the office responsible for FDA’s compliance
with FOIA. See 21 C.F.R. §§ 20.30, 20.40. When DFOI receives an electronic FOIA request, it
generates a control number that begins with four digits reflecting the calendar year in which the
request was received, followed by the number of FOIA requests received by DFOI to date in that
particular calendar year. For example, Plaintiff’s request has the control number “2021-5683”
because it is the 5,683rd FOIA request received by FDA in calendar year 2021.
9. FDA provides expedited processing of a request for records when the requester
demonstrates a compelling need and in other cases determined by the agency. See5 U.S.C.
§552(a)(6)(E). A compelling need exists when: (1)A failure to obtain requested records on an
expedited basis could reasonably be expected to pose an imminent threat to the life or physical
safety of an individual; or(2) With respect to a request made by a person primarily engaged in
disseminating information, there is a demonstrated urgency to inform the public concerning actual
or alleged Federal Government activity. Id. DFOI reviews requests for expedited processing and
sends a letter to the requester documenting FDA’s determination as to whether expedited
processing has been granted or denied. In accordance with 21 C.F.R. § 20.44, requests that have
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-4-been granted expedited processin g are processed a s soon as practicable, on a first-in, first-out basis
based on the date of receipt.
10. Because of FDA’s size and the large number of records generated during the course
of agency business, and the different components within FDA, the agency’s FOIA program is
decentralized. After a FOIA request is received and logged by DFOI, the request is assigned to
the FDA components reasonably likely to possess responsive records, which then process the
request. FOIA reviewers within each assigned component process potentially responsive records
and determine whether they should be released in full, redacted in part, or withheld in their entirety
under any applicable FOIA exemption or other statutory or regulatory provision.
FDA’S PUBLICATION OF INFORMATION RELATED TO COMIRNATY VACCINE
11. In an effort to inform the public about its work related to COVID-19, FDA has
made an abundance of information available on its website – both about the Comirnaty vaccine
specifically and the agency’s COVID-19 response generally. The homepage of FDA’s website
prominently features a link to information about the “FDA COVID-19 Response.” FDA,
https://www.fda.gov/ . Clicking on that link takes the user to a page with numerous links to
additional information about FDA’s response. The linked webpages provide information about
COVID-19 vaccines, emergency use authorizations, personal protective equipment, FDA guidance
documents, Frequently Asked Questions, and resources for health professionals, among many
other things. FDA, Coronavirus Disease 2019 (COVID-19), https://www.fda.gov/emergency-
preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-
covid-19.
12. From that page, the user can access the “Comirnaty and Pfizer-BioNTech COVID-
19 Vaccine” page. FDA, Comirnaty and Pfizer-BioNTech COVID-19 Vaccine,
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-5-https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid- 19/
comirnaty-and-pfizer-biontech-covid-19-vaccine#comirnaty (printout attached as Exhibit A to this
declaration). That page contains links to a host of important information about the Comirnaty
vaccine, including Frequently Asked Questions for Comirnaty, information sheets for healthcare
providers, regulatory information, media materials and webcasts, advisory committee information,
and even links to video recordings of virtual meetings of FDA’s advisory committee (the Vaccines
and Related Biological Products Advisory Committee). Id. The webpage even includes
translations of certain information in multiple languages, including Spanish, Chinese, Korean,
Russian, among many others. Id.
13. Clicking on the “Comirnaty Information” link on that page brings the user to yet
another page with more information specific to the Comirnaty vaccine. FDA, Comirnaty,
https://www.fda.gov/vaccines-blood-biologics/comirnaty . This page contains the “Action
Package” for Comirnaty, required by the Food and Drug Administration Amendments Act of 2007
to be posted within 30 days of approval. The agency expects the Action Package to be of interest
and most useful to the public in understanding its approval decision. It provides access to the
package insert, the Summary Basis for Regulatory Action, the Approval Letter, FDA decision
memoranda, and approval history. Many of these records were posted shortly after the Comirnaty
biological license application (“BLA”) was approved on August 23, 2021. For example, FDA
posted its “Summary Basis for Regulatory Action” the day after the Comirnaty BLA was
approved; it posted the Action Package, including FDA discipline review memos such as clinical,
statistical and toxicology reviews, approval letter, and package insert, within 25 days of approval.
FDA’s Comirnaty page currently contains links to approximately 700 pages of Action Package
records related to the Comirnaty vaccine licensure. Id. These records often contain summaries of
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-6-the information and data submitted by Pfizer and BioNTech that FDA reviewed and assessed, as
well as FDA’s assessment, that support FDA’s decision to licensethe Comirnaty vaccine. As just
one example of the types of information available, there is a 107-page August 23, 2021, “BLA
Clinical Review Memorandum.” That memorandum includes sections entitled, “Clinical and
Regulatory Background,” “Submission Quality and Good Clinical Practices,” Significant
Efficacy/Safety Issues Related to Other Review Disciplines,” Discussion of Individual
Studies/Clinical Trials,” and the FDA reviewers’ conclusions and recommendations based on the
data reviewed. See id. (under link to “Approval History, Letters, Reviews, and Related Documents
– COMIRNATY”).
14. FDA continues to regularly update these websites to provide the most current and
relevant information about COVID-19 to the public as soon as possible.
FDA’S PROCESSING OF PLAINTIFF’S REQUEST
15. On August 27, 2021, Plaintiff submitted to FDA a request (“Plaintiff’s Request”)
seeking, “[a]ll data and information for the Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e)
with the exception of publicly available reports on the Vaccine Adverse Events Reporting
System.” Plaintiff’s Complaint, ECF No. 1-1, Ex. A.1 at 1. FDA assigned Plaintiff’s Request the
control number 2021-5683. Plaintiff’s Request is extremely broad, calling for the agency to review
the entire BLA for the Pfizer-BioNTech Comirnaty COVID-19 vaccine to determine which
information is available for release to the public under 21 C.F.R. § 601.51(e).
16. I assigned Plaintiff’s Request to CBER for processing because it sought
information – a BLA – in CBER’s custody. CBER’s processing of Plaintiff’s Request is described
in more detail in the December 6, 2021, Declaration of Suzanne Burk (“Burk Decl.”), ECF No. 23
at Ex. A. As described in that declaration, CBER expended great efforts to negotiate the scope of
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-7-Plaintiff’s request—and in particular, to supply Plaintiff with information it could use to narrow
its Request to a more manageable universe of documents, which the FDA could, correspondingly,
process more quickly—as well as a production schedule for Plaintiff’s Request. However, to date,
the parties have not been able to agree to either any modification of the scope of Plaintiff’s request,
or to a production schedule. See Burk Decl. ¶¶ 26-27.
REQUEST FOR EXPEDITED PROCESSING
17.Plaintiff’s Request included a request for expedited processing. I carefully
reviewed that request for expedited processing, and I determined that Plaintiff did not
demonstrate a compelling need under 5 U.S.C. § 552(a)(6)(E), in substantial part because of the
large amounts of information that have already been made available to the public about the
Comirnaty vaccine and related FDA activities. A compelling need exists when: (1) A failure
to obtain requested records on an expedited basis could reasonably be expected to pose an
imminent threat to the life or physical safety of an individual; or (2) With respect to a request
made by a person primarily engaged in disseminating information, there is a demonstrated
urgency to inform the public concerning actual or alleged Federal Government activity. Id.
Department of Justice guidance advises agencies to “carefully” assess the merits of expedited
processing requests “[b]ecause the granting of a request for expedition necessarily works to the
direct disadvantage of other FOIA requesters.” U.S. Department of Justice, FOIA Update: OIP
Guidance: When to Expedite FOIA Requests, https://www.justice.gov/oip/blog/foia-
update-oip-guidance-when-expedite-foia-requests .
18.Plaintiff’s Request did not contain any basis to conclude that a failure to obtain
records on an expedited basis would pose a threat to any individual. As a result, I concluded that
Plaintiff had not satisfied the first criterion for expedited processing.
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-8-19.Plaintiff’s Request did assert that Plaintiff was an organization primarily engaged
in disseminating information and explained why it believed it was urgent to inform the public
about government activities related to the Comirnaty vaccine. Plaintiff first explained that it
believed that there was an “ongoing, public national debate” about FDA’s decision to license the
Comirnaty vaccine, quoting numerous individuals, including a number of Plaintiff’s members,
with varying opinions about the vaccine. Second, Plaintiff noted that many organizations had
mandated COVID-19 vaccines for their members or employees.
20.After considering Plaintiff’s explanation, I determined that Plaintiff had not
established that it had demonstrated urgency to inform the public concerning actual or alleged
Federal Government activity, largely because there is a significant amount of information already
available to Plaintiff and the public concerning FDA’s activities surrounding the Comirnaty
vaccine. As discussed above (see, supra, ¶¶ 11-14), FDA is posting a significant amount of
information related to the Comirnaty vaccine on its website on an ongoing basis. The documents
posted by the agency currently contain, among other things, FDA review memoranda, which
include summaries of safety and effectiveness data, as well as FDA reviewers’ analyses of them.
FDA’s sister agency, the Centers for Disease Control and Prevention (“CDC”) also maintains a
website with additional information about Comirnaty ingredients, summaries of safety data, and
clinical trial evidence about efficacy. CDC, Pfizer-BioNTech COVID-19 Vaccine (also known as
COMIRNATY) Overview and Safety, https://www.cdc.gov/coronavirus/2019-
ncov/vaccines/different-vaccines/Pfizer-BioNTech.html . CDC also provides the public with
access to its WONDER database, which contains adverse event report data collected through the
U.S. Vaccine Adverse Event Reporting System. CDC, How to Access VAERS Data through
VAERS WONDER System, https://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/
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-9-vaers/access-VAERS-data.html . As a result, the public has access to a large amount of information
about the vaccine and government actions related to the vaccine’s review and approval.
21.The fact that people may have differing opinions about a certain FDA-regulated
product does not create “urgency” within the meaning of the expedited processing standard for the
agency to produce an entire BLA – especially in light of the amount of information published on
FDA’s website. Nor does the fact that certain individuals may be administered a certain product.
FDA approves medical products regularly in the course of agency business. It is not unheard of
for those approvals to be the subject of controversy, and there are almost always people who are
administered the products shortly after approval. Such a situation cannot be deemed to create an
urgent need for the agency to expedite its review and processing of the hundreds of thousands of
pages of records, especially when the agency routinely publishes summaries of safety and efficacy
information on its website (as it did here). If Plaintiff’s view became the standard, a great number
of FDA’s FOIA requests would qualify for expedited processing, and requesters with non-
expedited requests would have their wait times extended – possibly significantly. Thus, Plaintiff’s
claim that its request would fulfill an urgent demand is not supported, and I denied its request for
expedited processing.
ALLOCATION OF AGENCY RESOURCES
22. I understand that Plaintiff has suggested that FDA should reallocate resources from
other agency functions to help process Plaintiff’s Request. This suggestion is not feasible, or even
beneficial, for a number of reasons. First, performing disclosure reviews is a specialized skill that
requires training and expertise that the vast majority of FDA staff does not have. It is not
reasonable to expect that a microbiologist who performs laboratory assays, a pharmacist who
reviews drug applications, a badging office employee who issues credentials, or a mail room clerk
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-10-who organizes mail can simply begin performing disclosure review without significant training.
Moreover, it would be contrary to FDA’s public health mission to pull staff off reviewing cancer
treatment applications or building counterfeit medication investigations to have them conduct
work for which they are untrained and unqualified. Second, as Director of DFOI, I do not have
authority to order FDA staff from other program offices – many of whom are actively involved in
the agency’s extensive efforts to respond to the COVID-19 pandemic – to support the agency’s
disclosure functions. Further, even if the agency did suddenly allocate significant new monetary
resources to hire new disclosure staff, it would take substantial time to recruit and hire new staff,
bring them on board, and provide them with the necessary training to become competent to perform
disclosure reviews. FDA estimates that it takes approximately two years to fully train a new
disclosure reviewer. In the meantime, experienced reviewers would be needed to supervise and
review their work – thus decreasing the amount of time that experienced reviewers can spend
reviewing records. As a result, it is not reasonable to expect that FDA will be able to respond to
Plaintiff’s Request more quickly by allocating non-disclosure resources to processing it. In fact,
to do so would significantly impede FDA’s public safety role.
23. And, as discussed in the following section, it is not feasible for the agency to
reallocate its existing disclosure resources to work on Plaintiff’s Request because the agency’s
disclosure staff is already over-extended by existing disclosure obligations.
PROCESSING WORKLOAD OF DISCLOSURE OFFICES OUTSIDE OF CBER
24. As an initial matter, the disclosure office of each FDA component has its own
specialized responsibilities and expertise. Thus, although all disclosure staff will be familiar with
general principles of FOIA, staff from different centers will be trained to review information
regularly generated within that center. For example, CBER reviewers are familiar with the types
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-11- of information regularly contained in BLAs and are trained to identify information that may be
exempt from disclosure in those types of files; CBER reviewers would not be familiar with the
types of records commonly processed by other parts of the agency, such as premarket tobacco
product applications or food additive petitions. The converse is also true; reviewers in FDA’s
Center for Food Safety and Applied Nutrition (“CFSAN”) are familiar with records regularly
generated within CFSAN, but would not have the same expertise as a CBER reviewer when
looking at a BLA. Thus, even disclosure staff within the agency should not be considered
interchangeable.
25. Further, on March 13, 2020, the Presidentdeclared a national emergency due tothe
ongoing COVID-19 pandemic. Since the beginning of this emergency, FDA has been flooded
with FOIA requests related to the pandemic.
26. Specifically, in the last fiscal year, FDA received approximately 8,529 FOIA
requests, many of which are directly related to COVID-19. Of these, an extremely high 99requests
(1.16%) have been granted expedited processing. Historically, FDA has had fewer than five
expedited requests at any one time, and often fewer than five. For example, in 2019, FDA granted
expedited process for only 0.017% of requests received. In short, the number of FOIA requests
meriting expedited processing has grown exponentially since the beginning of the COVID-19
pandemic.
27. Further complicating matters, many of the more recent FOIA requests are more
complex and are expected to take longer to process than typical FOIA requests received prior to
the beginning of the COVID-19 pandemic. Many requests for information related to COVID-19
require collaboration among federal agencies because they involve records (such as emails) that
may have originated in other agencies. Department of Justice guidance advises federal agencies
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-12- to consult with the originating agency for disclosure determinations. U.S. Department of Justice,
FOIA Update: OIP Guidance: Referral and Consultation Procedures,
https://www.justice.gov/oip/blog/foia-update-oip-guidance-referral-and-consultation-procedures .
As a result, FDA regularly collaborates with other federal agencies, such as CDC, the National
Institutes of Health, and the Department of Health and Human Services, about records responsive
to requests. These consultations add both time and complication to the process for responding to
FOIA requests.
28. Coupled with the unprecedented number of FOIA requests that merit expedited
processing and the increased complexity of requests, FDA recently experienced a significant
increase in FOIA litigation. Between calendar years 2017 and 2019, the number of FOIA lawsuits
filed against the Agency grew by approximately 70%; between calendar years 2018 and 2020, the
number of FOIA lawsuits filed against FDA grew by approximately 200%. Although the number
of lawsuits so far in 2021 has decreased from 2020 levels, FDA has been the subject of 11 lawsuits
in 2021, which is an increase of 83% from 2018 level. Currently, FDA is involved in
approximately 34 active FOIA litigations, with nine matters involving COVID-19 records.
29. At the review and redaction phase, certainFDA components have had to shift some
of their FOIA reviewers from responding to FOIA requests in the normal course to almost
exclusively processing FOIA requests in litigation. This diversion of staff resources to respond to
ever increasing litigation and impending court deadlines means that fewer initial FOIA requests
are beingprocessed,and at a slower pace, which is causingeven more litigation.
30. In addition to FOIA, FDA also has numerous other document processing
obligations, including those arising from subpoenas;non-FOIA litigations;oversight requests from
Congress; requests and domestic and foreign regulatory bodies; and other statutory disclosure
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-13- mandates. In some agency offices, the same staff that handles FOIA requests also handles these
other disclosure projects as they rely on similar disclosure skills. As a result, it would not be
feasible for FDA to shift resources from other disclosure offices to help CBER process Plaintiff’s
Request. In the following paragraphs, I discuss the current workload of various FDA components.1
Center for Drug Evaluation and Research (“CDER”)
31. As of November 30, 2021, CDER is responsible for processing 855 pending FOIA
requests. This is a significant increase in pending requests compared to past years, partly due to
increased burden resulting from work related to COVID-19 FOIA requests and other disclosure
obligations. CDER is responsible for processing at least 170 FOIA requests related to COVID-
19. The following chart illustrates the increase in the length of CDER’s FOIA queue as of
November 30 of each calendar year.
Figure 1: Pending FOIA Requests in CDER as of November 30 of each year from 2018 to 2021.
1 I do not include a discussion of CBER’s workload because that information was included in the December 6, 2021,
Burk Declaration. ECF No. 23, Ex. A. 0100200300400500600700800900
2017 2018 2019 2020 2021 2022CDER-Pending FOIA Requests as of Nov. 30 of
Each Year
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-14-32. In addition to processing FOIA requests, CDER is also responsible for processing
other document requests made by Congress; theU.S. Government Accountability Office;foreign,
state, and local governments; and other federal agencies. Although these requests are not made
under FOIA and are not processed in CDER’s FOIA tracks, they are processed by CDER’s FOIA
reviewers because of the similar nature of the work to FOIA processing and the need for
consistency in reviewing and redacting responses to information requests. Since 2019, these
responses have required the attention of up to four employees. Because some of these employees
were pulled from other tasks to work on these matters, there was a corresponding decrease in
reviewers’ time available to respond to FOIA requests. In recent years, CDER has produced tens
of thousands of pages in response to requests from foreign regulatory authorities for documents
regarding FDA inspections of foreign drug manufacturers, and in response to requests from the
Department of Justice related to its investigations of pharmaceutical companies. CDER also has
other statutory disclosure obligations under the Food and Drug Administration Amendments Act
of 2007, which requires that New Molecular/Biological Entity (NM/BE) action packages be
published on CDER’s web page within 30 days of approval. In 2019, CDER reviewed and
redacted 46 NM/BE action packages, and in 2020, CDER reviewed and redacted 20 NM/BE action
packages, each of which typically contains thousands of pages.
Office of the Commissioner (“OC”)
33. As of November 30, 2021, OC has 435 pending FOIA requests. At this time, OC
has 1 full time employee working on FOIA requests. Since the fall of 2020, OC has brought in
detailees for 90 to 120 day periods to assist the FOIA FTE. Despite my other duties, including
management of my division, I have been assisting with FOIA review for COVID requests in OC,
as well as keeping the non-COVID OC FOIA workload moving. OC is currently involved in 8
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-15-activelitigation matters. As with CDER, this represents a significant increase in pending requests
compared to past years. The following chart illustrates the increase in the length of OC’s FOIA
queue as of November 30 of each calendar year.
Figure 2: Pending FOIA Requests in OC as of November 30 of each year from 2018 to 2021.
Center for Devices and Radiological Health (“CDRH”)
34. Currently, CDRH has 2,010 pending FOIA requests, approximately 124 of which
are related to COVID-19. The following chart illustrates the length of CDRH’s FOIA queue as of
November 30 of each calendar year. Although CDRH’s queue has not changed as dramatically as
other FDA components, it remains the longest queue in the agency.050100150200250300350400450500
2017 2018 2019 2020 2021 2022OC-Pending FOIA Requests as of Nov. 30 of Each
Year
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-16-Figure 3: Pending FOIA Requests in CDRH as of November 30 of each year from 2018 to 2021.
35. Other than FOIA requests, CDRH’s FOIA Office is also responsible for responding
to subpoenas and non-FOIA record requests made by Congress; foreign, state, and local
governments; and other federal agencies. Since 2015, these responses have required the attention
of up to 22 employees. Because some of these employees were pulled from other tasks to work
on these matters, there was a corresponding decrease in reviewers’ time available to respond to
FOIA requests. Within the past four years alone, CDRH produced tens of thousands of pages of
documents in response to requests from other federal agencies related to their investigation of
medical device companies. Furthermore, since 2018, CDRH has responded to numerous federal
subpoenas, with quick turnarounds for productions that have required CDRH reviewers to stop
processing FOIA requests to respond to these subpoenas. Specifically, two of the subpoenas have
yielded over hundreds of thousands of pages each.
Other FDA Components
36. The components highlighted above are not outliers. Other FDA components have
significant queues, some of which have grown recently as a result of increased workload related 05001000150020002500
2017 2018 2019 2020 2021 2022CDRH-Pending FOIA Requests as of Nov. 30 of
Each Year
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-17-to COVID-19. For example, the Office of Regulatory Affairs alone has devoted over 1,500 hours
to responding to COVID-19 FOIA requests and has seen its number of pending requests increase
from 28 in November 2018 to 91 in November 2021. Although largely unrelated to the COVID-
19 pandemic, FDA’s Center for Veterinary Medicine has seen its number of pending requests jump
from 102 in November 2018 to 318 in November 2021, due to an increase of FOIA requests
unrelated to COVID-19.
37. FDA’s Center for Food Safety and Applied Nutrition and Center for Tobacco
Products have not encountered the same influx of COVID-19 FOIA requests, so their FOIA queues
have remained fairly steady in the 2018-2021 timeframe. But they continue to maintain queues in
the 65-75 range, so their resources are fully consumed with their standard responsibilities, which
also include non-FOIA disclosure projects, such as Privacy Act requests.
38. Based on all of the information above, none of FDA’s other disclosure offices are
able to assume the burden of taking on a significant role in the review of CBER records responsive
to Plaintiff’s Request without compromising their ability to keep up with their own disclosure
review responsibilities, especially considering that these staff are not specifically trained to review
the records at issue in this case.
EFFORTS TO REDUCE BACKLOGS
39. FDA’s various FOIA offices have taken numerous steps to reduce backlogs and
improve processing time. Specifically, FDA’s FOIA offices are recruiting and hiring new
employees where funding allows; proactively posting online frequently requested documents to
reduce the need for new FOIA requests; cross-training employees in complex disclosure matters
to assist with complex track requests; evaluating requests daily in order to shift them to
experienced redactors as needed; and, where possible, proactively contacting FOIA requesters to
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-18-negotiate the scope of requests to in order to produce documents quickly. In particular, since
August 2020, CDER has brought onsixnew employees to assist with FOIA processing. Similarly,
CDRH completed a business process improvement review of its FOIA program in October 2019,
which included identifying hiring needs; updating workflows, processes, and procedures; training
reviewers; and additional tracking of FOIA requests. Between September and December 2019,
CDRH acquired a multi-year contract that currently providesseven contractors to assist in reducing
FOIA backlogs and hired additional full-time reviewers to process FOIA requests and other
disclosure tasks. Unfortunately, this review was conducted before the onslaught of COVID-related
FOIA requests were submitted, and therefore the process changes have not achieved results as
quickly as expected.
CONCLUSION
40. In sum, FDA is committed to transparency in all aspects of its work, especially its
response to the COVID-19 pandemic. The agency has taken proactive steps to provide an abundant
amount of information to the public about the Comirnaty vaccine as soon as possible. That
information is available on FDA’s website, which is being updated regularly. FDA has also taken
reasonable steps to respond to Plaintiff’s Request, as discussed in greater detail in the Burk
Declaration. But Plaintiff’s Request does not satisfy the statutory standard for granting expedited
processing. Further, given the limited number of FDA staff available to perform disclosure
reviews and the heavy workload FDA’s disclosure offices are facing, it would be unduly
burdensome for FDA to reallocate resources from agency components other than CBER to process
Plaintiff’s Request. If required to do so, FDA’s ability to perform its other agency functions,
including responding to other document requests, could be impaired.
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-19-Pursuant to 28 U.S.C. §1746, I declare under the penalty of perjury that the foregoing is
true and correct.
Executed on December 13, 2021, in Rockville, Maryland.
_____________________
SARAH B. KOTLER
Director of Division of Freedom of Information
Office of the Executive Secretariat
Food and Drug Administration
U.S. Department of Health and Human Services
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KOTLER DECLARTION
EXHIBIT A
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Comirnaty and Pfizer-BioNTech COVID-19 Vaccine
November 19, 2021: FDA expands eligibility for COVID-19 vaccine boos ters to vaccine reci pients 18 and older after completion of primary
vaccination. Read more... (/news-events/pre ss-announcements/coronavirus-covid-19-updat e-fda-expands-eligibility-covid-19-vaccine -
boosters)
October 29, 2021: FDA expands emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine to include children 5 through 11
years of age. Read the press release (/news-events/press-announcements/fda- authorizes-pfizer-bi ontech-covid-19-vaccine-emergency-use-
children-5-through-11-years-age) and watch the press conference (https://y outu.be/WLbGnS-kqTY ) (http://www.fda.gov/about-
fda/website-policies/website-disclaimer).
Comirnaty Information
Pfizer-BioNTech Fact Sheets
Pfizer-BioNTech Fact Sheet Translations
Información sobre las vacunas para el COVID-19 (https://www.fda.g ov/about-fda/fda-en-espanol/info rmacion-sobre-la s-vacunas-para- el-covid-19)
On August 23, 2021, FDA announced the first approval of a COVID-19 vaccine. The vacci ne has been known as the
Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 in
individuals 16 years of age and older.
Pfizer-BioNTech COVID-19 Vaccine is authorized for emergency use and is available under the EUA as a two-dose
primary series in individuals 5 years of age and older, as a third primary series dose for individuals 12 years of age
and older who have been determined to have certain kinds of immunocompromi se, and as a single booster dose in
people 18 years of age and older.
The Pfizer-BioNTech COVID-19 Vaccine is also authorized for use as a hetero logous (or “mix and match”) booster
dose following completion of primary vaccination with a different available COVID-19 vaccine. For example,
Moderna and Janssen COVID-19 vaccine re cipients 18 years of age and older ma y receive a single booster dose of
the Pfizer-BioNTech COVID-19 Vaccine.On November 17, 2021, CDC, in consultation with FDA, issued emergency use instructions
(https://www.cdc.gov/vaccines/covid-19/e ui/index.html) to provide information about the use of the vaccine as an
additional primary series dose or as a booster dose in certain individuals (https:// www.cdc.gov/vaccines/covid-
19/clinical-considerations/covid-19- vaccines-us.html#people- vaccinated-outside-us) who completed vaccination
with certain non-FDA-authorized or -approved COVID-19 vaccines.
Comirnaty (/vaccines-blood-biologics/comirnaty) Information
Information Last Updated
Package Insert (/media/151707/download) August 23, 2021
Summary Basis for Regulatory Action (https://www.fda.gov/media/151733/download) November 8, 2021Page 1 of 7 Comirnaty and Pfize r-BioNTech COVID-19 Vaccine | FD A
12/8/2021 https://www.fda.gov/emer gency-preparedness-an d-response/coronavirus-diseas e-2019-cov...
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Pfizer-BioNTech Fact Sheets (English) and FAQs
Pfizer-BioNTech Regulatory InformationInformation Last Updated
Approval Letter (https://www. fda.gov/media/151710/download) August 23, 2021
FAQ for Comirnaty (COVID-19 Vaccine mRNA) (/va ccines-blood-biologics/qa-comirnaty-covid-19-
vaccine-mrna) (Español (/vaccines-blood-biologics/pregunt as-y-respuestas-sobre-comirnaty-vacuna-
de-arnm-contra-el-covid-19))October 20, 2021
CDC-issued Emergency Use Inst ructions (https://www.cdc.gov/va ccines/covid-19/eui/index.html) November 17, 2021
Fact Sheet / FAQs Vaccine Recipient Group Last Updated
For Healthcare Provider s (/media/153713/download) 12 years of age and older,
purple cap (must dilute)November 19, 2021
For Healthcare Provider s (/media/153715/download) 12 years of age and older, gray
cap (no dilution) This
formulation is not yet available in the United States.November 19, 2021
For Healthcare Provider s (/media/153714/download)
5 - 11 years of age, orange cap (must dilute)October 29, 2021
For Recipients and Caregi vers (/media/153716/download)
12 years of age and older November 19, 2021
For Recipients and Caregi vers (/media/153717/download) 5 - 11 years of age October 29, 2021
Frequently Asked Questions on the Pfizer-BioNTech COVID-19
Vaccine (/emergency-preparedness-and-response/coronavirus-
disease-2019-covid-19/pfizer- biontech-covid-19-vaccine-
frequently-asked-questions)All November 4, 2021
Information Date
Decision Memorandum Adde ndum (/media/154358/download) November 19, 2021
Decision Memorandum (/media/154357/download) November 19, 2021
Letter of Authorization (R eissued) (/media/150386/download) November 19, 2021
Decision Memorandum (/media/153947/download) October 29, 2021
Advisory Committee Meeting Information (/a dvisory-committees/advisory-committee-
calendar/vaccines-and-re lated-biological-products-advisory -committee-octobe r-26-2021-meeting-
announcement)October 26, 2021
Decision Memorandum (/media/153482/download) October 20, 2021
Decision Memorandum (/media/152432/download) September 24, 2021
Advisory Committee Meeting Information (/a dvisory-committees/advisory-committee-
calendar/vaccines-and-re lated-biological-products-advisory-c ommittee-september-17-2021-meeting-
announcement)September 17, 2021Page 2 of 7 Comirnaty and Pfize r-BioNTech COVID-19 Vaccine | FD A
12/8/2021 https://www.fda.gov/emer gency-preparedness-an d-response/coronavirus-diseas e-2019-cov...
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Media Materials and WebcastsInformation Date
Concurrence Letter (/media/151731/download) August 22, 2021
Decision Memorandum (https://www. fda.gov/media/151613/download) August 12, 2021
Letter Granting EUA Amendment (http s://www.fda.gov/media/148877/download) May 19, 2021
FDA Decision Memorandum (/media/148542/download) May 10, 2021
Letter Granting EUA Amendm ent (/media/147390/download) April 6, 2021
Letter Granting EUA Amendm ent (/media/145493/download) January 22, 2021
Letter Granting EUA Amendm ent (/media/144955/download) January 6, 2021
FDA Decision Memorandum (/media/144416/download) December 11, 2020
Advisory Committee Meeting Information (/a dvisory-committees/advisory-committee-
calendar/vaccines-and-re lated-biological-products-advisory -committee-decemb er-10-2020-meeting-
announcement)December 10, 2020
Information Date
Press Release (/news-events/press-announcements/coronavirus-covid-19-update-fda-expands-
eligibility-covid-19-vaccine-boosters)November 19, 2021
Press Release (/news-events/press-announcements/fda-authorizes-pfize r-biontech-covid-19-
vaccine-emergency-use-child ren-5-through-11-years-age)October 29, 2021
Press Conference (https://youtu.be/WLbGnS-kqTY ) (http://www.fda.gov/a bout-fda/website-
policies/website-disclaimer)October 29, 2021
Advisory Committee Webcast (https://youtu.be/laaL0_xKmmA) (http://www.fda.gov/about-
fda/website-policies/website-disclaimer)October 26, 2021
Press Release (/news-events/press-announceme nts/coronavirus-covid-19-update-fda-takes-
additional-actions-use-booster-dose-covid-19-vaccines)October 20, 2021
Media Call (https://youtu.be/rou7tf4vaUU) (http://www.fda.gov/about-fda/website-
policies/website-disclaimer)October 20, 2021
Press Release (/news-events/press-announcements/fda-authorizes-booster-dose-pfizer-biontech-
covid-19-vaccine-certain-populations)September 22, 2021
Advisory Committee Webcast (ht tps://youtu.be/WFph7-6t34M) (http://www.fda.gov/about-
fda/website-policies/website-disclaimer)September 17, 2021
Press Release (/news-events/press-announceme nts/fda-approves-fir st-covid-19-vaccine) August 23, 2021
Press Release (/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-
additional-vaccine-dose-ce rtain-immunocompromised)August 12, 2021
FDA In Brief (/news-events/press-announcements/fd a-brief-fda-authorizes-longer-time-refrigerator-
storage-thawed-pfizer-biontech-covid-19-vaccine)May 19, 2021
Press Release (/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-
pfizer-biontech-covid-19-vaccine-emergency-use)May 10, 2021Page 3 of 7 Comirnaty and Pfize r-BioNTech COVID-19 Vaccine | FD A
12/8/2021 https://www.fda.gov/emer gency-preparedness-an d-response/coronavirus-diseas e-2019-cov...
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Translations of the Pfizer-BioNTech Fact Sheet for Recipients and CaregiversInformation Date
Press Conference (https: //youtu.be/npjhwpConSw) (http://www.fda.gov/ about-fda/website-
policies/website-disclaimer)May 10, 2021
Press Release (/news-events/press-announcements/coronavirus-covid-19-update-fda-allows-more-
flexible-storage-transport ation-conditions-pfizer)February 25, 2021
Press Release (/news-events/press-announcements/fda-takes-key-action-f ight-against-covid-19-
issuing-emergency-use-authorization-first-covid-19)December 11, 2020
Press Conference (https://youtu.be/L0K3RsIZIP0) (http://www.fda.gov/ about-fda/website-
policies/website-disclaimer)December 11, 2020
Advisory Committee Webcast (ht tps://youtu.be/owveMJBTc2I) (http://www.fda.gov/about-
fda/website-policies/website-disclaimer)December 10, 2020
Fact Sheet Vaccine Recipient Group Language
HOJA INFORMATIVA DE VACUNAS PA RA RECEPTORES Y CUIDADORES
SOBRE LA VACUNA DE PFIZER-BIONT ECH CONTRA EL COVID-19 PARA
PREVENIR LA ENFERMEDAD DEL CORONAVIRUS 2019 (COVID-19) PARA
USO EN PERSONAS DE 5 A 11 AÑOS (/media/153829/download)
(October 29, 2021) 5 - 11 years of age Español (Spanish)
HOJA INFORMATIVA DE VACUNAS PA RA RECEPTORES Y CUIDADORES
SOBRE COMIRNATY (VACUNA DE ARNm CONTRA EL COVID-19) Y LA
VACUNA DE PFIZER-BIONTECH CONTRA EL COVID-19 PARA PREVENIR LA
ENFERMEDAD DEL CORONAVIRUS 2019 (COVID-19) PARA USO EN
PERSONAS DE 12 AÑOS O MÁS (/media/144625/download)
(October 29, 2021)12 years of age and older
(/media/144615/download)Español (Spanish)
(/media/144615/download)
为接种者和护理者提供的关于用于预防2019 新冠肺炎（COVID-19 ）的
辉瑞生物技术公司2019 新冠肺炎疫苗以个人使用的信息概况说明书 5
岁至11岁(/media/154061/download)
(October 29, 2021)5 - 11 years of age 中文 (Chinese, Simplified)
关于复必泰 (2019核糖核酸新冠肺炎疫苗) 以及辉瑞-BioNTech2019 新
冠肺炎疫苗预防2019 新冠肺炎的接受者和护理者须知
(/media/144615/download)
(October 29, 2021)12 years of age and older 中文 (Chinese, Simplified)
ﻪﮔﺭﺑیﻭﺎﺣﺕﺎﻋﻼﻁﺍﺕﺎﻣﻭﻠﻌﻣﻭیﺍﺭﺑﻥﺎﻳﺿﺎﻘﺗﻣﻭﻥﻳﻟﺅﺳﻣﯽﺗﺷﺍﺩﻬﺑﺭﺩﺩﺭﻭﻣﻖﻳﺑﻁﺗﻥﻳﺳﮐﺍﻭ
PFIZER-BIONTECH ﺭﺩﻥﺎﻳﻣﻪﮑﻳﺩﺍﺭﻓﺍﺭﺩﻥﻳﻧﺳ 2019ﺽﺭﻣﻉﻭﻳﺷءﻪﺗﻓﺎﻳﻝﺎﺳ 19ﺩﻳﻭﻭﮐ
ﻝﺎﺳﺭﺍﺭﻗﺩﻧﺭﺍﺩ 11ﯽﻟﺍ 5. (/media/153840/download)
(October 29, 2021)5 - 11 years of age یﺭﺩ ( ,Dari)
ﻪﺣﻔﺻﺕﺎﻣﻭﻠﻌﻣﻥﻳﺳﮐﺍﻭیﺍﺭﺑﺕﻓﺎﻳﺭﺩﻩﺩﻧﻧﮐﻥﺎﮔﻭﺕﺑﻗﺍﺭﻣﻩﺩﻧﻧﮐﻥﺎﮔ
(٩١،ﻡﺍﺭﺍﻥﺍیﺍ -ﻥﻳﺳﮐﺍﻭﺩﻳﻭﻭﮐ )ﺭﺩﺩﺭﻭﻣﯽﺗﻧﺭﻳﻣﻭﮐ
-ﺩﻳﻭﻭﮐ )ﻭﻳﺑﻥﺍﮏﺗیﺍﺭﺑیﺭﻳﮔﻭﻠﺟﺯﺍﺽﺭﻣﺱﻭﺭﻳﻭﺎﻧﻭﺭﮐ٩١٠٢ -٩١ﺭﺯﻳﺎﻓ -ﻭﻥﻳﺳﮐﺍﻭﺩﻳﻭﻭﮐ
(٩١/(media/153840/download)
(October 29, 2021)12 years of age and older
یﺭﺩ ( ,Dari)Page 4 of 7 Comirnaty and Pfize r-BioNTech COVID-19 Vaccine | FD A
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Fact Sheet Vaccine Recipient Group Language
FYÈ ENFÒMASYON SOU VAKSEN POU RECIPÈ AK MOUN K’AP PRAN SWEN
SANTE SOU VAKSEN PFIZER-BIONTEC H COVID-19 POU ANPECHE MALADI
CORONAVIRUS 2019 (COVID- 19) POU ITILIZE NAN MOUN KI GEN 5 AN RIVE
11 AN DE LAJ (/media/154063/download)
(October 29, 2021)5 - 11 years of age Kreyòl Ayisyen (Haitian Creole)
FYÈ ENFÒMASYON SOU VAKSEN POU RECIPÈ AK MOUN K’AP PRAN SWEN
SANTE SOU COMIRNATY (VAKSEN POU COVID-19, mRNA) AK VAKSEN
PFIZER-BIONTECH COVID-19 POU AN PECHE MALADI CORONAVIRUS 2019
(COVID-19) (/media/144618/download)
(October 29, 2021)12 years of age and
olderKreyòl Ayisyen (H aitian Creole)
DAIM NTAWV QHIA TSEEB TXOG TSHUAJ TIV THAIV KAB MOB RAU COV
NEEG TAU TXAIS KEV PAB THIAB COV NEEG ZOV TU TXOG QHOV TSHUAJ
TIV THAIV KAB MOB COVID-19 PFIZER -BIONTECH LOS TIV THAIV TUS KAB
MOB CORONAVIRUS 2019 (COVID-19) NTAWM COV TIB NEEGHNUB
NYOOG 5 TXOG 11 XYOOS (/media/154064/download)
(October 29, 2021)5 - 11 years of age Hmoob (Hmong)
DAIM NTAWV QHIA TSEEB RAU COV NEEG TAU TXAIS KEV PAB THIAB COV
NEEG ZOV TU TXOG CO MIRNATY (TSHUAJ TIV TH AIV KAB MOB COVID-19,
mRNA) THIAB QHOV TSHUAJ TIV THAIV KAB MOB COVID-19 PFIZER-
BIONTECH LOS TIV THAIV TUS KA B MOB CORONAVIRUS 2019 (COVID-19)
(/media/144653/download)
(October 29, 2021)12 years of age and older Hmoob (Hmong)
បញ្ជីេហតុការណ៍ព័ត៌ʤនʼ ͋ក់ˏំងស្រមʤប ់អ្នកទទួល
និងអ្នកែថរɽំអ្◌ា◌ ំពីʼ͋ក់ˏំេងវ ̩េ◌សឺបយូទិចកូវ̡ដ19 (PFIZER-BIONTECH
COVID-19) ហេដើមʊីបȯ្ករជម្ងឺកូវ̡ដ-19(COVID-19)
ស្រមʤប ់ហ្រមេបើ្រʤស់Ⱦម្◌ួយបុគ្គលថដលʤនˢយ ុȴប់ពី5 ដល់11
ȹ ្ន ំ(/media/154065/download)
(October 29, 2021)5 - 11 years of age ʟˏអង ់េគ្លស(Khmer)
╝ŢĿΌήĦ⌡Λ þ♠∩ώ╫Г⌡ό►╘□ο ÝψĠθ·ė♣►╝ψĴ╙Ý ┴┴Ρ♫╘΄ ·Ĵ╙Ýί└♠║θ
Ĵθ╫Ό□ο ÝψĠθ · COMIRNATY (COVID-19 VACCINE, mRNA) ╘΄·Ħ℅ΖĦĜΖ
╝○Ο┴΄Ď ÝΞ″Ύź 19 (PFIZER-BIONTECH COVID-19)
ήźΧ■╞Ό╝Ą ý♠ľ■ĂΖ ÝΞ″Ύź -19(COVID-19) (/media/144760/download)
(October 29, 2021)12 years of age and older ʟˏអង ់េគ្លស(Khmer)
5 세에서 11 세에해당하는사람들에게코로나바이러스감염증 2019
(COVID-19) 를예방하기위한화이저 (PFIZER)- 바이오엔텍 (BIONTECH)
코비드-19 백신에대한환자와의료진을위한백신정보지
(/media/154076/download)
(October 29, 2021)5 - 11 years of age 한국어 (Korean)
코로나바이러스감염증 2019 (COVID-19) 를예방하기위한코멀나티
(코비드-19 백신, 메신저 RNA) 와화이저 (PFIZER)- 바이오엔텍
(BIONTECH) 코비드-19 백신에대한환자와의료진을위한백신정보
지(/media/144620/download)
(October 29, 2021)12 years of age and older 한국어 (Korean)Page 5 of 7 Comirnaty and Pfize r-BioNTech COVID-19 Vaccine | FD A
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Fact Sheet Vaccine Recipient Group Language
ﻭﺍﻥﻠﮐﻭﺭﺗ۵ﻩﻝﻱکﻭﻭﻧﮐﻭﺍﻱﺍﺭﻠﻣﻧﻫﻭﺍﻥﺗﻭﻭﻧﮑﭘﯽﺳﻳﺧﺍﺩﮑﺳﺍﻭﻥﻫﻪﭘیړﺍﺍﻭﮑﺳ
(PFIZER-BIONTECH COVID-19) ﺩ PFIZER- ﻥﺍﺭسﻏﻭ ) کﻭﻭﭔ -ﻡ٩١ډ ( ﺩﻝﭘﺍﺭﻫﺦﻧﻳﻭﻳ
کﻭﻝﺎﮐﺩ٩١٠٢ېﺩکﮏﺳﺎﻧﻭپﻭﺭﭔﻝﮑﻧﻭ١١پﺎﻬؕﻲﻳﻘﺗﻥﻘﺣېﻭﻣﺍﻭﻧﻠﻌﻣ -یﻭﺭﺳﻭ٩١ډﭔﻭ
کﻭ -ﻥﺍﺭﻧﺩﯽﮐﮏﺳﺍﻭ٩١ډﭔﻭ BI (/media/154106/download)
(October 20, 2021)5 - 11 years of age Pashto
FICHA INFORMATIVA PARA DESTINATÁRIOS CUIDADORES SOBRE A
VACINA PFIZER-BIONTECH COVID-19 PARA PREVENIR A DOENÇA DO
CORONAVÍRUS 2019 (COVID-19) PARA USO EM INDIVÍDUOS DE 5 A 11
ANOS DE IDADE (/m edia/154056/download)
(October 29, 2021)5 - 11 years of age Português (Portuguese)
FICHA INFORMATIVA PARA DESTINATÁRIOS E CUIDADORES SOBRE
COMIRNATY (COVID-19 VACINA, mR NA) E VACINA PFIZER-BIONTECH
COVID-19 PARA PREVENIR A DOENÇA DO CORONAVÍRUS 2019 (COVID-19)
(/media/144623/download)
(October 29, 2021)12 years of age and older Português (Portuguese)
ИНФОРМАЦИОННЫЙБЮЛЛЕТЕНЬДЛЯРЕЦИПИЕНТОВИ
СПЕЦИАЛИСТОВПОУХОДУОВАКЦИНЕ PFIZER-BIONTECH
COVID-19 ДЛЯПРЕДОТВРАЩЕНИЯЗАБОЛЕВАНИЯ
КОРОНАВИРУСНОЙИНФЕКЦИЕЙ 2019 (COVID-19) УЛИЦВ
ВОЗРАСТЕОТ 5 ДО 11 ЛЕТ (/media/154069/download)
(October 29, 2021)5 - 11 years of age Русский (Russian)
ИНФОРМАЦИОННЫЙБЮЛЛЕТЕНЬДЛЯРЕЦИПИЕНТОВИ
СПЕЦИАЛИСТОВПОУХОДУОВАКЦИНАХ COMIRNATY ( мРНК -
ВАКЦИНЕПРОТИВ COVID-19) ИВАКЦИНЕ PFIZER-BIONTECH
COVID-19 ДЛЯПРЕДОТВРАЩЕНИЯЗАБОЛЕВАНИЯ
КОРОНАВИРУСНОЙИНФЕКЦИЕЙ 2019 (COVID-19)
(/media/144624/download)
(October 29, 2021)12 years of age and older Русский (Russian)
BAKUNA IMPORMASYON FACT SHEET PARA SA MGA TUMANGGAP AT
MGA TAGAPAG-ALAGA TUNGKOL SA PFIZER-BIONTECH COVID-19
BAKUNA UPANG MAIWASAN ANG CORONAVIRUS DISEASE 2019 (COVID-
19) PARA SA PAGGAMIT SA MGA INDIBIDWAL 5 HANGGANG 11 TAONG
GULANG (/media/154071/download)
(October 29, 2021)5 - 11 years of age Tagalog (Tagalog)
FACT SHEET NG IMPORMASYON SA BAKUNA PARA SA MGA TANGGAP AT
CAREGIVERS TUNGKOL SA COMIRN ATY (COVID-19 VACCINE, mRNA)AT
BAKUNA NA PFIZER-BIONTECH COVID-19 UPANG MAIWASAN ANG
CORONAVIRUS DISEASE 2019 (COVID -19) (/media/144663/download)
(October 29, 2021)12 years of age and older Tagalog (Tagalog)
BẢNG THÔNG TIN V Ề VẮC XIN DÀNH CHO NG ƯỜI NHẬN VÀ NGƯỜI
CHĂM SÓC VỀ VẮC XIN PFIZER-BIONTECH COVID-19 NH ẰM PHÒNG
NGỪA BỆNH CORONAVIRUS 2019 (COVID-19) ĐỂ SỬ DỤNG CHO CÁ
NHÂN TỪ 5 TỚI 11 TUỔI (/media/154074/download)
(October 29, 2021)5 -11 years of age Ti ếng Việt (Vietnamese)Page 6 of 7 Comirnaty and Pfize r-BioNTech COVID-19 Vaccine | FD A
12/8/2021 https://www.fda.gov/emer gency-preparedness-an d-response/coronavirus-diseas e-2019-cov...
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Fact Sheet Vaccine Recipient Group Language
TỜ DỮ KIỆN THÔNG TIN V Ề VẮC XIN DÀNH CHO NG ƯỜI NHẬN VÀ
NGƯỜI CHĂM SÓC VỀ COMIRNATY (V ẮC XIN COVID-19, mRNA)VÀ V ẮC
XIN PFIZER-BIONTECH COVID-19 ĐỂ PHÒNG NG ỪA BỆNH CORONAVIRUS
2019 (COVID-19) (/media/144626/download)
(October 29, 2021)12 years of age and older Ti ếng Việt (Vietnamese)
2019-YIL KORONAVIRUS KASALLIGININ G (COVID-19) OLDINI OLINISH
UCHUN PFIZER-BIONTECH COVID-19 VAKSINA HAQIDA UNI OLUVCHILAR
VA ULARNI PARVARISHLAYDIGAN SHAXSLAR UCHUN VAKSINA HAQIDA
MA’LUMOTLAR VARAKASI 5 DAN 11 YOSHGACHA
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(October 29, 2021)5 -11 years of age O'zbek (Uzbek)
QABUL QILUVCHILAR VA PARVARIS H QILUVCHILAR UCHUN COMIRNATY
(COVID-19 Vaksina, mRNA) VA PFIZER-BIONTECH COVID-19 VAKSINASI
KORONAVIRUS 2019 (COVID-19) KA SALLIGINI OLDINI OLISH UCHUN
Vaksina HAQIDA MA`LUMOT VA RAQASI (/media/153841/download)
(October 29, 2021)12 years of age and older O'zbek (Uzbek)Page 7 of 7 Comirnaty and Pfize r-BioNTech COVID-19 Vaccine | FD A
12/8/2021 https://www.fda.gov/emer gency-preparedness-an d-response/coronavirus-diseas e-2019-cov...
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EXHIBIT E
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1Konkoly, Antonia (CIV)
From: Aaron Siri <[email protected]>
Sent: Wednesday, December 8, 2021 4:23 PM
To: Enlow, Courtney D. (CIV)
Cc: Elizabeth Brehm; Gabrielle Palmer
Subject: [EXTERNAL] RE: PHMPT v. FDA, No. 21-cv-1058 (N.D. Tex.)
Good afternoon, Courtney,
Thank you for the response. Four hopefully simple questions/requests:
1.You claim it would take 1.5 days to determine the number of lines in the 126 data files, each similar to a
spreadsheet. That estimate is difficult to understand since I would imagine it would require no more than someone
opening each file, recording the total
number of lines for each one, and then adding up the total number of lines. A
paralegal at our firm could accomplish that task in less than an hour. Please explain why it would take 1.5 days to open
each file and record the total number of lines in ea ch file?
2.For the data files, please provide the column headers. My client would like to see these to determine if there is
anything that can be streamlined.
3.Please provide a more precise number for the category you indicated has “tens of thousan ds of addition al pages.”
4.Would the FDA be interested in hiring qualified unpaid volunteers to assist with reviewing the documents requested
by PHMPT?
Best regards,
Aaron
From: Enlow, Courtney D. (CIV) <[email protected]>
Sent: Thursday, December 2, 2021 2:25 PM
To: Aaron Siri <[email protected]>
Cc: Elizabeth Brehm <[email protected]>; Gabrielle Palmer <[email protected]>
Subject: RE: PHMPT v. FDA, No. 21‐cv‐1058 (N.D. Tex.)
Good afternoon Aaron,
With regard to your first two questions, FDA will not be able to make those assessments at this time. In order for FDA to
deter mine (1) the number of lines of spreadsheet data or (2) the total number of pages for each line of the 87‐page
Index, FDA would need to perform a search by hand. In other words, an individual would have to click open each file
listed on the 87‐page Index to determine the size of the file, and then manually record the file’s size. To perform that
search for the number of lines of spreadsheet data, FDA estimates that it would take 1.5 days of a staff member’s time;
to provide the page counts for each entry in the Index, FDA estimates that it would take several days of a staff member’s
time. Due to the heavy burden such an effort would place on FDA’s limited resources, it is not feasible for FDA to
provide those estimates.
With regard to your third question, are you asking whether there is any data in the Comirnaty biological product file that
are not accounted for in the Index or the estimated 329,000+ page count? If so, the Cominarty biological product file
also contains supplements, amendments, and product correspondence. FDA estimates that there are approximately
App140Case 4:21-cv-01058-P Document 30 Filed 12/13/21 Page 30 of 36 PageID 1420Case 4:21-cv-01058-P Document 30 Filed 12/13/21 Page 30 of 36 PageID 1420
239,000 pages of records in that category. In addition, there may be investigational new drug records that may be
supportive of the BLA. Although FDA cannot provide a precise count at this time, FDA estimates that there would be
tens of thousands of additional pages in this category. These page counts are in addition to FDA’s estimate of 329,000+
pages (plus data files) in the original Cominarty BLA.
If Plaintiff is amenable to the schedule I proposed yesterday, please let me know this week so that we can inform the
Court.
Thanks,
Courtney
Courtney Enlow
Trial Attorney
U.S. Department of Justice
Civil Division, Federal Programs Branch
1100 L Street, N.W., Room 12102
Washington, D.C. 20005
(202) 616‐8467
[email protected]
From
: Aaron Siri <[email protected]>
Sent: Wednesday, December 01, 2021 5:56 PM
To: Enlow, Courtney D. (CIV) <[email protected] >
Cc: Elizabeth Brehm <[email protected] >; Gabrielle Palmer <[email protected]>
Subject: [EXTERNAL] RE: PHMPT v. FDA, No. 21‐cv‐1058 (N.D. Tex.)
Good afternoon Courtney,
Thank you for the note. In order for me to have a meaningful conversation with my client, can you please let me know
(1)approximately how many lines of spreadsheet data would need to be processed, (2) the approximate total number of
pages for each line item in the Index of Comirnaty BLA you previously provided (copy attached) and (3) what else is in
the biological product file for Comirnaty that is not reflected in the attached and is that included in the estimated
329,000 page coun t (and if not, how ma ny pages does that consist of).
Thank you,
Aaron
From: Enlow, Courtney D. (CIV) <[email protected] >
Sent: Wednesday, December 1, 2021 8:35 AM
To: Aaron Siri <[email protected] >; Gabrielle Palmer <[email protected] >
Cc: Elizabeth Brehm <[email protected] >
Subject: RE: PHMPT v. FDA, No. 21‐cv‐1058 (N.D. Tex.)
Good morning Aaron,
With regard to PHMPT v. FDA, No. 21‐cv‐1058 (N.D. Tex.), FDA has now had the opportunity to assess the number of
responsive pages and to estimate processing times for additional portions of Plaintiff’s priority list. In light of that
assessment, FDA
proposes that it produce the non‐exempt portions of the following records by the below dates:
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3By December 13,
2021, FDA plans to produce publicly releasable information from:
oPlaintiff’s priority item #1‐ CRF files for site 1055 (~2,030 pages);
oCompletion of Plaintiff’s priority item #5‐
Four addi
tional .txt files that were listed on p. 10 of the index;
Four additional SAS files (not specifi c ally listed on Plaintiff’s priority list, but mentioned as
something Plaintiff was interested in).
oPublicly releasable information from the following additional sections of the original Comirnaty BLA:
Section 2.5 – Clinical Overview (~333 pages)
Section 2.7.3 – Summary of Clinical Efficacy (~182 pages)
Section 2.7.4 – Summary of Clinical Safe ty (~344 pages)
By December 30, 2021, FDA plans to produce publicly releasable information from Plaintiff’s priority item #2 –
CRF files for site 1081 (~3,380 pages);
By January 18, 2022, FDA plans to produce publicly releasable information from Plaintiff’s priority item #3 – CRF
files for site 1096 (~2,937 pag
es); and
By January 31, 2022, FDA plans to produce publicly releasable information from Plaintiff’s priority item #4 – CRF
files for site 1128 (~3,452 pages).
Under this schedule, by the end of January 2022, FDA expects to have produced publicly releasable information from
more than 12 ,000 pages of records and 10 unpaginated .txt or SAS data files. (This page and file count includes records
produced to Plaintiff on November 17, 2021, and records that will be produced to Plaintiff later today.) FDA will also
have completed production of seven of the first eight items on the priority list Plaintiff provided to FDA on November 4,
2021.
After the January 31, 2022 production, FDA proposes to make one production at the end of each subsequent month
totaling a minimum the non‐exempt portions of 500 pages. (For purposes of calculating a “page count” of data records
that are not paginate d, FDA proposes considering twent
y lines of spreadsheet data the equivalent of one page. For
example, production of a spreadsheet containing 2,000 lines of data would be counted the equivalent of a 100‐page PDF
record.) To the extent feasible, FDA plans to continue to prioritize records from Plaintiff’s prio rity list. Although FDA
proposes a minimum rate of 500 pages a month, FDA will continue to produce records at a faster rate where feasible.
Please let me know if Plaintiff is amenable to this proposed schedule. If so, I propose that the parties file a joint status
report setting out the agr
eed‐upon schedule and requesting that the Court cancel the hearing set for December 14 and
the briefing deadlines.
Thanks,
Courtney
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4Courtney Enl
ow
Trial Attorney
U.S. Department of Justice
Civil Division, Federal Programs Branch
1100 L Street, N.W., Room 12102
Washington, D.C. 20005
(202) 616‐8467
[email protected]
From
: Enlow, Courtney D. (CIV)
Sent: Wednesday, November 17, 2021 1:40 PM
To: Aaron Siri <[email protected] >; Gabrielle Palmer <[email protected] >
Cc: Elizabeth Brehm <[email protected] >
Subject: PHMPT v. FDA, No. 21‐cv‐1058 (N.D. Tex.)
Good afternoon Aaron and Gabrielle,
I’ve attached correspondence from FDA and a release of records in PHMPT v. FDA, No. 21‐cv‐1058 (N.D. Tex.). Kindly
confirm receipt.
Thanks,
Courtney
Courtney Enlow
Trial Attorney
U.S. Department of Justice
Civil Division, Federal Programs Branch
1100 L Street, N.W., Room 12102
Washington, D.C. 20005
(202) 616‐
8467
[email protected]
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EXHIBIT F
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1Konkoly, Antonia (CIV)
From: Konkoly, Antonia (CIV)
Sent: Friday, December 10, 2021 8:57 PM
To: Aaron Siri; Elizabeth Brehm; Gabrielle Palmer
Cc: Enlow, Courtney D. (CIV)
Subject: PHMPT -- conferral questions
Hi Aaron et al –
I assume you saw the NOA that I entered earlier this week; I’m a colleague of Courtney’s and will be handling the
hearing on Tuesday. I look forward to working with you. We’ve conferred with FDA regarding the various questions
you’ve posed; please see below the agency’s respons es, in red.
1.) You claim it would take 1.5 days to determine the number of lines in the 126 data files, each similar to a
spreadsheet. That estimate is difficult to understand since I would imagine it would require no more than
someone opening each file, recording the total number of lines for each one, and then adding up the total
number of lines. A paralegal at our firm could accomplish that task in less than an hour. Please explain
why it would take 1.5 days to open each file and record the total number of lines in each file?
oFirst, FDA derived the number 126 came from its search of a specific portion of the BLA file (within
Section 5). However, FDA expects that there are data files in other sections of the application, so 126 is
likely not the full number of SAS files for the entir e BLA. Accordingly, some the time estimate accounts
for the time that would be needed to search for and locate other files. Additionally, SAS files are large
and can present technical difficulties for FDA staff to open and navigate. Both search time and expected
technical difficulties are thus accounted for in the 1.5 day estimate.
2.) For the data files, please provide the column headers. My client would like to see these to determine if
there is anything that can be streamlined.
oDue to the same technical difficulties noted above – which, on the ground, would make this task quite
time‐ consum ing – FDA is not able to accommodate this request at this time. In short, the diversion of
time this would involve would meaningfully undermine the agency’s ability to focus on its processing
work.
3.) Please provide a more precise number for the category you indicated has “tens of thousands of additional
pages.”
oFDA knows that there are a number of records in the IND section of the biological product file; however,
it would take a closer review of those pages to determine which information would be considered
supportive of the BLA/licensure and, thus, publicly available (subject to disclosure review) under 21
C.F.R. 601.51(e).
You may already be aware of this, but to make sure we’re on the same page – IND files may include
studies for several forms (different dose strengths, formulations, etc.) and/or indications (different
disease conditions, age groups, etc.). It’s possible for a biological product to be approved for only a
subset of the variations/indications for which it was originally studied. The portions of the IND file
related to the approved conditions would become part of the biological product file that would be
available for disclosure (subject to confidentiality review) once the product is approved; portions of the
IND related to unapproved forms/indications would remain confidential (as would the existence of these
portions).
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2To be clear, FDA disclosure staff have not yet determined whether portions of the IND section of the
Comirnaty file refer to forms or conditions that are have not been approved under a BLA. Thus, this
response should not be understood as an indication that any parts of the biological product file relate
to INDs associated with a product that has not been approved. But, before performing that review
(which would require a substantial investment of time from FDA), we cannot provide a precise page
estimate. Because, again, the FDA assesses that that this effort does not justify the diversion of
resources away from its processing work, it also cannot accommodate this request at this time.
4.) Would the FDA be interested in hiring qualified unpaid volunteers to assist with reviewing the documents
requested by PHMPT?
oThis is not an option. Non‐federal personnel – whether they be unpaid volunteers, or per your later
question, persons paid by the Plaintiff – cannot perform federal work.
5.) Provide a list of the sections of the index that were not disclosed in the PDF index you pr ovided.
oFDA provided the high‐level breakout of the entire original Comirnaty BLA. (See p. 1 of the Index
provided on 11‐4‐21.) However, in accordance with the purpose of the index—ie, to assist PHMPT in
honing in on the portions of the BLA that it is most interested in—F DA did not expand the index as to
Sections that were not identified by PHMPT’s Priority List. Additionally, other sections could not be
expanded because to do so could have revealed confidential information.
6.) An index for the documents in the BLA file that were not included in the index alr eady provided (meaning,
an index of the material that was not submitted as part of Comirnaty BLA application). The FOIA request,
on its face, was for more than just the Comirnaty BLA submitted by Pfizer.
oCreating the requested index would require FDA to create screen shots for each section, as it did for the
index it provided in Nove mber. Give
n the nature of the documents in these sections, FDA anticipates
that there would likely be confidential information in section titles, such that they could not be shared
with PHMPT. Again, FDA assess that it cannot reasonably divert resources away from its processing
efforts to this task at this time, in light of those circu
mstances.
Thanks,
Toni
Antonia Konkoly
Trial Attorney
U.S. Department of Justice
Civil Division | Federal Programs Branch
Direct line: (202) 514‐2395
email: [email protected]
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