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EXHIBIT A
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1IN THE 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
SECOND DECLARATION OF SUZANN BURK
I,Suzann Burk, hereby declare as follows:
1. I am the Director of the Division of Disclosure and Oversight Management
(“DDOM”), Office of Communication Outreach and Development(“OCOD”), Center for
Biologics Evaluation and Research (“CBER”), United States Food and Drug Administration
(“FDA”), in Silver Spring, Maryland. A summary of my work experience and current job
responsibilities is included in my December 6, 2021, declaration (ECF No. 23).
2. FDA is committed to transparency both in general and specifically with respect to
records related to the Comirnaty biologicslicense application (“BLA”). As explained in more
detail in the Declaration of Sarah B. Kotler(“Kotler Decl.”) (ECF No. 30), from the time the
Comirnaty BLA was approved, FDA endeavored to publish on its website information relevant
to the public’s interest in the Comirnaty vaccine. Kotler Decl. ¶¶11-14. FDA’s transparency
efforts began the day after the BLA was approved when it posted the “Summary Basis for
Regulatory Action” on its website. Id.¶13. Those efforts continued when FDA posted
numerous FDA discipline review memos, including clinical, statistical, and toxicology reviews
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2as part of the “Action Package” 25 days a fter approval. Id. That information, along with the
other information on FDA’s website, provides the public with substantial in formation that it can
use to evaluate FDA’s determination approving the Comirnaty vaccine for use in individuals 16
years and older.
3. FDA has reaffirmed its commitment to transparency by providing copious
information to Plainti ff in response to its FOIA request, number 2021-5683 (Plainti ff’s “FOIA
Request”). FDA has already produced to Plainti ff over 7,000 pages of respon sive records plus
several unpaginated data files, and expects—and is on track—to have produced over 12,000
pages of responsive records by January 31, 2022. Declaration of Suzann Burk (“First Burk
Decl.”), ECF No. 23, ¶¶ 27-28.
4. As discussed in more detail below, FDA has begun to take dramatic, and indeed
unprecedented, actions in an e ffort to comply with this Court’s January 6, 2022, order requiring
production of 55,000 pages every thirty days beginning on March 1, 2022. These efforts include
working to hire at least fifteen outside contract sta ff to help process these records; creating
“details” to allow current FDA sta ff from other parts of the agency to work on matters related to
this case; obtaining help from staff members from other parts of OCOD and CBER; temporarily
receiving assistance from other FDA disclosure o ffices to meet production deadlines in other
FOIA litigation; and reaching out to the vaccine sponsors for assistance identifying information
that they consider confidential. Once fully implemented, these steps will dramatically increase the
agency’s ability to produce records to Plaintiff at a greatly accelerated rate, but they come at
significant cost (estimated to be at least $4 to 5 million) to FDA’s other disclosure work—and to
its public health mission. The agency hopes that these efforts will allow it to achieve the
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3production rate required by the Court’sorder, but even with these maximal and unprecedented
efforts, it is not possible to guarantee that FDA will be able to fully comply.
Actions Taken Following January 6, 2022, Order
5. After receiving this Court’s January 6, 2022, Order (ECF No. 35) requiring FDA
to produce 55,000 pages of records every thirty days beginning on March 1, 2022, FDA has
taken extraordinary and unprecedented measures to increase its capacity to review and produce
responsive records.
Hiring of Contractors
6. FDA has initiated the process of hiring at least fifteen full-time contract staff to
help process records responsive to Plaintif f’s FOIA Request. FDA anticipates that eleven of those
contract staff will be able to assist with processing records that do not require review for trade
secret or confidential commercial information; the remaining four contract staff would have the
background necessary (with training and oversight from the current FOIA staff at CBER) to help
process more complex records. In addition to reviewing and redacting responsive records, these
contract staff members would assist with administrative steps required to prepare records for
production (finalizing redactions, applying Bates numbers, etc.).
7. Although FDA anticipates that these contract staff will help expand FDA’s
processing capacity signif icantly once they are in place, it will take time to advertise for these
positions, select appropriate contract staff members, and train selected workers so that they can
meaningfully contribute to the review and production process. Notably, this would likely slow, at
least initially, the ef ficiency of the current ALFOI staff working on the litigation as they will need
to spend time partnering with the new contract staff to provide training and oversight.
See Declaration of Sarah B. Kotler (“Kotler Decl.”), Dec. 13, 2021, ECF No. 30, ¶ 22.
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4Details for Agency Staff
8. CBER is going to publish an agency-wide advertisement for eight “detail”
positions to work on reviewing and producing materials responsive to Plaintiff’s FOIA Request.
These details would allow agency staff who work in other parts of FDA to be selected for the
opportunity to temporarily work on this matter in CBER.
9. As with the contract staff described above, there will be some lag before these
detailees are able to begin working on this project. CBER plans to start publishing advertisements
for these details by approximately February 1, 2022. Once the detail opportunities are posted,
CBER will need to allow a period of time for submitting applications, and then CBER will need to
select candidates from the applications received. Once detailees are selected, they will need to be
trained to perform work on these files. CBER does not expect that agency staff selected for these
details will have the requisite experience and training to immediately begin working at full
strength. Notably, this would likely slow, at least initially, the efficiency of the current ALFOI
staff working on the litigation as they will need to spend time partnering with the new detailed
staff to provide training and oversight. See Kotler Decl. ¶ 22.
Reassignment of Staf f within CBER’s OCOD
10. Recognizing that ef forts to bring on contractors and detailees will take time, CBER
has already reallocated center resources and staff to prioritize the processing of this FOIA request
to attempt to address this matter as quickly as possible. Prior to entry of this Court’s January 6
order, CBER’s Access Litigation and Freedom of Information Branch (“ALFOI”) had dedicated
approximately three “full time equivalents” to the processing of this request. Now, approximately
five and a half of ALFOI’s ten “full-time equivalents” are being dedicated to reviewing and
redacting records related to this litigation .
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511. Further, CBER has also already temporarily reassigned five additional staff
members from other divisions of OCOD to assist ALFOI with processing this request for the
interim in which some of the other efforts described in this declaration are being ramped up.
These reassigned staff members will require training in order to complete the tasks necessary to
accelerate production in this matter.
Receiving Assistance with Other Litigation Deadlines
12. FDA has disclosure obligations in several other FOIA litigations that involve
CBER. In at least one case, where CBER had agreed to contribute 450 pages toward FDA’s
overall monthly production quota, CBER has asked other agency components to take on extra work
to allow CBER to devote more resources to this matter. Under such an arrangement, CBER would
temporarily reduce its production rate to zero in that case, while other agency components would
take on the work that CBER is not able to do. Doing so would allow CBER ALFOI staff that
would otherwise have been working on that production to devote more time to this production,
while CBER ramps up its production capacity.
Working with Vaccine Sponsors to Identify Records that Do Not Contain Exemption 4 Material
13. FDA has also contacted Comirnaty sponsors Pfizer-BioNTech to seek their
assistance, initially, in identifying sections of the BLA that do not contain any trade secret or
confidential commercial information subject to FOIA Exemption 4. FDA has requested the
sponsors to provide this information to it by February 1, 2022.
14. By knowing which records the sponsors believe do not contain information
protected by FOIA Exemption 4, FDA will be able to streamline its disclosure review. Although
FDA will still need to review these records for other types of information protected by the FOIA
Exemptions (most notably, Exemption 6, which protects the privacy interests of clinical
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6participants) it will be able to move more quickly through the records if it does not need to search
for Exemption 4 material. Further, it would allow FDA to assign less experienced staff or staff
from other parts of the agency to work on these records. As discussed in the Kotler Declaration,
reviewing files like BLAs requires specialized training and experience – especially for identifying
trade secret and confidential commercial information. See Kotler Decl. ¶ 24. By eliminating the
need to search these records for information protected under Exemption 4, less training will be
required for staff outside of ALFOI to review the af fected subset of documents.
15. In addition, FDA is actively assessing other potential ways in which it may properly
enlist Pfizer-BioNTech to assist with streamlining the processing of the records at issue in this suit.
Overall Increase in Production Capacity
16. Once fully implemented, these dramatic efforts will greatly increase FDA’s
capacity for responding to Plaintif f’s FOIA Request. Between contract staff and detailees, CBER
will be adding approximately 23 new individuals to help ALFOI’s efforts. See, supra,
¶¶ 6, 8. When those 23 individuals are fully added to CBER’s existing efforts (see, supra, ¶ 10,
11), ALFOI expects that its capacity will be approximately tripled from the time the new
individuals are fully trained through the end of this production.
17. Other actions – temporarily reassigning staff from other parts of OCOD and CBER
and asking other FDA components to take on CBER’s other litigation obligations in the short term
– will provide additional resources in the short term that will help CBER bridge the gap while it
awaits the contractors and detailees to arrive and be trained. And, as described above, efforts to
work with the vaccine sponsors may help to streamline CBER’s review by
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7limiting the amount of time it needs to spend searching for trade secret and confidential
commercial in formation.
18. But even with these e fforts, it is impossible to guarantee that FDA will be able to
produce 55,000 pages every thirty days beginning March 1, 2022, as required by this Court’s
January 6, 2022, Order. In my first declaration, I estimated that if each of ALFOI’s 10 staff
members devoted all of their working hours to this production, they would be expected to be able to
produce 25,410 pages in 11 weeks (or approximately 10,000 pages per month). See First Burk
Decl. ¶ 31.
19. As discussed above, FDA’s most far-reaching efforts to increase production
capacity – hiring contractors and bringing on detailees – necessarily take time to implement. The
agency has to advertise the positions, select qualified candidates, bring the selected candidates on
board, and train them so that they can contribute to CBER’s production efforts. As a result, very
few, if any, of those additional individuals will be in place before the March 1, 2022 deadline.
The temporary measures CBER has implemented will increase production capacity, but it is not
certain that the combination of the temporary additional sta ffing and current sta ff’s tireless
efforts will be sufficient to more than quintuple ALFOI’s estimated maximum production
capacity in the time be fore the new hiring is completed.
20. Even once the new hires fully take e ffect, meeting the production burden of
55,000 pages per month will pose a challenge to the agency. As discussed above, FDA is
making every e ffort to comply with this Court’s order in good faith. But in months where the
agency is processing especially challenging records or may be dealing with sta ff reductions due
to illness, attrition, or other reasons beyond FDA’s control, the enormity of a 55,000 page per
month obligation could still prove to be too much.
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8Adverse Impact of Actions on FDA’s Disclosure and Public Health Work
21. The actions described above exceed what the agency considers feasible for
processing a single FOIA request and, in fact, represent the maximum efforts FDA can apply to
this matter. FDA cannot expand its efforts beyond what it has already committed to do. The
dramatic ef forts FDA has undertaken to attempt to comply with the Order have already severely
impacted agency functions, and they will continue to do so for the foreseeable future.
22. First, FDA’s plan to hire at least fifteen contract staff to assist with the review
requires a significant financial commitment from the agency. Although exact figures are not yet
available, FDA expects that the expense of hiring these contractors will cost at least three million
dollars. Money spent on contractors to review Plaintiff’s FOIA Request is then unavailable to
fund other important public health priorities, such as hiring staff to review applications for new
medical products or to inspect FDA-regulated establishments, purchasing laboratory equipment to
run analytical testing, or training staff on new scientific advances and technologies.
23. Further, within ALFOI, the fact that about 55 percent of the branch’s full-time
equivalents are devoted to this matter means that other ALFOI disclosure work, including
hundreds of other FOIA requests, many of which also seek information related to COVID-19, are,
of necessity created by the Court’s Order, being sidelined. In my December 6, 2021, declaration, I
showed the dramatic increase in FOIA backlog that CBER had suffered in recent years. First Burk
Decl., ¶ 21. I copy that chart again here.
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9Figure 1: Number of pending FOIA requests pending in CBER at the end of each calendar year.
(2018 value was taken from end of January 2019 because December 2018 data were unavailable
due to government shutdown. 2021 value was current as of November 26, 2021.)
Further, FDA has no control over the number of new FOIA requests that it may receive, and that
number can be expected to be substantial, especially if new vaccines or other biological products
related to COVID-19 are approved. With the resourcesthat FDA isallocating to fulfilling
Plaintiff’s request, I expect that CBER’s backlog will continue to increase –likely dramatically –
including for requests seeking information from CBERrelated to COVID-19.
24. Borrowing resources from other agency components also comes with tradeoffsfor
the agency. As CBER requests assistance from other parts of OCOD and CBER, as well as
other FDA disclosure offices in an effort to satisfy this Court’s order, those offices will have
fewer staff members available to perform their work. Many of those offices are already
constrained by a lack of resources, and in the case of other FDA disclosure offices, many are
experiencing their own FOIA backlogs. SeeKotler Decl. ¶¶24-38. Any resources diverted from
those offices to support CBER’s effortsin this matterwill inevitably exacerbate their own
resource constraints, likely leading to longer backlogs –and greater exposure to costly litigation 050100150200250300350400450500
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022CBER Number of Pending FOIA Requests by Year
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10– in those agency components as well. Further, although FDA does not yet know from which
offices the eight proposed detailees will come, the detailees’ home offices will lose the
productive capacity of a staff member, likely leading to reduced output.
25. For these reasons, and as expressed in the Kotler Declaration, FDA simply cannot
take these same measures in response to every FOIA request or every FOIA litigation. The steps
FDA has taken in this case have already placed an extraordinarily heavy burden on the agency’s
disclosure capability and its public health mission. Extending this type of response beyond this
case would dramatically compound the harm. Thus, the agency’s efforts in this case should not be
viewed as precedent for what may be possible in future situations, including for FOIA requests for
other records related to COVID-19. Indeed, as outlined above (see, supra, ¶¶ 20-23), and in the
Kotler Declaration, the agency’s processing of this request is diverting resources from other
agency priorities. It is also reducing the agency’s capacity to process other FOIA requests, thereby
extending wait times of other FOIA requesters – including other requesters seeking records related
to the COVID-19 pandemic.
BENEFIT OF MODIFYING ORDER
26. Modifying the current order to reduce FDA’s March 1 and March 31, 2022,
productions to 10,000 pages and making FDA’s first 55,000-page production due on May 2,
2022,1 would increase FDA’s likelihood of being able to comply with the Court’s Order. First,
and most importantly, it would allow many of the unprecedented measures de scribed above to
take effect. It would allow time for many, if not all, of the contingent of contract and detail sta ff
to be brought on board be fore requiring FDA to produce 55,000 pages every thirty days.
1Under the Court’s current order, FDA’s first 55,000-page production would be due on March 1, 2022; the second
would be due on March 31, 2022. The deadline for the third production would then fall on Saturday, April 30, 2022.
FDA interprets deadlines that would fall on weekends or holidays to be due on the next business day –in this case,
Monday, May 2, 2022.
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11
27. Second, it would allow FDA more time to work with the vaccine sponsors to
accurately locateany trade secret or confidential commercial information that may be protected
from disclosure by statute. As noted above, FDA sent a letter to the vaccine sponsors on January
14, 2022,requesting that they identify any sections of the Comirnaty BLA that they knew did not
contain any trade secret orconfidential commercial information. FDA continues to look for
opportunities to work with Pfizer-BioNTechto create efficiencies in the review process, and it
expects to make additional requests in the future. Extending the date for the first55,000-page
production to May 2, 2022, will allow more time for the initial phase of the agency’s work with
the vaccine sponsorsto occur.
28. Although it cannot be guaranteed, I expect that reducing the size of FDA’s March
1 and 31, 2022 productions to 10,000 pageswould significantly increase the likelihood that FDA
will be able to comply with the Court’s order.
CONCLUSION
29. FDA is committed to transparency and is doing everything possible to achieve
compliance with this Court’s January 6, 2022, Order. The efforts FDA has begun to undertake
will significantly enhance its ability to review and produce records in this litigation, but many of
them will take time to be fully implemented. Extending the deadline for FDA’s first 55,000-
page production to May 2, 2022,would reduce the chances that FDA will be unable to comply
with the Order.
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12
Pursuant to 28 U.S.C. §1746, I declare under the penalty of perjury that the foregoing is
true and correct.
Executed on January 18, 2022, in Silver Spring, Maryland.
_________________________________
Suzann Burk
Director
Division of Disclosure and Oversight Management,
Office of Communication, Outreach and
Development
Center for Biologics Evaluation and Research
Food and Drug Administration
U.S. Department of Health and Human Resources
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EXHIBIT B
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1IN THE 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
DECLARATION OF DOUGLAS WEINFIELD
I, Douglas Weinfield, do hereby declare and state:
1. I have served as the Associate Chief Counsel for Discovery within the Office of
the Chief Counsel (“OCC”), United States Food and Drug Administration (“FDA”) since July of
2018. As Associate Chief Counsel for Discovery, I am responsible for case-related discovery
issues, including electronic discovery on behalf of FDA. My duties include, among other things,
developing discovery-related policies; training FDA employees regarding discovery; assisting
FDA in responding to discovery requests; advising FDA regarding discovery software and
implementation relating to electronic discovery; and coordinating with other government entities,
including the U.S. Department of Justice (“DOJ”), regarding electronic discovery.
2. Prior to joining FDA, I was at the law firm of Williams & Connolly, LLC,for
more than 13 years, where I directedsingle and multiple teams of attorneys in complex
document review projects, and performed document review myself. In all, I have more than 18
years of experience performing and directing electronic discovery reviews, ranging from basic,
short review, to complex reviews spanning millions of documents and multiple years, including
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2international matters. This experience includes document review related to sensitive criminal and
civil litigation. I have directed and/or performed document review in more than 125 matters and
cases.
3. The statements made in this declaration are based upon my personal knowledge
and expertise in litigation and eDiscovery both in private practice and at FDA. Hereafter,
references to “documents” include electronic documents and references to “document review”
include electronic document review.
4. In my experience, there are significant differences between document review
conducted by a private law firm with commercial clients and that conducted by the federal
government. Those differences preclude a simple apples-to-apples comparison, primarily due to
the differences in the nature of the material reviewed, and the nature of the review and redaction
process.
5. During my time in private practice, a review speed of 50 documents per hour was
within the normal range for document review in a complex matter, with different document
reviews going at a slower or faster rate depending on the nature of the material. Variables that
might shift that number up or down in private practice included the length of the documents, the
complexity of the issues, the complexity of the law, and the relative prevalence of privileged
material.
6. In my experience in private practice reviews, it was commonplace that a notable
number of documents were promptly identifiable as non-responsive, which allowed each
document to be reviewed in less than a minute. Moreover, in private practice reviews, frequently
most of the documents in a review were emails, often short emails of one to three pages, which
usually could be reviewed in a minute or less.
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37. In comparison, the documents under review in the present matter, explicitly
requested under the Freedom of Information Act, contain limited non-responsive documents.
This also largely moots the use of Artificial Intelligence (“A.I.”) or technology assisted review
(“TAR”) approaches to reviewing these documents. Further, theycontain relatively few or no
emails. Therefore, these documents cannot be reviewed at such a rapid pace.
8. In private practice, the review of documents was relatively straightforward.
Identifying relevance, responsiveness, privilege, hot documents, confidentiality, attorney-eyes
only designation, and coding categories were usually simple tasks. Issues such as privilegewere
typically readily discernable via a scan for readily identifiable terms such as “attorney-client” or
the names of attorneys or paralegals, or in the case of confidentiality or coding categories, via a
scan for otherreadily identifiableterms.
9. In private practice, the bases for redaction in the overwhelming majority of
reviews were attorney-client privilegeand/or the work-product doctrine, which are usually easily
identifiable by the reviewing attorney. These reviews rarely required consultation with subject
matter or programmatic staff or experts, if at all. Additionally, there were infrequent redactions
of material as confidential or as containing personally identifiable information, again depending
on the nature of material under review.
10. In contrast, at FDA, redactions are made for a broader range of reasons than is the
case for private law firms, and an FDA document review typically contains much more redacted
or withheld material than is true in a private practice review. Relevant to the present case, FDA
redactions are made to protect trade secret information, confidential business information, and
personally identifiable information. Many of these redactions or withholdings implicate the
commercial and privacy interests of third parties, as well as FDA’s statutory and/or regulatory
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4duty to protect such information, which is often provided to FDA by a third party with the
expectation that the information will not be further disseminated. Identifying the material to be
redacted is usually more difficult and time-consuming than identifying the attorney-client or
work product material to be redacted in private practice reviews.
11. Based on my experience in private practice, for efficiency’s sake it is the usual
practice there to conduct a two-pass review. The first, quicker, pass usually identifies relevance,
privilege, and specific issues of particular importance for that matter, as well as documents that
need redaction or further review or are unreadable. The second, slower, pass usually re dacts the
relatively smaller number of documents which contain privileged material, which, generally, was
readily identifiable. In addition, it is common for an attorney substantively involved with the
matter to conduct a third review of some or all of the documents, for quality control.
12. Document reviews in private practice rarely require significant specific subject
matter expertise; rather, the document reviews are highly similar from review to review. A small
degree of training regarding the specific content at the beginning of a new review is common,
usually lasting a day or two at most, and often less, with further learning over the course of the
review.
13. At FDA, document review and redaction are usually performed by reviewers with
subject matter experience, usually with years or decades of experience reviewing documents in a
particular area, such as drugs, devices, food, biologics, tobacco, or veterinary medicine. This
knowledge is important to identify often subtle issues which arise in the course of document
review and identifying material which needs to be redacted. Identification of commercially
sensitive information in a biologics license application, for example, is usually significantly
harder (and requires more specialized expertise) than identification of redactions based on
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5 attorney-client privilege or work-product doctrine, which comprise the vast majority of
redactions in private practice document reviews. Due to the challenges in identifying these issues,
and the relatively high number of redactions to be made, it is FDA’s practice to conduct a single
pass review which includes redacting protected material at the time it is identified, because a
second pass would require a re-identification of these subtle issues, and nearly double the effort
and time to find them. In addition to this single pass review, FDA often conducts a quality
control review, similar to reviews in private practice. This intermittent process of identifying
issues, pausing the review to redact, and continuing the review, is intrinsically slower than the
comparatively simple two-pass reviews usually conducted by private law firms, which require no
such pausing, and which typically have much less material to redact.
14. Even in the unusual circumstance that the third party that submitted documents is
involved in helping the agency identify trade secrets or confidential commercial information in
them, FDA will still have a role in reviewing records prior to release.
Pursuant to 28 U.S.C. § 1746, I declare under the penalty of perjury that the foregoing is true and
correct.
Executed on this 18th day of January 2022 in Washington, District of Columbia.
_____________________________________
Douglas Weinfield
Associate Chief Counsel for Discovery
US Food and Drug Administration
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