Letter to Sponsors, Applicants and Regulated Entities 

June 6, 2023 

The Coronavirus Disease 2019 (COVID-19) public health emergency (PHE) declared under

section 319 of the Public Health Service Act expired on May 11, 2023. Additional HHS 

resources on the transition are available. This letter provides updated information from the 

previous letter of June 9, 2022, to assist sponsors, applicants, and other CBER-regulated 

entities as FDA’s Center for Biologics Evaluation and Research (CBER) transitions back to 

normal operations in calendar year 2023. 

CBER took the steps described in previous letters posted on the Center’s website to prioritize 

work that advanced the nation’s public health response during the national emergency. These 

steps sought to address the impact of COVID-19 on day-to-day operations in CBER and for 

industry, while ensuring that government and private sector efforts to respond to the public

health emergency (PHE) received the highest priority.

The impact of COVID-19 on CBER during the PHE was unprecedented and placed 

tremendous burdens on product development, approval, and surveillance functions. CBER 

received 233 INDs/IDEs, 6,336 Expanded Access INDs, and held 188 formal meetings

focusing on COVID-19 products. To date, CBER has approved 3 BLA/BLA supplements, 

authorized 5 EUAs (and multiple EUA revisions), and allowed over 6000 expanded access 

treatment requests aimed at preventing or treating COVID-19 to proceed. See Biological 

Approvals by Year. 

While CBER’s COVID-19 workload has been greatly reduced in most areas, there remains 

significantly increased regulatory work related to COVID-19 vaccines. In addition, CBER’s 

non-COVID-19 vaccine review workload continues to be substantial. Therefore, for the 

remainder of this calendar year, CBER will continue prioritizing resources for COVID-19

vaccine regulatory work over non-COVID-19 vaccine work, as needed, to meet public health 

needs, including to protect against new variants. 

For additional information on COVID-19 see Coronavirus Disease 2019 (COVID-19).

CBER Meetings 

At the beginning of the COVID-19 PHE, CBER leveraged technology to convert all applicant 

and sponsor in-person meetings to virtual meetings. Beginning on February 13, 2023, CBER 

restarted accepting requests for certain in-person, Face-to-Face (FTF) industry PDUFA 

meetings (with a hybrid component). CBER will transition in phases to accepting requests for 
in-person meetings for all types of FTF formal meetings. Sponsors and applicants should 

monitor the Formal Meetings for CBER-Regulated Products Webpage for updates regarding 

in-person meetings. 

 

FDA Guidance 

In the Federal Register of March 2023, FDA published a notice addressing the Agency’s COVID19-related guidance documents, including which of those documents would no longer be in effect 

after the expiration of the COVID-19 PHE, and which of those guidance documents FDA was 

revising to temporarily continue in effect. Please see COVID-19-Related Guidance Documents 

for Industry, FDA Staff, and Other Stakeholders for further information.

Processing of Incoming Documents and CBER Responses

The CBER Document Control Center (DCC) processes regulatory applications and 

submissions regardless of format or method of delivery. 

Commercial applicants and sponsors must be submitted in the standard eCTD format using 

the Electronic Submission Gateway (ESG) as described in guidance for industry, Providing

Regulatory Submission in Electronic Format – Certain Human Pharmaceutical Product

Applications and Related Submissions Using the eCTD Specifications. Questions about the 

eCTD format or the ESG can be submitted to esubpred@fda.hhs.gov. 

For routine submissions that are not subject to or are exempted from the eCTD requirements, 

applicants have the option of submitting via email. The FDA has a 150MB size limit for 

email/attachments. In some instances, larger email submissions can be serialized in several 

emails (i.e., 1 of 2, 2 of 2).

CBER prefers that submissions not subject to or exempted from the electronic submission 

requirements under section 745A of the FD&C Act as described in the 745(A) binding 

guidance and CBER Applications Submissions Guidance be sent in the following manner (in 

order of preference):

 

• FDA Electronic Submission Gateway

• CBER submission email box (150MB max): CBERDCC_eMailSub@fda.hhs.gov 

• Electronic media (USB drive, DVD/CD) with no paper components 

• Paper submissions
Paper and physical media submission should be sent to:

U.S. Food and Drug Administration

Center for Biologics Evaluation and Research

Document Control Center

10903 New Hampshire Ave.

WO71, G112

Silver Spring, MD 20993-0002

Regulatory communications from CBER to sponsors and applicants will generally be sent via 

secure e-mail. To establish secure email, please follow the instructions in SOPP 8119 Use of 

Email for Regulatory Communications, Appendix A. 

As always, the following can be sent to CBER via non-secure email: Requests for Individual 

Patient INDs under Expanded Access, including for emergency use; Compassionate Use 

IDEs; Requests for EUAs and Pre-EUAs; Emergency requests for alternative procedures or 

exceptions under 21 CFR 640.120; and requests for information that are general in nature. 

For more information about requesting expanded access for medical devices, see Expanded 

Access for Medical Devices | FDA. 

Extension of Response Due Dates for Device Marketing Applications Currently on Hold

FDA announced in the Federal Register on June 7, 2022, the withdrawal of the guidance 

document entitled, “Effects of the COVID-19 Public Health Emergency on Formal Meetings 

and User Fee Applications for Medical Devices—Questions and Answers (Revised),” which 

was issued in June 2020 (and updated December 2020). This guidance described FDA’s 

policy on applicant response due dates for marketing submissions that were on hold, 

recognizing that applicants might face challenges in meeting their applicable response dates 

due to the impact of COVID-19. FDA withdrew this guidance on July 7, 2022. As stated in the 

withdrawal notice, for submissions or applications that receive a major deficiency letter for 

PMA and HDE applications or additional information letters for 510(k)s and De Novo requests 

prior to July 7, 2022, FDA does not intend to consider the submission or application to be 

withdrawn for an additional 180 days beyond the relevant response date. For submissions or 

applications that receive a major deficiency letter or additional information letter after July 7, 

2022, FDA will generally consider the application or submission to be withdrawn if a complete 

response is not received by the relevant response date identified in that letter.

FDA is planning to retain with appropriate changes to guidance document, Supplements for 

Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions 
During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised) | FDA, 

after expiration of the COVID-19 PHE declaration. During that time, FDA plans to further revise 

this guidance with any appropriate changes based on comments received and the Agency's 

experience with implementation. Please monitor the FDA website for further information. 

Conduct of Clinical Trials involving Medical Products

Recognizing that the COVID-19 pandemic may impact the conduct of clinical trials and could 

result in protocol modifications or unavoidable protocol deviations, FDA issued Guidance on

Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health 

Emergency to assist sponsors. This guidance is intended to remain in effect until November 

7, 2023, unless superseded by a revised final guidance before that date. For further 

information, refer to the Federal Register Notice of March 13, 2023. Questions on specific 

clinical trials should be directed to the assigned product office.

Postmarket and Compliance Activities

In response to the ongoing COVID-19 pandemic, CBER paused certain lot release 

activities beginning on March 23, 2020, and was not receiving biological product samples 

or protocols in physical form (paper or CD-ROM) until further notice. CBER is resuming

normal Lot Release operations in 2023. Applicants should monitor the CBER Lot Release

website for updates regarding lot release activities. 

 

How to submit an Inquiry for a Single Patient IND 

FDA is committed to increasing awareness and facilitating expanded access to 

investigational drugs for use in patients with serious or immediately life-threatening 

COVID-19. For additional information on gaining access to investigational drugs please 

see Expanded Access. 

Emergency Use Authorization

The ending of the PHE will not impact FDA’s ability to authorize devices (including 

tests), treatments or vaccines for emergency use. Emergency Use Authorizations 

(EUAs) for products will remain in effect until the relevant EUA declaration is terminated 

or the EUA is revoked, and the agency may continue to issue new EUAs going forward 

when criteria for issuance are met. For questions on the EUA process, please contact

CBEREUA@fda.hhs.gov.

If you have any questions about this communication, please contact the Office of 
Communication, Outreach and Development via email at Industry.Biologics@fda.hhs.gov, 

240-402-8010, or 800-835-4709. 

Sincerely, 

 

/s/ 

 

Christopher C. Joneckis, PhD 

Associate Director for Review Management 

Office Director, Office of Regulatory Operations 

Center for Biologics Evaluation and Research 

U.S. Food and Drug Administration