Regulatory Submissions in Electronic and Paper Format for CBER-Regulated Products

Regulatory Submissions in Electronic Format

Sponsors and applicants are encouraged to send applications and other regulatory submissions electronically via the FDA Electronic Submissions Gateway (ESG) to CBER. When submitting via ESG, place all documents in a WebTrader folder and upload by folder to ESG. A complete submission should generate a single core id number.  Please do not zip the file when submitting thru the Gateway. For instructions on submitting by ESG folder see item 17 of ESG Frequently Asked Questions at https://www.fda.gov/industry/create-esg-account/frequently-asked-questions.

For information on electronic submissions see:
https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/regulatory-submissions-electronic-format-cber-regulated-products.

Sponsors and applicants should utilize the FDA eSubmitter tool to create an electronic application for Whole Blood and blood components including Source Plasma for submittal to the FDA. For information on Blood Products eSubmitter Program see https://www.fda.gov/industry/fda-esubmitter/blood-products-esubmitter-program.

Most submissions are sent electronically through FDA’s Electronic Submission Gateway. For submissions exempted from 745(A) binding guidance and not subject to CBER Applications Submissions Guidance please submit in the following manner (in order of preference):

1. FDA Electronic Submission Gateway
2. CBER submission email box (150MB max):  CBERDCC_eMailSub@fda.hhs.gov
3. Electronic media (USB drive, DVD/CD) with no paper components
4. Paper submissions

Although electronic or email submission is preferred, requestors may submit paper or electronic media (USB drive, CD, DVD) documents and other regulatory correspondence to the Document Control Center at CBER mailing address:

U.S. Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Avenue
WO71, G112
Silver Spring, MD 20993-0002

• It is critical to address all regulatory correspondence to the CBER Document Control Center at the above White Oak address.
• Staff names should NOT be placed on the document packaging or envelope address for regulatory correspondence.  Addressing documents to individual staff members, Division or Branch Directors or simply a Branch or Division will result in a delay in CBER officially receiving the documents, and a possible delay in review, assigning meetings, or other regulatory activities.
• Regulatory documents delivered by couriers should be delivered to the CBER Document Control Center in Room G112 on the ground floor of building 71.
• The CBER Document Control Center is open and will accept documents from 8:00 to 4:30 EST

Adverse Event and Product Deviation Reporting:

Adverse event reports and product deviation reports should be submitted as outlined within https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/compliance-actions-biologics. Below are additional sites to submit reports electronically or on paper:

• For information on how to report an adverse event for a CBER-regulated product other than a vaccine, see https://www.accessdata.fda.gov/scripts/medwatch/
• For information on how to report an adverse event for a vaccine including mailing address for paper submissions see https://vaers.hhs.gov/reportevent.html
• For the mailing address of paper FDA Adverse Event Reporting Systems (FAERS) reports, see https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-electronic-submissions.
• For more information on how to report  IDE adverse events, see https://www.fda.gov/medical-devices/investigational-device-exemption-ide/faqs-about-investigational-device-exemption#adverse. These reports should be submitted to your IDE submission through CBER Document Control Center.

Submission of Lot Release Samples and Lot Release Protocols

• Official lot release samples should be sent to the CBER’s Sample Custodian new address listed below.
• Electronic lot release protocols can be submitted through the FDA Gateway at any time.
• Lot release protocols submitted in paper or CD-ROM electronic format should be sent to the CBER Sample Custodian address.

Sample Custodian Address at White Oak Campus

Food and Drug Administration
Center for Biologics Evaluation and Research
Sample Custodian
10903 New Hampshire Avenue
WO75-G707
Silver Spring, MD 20993-0002

For updated information on Lot Release please see:

https://www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/post-marketactivities/lotreleases/default.htm

Contacts at CBER

Additional information on contacts at CBER can be found at
https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/center-biologics-evaluation-and-research

Contact information for staff can be found at http://directory.psc.gov/employee.htm.

CBER General Numbers and the CBER Key Staff Directory can be found at https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/center-biologics-evaluation-and-research

Resources for You

• About the Center for Biologics Evaluation and Research