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GUIDANCE DOCUMENT

Availability of FDA’s eSubmitter Program for Regulatory Submissions from Licensed Blood Establishments Guidance for Industry August 2011

Final
Docket Number:
FDA-2011-D-0579
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

We, FDA, the Center for Biologics Evaluation and Research (CBER), are announcing to you, licensed blood establishments that collect Whole Blood and blood components, including Source Plasma, the availability of CBER’s eSubmitter Program (eSubmitter), an electronic submissions program. The eSubmitter program is intended to facilitate submission and processing of regulatory filings, including biologics license applications (BLAs), BLA supplements (BLSs), annual reports and amendments to pending eSubmitter applications and supplements. In this guidance, we describe how you may obtain and use the eSubmitter program.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2011-D-0579.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010