[Federal Register: August 8, 2006 (Volume 71, Number 152)]
[Notices]               
[Page 45057-45058]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08au06-67]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1992S-0251] (formerly 92S-0251)

 
Food and Drug Administration Electronic Submissions Gateway

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the FDA Electronic Submissions Gateway (ESG) for the 
receipt and processing of electronic submissions provided so that the 
Center for Biologics Evaluation and Research (CBER), the Center for 
Drug Evaluation and Research (CDER), and the Center for Devices and 
Radiological Health (CDRH) can receive regulatory submissions 
electronically. The FDA ESG enables applicants to send applications and 
other submissions for review using the Internet, provides a single 
point of entry for these submissions, and fulfills goals identified in 
the Prescription Drug User Fee Act (PDUFA III).

[[Page 45058]]


FOR FURTHER INFORMATION CONTACT: Michael B. Fauntleroy, CBER (HFM-25), 
Food and Drug Administration, 11400 Rockville Pike, RKWL rm. 4119, 
Rockville, MD 20857, 301-827-5132, e-mail: 
michael.fauntleroy@fda.hhs.gov or William H. Taylor, Office of the 

Commissioner (HFA-83), Food and Drug Administration, 5600 Fishers Lane, 
rm. 16B-45, Rockville, MD 20857, 301-255-6734, e-mail: 
william.taylor@fda.hhs.gov.


SUPPLEMENTARY INFORMATION: FDA receives a variety of electronic 
submissions under 21 CFR 11.2(b), including biological license 
applications (BLAs), new drug applications (NDAs), drug master files 
(DMFs), investigational new drug applications (INDs), and 
investigational device exemptions (IDEs), as well as their associated 
correspondence and other types of regulatory submissions. The FDA ESG 
supports the receipt and processing of electronic submissions through 
the use of a single point of entry.
    The increasing number of electronic submissions highlights a 
critical need to automate and standardize the receipt of these 
submissions and their delivery to the appropriate centers. The FDA ESG 
automates the receipt, acknowledgment (to the applicant/sponsor), 
routing, and notification (to a receiving center) of electronic 
submissions via the Internet and meets the standards for the electronic 
exchange of information adopted by the American National Standards 
Institute (ANSI) and the National Institute of Standards and Technology 
(NIST).
    The FDA ESG offers two secure communication options for applicants 
that have established gateway systems. One utilizes simple mail 
transfer protocol (SMTP) with secure multi-purpose internet mail 
extensions (S/MIME) to provide secure e-mail communication and the 
other supports faster information exchange and utilizes hypertext 
transfer protocol secure (HTTPS) to provide real-time Internet 
communication. The FDA ESG also offers a secure WebTrader submission 
option for applicants who do not have gateway systems. The WebTrader is 
a no-cost applet which can be downloaded from FDA and requires only a 
standard security certificate to provide the applicants with a secure 
Internet connection to FDA. The WebTrader addresses the need to expand 
participation in electronic submissions without costly expenditures for 
infrastructure upgrades and gateway systems.
    Use of the FDA ESG is voluntary. Electronic format submissions may 
be made through the gateway or may continue to be made on physical 
media. Information on the FDA ESG is available on the following Web 
site: http://www.fda.gov/esg/. Except where FDA has promulgated 

regulations requiring submission in electronic format, applicants/
sponsors may also continue to make regulatory submissions on paper.
    If you wish to use the FDA ESG, you should send an e-mail to 
esgprep@fda.gov to begin the registration process. Include your name, 

phone number, and the name of the company you represent. Please state 
whether you are using the WebTrader, SMTP, or HTTPS for submissions.

    Dated: July 31, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-12808 Filed 8-7-06; 8:45 am]

BILLING CODE 4160-01-S