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[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]
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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.
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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]
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