[Federal Register: October 22, 2003 (Volume 68, Number 204)]
[Notices]
[Page 60395]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22oc03-104]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0465]
Draft Guidance for Industry on Providing Regulatory Submissions
in Electronic Format--General Considerations; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Providing
Regulatory Submissions in Electronic Format--General Considerations.''
The draft guidance discusses general issues common to all types of
electronic regulatory submissions and updates the guidance of the same
name, issued in January 1999. The update now includes information for
the Center for Devices and Radiological Health (CDRH), the Center for
Food Safety and Applied Nutrition (CFSAN), and the Center for
Veterinary Medicine (CVM) and reflects advances in technology as well
as lessons learned from experience with electronic submissions received
over the past several years.
DATES: Submit written or electronic comments on the draft guidance by
December 22, 2003. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Training and Communications, Division of
Communications Management, Division of Drug Information (HFD-240),
Center for Drug Evaluation and Research (CDER), 5600 Fishers Lane,
Rockville, MD 20857, or to the Office of Communication, Training, and
Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and
Research (CBER), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448, or to the Communications Staff (HFV-12),
Center for Veterinary Medicine, Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive
label to assist that office in processing your requests. Submit
telephone requests to 800-835-4709 or 301-827-1800. Submit written
comments on the draft guidance to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Randy Levin, Food and Drug Administration, CDER (HFD-140), 5600 Fishers Lane, Rockville, MD 20857, 301-594-5411, levinr@cder.fda.gov,
or
Michael Fauntleroy, Food and Drug Administration CBER (HFM-025),
1401 Rockville Pike, Rockville, MD 20852, 301-827-5132, or
Stuart Carlow, Food and Drug Administration, CDRH (HFZ-040), 2098
Gaither Rd., Rockville, MD 20850, 301-594-4550, or
JoAnn Ziyad, Food and Drug Administration CFSAN (HFS-206), 5100
Paint Branch Pkwy., College Park, MD 20740, 202-418-3116, or
Elizabeth Parbuoni, Food and Drug Administration, CVM (HFV-16),
7519 Standish Pl., Rockville, MD 20835, 301-827-4621.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
draft guidance for industry entitled ``Providing Regulatory Submissions
in Electronic Format--General Considerations.'' The draft guidance
discusses general issues common to all types of electronic regulatory
submissions and updates the guidance of the same name, which was issued
in January of 1999. The update now includes information for CDRH,
CFSAN, and CVM and reflects advances in technology as well as lessons
learned from experience with electronic submissions received over the
past several years. Changes from the 1999 version of the draft guidance
include a new section describing the relationship of electronic
submissions to 21 CFR part 11. There are updates on the recommendations
for creating portable document format documents including specific
guidance for the use of fonts. New file formats for data, specifically
extensible markup language and standardized markup language are
introduced. The electronic transmission of files is discussed.
This draft guidance is being issued as a level 1 guidance,
consistent with FDA's regulation on good guidance practices regulation
(21 CFR 10.115). It represents the agency's current thinking on
``Providing Regulatory Submissions in Electronic Format--General
Considerations.'' It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statute and regulations.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the draft guidance.
Two copies of mailed comments are to be submitted, except that
individuals may submit one copy. Comments are to be identified with the
docket number found in brackets in the heading of this document. The
draft guidance and received comments are available for public
examination in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.
Copies of this draft guidance for industry are available on the
Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm, and http://www.fda.gov/cvm/guidance/
ov/cvm/guidance/
guidance.html.
Dated: October 14, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-26571 Filed 10-21-03; 8:45 am]
BILLING CODE 4160-01-S