[Federal Register Volume 68, Number 204 (Wednesday, October 22, 2003)]
[Notices]
[Page 60395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-26571]


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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Draft Guidance for Industry on Providing Regulatory Submissions 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availability of a draft guidance for industry entitled ``Providing 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The draft guidance discusses general issues common to all types of 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DATES:  Submit written or electronic comments on the draft guidance by 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Office of Training and Communications, Division of 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comments on the draft guidance to the Division of Dockets Management 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, [email protected], 
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://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/guidelines.htm, and http://www.fda.gov/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]
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