[Federal Register Volume 68, Number 168 (Friday, August 29, 2003)]
[Notices]
[Pages 52044-52045]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-22183]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0367]


Draft Guidance for Industry on Providing Regulatory Submissions 
in Electronic Format--Human Pharmaceutical Applications and Related 
Submissions; 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availability of a draft guidance for industry entitled ``Providing 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--Human Pharmaceutical 
Product Applications and Related Submissions.'' This is one in a series 
of guidance documents on providing regulatory submissions to FDA in 
electronic format. This guidance discusses issues related to the 
electronic submission of new drug applications (NDAs), abbreviated new 
drug applications (ANDAs), biologics licensing applications (BLAs), 
investigational new drug applications (INDs), master files, advertising 
material, and promotional labeling. The submission of these documents 
in electronic format should improve the agency's efficiency in 
processing, archiving, and reviewing them.

DATES: Submit written or electronic comments on the draft guidance by 
October 28, 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, or to the Office of Communication, Training, 
and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation 
and Research, Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448. Send one self-addressed adhesive label to 
assist that office in processing your requests. 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on the draft guidance to the Division of Dockets Management (HFA-305), 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. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Randy Levin, Center for Drug 
Evaluation and Research (HFD-001), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301/594-5411, e-mail: 
[email protected], or
    R. Yetter, Center for Biologics Evaluation and Research (HFM-25), 
Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 
301-827-5349.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Providing Regulatory Submissions in Electronic Format--Human 
Pharmaceutical Product Applications and Related Submissions.'' This 
draft document provides guidance to industry regarding submission of 
marketing applications (NDAs, ANDAs, BLAs), INDs, and related 
submissions (master files, advertising, and promotional

[[Page 52045]]

labeling) in electronic format based on the International Conference on 
Harmonisation Electronic Common Technical Document specification.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on providing 
applications and related submissions in electronic format. 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 statutes and 
regulations.

II. Comments

    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.

III. Paperwork Reduction Act of 1995

    This notice contains no new collections of information. The 
information requested for human drug and biological products is already 
covered by the collection of information on postmarketing safety 
reporting regulations (21 CFR parts 312, 314, and 601) submitted to the 
Office of Management and Budget (OMB) for review and clearance. This 
notice announces the availability of a guidance that provides 
applicants with an alternative mechanism for submitting applications 
and related submissions to the agency.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cder/guidance/index.htm or at http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: August 21, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-22183 Filed 8-28-03; 8:45 am]
BILLING CODE 4160-01-S