[Federal Register Volume 69, Number 24 (Thursday, February 5, 2004)]
[Notices]
[Pages 5552-5553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-2536]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0041]


Draft Guidance for Industry on Providing Regulatory Submissions 
in Electronic Format--Content of Labeling; 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availability of a draft guidance for industry entitled ``Providing 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--Content of Labeling.'' 
This draft guidance is one in a series of guidance documents on 
providing regulatory submissions to the FDA in electronic format. In 
the Federal Register of December 11, 2003 (68 FR 69009), FDA published 
a final regulation (the electronic labeling rule) requiring that the 
content of labeling for marketing applications be submitted in 
electronic format in a form that FDA can process, review, and archive. 
The draft guidance provides information on submitting the content of 
labeling in electronic format for review with new drug applications 
(NDAs), abbreviated new drug applications (ANDAs), and biological 
license applications (BLAs).

DATES: Submit written comments on the draft guidance by April 5, 2004. 
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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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 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the draft guidance to the Division of Dockets Management (HFA-305), 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. 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-140), Food 
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-
594-5411, e-mail: <a href="/cdn-cgi/l/email-protection#e08c8596898e92a083848592ce868481ce878f96"><span class="__cf_email__" data-cfemail="90fcf5e6f9fee2d0f3f4f5e2bef6f4f1bef7ffe6">[email protected]</span></a>, or
Robert Yetter, Center for Biologics Evaluation and Research (HFM-25), 
Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 
301-827-0373.

SUPPLEMENTARY INFORMATION:

I. Background

    In December 2003, FDA published the electronic labeling regulation, 
which requires the submission of the content of labeling in electronic 
format for marketing applications. The requirements of the electronic 
labeling rule can be found in 21 CFR 314.50(l) for NDAs, 21 CFR 
314.94(d) for ANDAs, 21 CFR 601.14(b) for BLAs, and 21 CFR 314.81(b) 
for annual reports on marketing applications. The regulations specify 
that the content of labeling must be submitted electronically in a form 
that FDA can process, review, and archive. The regulations also state 
that FDA will periodically issue guidance on how to provide the 
electronic submission.

II. The Draft Guidance

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Providing Regulatory Submissions in Electronic Format--
Content of Labeling.'' The draft guidance provides information on how 
to submit the content of labeling in electronic format.
    In the preambles of the proposed and final rules on electronic 
labeling, FDA identified portable document format (PDF) as the only 
type of electronic file format that the agency has the ability to

[[Page 5553]]

accept for processing, reviewing, and archiving. Recent recommendations 
from the Institute of Medicine and the National Committee on Vital and 
Health Statistics and mandates in the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003 (Public Law 108-173) have 
created a new role for electronic labeling information. Electronically 
formatted content of labeling will be used to support health 
information management initiatives such as electronic prescribing and 
the electronic health record (EHR).
    Because FDA's current procedures using PDF are not adequate to 
support these initiatives, the agency is proposing to change the way it 
processes, reviews, and archives the content of labeling. We are 
proposing to adopt a new technology for exchanging information between 
computer systems developed by Health Level Seven (HL7), a standards 
development organization accredited by the American National Standards 
Institute. The new technology, Clinical Document Architecture (CDA), 
allows information to be exchanged in extensible markup language (XML) 
and is the standard being investigated for the EHR. FDA, working with 
other interested parties in HL7, has adapted CDA for labeling in a 
proposed HL7 standard called Structured Product Labeling (SPL).
    FDA is developing an automated system using SPL for processing and 
managing labeling and labeling changes. When the draft guidance is 
finalized, absent significant objections, FDA is likely to identify SPL 
in public docket number 92S-0251 as a format that we can use to 
process, review, and archive the content of labeling. During our 
transition to the automated system, the agency would be able to accept 
the content of labeling in either PDF or SPL file format. After the 
automated system is implemented, PDF would no longer be a format that 
we can use to process, review, and archive the content of labeling. At 
this time, it is our goal to complete the transition to SPL format for 
content of labeling submissions by the end of 2004.
    This draft guidance is being issued consistent with FDA's good 
guidance practices (GGPs) regulation (21 CFR 10.115). The draft 
guidance, when finalized, will represent the agency's current thinking 
on providing in electronic format the content of labeling required in 
21 CFR parts 314 and 601. 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.

III. 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.

IV. Paperwork Reduction Act of 1995

    The information requested for human drug and biological products in 
this guidance is already covered by the collection of information in 
``Requirements for Submission of Labeling for Human Prescription Drugs 
and Biologics in Electronic Format'' (Office of Management and Budget 
control number 0910-0530, expiring November 30, 2006).

V. Electronic Access

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

    Dated: January 25, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-2536 Filed 2-3-04; 9:39 am]
BILLING CODE 4160-01-S


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