[Federal Register: April 21, 2005 (Volume 70, Number 76)]
[Notices]               
[Page 20759-20760]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21ap05-62]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0041]

 
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 guidance for industry entitled ``Providing Regulatory 
Submissions in Electronic Format--Content of Labeling.'' This guidance 
is one in a series of guidance documents on providing regulatory 
submissions to FDA in electronic format. FDA's regulations require that 
the content of labeling for marketing applications be submitted in 
electronic format in a form that FDA can process, review, and archive. 
The 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) for biological products that meet the definition of 
drug in the Federal Food, Drug, and Cosmetic Act.

DATES: Submit written or electronic comments on agency guidances at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies of the 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 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 See the SUPPLEMENTARY INFORMATION 

section for electronic access to the 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: levinr@cder.fda.gov, 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 the Federal Register of December 11, 2003 (68 FR 69009), FDA 
published a final regulation (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 Sec.  314.50(l) (21 CFR 314.50(l)) for 
NDAs, Sec.  314.94(d) for ANDAs, Sec.  601.14(b) for BLAs, and Sec.  
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 Guidance

    FDA is announcing the availability of a guidance for industry 
entitled ``Providing Regulatory Submissions in Electronic Format--
Content of Labeling.'' The 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 
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 Federal health 
information management initiatives such as electronic prescribing; the 
electronic health record (EHR), which will provide health care 
providers, patients, and other authorized users access to patient 
information in electronic format; and

[[Page 20760]]

the DailyMed, a new way to distribute up-to-date and comprehensive 
medication information in a computerized format for use in health care 
information systems.
    Because FDA's current procedures using PDF are not adequate to 
support these initiatives, the agency is changing the way it processes, 
reviews, and archives the content of labeling. We are adopting 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, based on 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 parties in HL7 (experts from HL7, industry, and technology 
solution providers), has adapted CDA for labeling in an HL7 standard 
called Structured Product Labeling (SPL).
    FDA is developing an automated system using SPL for processing and 
managing labeling and labeling changes. FDA's Center for Drug 
Evaluation and Research has identified SPL in public docket number 
1992S-0251 as a format that FDA can use to process, review, and archive 
the content of labeling. During our transition to the automated system, 
the agency is able to accept the content of labeling in either PDF or 
SPL file format. After the automated system is implemented, PDF will 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 fall 
2005.
    In the Federal Register of February 5, 2004 (69 FR 5552), FDA 
published a document announcing the availability of a draft guidance 
for industry and gave interested persons an opportunity to submit 
comments by April 5, 2004. Based on comments received on the draft 
guidance, the agency has taken the following actions:
     Lengthened the timeframe for the agency's implementation 
of the automated system using SPL;
     Developed a Web site (on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/datacouncil/spl.html
) to provide technical support for 

the transition to SPL, including links to SPL-related documents and 
resources, stylesheet files for viewing SPL files, and example labels; 
and
     Revised the guidance to clarify the procedures for 
submitting content of labeling in electronic format.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on providing the content of labeling in 
electronic format as 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 guidance at any 
time. 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 
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

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in this guidance have been approved under 
OMB control number 0910-0530, expiring November 30, 2006.

V. Electronic Access

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


    Dated: April 15, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7946 Filed 4-20-05; 8:45 am]

BILLING CODE 4160-01-S