[Federal Register Volume 80, Number 61 (Tuesday, March 31, 2015)]
[Notices]
[Page 17047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-07269]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0815]


Electronic Study Data Submission; Data Standards; Recommending 
the Use of the World Health Organization Drug Dictionary

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
support for the World Health Organization (WHO) Drug Dictionary 
(available at http://www.who-umc.org/), which is maintained and updated 
by the Uppsala Monitoring Centre. FDA is encouraging sponsors and 
applicants to use WHO Drug Dictionary codes in investigational study 
data provided in regulatory submissions to the Center for Drug 
Evaluation and Research and to the Center for Biologics Evaluation and 
Research. The WHO Drug Dictionary contains unique codes for identifying 
drug names and evaluating medicinal product information, including 
active ingredients and therapeutic uses. Typically, WHO Drug Dictionary 
is used to code concomitant medications used by subjects during the 
course of a clinical trial. WHO Drug Dictionary will be listed in the 
FDA Data Standards Catalog posted to FDA's Study Data Standards 
Resources Web site at http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm

DATES: Although you can comment on this notice at any time, to ensure 
that the Agency considers your comments submit either electronic or 
written comments by May 5, 2015.

ADDRESSES: Submit written requests for single copies of the documents 
to the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002 or the 
Office of Communication, Outreach, and Development, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. 
Send one self-addressed adhesive label to assist that office in 
processing your requests.
    Submit electronic comments to http://www.regulations.gov. Submit 
written comments to the Division of Dockets Management (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852.

FOR FURTHER INFORMATION CONTACT: Ron Fitzmartin, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave. Bldg. 51, rm. 1192, Silver Spring, MD 20993-002, 
<a href="/cdn-cgi/l/email-protection#8cfee3e2ede0e8a2eae5f8f6e1edfef8e5e2cceae8eda2e4e4ffa2ebe3fa"><span class="__cf_email__" data-cfemail="186a777679747c367e716c6275796a6c7176587e7c793670706b367f776e">[email protected]</span></a>; or Stephen Ripley, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave. Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 
<a href="/cdn-cgi/l/email-protection#54272031243c313a7a263d2438312d143230357a3c3c277a333b22"><span class="__cf_email__" data-cfemail="cbb8bfaebba3aea5e5b9a2bba7aeb28badafaae5a3a3b8e5aca4bd">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: 

I. Background

    The use of a common dictionary to code concomitant medications is 
an important component of study data standardization. Generally, 
controlled terminology standards specify the key concepts that are 
represented as definitions, preferred terms, synonyms, codes, and code 
system. The analysis of study data is greatly facilitated by the use of 
controlled terms for clinical or scientific concepts that have 
standard, predefined meanings and representations. WHO Drug Dictionary 
contains unique codes as drug names and corresponding medicinal product 
information, including active ingredients and the Anatomical 
Therapeutic Chemical (ATC) classification system for the therapeutic 
uses. Typically, sponsors and applicants use WHO Drug Dictionary to 
code and analyze concomitant medications taken by subjects during the 
course of clinical trials.
    Although use of WHO Drug Dictionary codes are not required at this 
time, FDA now supports and encourages the use of WHO Drug Dictionary 
coded concomitant medications used in clinical trials. For purposes of 
this notice, ``supported'' means the receiving Center has established 
processes and technology to support receiving, processing, reviewing, 
and archiving files in the specified standard.
    FDA is now encouraging sponsors and applicants to provide WHO Drug 
Dictionary codes for concomitant medication data in investigational 
studies provided in regulatory submissions (e.g., investigational new 
drug applications, new drug applications, abbreviated new drug 
applications, and biologics license applications). The codes should 
include the drug product trade name where available, the active 
ingredient(s) and the ATC class.

II. Comments

    Interested persons may submit either electronic comments to http://www.regulations.gov or written comments regarding this notice to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: March 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07269 Filed 3-30-15; 8:45 am]
BILLING CODE 4164-01-P


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